A Prospective, Multi-center, Randomized Controlled Study to Evaluate the Safety and Effectiveness of REAL INTELLIGENCE™ CORI™ in Unicondylar Knee Arthroplasty (UKA) Procedures
Phase: NA
Conditions: Non-inflammatory Degenerative Joint Disease, Osteoarthritis, Avascular Necrosis, Requires Correction of Functional Deformity, Fracture, Knee
Sponsor: Smith & Nephew, Inc.

Clinical Protocol  
Study Number: CORI.2019.06
A Prospective, Multi-center, Randomized 
Controlled Study to Evaluate the Safety and 
Effectiveness of REAL INTELLIGENCE™ CORI™ in 
unicondylar knee arthroplasty (UKA) Procedure
Version: 4.0-Master, 07 Sep 
2022
Page: 1 of 167   
 
CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. 
and is intended for use only by Smith+Nephew and its manufacturer. It shall not be reproduced or copied in whole or in 
part, nor shall the contents be disclosed by any means without prior written permission from Smith+Nephew, nor shall 
anyone make any use of it that is contrary to the expressed or implied wishes of Smith+Nephew. 
TMP-CD-05-01 Clinical Protocol - Device – Revision D; SOP-CD-05 Clinical Protocol
Sponsor Name and Address:
Smith & Nephew, Inc., 1450 E. Brooks Road, 
Memphis, TN 38116, United States
Investigational Product(s) 
REAL INTELLIGENCE™ CORI™(referred as 
“CORI” throughout this document) 
Single Identification Number 
of Clinical Investigation 
CORI.2019.06
 
Protocol Author(s): 
Manvendra Saxena, Clinical Study Manager 
Babajide Olayinka, Senior Biostatistician
Summary of Revision 
History
Version 2.0 04 Sep 2020 
Version 2.1 14 Jan 2021  
Version 3.0-Master 03 Mar 2021 
Version 4.0-Master 07 Sep 2021 
 

Clinical Protocol  
Study Number: CORI.2019.06
A Prospective, Multi-center, Randomized 
Controlled Study to Evaluate the Safety and 
Effectiveness of REAL INTELLIGENCE™ CORI™ in 
unicondylar knee arthroplasty (UKA) Procedure
Version: 4.0-Master, 07 Sep 
2022
Page: 2 of 167   
 
CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. 
and is intended for use only by Smith+Nephew and its manufacturer. It shall not be reproduced or copied in whole or in 
part, nor shall the contents be disclosed by any means without prior written permission from Smith+Nephew, nor shall 
anyone make any use of it that is contrary to the expressed or implied wishes of Smith+Nephew. 
TMP-CD-05-01 Clinical Protocol - Device – Revision D; SOP-CD-05 Clinical Protocol
1
SIGNATURES
1.1 PRINCIPAL INVESTIGATOR SIGNATURE PAGE 
This page will be returned to Smith & Nephew Inc. and a copy retained at the 
investigational site. 
I have read the attached protocol entitled “A Prospective, Multi-center, 
Randomized Controlled Study to Evaluate the Safety and Effectiveness of REAL 
INTELLIGENCE™ CORI™ in unicondylar knee arthroplasty (UKA) Procedure”, version 
4.0-Master, dated 07Sep2022, and agree to abide by all provisions set forth herein. 
I agree to comply with the Investigator’s Obligations stipulated in Section 22.6 
Principal Investigator Obligations according to ISO 14155:2020 and all applicable 
local legislation and regulations. 
I agree to ensure that the confidential information contained in this document will 
not be used for any purpose other than the conduct of the described clinical 
investigation without the prior written consent of Smith & Nephew Inc. 
 
 
Name, Address, 
Professional Position
Signature and Date / DocuSign Stamp
 
 
 
 

Clinical Protocol  
Study Number: CORI.2019.06
A Prospective, Multi-center, Randomized 
Controlled Study to Evaluate the Safety and 
Effectiveness of REAL INTELLIGENCE™ CORI™ in 
unicondylar knee arthroplasty (UKA) Procedure
Version: 4.0-Master, 07 Sep 
2022
Page: 3 of 167   
 
CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. 
and is intended for use only by Smith+Nephew and its manufacturer. It shall not be reproduced or copied in whole or in 
part, nor shall the contents be disclosed by any means without prior written permission from Smith+Nephew, nor shall 
anyone make any use of it that is contrary to the expressed or implied wishes of Smith+Nephew. 
TMP-CD-05-01 Clinical Protocol - Device – Revision D; SOP-CD-05 Clinical Protocol
1.2 COORDINATING INVESTIGATOR APPROVAL 
I have read the attached protocol entitled “A Prospective, Multi-center, 
Randomized Controlled Study to Evaluate the Safety and Effectiveness of REAL 
INTELLIGENCE™ CORI™ in unicondylar knee arthroplasty (UKA) Procedure”, 
version 4.0-Master, dated 07Sep2022, and agree to abide by all provisions set 
forth therein.  
 
 
Name, Address, 
Professional Position
Signature and Date / DocuSign Stamp
 
 
 

Clinical Protocol 
Study Number: CORI.2019.06
A Prospective, Multi-center, Randomized 
Controlled Study to Evaluate the Safety and 
Effectiveness of REAL INTELLIGENCE™ CORI™ in 
unicondylar knee arthroplasty (UKA) Procedure
Version: 4.0-Master, 07 Sep 
2022
Page: 4 of 167
CONFIDENTIAL AND PROPRIETARY
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. 
and is intended for use only by Smith+Nephew and its manufacturer. It shall not be reproduced or copied in whole or in 
part, nor shall the contents be disclosed by any means without prior written permission from Smith+Nephew, nor shall 
anyone make any use of it that is contrary to the expressed or implied wishes of Smith+Nephew.
TMP-CD-05-01 Clinical Protocol - Device – Revision D; SOP-CD-05 Clinical Protocol
1.3 SPONSOR APPROVAL
Name and Title
Signature and Date / DocuSign Stamp
Rachael Winter, 
Senior Director, Global 
Clinical Operations 
Julian Yang, Director,
China Clinical Affairs
Julie Lankiewicz, 
Clinical Strategy Director 
Robotics
Michael Robinson,
Independent Statistician 
signing on behalf of
Director Biostatistics & 
Data Management

Clinical Protocol 
Study Number: CORI.2019.06
A Prospective, Multi-center, Randomized 
Controlled Study to Evaluate the Safety and 
Effectiveness of REAL INTELLIGENCE™ CORI™ in 
unicondylar knee arthroplasty (UKA) Procedure
Version: 4.0-Master, 07 Sep 
2022
Page: 5 of 167
CONFIDENTIAL AND PROPRIETARY
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. 
and is intended for use only by Smith+Nephew and its manufacturer. It shall not be reproduced or copied in whole or in 
part, nor shall the contents be disclosed by any means without prior written permission from Smith+Nephew, nor shall 
anyone make any use of it that is contrary to the expressed or implied wishes of Smith+Nephew.
TMP-CD-05-01 Clinical Protocol - Device – Revision D; SOP-CD-05 Clinical Protocol
Luca Orlandini, 
VP Medical Affairs
Lisa Ewing, Director, 
Regulatory Affairs 
Orthopedics & Robotics
Kerry Geng, 
Senior. Director, Head of 
Regulatory Affairs and 
Quality
Kate Drysdale
Senior Clinical Compliance 
and Training Manager

Clinical Protocol  
Study Number: CORI.2019.06
A Prospective, Multi-center, Randomized 
Controlled Study to Evaluate the Safety and 
Effectiveness of REAL INTELLIGENCE™ CORI™ in 
unicondylar knee arthroplasty (UKA) Procedure
Version: 4.0-Master, 07 Sep 
2022
Page: 6 of 167   
 
CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. 
and is intended for use only by Smith+Nephew and its manufacturer. It shall not be reproduced or copied in whole or in 
part, nor shall the contents be disclosed by any means without prior written permission from Smith+Nephew, nor shall 
anyone make any use of it that is contrary to the expressed or implied wishes of Smith+Nephew. 
TMP-CD-05-01 Clinical Protocol - Device – Revision D; SOP-CD-05 Clinical Protocol
2
SYNOPSIS
Title of Study:
A Prospective, Multi-center, Randomized Controlled Study to 
Evaluate 
the 
Safety 
and 
Effectiveness 
of 
REAL 
INTELLIGENCE™ CORI™ in unicondylar knee arthroplasty 
(UKA) procedure
Study Design:
Prospective, multi-center, randomized controlled study 
Study Type: 
Post-market study in Australia, New Zealand, South Korea & 
China (Hong Kong)  
Pre-market study in China Mainland 
Study Product: 
REAL INTELLIGENCE™ CORI™ (CORI) is a computer-assisted 
orthopedic surgical navigation and burring system. CORI is 
designed to aid surgeons in planning and executing a 
procedure involving bone preparation for unicondylar knee 
arthroplasty (UKA) and total knee arthroplasty (TKA) 
procedures. 
CORI is comprised of a console control unit, optical tracking 
camera, primary and secondary input displays (tablet and 
optional display monitor), and foot pedal. The CORI software 
consists of a patient and user management module, a surgical 
planner, and an intra-operative cutting module. 
Comparison Groups
Conventional 
approach 
with 
conventional 
manual 
instrumentation will be used as the comparison group. 
Study Purpose:
This is a prospective randomized controlled study to 
demonstrate the safety and effectiveness of CORI and to 
register CORI in China mainland. 

Clinical Protocol 
Study Number: CORI.2019.06
A Prospective, Multi-center, Randomized 
Controlled Study to Evaluate the Safety and 
Effectiveness of REAL INTELLIGENCE™ CORI™ in 
unicondylar knee arthroplasty (UKA) Procedure
Version: 4.0-Master, 07 Sep 
2022
Page: 7 of 167
CONFIDENTIAL AND PROPRIETARY
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. 
and is intended for use only by Smith+Nephew and its manufacturer. It shall not be reproduced or copied in whole or in 
part, nor shall the contents be disclosed by any means without prior written permission from Smith+Nephew, nor shall 
anyone make any use of it that is contrary to the expressed or implied wishes of Smith+Nephew.
TMP-CD-05-01 Clinical Protocol - Device – Revision D; SOP-CD-05 Clinical Protocol
Primary Objective:
To evaluate the use of CORI in unicondylar knee arthroplasty 
(UKA) procedures in achieving post-operative leg alignment
as compared to procedures using conventional manual 
instruments.
Secondary 
Objective(s):
To generate safety and performance evidence supporting the 
use of CORI procedures.
To assess the safety and performance of CORI up to 12 
months after surgery
as compared to procedures using 
conventional manual instruments.
Other Objective(s):
To collect CORI system time and cutting time of the robotic 
drill from the CORI Case Report.
Sample Size:
140 in total: 
70 CORI procedure for UKA
70 Conventional procedures for UKA
The statistical justification for CORI UKA is based on data 
collected from the NAVIO™
Navigation System, the 
former generation of CORI.
N=70 subjects per arm, based on post-operative 
alignment (±3 degrees) with expected 92.1% NAVIO™ 
vs. 73.4% from a historical control.
Number of Study 
Sites:
Up to 8 sites
Targeted Global 
Regions:
Australia, China Mainland, China (Hong Kong), South Korea,
and New Zealand

Clinical Protocol  
Study Number: CORI.2019.06
A Prospective, Multi-center, Randomized 
Controlled Study to Evaluate the Safety and 
Effectiveness of REAL INTELLIGENCE™ CORI™ in 
unicondylar knee arthroplasty (UKA) Procedure
Version: 4.0-Master, 07 Sep 
2022
Page: 8 of 167   
 
CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. 
and is intended for use only by Smith+Nephew and its manufacturer. It shall not be reproduced or copied in whole or in 
part, nor shall the contents be disclosed by any means without prior written permission from Smith+Nephew, nor shall 
anyone make any use of it that is contrary to the expressed or implied wishes of Smith+Nephew. 
TMP-CD-05-01 Clinical Protocol - Device – Revision D; SOP-CD-05 Clinical Protocol
Inclusion Criteria:
1. Subject is a suitable candidate for a UKA procedure 
using CORI and a compatible Smith & Nephew (S+N)
Knee implant system. 
2. Subject requires a cemented UKA as a primary 
indication that meets any of the following conditions:  
a) Non-inflammatory 
degenerative 
joint 
disease, 
including osteoarthritis 
b) Avascular necrosis 
c) Requires correction of functional deformity 
d) Requires 
treatment 
of 
fractures 
that 
were 
unmanageable using other techniques 
3. Subject is of legal age to consent and considered 
skeletally mature (  18 years of age at the time of 
surgery).  
4. Subject agrees to consent to and to follow the study 
visit schedule (as defined in the study protocol and 
informed consent form), by signing the Ethics 
Committee (EC) or Institutional Review Board (IRB) 
approved informed consent form. 
5. Subject plans to be available through one (1) year 
postoperative follow-up. 
6. Applicable routine radiographic assessment is possible.
Exclusion Criteria:
1. Subject receives a UKA on the index joint as a revision for 
a previously failed surgery, or need for complex implants, 
or any other implant than a standard UKA (e.g., stems, 
augments, or custom-made devices). 
2. Subject has been diagnosed with post-traumatic arthritis 

Clinical Protocol  
Study Number: CORI.2019.06
A Prospective, Multi-center, Randomized 
Controlled Study to Evaluate the Safety and 
Effectiveness of REAL INTELLIGENCE™ CORI™ in 
unicondylar knee arthroplasty (UKA) Procedure
Version: 4.0-Master, 07 Sep 
2022
Page: 9 of 167   
 
CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. 
and is intended for use only by Smith+Nephew and its manufacturer. It shall not be reproduced or copied in whole or in 
part, nor shall the contents be disclosed by any means without prior written permission from Smith+Nephew, nor shall 
anyone make any use of it that is contrary to the expressed or implied wishes of Smith+Nephew. 
TMP-CD-05-01 Clinical Protocol - Device – Revision D; SOP-CD-05 Clinical Protocol
3. Subject receives simultaneous bilateral UKA
OR a 
unilateral UKA with contralateral TKA.
4. Subject has one or more of the following arthroplasties 
that are not fully healed and well-functioning, as 
determined by the investigator: 
-Contralateral primary TKA or UKA, however, the subject 
can only have one knee enrolled in this study.
5. Subject does not understand the language used in the 
Informed Consent Form.  
6. Subject does not meet the indication or is contraindicated 
for UKA according to specific S+N knee system’s 
Instructions for Use (IFU).  
7. Subject has active infection or sepsis (treated or 
untreated). 
8. Subject is morbidly obese with a body mass index (BMI) 
greater than 40. 
9. Subject is pregnant or breast feeding at the time of 
surgery. 
10. Subject, in the opinion of the Investigator, has advanced 
osteoarthritis or joint disease at the time of surgery and 
was better suited for an alternate procedure.  
11. Subject currently enrolled in another orthopedic clinical 
trial study.  
12. Subject has a condition(s) that may interfere with the UKA 
survival or outcome (i.e., Paget’s or Charcot’s disease, 
vascular insufficiency, muscular atrophy, uncontrolled 
diabetes, moderate to severe renal insufficiency or 
neuromuscular disease, or an active, local infection).  

Clinical Protocol  
Study Number: CORI.2019.06
A Prospective, Multi-center, Randomized 
Controlled Study to Evaluate the Safety and 
Effectiveness of REAL INTELLIGENCE™ CORI™ in 
unicondylar knee arthroplasty (UKA) Procedure
Version: 4.0-Master, 07 Sep 
2022
Page: 10 of 167   
 
CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. 
and is intended for use only by Smith+Nephew and its manufacturer. It shall not be reproduced or copied in whole or in 
part, nor shall the contents be disclosed by any means without prior written permission from Smith+Nephew, nor shall 
anyone make any use of it that is contrary to the expressed or implied wishes of Smith+Nephew. 
TMP-CD-05-01 Clinical Protocol - Device – Revision D; SOP-CD-05 Clinical Protocol
13. Subject in the opinion of the Investigator has an 
emotional or neurological condition that would pre-empt 
their ability or willingness to participate in the study 
including mental illness, intellectual disability, drug or 
alcohol abuse. 
14. Subject, in the opinion of the Investigator, has a 
neuromuscular disorder that prohibited control of the 
index joint. 
15. Subject is a prisoner or meets the definition of a 
Vulnerable Subject per ISO 14155:2020 Section 3.55. 
Study Duration: 
Estimated timeline:
 
Study period: 36 months  
 
Start enrolment: April 2022 
 
Last subject first visit: March 2024 
 
Last subject last visit: April 2025 
Primary endpoint:
Post-operative leg alignment via radiographic assessment 
(the proportion of subjects achieving planned post-operative 
leg alignment 6 weeks after surgery, defined as ± 3° from 
target)
Secondary 
endpoint(s): 
Component Alignment 
 
Radiographic assessment (Presence of radiolucent 
lines, osteolysis & implant migration) 
 
2011 Knee Society Score (2011 KSS) 
 
Oxford Knee Score (OKS) 
 
Forgotten Joint Score (FJS-12) 
 
Five-level EuroQol five-dimensional (EQ-5D-5L) Visual 
Analogue Scale (VAS) and index scores 

Clinical Protocol  
Study Number: CORI.2019.06
A Prospective, Multi-center, Randomized 
Controlled Study to Evaluate the Safety and 
Effectiveness of REAL INTELLIGENCE™ CORI™ in 
unicondylar knee arthroplasty (UKA) Procedure
Version: 4.0-Master, 07 Sep 
2022
Page: 11 of 167   
 
CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. 
and is intended for use only by Smith+Nephew and its manufacturer. It shall not be reproduced or copied in whole or in 
part, nor shall the contents be disclosed by any means without prior written permission from Smith+Nephew, nor shall 
anyone make any use of it that is contrary to the expressed or implied wishes of Smith+Nephew. 
TMP-CD-05-01 Clinical Protocol - Device – Revision D; SOP-CD-05 Clinical Protocol
Other exploratory 
endpoint(s):
Each enrolled subject’s CORI Case Report will be collected to 
document the system time and cutting time of the robotic drill.
Safety Data
All adverse events (AEs) and complications occurring 
from the time of subject enrollment until study 
termination or study completion including intra-
operative adverse events and complications.  
Device related re-intervention
 
Device Deficiencies 
 
Knee implant revision rate 
All AEs will be categorized in terms of seriousness and 
relatedness to the study device or to the surgical procedure 
(Adverse Events, Serious Adverse Events, Adverse Device 
Effects, Serious Adverse Device effects). All Serious Adverse 
Device Effects will be further categorized as Anticipated or 
Unanticipated. The definitions for each of these categories are 
based on ISO 14155:202020 and applicable local laws and 
regulations. 
 
 

Clinical Protocol  
Study Number: CORI.2019.06
A Prospective, Multi-center, Randomized 
Controlled Study to Evaluate the Safety and 
Effectiveness of REAL INTELLIGENCE™ CORI™ in 
unicondylar knee arthroplasty (UKA) Procedure
Version: 4.0-Master, 07 Sep 
2022
Page: 12 of 167   
 
CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. 
and is intended for use only by Smith+Nephew and its manufacturer. It shall not be reproduced or copied in whole or in 
part, nor shall the contents be disclosed by any means without prior written permission from Smith+Nephew, nor shall 
anyone make any use of it that is contrary to the expressed or implied wishes of Smith+Nephew. 
TMP-CD-05-01 Clinical Protocol - Device – Revision D; SOP-CD-05 Clinical Protocol
STUDY SCHEDULE  
 
 
 
 
 
 
 
 
 
 

Clinical Protocol  
Study Number: CORI.2019.06
A Prospective, Multi-center, Randomized 
Controlled Study to Evaluate the Safety and 
Effectiveness of REAL INTELLIGENCE™ CORI™ in 
unicondylar knee arthroplasty (UKA) Procedure
Version: 4.0-Master, 07 Sep 
2022
Page: 13 of 167   
 
CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. 
and is intended for use only by Smith+Nephew and its manufacturer. It shall not be reproduced or copied in whole or in 
part, nor shall the contents be disclosed by any means without prior written permission from Smith+Nephew, nor shall 
anyone make any use of it that is contrary to the expressed or implied wishes of Smith+Nephew. 
TMP-CD-05-01 Clinical Protocol - Device – Revision D; SOP-CD-05 Clinical Protocol
Schedule of 
events  
Pre-
Operative 
Data 
-90 to 0 
days 
Operative 
Data 
& 
Discharge 
Day 1 (+ up 
to 9 days)
6 weeks
42 ± 14 
days 
6 months
185 ± 14 
days 
12 months
 
365 
± 
30 
days 
Informed 
Consent 
x
 
Demographics/ 
Medical  History 
x
 
Inclusion/Exclusi
on  
x
 
Preoperative 
Examinations 
(e.g. ECG, Blood 
Routine 
Examination, 
Biochemical 
Examination, 
Coagulation 
Examination)1
x
 
Pregnancy Test2
x
 
Concomitant 
Medication
x
 
Concomitant 
Medication 
Update
x
x
x 
x 
Operative 
Data 
Collection
x
 
CORI Case 
Report (System 
time & cutting 
time)
x
 
Discharge Data 
Collection
x
 
Leg alignment 
Long leg X-ray 
AP3 
x
(x)4 
x
(x)5 

Clinical Protocol  
Study Number: CORI.2019.06
A Prospective, Multi-center, Randomized 
Controlled Study to Evaluate the Safety and 
Effectiveness of REAL INTELLIGENCE™ CORI™ in 
unicondylar knee arthroplasty (UKA) Procedure
Version: 4.0-Master, 07 Sep 
2022
Page: 14 of 167   
 
CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. 
and is intended for use only by Smith+Nephew and its manufacturer. It shall not be reproduced or copied in whole or in 
part, nor shall the contents be disclosed by any means without prior written permission from Smith+Nephew, nor shall 
anyone make any use of it that is contrary to the expressed or implied wishes of Smith+Nephew. 
TMP-CD-05-01 Clinical Protocol - Device – Revision D; SOP-CD-05 Clinical Protocol
Standard Lateral 
X-ray
(x)4 
x
x 
Standard A/P X-
ray
x 
KSS
x
x
x 
x 
OKS
x
x
x 
x 
FJS-12 
x
x
x
EQ-5D-5L
x
x
x
x
Safety 
Assessment 
x
x
x
x
End of Study/Exit 
(x)6
(x)6
x 
1
Only applicable at site in China
2
Only Applicable at site in China
3
Pre-operative long leg X-rays (A/P) collected 6-months prior to the date of surgery is 
admissible. 
4
Post-operative standing weight bearing long leg X-rays (A/P) and standard lateral X-rays may 
be taken at discharge.  
5
Only if standing weight bearing long leg A/P X-ray is taken as a standard of care at 12 months. 
6
Exit form to be completed at the point of withdrawal if the study is not completed 
 
 

Clinical Protocol  
Study Number: CORI.2019.06
A Prospective, Multi-center, Randomized 
Controlled Study to Evaluate the Safety and 
Effectiveness of REAL INTELLIGENCE™ CORI™ in 
unicondylar knee arthroplasty (UKA) Procedure
Version: 4.0-Master, 07 Sep 
2022
Page: 15 of 167   
 
CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. 
and is intended for use only by Smith+Nephew and its manufacturer. It shall not be reproduced or copied in whole or in 
part, nor shall the contents be disclosed by any means without prior written permission from Smith+Nephew, nor shall 
anyone make any use of it that is contrary to the expressed or implied wishes of Smith+Nephew. 
TMP-CD-05-01 Clinical Protocol - Device – Revision D; SOP-CD-05 Clinical Protocol
3
CONTENTS
Table of Contents
1
Signatures ................................................................................. 2
1.1 
Principal Investigator Signature Page ................................................................................ 2
1.2
Coordinating Investigator Approval ...................................................................................3
1.3 
Sponsor Approval ................................................................................................................... 4
2
Synopsis .................................................................................... 6
To assess the safety and performance of CORI up to 12 months after surgery...................... 7
3
Contents.................................................................................. 15
3.1 
List of Tables ......................................................................................................................... 17
3.2 
List of Figures ........................................................................................................................ 18
3.3 
List of Abbreviations And definitions ................................................................................ 19
4
Introduction ............................................................................ 22
4.1 
Background ............................................................................................................................ 22
4.2 
Literature Summary ............................................................................................................. 25
4.3 
Study Purpose ....................................................................................................................... 32
4.4 
Safety Considerations ......................................................................................................... 32
5
Objective(s) ............................................................................ 36
5.1 
Primary Objective ................................................................................................................. 36
5.2
Secondary Objective(s).......................................................................................................36
5.3
Other Objective(s) ...............................................................................................................36
5.4
Claims .....................................................................................................................................36
6
Investigational Product(s) and Comparator ............................ 37
6.1 
Identification ......................................................................................................................... 37
6.2 
Product Use ........................................................................................................................... 41
6.3 
Packaging and Labelling ..................................................................................................... 42
6.4 
Product Accountability Procedures ................................................................................... 43
6.5 
Surgical Technique ............................................................................................................... 44
6.6 
Medical Procedure ................................................................................................................ 44
7
Subject Enrollment and Withdrawal ........................................ 45
7.1 
Subject Population ............................................................................................................... 45

Clinical Protocol  
Study Number: CORI.2019.06
A Prospective, Multi-center, Randomized 
Controlled Study to Evaluate the Safety and 
Effectiveness of REAL INTELLIGENCE™ CORI™ in 
unicondylar knee arthroplasty (UKA) Procedure
Version: 4.0-Master, 07 Sep 
2022
Page: 16 of 167   
 
CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. 
and is intended for use only by Smith+Nephew and its manufacturer. It shall not be reproduced or copied in whole or in 
part, nor shall the contents be disclosed by any means without prior written permission from Smith+Nephew, nor shall 
anyone make any use of it that is contrary to the expressed or implied wishes of Smith+Nephew. 
TMP-CD-05-01 Clinical Protocol - Device – Revision D; SOP-CD-05 Clinical Protocol
7.2
Inclusion Criteria ..................................................................................................................46
7.3 
Exclusion Criteria .................................................................................................................. 46
7.4 
Screening ............................................................................................................................... 49
7.5
Informed Consent ................................................................................................................49
7.6 
Enrolment............................................................................................................................... 50
7.7
Lost to Follow-Up..................................................................................................................50
7.8 
Withdrawal ............................................................................................................................. 51
8
Study Design ........................................................................... 53
8.1 
Study Design ......................................................................................................................... 53
8.2 
Allocation and Blinding ........................................................................................................ 55
8.3 
Data Management ................................................................................................................ 56
8.4 
Study Endpoints ................................................................................................................... 57
8.5 
Methods Used to Minimize Bias and Maximize Validity ................................................ 58
9
Study Procedures .................................................................... 59
9.1 
Visits and Examinations ...................................................................................................... 59
9.2 
Study Methods and Measurements .................................................................................. 69
9.3 
Health Economics/Quality of Life ...................................................................................... 75
10 
Statistical Design ..................................................................... 77
10.1 
General ................................................................................................................................... 77
10.2 
Analysis Populations ............................................................................................................ 77
10.3
Baseline Data ........................................................................................................................78
10.4
Effectiveness Analysis .........................................................................................................78
10.5 
Safety Analyses .................................................................................................................... 84
10.6 
Interim Analyses .................................................................................................................. 84
11 
Sample Size Justification......................................................... 85
12 
Adverse Events and Device Deficiencies .................................. 86
12.1 
Definitions .............................................................................................................................. 86
12.2 
AE Coding Dictionary ........................................................................................................... 92
12.3 
Reporting Procedures .......................................................................................................... 93
12.4 
Unblinding of Investigational Product .............................................................................. 96
12.5 
Follow-up of Subjects with Adverse Events .................................................................... 96
13 
Investigator Obligations.......................................................... 97

Clinical Protocol  
Study Number: CORI.2019.06
A Prospective, Multi-center, Randomized 
Controlled Study to Evaluate the Safety and 
Effectiveness of REAL INTELLIGENCE™ CORI™ in 
unicondylar knee arthroplasty (UKA) Procedure
Version: 4.0-Master, 07 Sep 
2022
Page: 17 of 167   
 
CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. 
and is intended for use only by Smith+Nephew and its manufacturer. It shall not be reproduced or copied in whole or in 
part, nor shall the contents be disclosed by any means without prior written permission from Smith+Nephew, nor shall 
anyone make any use of it that is contrary to the expressed or implied wishes of Smith+Nephew. 
TMP-CD-05-01 Clinical Protocol - Device – Revision D; SOP-CD-05 Clinical Protocol
14
Sponsor and Monitor Responsibilities...................................... 97
14.1
Contract Research Organization........................................................................................98
14.2 
Site Qualification Visit ......................................................................................................... 98
14.3
Site Initiation Visit................................................................................................................98
14.4 
Interim Monitoring Visit ...................................................................................................... 98
14.5 
Sponsor Audits and Regulatory Inspection ..................................................................... 98
14.6
Close-out Visit.......................................................................................................................99
15
Protocol Deviations ................................................................. 99
16 
Protocol Amendments ............................................................. 99
17 
Confidentiality of the Study ................................................... 100
18 
Statements of Compliance..................................................... 100
19 
End of Study .......................................................................... 100
20 
Publication Policy .................................................................. 101
20.1 
Publication of Study Data ................................................................................................. 101
20.2 
Data Sharing ....................................................................................................................... 101
21 
References ............................................................................ 103
22 
Appendices............................................................................ 108
22.1 
Protocol Amendment ......................................................................................................... 108
22.2 
Sponsor Details ................................................................................................................... 142
22.3 
Instructions For Use & User Manuals ............................................................................. 142
22.4 
Equipment and Special Instructions ............................................................................... 142
22.5
Health Economic Outcome Measures/ Quality of Life Measures ..............................149
22.6 
Principal Investigator Obligations ................................................................................... 149
3.1 LIST OF TABLES 
Table 4.2-4-1 Demographic Information for the Navigation Knee Surgical Systems ............... 27 
Table 8.1- 8-1 Overview of Study Groups.......................................................................................... 53 
Table 9.1.1-9-1 Study Procedures by Visit ........................................................................................ 60 
Table 9.2.4-9-2 2011 Knee Society Score ......................................................................................... 72 
Table 12.1-12-1 Categories of Adverse Event .................................................................................. 86 
Table 12.1.4-12-2 Potential Anticipated Serious Adverse Device Effects (ASADE) .................. 89 

Clinical Protocol  
Study Number: CORI.2019.06
A Prospective, Multi-center, Randomized 
Controlled Study to Evaluate the Safety and 
Effectiveness of REAL INTELLIGENCE™ CORI™ in 
unicondylar knee arthroplasty (UKA) Procedure
Version: 4.0-Master, 07 Sep 
2022
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CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. 
and is intended for use only by Smith+Nephew and its manufacturer. It shall not be reproduced or copied in whole or in 
part, nor shall the contents be disclosed by any means without prior written permission from Smith+Nephew, nor shall 
anyone make any use of it that is contrary to the expressed or implied wishes of Smith+Nephew. 
TMP-CD-05-01 Clinical Protocol - Device – Revision D; SOP-CD-05 Clinical Protocol
Table 22.4-22-1 CORI Components................................................................................................... 143
Table 22.4-22-2 CORI Cart.................................................................................................................. 143
Table 22.4-22-3 CORI Monitor............................................................................................................ 143
Table 22.4-22-4 CORI Tray and Instrumentation .......................................................................... 143 
Table 22.4-22-5 CORI Shipping Inserts............................................................................................ 144 
Table 22.4-22-6 CORI Lids .................................................................................................................. 144 
Table 22.4-22-7 CORI Instrument Reduction Modules - Kits....................................................... 145
Table 22.4-22-8 CORI JOURNEY II UKA Inserts ............................................................................. 145
Table 22.4-22-9 CORI JOURNEY II Instrument Reduction Inserts ............................................. 145 
Table 22.4-22-10 Total Knee Instruments ....................................................................................... 146 
Table 22.4-22-11 CORI Disposables .................................................................................................. 147 
Table 22.4-22-12 CORI Country Bundles ......................................................................................... 147 
Table 22.4-22-13 CORI Welcome Box .............................................................................................. 148 
Table 22.4-22-14 CORI Product Documents / Other ..................................................................... 148 
Table 22.4-22-15 CORI Power Cords ................................................................................................ 149 
3.2 LIST OF FIGURES 
Figure 6.1-6-1 CORI ................................................................................................................................ 38 
Figure 6.1-6-2 CORI Reusable Instruments ...................................................................................... 40 
Figure 6.1-6-3 Extramedullary rod ...................................................................................................... 41 
Figure 6.1-6-4 Intramedullary rod ....................................................................................................... 41 
Figure 8.1-8-1 Study Recruitment Timeline ...................................................................................... 54
Figure 8.1-8-2 Study Flowchart ............................................................................................................ 55 
Figure 9.2-9-1 Leg alignment ............................................................................................................... 69 
Figure 9.2.2-9-2 A/P View ..................................................................................................................... 71 
Figure 9.2.2-9-3 Lateral View ............................................................................................................... 72 
Figure 12.3-12-1 Evaluation and Reporting of AE ............................................................................ 95 
Figure 12.3-12-2 Evaluation and Reporting of DD ........................................................................... 96 
Figure 6.1-6-2 CORI Reusable Instruments .................................................................................... 114 
Figure 6.1-6-2 CORI Reusable Instruments .................................................................................... 114 
Figure 8.1-8-1 Study Recruitment Timeline ............................................................................................... 140 

Clinical Protocol  
Study Number: CORI.2019.06
A Prospective, Multi-center, Randomized 
Controlled Study to Evaluate the Safety and 
Effectiveness of REAL INTELLIGENCE™ CORI™ in 
unicondylar knee arthroplasty (UKA) Procedure
Version: 4.0-Master, 07 Sep 
2022
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CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. 
and is intended for use only by Smith+Nephew and its manufacturer. It shall not be reproduced or copied in whole or in 
part, nor shall the contents be disclosed by any means without prior written permission from Smith+Nephew, nor shall 
anyone make any use of it that is contrary to the expressed or implied wishes of Smith+Nephew. 
TMP-CD-05-01 Clinical Protocol - Device – Revision D; SOP-CD-05 Clinical Protocol
 
3.3 LIST OF ABBREVIATIONS AND DEFINITIONS 
Abbreviation 
Definition
ADE
Adverse Device Effect(s)
AE
Adverse Event(s)
ACL
Anterior Cruciate Ligament
ANCOVA 
Analysis of Covariance  
A/P 
Antero-posterior 
ASADE
Anticipated Serious Adverse Device Effect 
AVN 
Avascular Necrosis 
BMI 
Body Mass Index
CAS
Computer-assisted navigation systems 
CE
Conformité Européene  
CI
Confidence Interval
CORI  
REAL INTELLIGENCE™ CORI™ 
eCRF 
Electronic Case Report Form(s) 
CRO
Contract Research Organization
CTA
Clinical Trial Agreement
CV 
Curriculum Vitae 
DD 
Device Deficiency(ies) 
DMP
Data Management Plan 
ECG 
Electrocardiogram  
EDC 
Electronic Data Capture
EQ-5D-5L
Five-level EuroQol five-dimensional
FAS
Full Analysis Set Population
FDA
Food and Drug Administration 
FJS-12 
Forgotten Joint Score
FU
Follow-Up

Clinical Protocol  
Study Number: CORI.2019.06
A Prospective, Multi-center, Randomized 
Controlled Study to Evaluate the Safety and 
Effectiveness of REAL INTELLIGENCE™ CORI™ in 
unicondylar knee arthroplasty (UKA) Procedure
Version: 4.0-Master, 07 Sep 
2022
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CONFIDENTIAL AND PROPRIETARY 
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and is intended for use only by Smith+Nephew and its manufacturer. It shall not be reproduced or copied in whole or in 
part, nor shall the contents be disclosed by any means without prior written permission from Smith+Nephew, nor shall 
anyone make any use of it that is contrary to the expressed or implied wishes of Smith+Nephew. 
TMP-CD-05-01 Clinical Protocol - Device – Revision D; SOP-CD-05 Clinical Protocol
Abbreviation 
Definition
GCP 
Good Clinical Practice
GDPR
EU Global Data Protection Regulation 
HIPAA
Health Information Portability Accountability Act
HKA
Hip-Knee-Ankle
HRQoL
Health Related Quality of Life
IB
Investigator’s Brochure
ICH
International Conference on Harmonization
IEC
Independent Ethics Committee 
IFU
Instructions for Use
IP
Investigational Product 
IRB 
Institutional Review Board
ISF 
Investigator Site File 
ITT 
Intention to Treat population 
2011 KSS
Knee Society Score, 2011
LCL 
Lateral Collateral Ligament
LL 
Lower Limit 
LOCF 
Last Observation Carried Forward 
MCL 
Medial Collateral Ligament 
NA or N/A
Not Applicable 
N (or n) 
Total Sample Size (or subgroup sample size) 
NAVIO 
NAVIO™ Navigation System
NMPA
National Medical Products Administration
OA 
Osteoarthritis  
OKS
Oxford Knee Score
OR
Operating room
PCL
Posterior Cruciate Ligament
PI
Principal Investigator
PICF
Patient Informed Consent Form 

Clinical Protocol  
Study Number: CORI.2019.06
A Prospective, Multi-center, Randomized 
Controlled Study to Evaluate the Safety and 
Effectiveness of REAL INTELLIGENCE™ CORI™ in 
unicondylar knee arthroplasty (UKA) Procedure
Version: 4.0-Master, 07 Sep 
2022
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CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. 
and is intended for use only by Smith+Nephew and its manufacturer. It shall not be reproduced or copied in whole or in 
part, nor shall the contents be disclosed by any means without prior written permission from Smith+Nephew, nor shall 
anyone make any use of it that is contrary to the expressed or implied wishes of Smith+Nephew. 
TMP-CD-05-01 Clinical Protocol - Device – Revision D; SOP-CD-05 Clinical Protocol
Abbreviation 
Definition
PMA
Pre-Market Authorization 
PP
Per-protocol Population 
PSI
Patient specific instrumentation
RA
Rheumatoid Arthritis 
RCT
Randomized Controlled Trial
S+N
Smith & Nephew, Inc., 1450 E. Brooks Road, Memphis, TN 38116, 
United States
SADE 
Serious Adverse Device Effect(s)
SAE
Serious Adverse Event(s) 
SAF
Safety population
SAP
Statistical Analysis Plan
TKA  
Total Knee Arthroplasty 
UKA 
Unicondylar Knee Arthroplasty 
UL 
Upper Limit 
USADE 
Unanticipated Serious Adverse Device Effect(s) 

Clinical Protocol 
Study Number: CORI.2019.06
A Prospective, Multi-center, Randomized 
Controlled Study to Evaluate the Safety and 
Effectiveness of REAL INTELLIGENCE™ CORI™ in 
unicondylar knee arthroplasty (UKA) Procedure
Version: 4.0-Master, 07 Sep 
2022
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CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. 
and is intended for use only by Smith+Nephew and its manufacturer. It shall not be reproduced or copied in whole or in 
part, nor shall the contents be disclosed by any means without prior written permission from Smith+Nephew, nor shall 
anyone make any use of it that is contrary to the expressed or implied wishes of Smith+Nephew. 
TMP-CD-05-01 Clinical Protocol - Device – Revision D; SOP-CD-05 Clinical Protocol
4
INTRODUCTION
4.1 BACKGROUND 
Arthritis is a clinical syndrome of joint pain accompanied by varying degrees of 
functional limitation and reduced quality of life. Two common etiologies of arthritis 
are degeneration of the joint, osteoarthritis (OA), and inappropriate inflammatory 
response, rheumatoid arthritis (RA). OA is characterized by loss of cartilage, 
remodeling of adjacent bone, and inflammation in the affected joint [1, 2]. RA is a 
progressive inflammatory disease that eventually causes systemic joint damage and 
disability [3]. Post-traumatic arthritis is a form of osteoarthritis following an injury 
to a joint. Inappropriate joint biomechanics due to deformities is the main risk 
factor for OA [4]. The joint biomechanics are directly affected by the malalignment 
of the lower extremities due to anatomical deformities [5]. Varus deformity is an 
excessive inward angulation of the lower leg and results in a bowlegged 
appearance. It may cause an overloading and cartilage wear in the medial knee 
compartment, which could support a degeneration of the knee joint leading to OA 
[5].  
As of 2010, there were approximately 250 million people globally with osteoarthritis 
of the knee joint (3.6% of the global population) [6]. The prevalence was higher in 
females than in males [6]. Initial treatment of arthritis may include physical 
therapy, nonsteroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen and 
corticosteroids which can be taken orally or by injection.  
Avascular necrosis (AVN) has several etiologies but fundamentally results from a 
decrease in blood flow to the affected bone, leading to cellular death [7]. Studies 
have reported a 3.4% and 9.4% incidence of spontaneous osteonecrosis in persons 
older than 50 and 65 years of age, respectively [8]. Initial treatment of AVN may 
include medication, stretching and not walking on the affected leg.  

Clinical Protocol 
Study Number: CORI.2019.06
A Prospective, Multi-center, Randomized 
Controlled Study to Evaluate the Safety and 
Effectiveness of REAL INTELLIGENCE™ CORI™ in 
unicondylar knee arthroplasty (UKA) Procedure
Version: 4.0-Master, 07 Sep 
2022
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CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. 
and is intended for use only by Smith+Nephew and its manufacturer. It shall not be reproduced or copied in whole or in 
part, nor shall the contents be disclosed by any means without prior written permission from Smith+Nephew, nor shall 
anyone make any use of it that is contrary to the expressed or implied wishes of Smith+Nephew. 
TMP-CD-05-01 Clinical Protocol - Device – Revision D; SOP-CD-05 Clinical Protocol
Complex epiphyseal fractures around the knee joint involve the distal femur or 
proximal end of the tibia. The management of these fractures especially in elderly 
patients is challenging [9]. 
When the damage to the joint is advanced or conservative treatment options are 
exhausted, knee arthroplasty is considered the most effective treatment for patients 
with any of these indications. 
Total knee arthroplasty (TKA) is a highly successful and frequently performed 
surgical treatment to reduce disability caused by end-stage osteoarthritis and other 
conditions affecting articular cartilage [10, 11]. Technical outcomes for TKA are 
excellent, with favorable postoperative health-related quality of life [12]. Also, 
survivorship of primary knee replacements is excellent with reported survivorship of 
82.3% at 25 years [13]. TKA has traditionally been indicated in the elderly 
population with relatively sedentary lifestyles, but more active, younger patients 
(<55) are receiving TKA due to the desire for a pain-free, active lifestyle with the 
demand projected to continue to increase for this group. A recent systematic review 
has shown that functional outcomes are similar in this population compared to 
elderly patients with no increase in the burden of revision [14]. 
Unicondylar knee arthroplasty (UKA) is a surgical treatment for patients with OA or 
AVN that only affects a single compartment of the knee [15, 16]. In 2018, 11% of 
all knee arthroplasties in the United Kingdom were compartmental knee 
arthroplasties (UKA) [17].  
In Australia, 660,000 primary TKAs and 60000 primary UKAs have been performed 
in 2018. Since 2003, the number of knee replacement procedures undertaken has 
increased by 128% [18].  
The escalating prevalence of end-stage OA places an increased burden on 
healthcare providers, especially on less experienced surgeons and facilities that 

Clinical Protocol 
Study Number: CORI.2019.06
A Prospective, Multi-center, Randomized 
Controlled Study to Evaluate the Safety and 
Effectiveness of REAL INTELLIGENCE™ CORI™ in 
unicondylar knee arthroplasty (UKA) Procedure
Version: 4.0-Master, 07 Sep 
2022
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CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. 
and is intended for use only by Smith+Nephew and its manufacturer. It shall not be reproduced or copied in whole or in 
part, nor shall the contents be disclosed by any means without prior written permission from Smith+Nephew, nor shall 
anyone make any use of it that is contrary to the expressed or implied wishes of Smith+Nephew. 
TMP-CD-05-01 Clinical Protocol - Device – Revision D; SOP-CD-05 Clinical Protocol
perform low numbers of arthroplasties [19, 20]. Lower volume hospitals (<25 
procedures/year) report higher revision rates and more complications by 5 to 8 
years compared to high volume hospitals (>200 procedures/years) [20, 21]. 
Therefore, technology or techniques that could improve outcomes and reduce the 
risk of revision are becoming increasingly important.  
Surgical factors that must be considered in knee arthroplasty include lower leg 
alignment, soft tissue balancing, maintenance of the joint line, and component size 
and fixation [22]. Malalignment of components in any anatomical plane can cause 
major complications including aseptic loosening, instability, poor function, 
polyethylene wear, and pain [22-24]. Additionally, implant malposition and 
malalignment of the joint can result in failure of the prosthesis [25]. When not 
 poor functional 
outcomes, decreased implant survivorship, increased wear, and early failure from 
component loosening may occur [26].  
Evidence has shown that neutral mechanical alignment provides optimal outcomes 
in knee arthroplasty, which is achieved with conventional alignment guides in 
approximately 75% of TKA cases [27]. For partial knee procedures, approximately 
30-60% of UKAs have been reported to be malaligned using conventional manual 
instruments [28]. The importance of alignment can be demonstrated by observing 
higher revision rates of UKA attributed to malposition or malalignment of partial 
knees [28, 29] while roughly 25% of TKAs have been revised for instability or 
malalignment [30]. 
As an alternative to mechanical alignment, kinematic alignment technique for knee 
arthroplasty aims to restore the individual knee anatomy and ligament tension, to 
restore native knee kinematics [31]. Kinematic alignment restores the obliquity and 
level of the joint line anatomically so the femoral component is slightly more valgus 

Clinical Protocol 
Study Number: CORI.2019.06
A Prospective, Multi-center, Randomized 
Controlled Study to Evaluate the Safety and 
Effectiveness of REAL INTELLIGENCE™ CORI™ in 
unicondylar knee arthroplasty (UKA) Procedure
Version: 4.0-Master, 07 Sep 
2022
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CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. 
and is intended for use only by Smith+Nephew and its manufacturer. It shall not be reproduced or copied in whole or in 
part, nor shall the contents be disclosed by any means without prior written permission from Smith+Nephew, nor shall 
anyone make any use of it that is contrary to the expressed or implied wishes of Smith+Nephew. 
TMP-CD-05-01 Clinical Protocol - Device – Revision D; SOP-CD-05 Clinical Protocol
(1° to 2°) and the tibial component is slightly more varus (1° to 2°) than 
mechanically aligned components.  
A significant innovation in knee arthroplasty has been the introduction of computer 
navigation and robotic-assisted surgery. One such technology is CORI. This system 
is a semi-autonomous image-free system. During the surgery, the surgeon maps 
the condylar landmarks and determines alignment indices to define the volume and 
orientation of bone to be removed. The tools to remove the bone and place the 
implants are controlled and manipulated by the surgeon with the guidance of a 3-
dimensional digital map of the surgical surface.  
Comparisons of navigation systems to conventional instruments have demonstrated 
that robotic platforms produce fewer positioning errors in both UKA and TKA [32-
34]. When used in medial or lateral UKA procedures, robotics reported short 
learning curves, increased accuracy in posterior tibial slope, and coronal tibial 
alignment in comparison to other alignment methods [35-37]. 
For China, CORI is an investigational device - for details of the full literature review, 
pre-clinical, clinical, safety data and a risk analysis refer to the Investigator’s 
Brochure (IB). 
4.2 LITERATURE SUMMARY
A thorough analysis of the literature was performed, and publications were 
identified that contained clinical outcomes, accuracy measurements, or safety 
information pertaining to the Navigation Knee Surgical Systems.  
Use of the Navigation Knee Surgical Systems was reported in 7 publications with 1 
being a prospective study and the remaining 6 being retrospective studies shown in 
Table 4.2-4-1. Three (3) of the studies solely reported on outcomes of the 
Navigation Knee Surgical Systems, three (3) compared the Navigation Knee Surgical 

Clinical Protocol 
Study Number: CORI.2019.06
A Prospective, Multi-center, Randomized 
Controlled Study to Evaluate the Safety and 
Effectiveness of REAL INTELLIGENCE™ CORI™ in 
unicondylar knee arthroplasty (UKA) Procedure
Version: 4.0-Master, 07 Sep 
2022
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CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. 
and is intended for use only by Smith+Nephew and its manufacturer. It shall not be reproduced or copied in whole or in 
part, nor shall the contents be disclosed by any means without prior written permission from Smith+Nephew, nor shall 
anyone make any use of it that is contrary to the expressed or implied wishes of Smith+Nephew. 
TMP-CD-05-01 Clinical Protocol - Device – Revision D; SOP-CD-05 Clinical Protocol
Systems to conventional instruments, and one (1) study compared the Navigation 
Knee Surgical Systems to conventional instruments, patient specific instrumentation 
(PSI), and computer-assisted navigation (CAS) systems. All of the studies were for 
the NAVIO™ Navigation System (NAVIO) and reported outcomes for UKA. The data 
provided in these publications is also applicable to the equivalent CORI. 
 
 

Clinical Protocol 
Study Number: CORI.2019.06
A Prospective, Multi-center, Randomized 
Controlled Study to Evaluate the Safety and 
Effectiveness of REAL INTELLIGENCE™ CORI™ in 
unicondylar knee arthroplasty (UKA) Procedure
Version: 4.0-Master, 07 Sep 
2022
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CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. 
and is intended for use only by Smith+Nephew and its manufacturer. It shall not be reproduced or copied in whole or in 
part, nor shall the contents be disclosed by any means without prior written permission from Smith+Nephew, nor shall 
anyone make any use of it that is contrary to the expressed or implied wishes of Smith+Nephew. 
TMP-CD-05-01 Clinical Protocol - Device – Revision D; SOP-CD-05 Clinical Protocol
Table 4.2-4-1 Demographic Information for the Navigation Knee Surgical 
Systems 
Primary 
Author 
Year 
Navigation 
System 
Indication Joints 
(n) 
Male 
(%) 
Age, 
mean±SD 
(range) 
Follow-up, 
mean±SD 
Batailler 
[38] 
2019 
NAVIO1
UKA 
80 
33.8 
69 ± 9.6 
(49-87) 
1.64 ± 
0.75 
years 
Battenberg 
[39] 
2019 
NAVIO1
UKA 
128 
57.8 
64.7 ± 9.6 
(45-92) 
2.3 years 
Canetti [40]
2018
NAVIO1
UKA
11
18.0
66.5 ± 6.8 
(57-79) 
2.87 ± 
0.88 
years 
Gregori 
[41] 
2016 
NAVIO1
UKA 
92 
- 
- 
Periop 
Herry [42] 
2017 
NAVIO1
UKA 
40 
32.5 
69 ± 9.6 
(49-87) 
Periop 
Vega Parra 
[43] 
2017 
NAVIO1
UKA 
47 
51.0 
67 
(45-77) 
1 year 
Sephton 
[44] 
2019 
NAVIO1  
UKA 
67 
49.0 
68 ± 10 
Periop 
Total 
414 
49.0%A 
(33.8-
57.8) 
66.8A 
(45-92) 
1.14 
years 
(Periop-
2.87) 
1 NAVIO™ Surgical System 
4.2.1 Demographic Information 
A total of 414 joints were reported in the reviewed literature. Herry et al.[42] and 
Canetti et al.[40] likely shared the same patient population as Batailler et al.[38] 
Therefore, these joints were not included in the total, but these publications were 
not excluded due to different outcomes being reported among the studies. The 
Navigation Knee Surgical Systems are used intraoperatively to assist with 
implantation of knee prostheses, and studies report on a combination of 
intraoperative alignment parameters, clinical outcomes, and safety information. 
Three (3) studies provided early postoperative follow-up between the perioperative 
period and one year post-operative time point. Four (4) additional studies reported 
follow-up of one year or longer, two of which reported outcomes after 2 years of 

Clinical Protocol 
Study Number: CORI.2019.06
A Prospective, Multi-center, Randomized 
Controlled Study to Evaluate the Safety and 
Effectiveness of REAL INTELLIGENCE™ CORI™ in 
unicondylar knee arthroplasty (UKA) Procedure
Version: 4.0-Master, 07 Sep 
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CONFIDENTIAL AND PROPRIETARY 
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part, nor shall the contents be disclosed by any means without prior written permission from Smith+Nephew, nor shall 
anyone make any use of it that is contrary to the expressed or implied wishes of Smith+Nephew. 
TMP-CD-05-01 Clinical Protocol - Device – Revision D; SOP-CD-05 Clinical Protocol
follow-up. The gender of the patients was almost evenly distributed, as men 
comprised 49% of the total population from all 7 publications. The age of patients 
undergoing UKA with the NAVIO ranged from 45 to 92 years with an average age of 
66.8 years for the total patient population from all 7 publications.  
4.2.2 Clinical Outcome 
Outcome measures were evaluated in three publications with Knee Society Score 
(KSS), satisfaction rate, return to sport, Lysholm scale, Forgotten Joint score (FJS-
12), University of California, Los Angeles (UCLA) activity scale, Knee injury and 
Osteoarthritis Outcome Score (KOOS) and Knee Society Function Score (KSFS) 
being reported. 
KSS, KSFS, and satisfaction rates were the most commonly employed outcome 
measures, being reported by both Batailler et al.[38] and Canetti et al.[40].These 
studies reported KSS and KSFS scores ranging from 92.6 to 96.4 and 90 to 97.2, 
respectively, indicating excellent functional outcomes. Satisfaction was scored on a 
scale from 1-5 with values corresponding with feeling disappointed to very satisfied. 
The percentages reported are the number of patients that indicated they were very 
satisfied with their procedure; this does not include patients that indicated they 
were just satisfied. Other outcome scores were reported in a single study, and none 
of these outcomes evidenced reduced function.  
Batailler et al.[38] and Canetti et al. compared patients operated on with NAVIO to 
patients who were operated on using conventional instruments. For KSFS and 
satisfaction rate, no statistically significant differences were observed between the 
two groups. However, Canetti et al. observed a statistically significant increase in 
KSS and quicker return to sport for NAVIO. As the KSS difference was not observed 
in the larger cohort of Batailler et al.[38], the observed difference may be due to 
the smaller sample size. The percentage of patients returning to sports, UCLA, 

Clinical Protocol 
Study Number: CORI.2019.06
A Prospective, Multi-center, Randomized 
Controlled Study to Evaluate the Safety and 
Effectiveness of REAL INTELLIGENCE™ CORI™ in 
unicondylar knee arthroplasty (UKA) Procedure
Version: 4.0-Master, 07 Sep 
2022
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part, nor shall the contents be disclosed by any means without prior written permission from Smith+Nephew, nor shall 
anyone make any use of it that is contrary to the expressed or implied wishes of Smith+Nephew. 
TMP-CD-05-01 Clinical Protocol - Device – Revision D; SOP-CD-05 Clinical Protocol
Lysholm scale, and FJS-12 were not statistically significant between the two 
cohorts.  
Overall, patients undergoing knee procedures with NAVIO showed improved KSS, 
KSFS, KOOS, and UCLA scores compared to pre-operative values. 
4.2.3 Mechanical Alignment Accuracy 
The Navigation Knee Surgical Systems are intended to assist in planning and 
executing a procedure involving bone preparation for UKA procedures. Publications 
have provided accuracy measurements for the Navigation Knee Surgical Systems 
themselves and compared to conventional instruments. Three (3) publications 
investigated alignment accuracy in various planes, the incidence of outliers, and 
restitution of the joint line [38, 41, 42]. 
The reviewed publications indicate that the Navigation Knee Surgical Systems can 
produce the desired mechanical axis, hip knee ankle angle, coronal femoral angle, 
coronal tibial angle, tibial slope, and joint line deviation in the majority of cases. 
Outliers were reported for most of the angular alignment parameters, and only one 
study indicated a rate higher than 15% [38]. This increased outlier rate is likely due 
to the decreased tolerance imposed by the authors as outliers were defined as being 
within 2° of the desired value compared to the standard 3°.  
Batailler et al.[38] and Herry et al.[42] compared alignment with NAVIO to 
conventional instrumentation. Statistically significant differences were not observed 
between the hip knee ankle angle or tibial slope for medial or lateral UKAs. 
However, there were statistically fewer outliers for NAVIO in the hip knee ankle 
angle for medial and lateral UKA, the tibial slope for medial UKA, and the coronal 
tibial angle. In addition, the joint line was significantly less distalized when NAVIO 
was used.     

Clinical Protocol 
Study Number: CORI.2019.06
A Prospective, Multi-center, Randomized 
Controlled Study to Evaluate the Safety and 
Effectiveness of REAL INTELLIGENCE™ CORI™ in 
unicondylar knee arthroplasty (UKA) Procedure
Version: 4.0-Master, 07 Sep 
2022
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CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. 
and is intended for use only by Smith+Nephew and its manufacturer. It shall not be reproduced or copied in whole or in 
part, nor shall the contents be disclosed by any means without prior written permission from Smith+Nephew, nor shall 
anyone make any use of it that is contrary to the expressed or implied wishes of Smith+Nephew. 
TMP-CD-05-01 Clinical Protocol - Device – Revision D; SOP-CD-05 Clinical Protocol
Using the Navigation Knee Surgical Systems results in a knee prosthesis that is well 
aligned and implanted according to the surgical plan. This is supported by 
satisfactory angular outcomes in the mean mechanical axis, hip knee ankle angle, 
coronal femoral angle, coronal tibial angle, and tibial slope. In addition, the joint line 
was less distal compared to when conventional instrumentation was utilized.  
 
 

Clinical Protocol 
Study Number: CORI.2019.06
A Prospective, Multi-center, Randomized 
Controlled Study to Evaluate the Safety and 
Effectiveness of REAL INTELLIGENCE™ CORI™ in 
unicondylar knee arthroplasty (UKA) Procedure
Version: 4.0-Master, 07 Sep 
2022
Page: 31 of 167   
 
CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. 
and is intended for use only by Smith+Nephew and its manufacturer. It shall not be reproduced or copied in whole or in 
part, nor shall the contents be disclosed by any means without prior written permission from Smith+Nephew, nor shall 
anyone make any use of it that is contrary to the expressed or implied wishes of Smith+Nephew. 
TMP-CD-05-01 Clinical Protocol - Device – Revision D; SOP-CD-05 Clinical Protocol
4.2.4 Adverse Events & Complications
Complications related to the surgery, revision of the implant, and general 
complications were reported in the 7 included publications. Overall, the revision rate 
for prostheses implanted using the Navigation Knee Surgical Systems was 1.2% 
(5/414 procedures). Revisions were due to aseptic loosening without implant 
malpositioning (3, 0.7%) and unexplained pain (2, 0.5%). Additional reoperations 
included three (3) arthroscopic partial lateral meniscectomies, two (2) arthroscopic 
arthrolyses, and one (1) arthrotomy and lavage. Batailler et al.[38] noted that 
complications that affect robotic-assisted techniques (e.g., pin-site infections, 
broken pins, or fractures at the pin site) did not occur in their cohort.  
4.2.5 Conclusion 
Using the Navigation knee surgical systems results in a knee prosthesis that is 
implanted according to the patient specific surgical plan. This is evidenced by 
satisfactory angular outcomes and restitution of the joint line. In addition, patients 
undergoing these procedures with the Navigation knee surgical systems showed 
improved outcomes scores compared to pre-operative values. The clinical outcomes, 
alignment accuracy, and adverse events for the Navigation Knee Surgical Systems 
reported in the literature are similar to those reported for comparable devices.  
 
 

Clinical Protocol 
Study Number: CORI.2019.06
A Prospective, Multi-center, Randomized 
Controlled Study to Evaluate the Safety and 
Effectiveness of REAL INTELLIGENCE™ CORI™ in 
unicondylar knee arthroplasty (UKA) Procedure
Version: 4.0-Master, 07 Sep 
2022
Page: 32 of 167   
 
CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. 
and is intended for use only by Smith+Nephew and its manufacturer. It shall not be reproduced or copied in whole or in 
part, nor shall the contents be disclosed by any means without prior written permission from Smith+Nephew, nor shall 
anyone make any use of it that is contrary to the expressed or implied wishes of Smith+Nephew. 
TMP-CD-05-01 Clinical Protocol - Device – Revision D; SOP-CD-05 Clinical Protocol
4.3 STUDY PURPOSE
This is a prospective, multi-center, randomized controlled study to demonstrate the 
safety and effectiveness of CORI to support the regulatory approval by the National 
Medical Products Administration (NMPA) in China. Data collected in this study may 
also be used to maintain product registration in global markets including, but not 
limited to, Australia (Therapeutic Goods Administration (TGA)) and Europe 
(Conformité Européene (CE)). 
4.4 SAFETY CONSIDERATIONS
CORI’s intended use, indications and contraindications can be found in the User’s 
Manual & Instructions for Use (IFU) for Australia, China (Hong Kong), South Korea, 
and New Zealand or the Investigator’s Brochure for China Mainland. 
4.4.1 Intended Use 
CORI is intended to assist the surgeon in providing software-defined spatial 
boundaries for orientation and reference information to anatomical structures during 
orthopedic procedures. 
4.4.2 Indications 
CORI is indicated for use in surgical knee procedures, in which the use of 
stereotactic surgery may be appropriate, and where reference to rigid anatomical 
bony structures can be determined. These procedures include unicondylar knee 
replacement (UKR) and total knee arthroplasty (TKA).  
CORI is indicated for use with cemented implants only.  

Clinical Protocol 
Study Number: CORI.2019.06
A Prospective, Multi-center, Randomized 
Controlled Study to Evaluate the Safety and 
Effectiveness of REAL INTELLIGENCE™ CORI™ in 
unicondylar knee arthroplasty (UKA) Procedure
Version: 4.0-Master, 07 Sep 
2022
Page: 33 of 167   
 
CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. 
and is intended for use only by Smith+Nephew and its manufacturer. It shall not be reproduced or copied in whole or in 
part, nor shall the contents be disclosed by any means without prior written permission from Smith+Nephew, nor shall 
anyone make any use of it that is contrary to the expressed or implied wishes of Smith+Nephew. 
TMP-CD-05-01 Clinical Protocol - Device – Revision D; SOP-CD-05 Clinical Protocol
4.4.3 Contraindications
CORI is not intended to be used on children, pregnant women, patients who have 
mental or neuromuscular disorders that do not allow control of the knee joint, or 
any other patients contraindicated for knee replacement. 
4.4.4 Environments of Use 
CORI is intended to be used by trained medical professionals in a hospital or clinical 
setting equivalent to an orthopedic surgery suite. The CORI Instruments will be 
used in a sterile environment and must be sterilized prior to use.  
4.4.5 Potential Adverse Effects 
As with any surgical procedure, there is risk involved. Potential complications 
accompanying surgery may occur, including allergic reaction (anaphylactic and 
minor), infection, mild to serious physical injury, localized static shock, delay in the 
operation, surgical site nerve injury, vascular injuries of the lower extremity, soft 
tissue damage, major bone gouging at the surgical site, bone fracture, immature 
implant failure, unstable knee joint, limited or restricted knee range of motion, 
major blunt impact injury, unintended laceration/puncture wound, and 
osteonecrosis.  
The CORI User’s Manual (Document ID: 500230, REAL INTELLIGENCE™ CORI™ for 
Knee Arthroplasty) states the following warnings and cautions: 
 
CORI is a surgical tool designed to provide assistance to the surgeon; it is not 
a substitute for the surgeon’s experience and skill. The surgeon is responsible 
for implant planning and the conduct of the surgery during which CORI is being 
used. 

Clinical Protocol 
Study Number: CORI.2019.06
A Prospective, Multi-center, Randomized 
Controlled Study to Evaluate the Safety and 
Effectiveness of REAL INTELLIGENCE™ CORI™ in 
unicondylar knee arthroplasty (UKA) Procedure
Version: 4.0-Master, 07 Sep 
2022
Page: 34 of 167   
 
CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. 
and is intended for use only by Smith+Nephew and its manufacturer. It shall not be reproduced or copied in whole or in 
part, nor shall the contents be disclosed by any means without prior written permission from Smith+Nephew, nor shall 
anyone make any use of it that is contrary to the expressed or implied wishes of Smith+Nephew. 
TMP-CD-05-01 Clinical Protocol - Device – Revision D; SOP-CD-05 Clinical Protocol
 
CORI and accessories should be used only by, or under the supervision of, a 
qualified surgeon or qualified member of his or her staff who is familiar with 
this document and has received training from S+N. 
 
Use of equipment not specifically designated in this manual as compatible with 
CORI may result in the system not functioning properly, leading to patient or 
user injury. 
 
Refer servicing only to trained service personnel. Equipment damage, personal 
injury, or death may result if CORI is not serviced properly. 
 
To avoid risk of electrical shock, only connect the CORI Cart to a supply main 
with protective earth. 
 
Modification of CORI can cause the system to malfunction and could result in 
user and/or patient injury. 
 
Connecting electrical equipment to the multiple socket output effectively leads 
to creating a Medical Equipment System and could result in a reduced level of 
safety. 
 
The transformer outlet is only to be used for CORI components. Do not connect 
any other device or improper extension cord to the transformer (max. load 600 
VA) outlet. Failure to comply with this warning may result in shock hazard or 
product damage. 
 
Additional equipment connected to medical electrical equipment must comply 
with the respective IEC or ISO standards. All configurations shall comply with 
the requirements for medical electrical systems (see IEC 60601-1). Anyone 
connecting additional equipment to medical electrical equipment configures a 
medical system and is therefore responsible that the system complies with the 
requirements for medical electrical systems. Attention is drawn to the fact that 
local laws take priority over the above-mentioned requirements. If in doubt, 
contact a qualified Biomedical technician or your local Smith & Nephew 
representative. 

Clinical Protocol 
Study Number: CORI.2019.06
A Prospective, Multi-center, Randomized 
Controlled Study to Evaluate the Safety and 
Effectiveness of REAL INTELLIGENCE™ CORI™ in 
unicondylar knee arthroplasty (UKA) Procedure
Version: 4.0-Master, 07 Sep 
2022
Page: 35 of 167   
 
CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. 
and is intended for use only by Smith+Nephew and its manufacturer. It shall not be reproduced or copied in whole or in 
part, nor shall the contents be disclosed by any means without prior written permission from Smith+Nephew, nor shall 
anyone make any use of it that is contrary to the expressed or implied wishes of Smith+Nephew. 
TMP-CD-05-01 Clinical Protocol - Device – Revision D; SOP-CD-05 Clinical Protocol
 
Any person who connects external equipment to signal input and signal output 
ports or other connectors has formed a system and is therefore responsible for 
the system to comply with the requirements of IEC 60601-1. If in doubt, 
contact a qualified Biomedical technician or your local Smith & Nephew 
representative. 
 
Only USB-powered devices, such as USB flash drives, should be connected to 
CORI USB ports. Any person that connects a self-powered USB device has 
formed a medical system and is therefore responsible for the system to comply 
with the requirements of IEC 60601-1. If in doubt, contact a qualified 
Biomedical technician or your local Smith & Nephew representative. 
 

Clinical Protocol 
Study Number: CORI.2019.06
A Prospective, Multi-center, Randomized 
Controlled Study to Evaluate the Safety and 
Effectiveness of REAL INTELLIGENCE™ CORI™ in 
unicondylar knee arthroplasty (UKA) Procedure
Version: 4.0-Master, 07 Sep 
2022
Page: 36 of 167   
 
CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. 
and is intended for use only by Smith+Nephew and its manufacturer. It shall not be reproduced or copied in whole or in 
part, nor shall the contents be disclosed by any means without prior written permission from Smith+Nephew, nor shall 
anyone make any use of it that is contrary to the expressed or implied wishes of Smith+Nephew. 
TMP-CD-05-01 Clinical Protocol - Device – Revision D; SOP-CD-05 Clinical Protocol
5
OBJECTIVE(S)
5.1 PRIMARY OBJECTIVE
The primary objective of this study is to evaluate the use of CORI in UKA procedures
in achieving post-operative leg alignment as compared to procedures using 
conventional manual instruments. 
5.2 SECONDARY OBJECTIVE(S)
The secondary objective of this study is to generate safety and performance 
evidence supporting the use of CORI procedures. To assess the safety and 
performance of CORI up to 12 months after surgery as compared to procedures 
using conventional manual instruments. 
5.3 OTHER OBJECTIVE(S)
Other objectives are to collect the system time and cutting time of the robotic drill 
from the CORI Case Report. 
5.4 CLAIMS
No claims to be confirmed by this investigation. 
 
 

Clinical Protocol 
Study Number: CORI.2019.06
A Prospective, Multi-center, Randomized 
Controlled Study to Evaluate the Safety and 
Effectiveness of REAL INTELLIGENCE™ CORI™ in 
unicondylar knee arthroplasty (UKA) Procedure
Version: 4.0-Master, 07 Sep 
2022
Page: 37 of 167   
 
CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. 
and is intended for use only by Smith+Nephew and its manufacturer. It shall not be reproduced or copied in whole or in 
part, nor shall the contents be disclosed by any means without prior written permission from Smith+Nephew, nor shall 
anyone make any use of it that is contrary to the expressed or implied wishes of Smith+Nephew. 
TMP-CD-05-01 Clinical Protocol - Device – Revision D; SOP-CD-05 Clinical Protocol
6
INVESTIGATIONAL PRODUCT(S) AND COMPARATOR
6.1 IDENTIFICATION  
6.1.1 Investigational Product 
CORI is a computer-assisted orthopedic surgical navigation and burring system. It is 
designed to aid surgeons in planning and executing a procedure involving bone 
preparation for unicondylar knee arthroplasty (UKA) and total knee arthroplasty 
(TKA) procedures. 
CORI is currently avaible for the use of the following S+N UKA implant Systems, the 
implant system will be selected according to the registration status in each country. 
Table 6.1-6-1 S+N Implant Systems available with CORI 
Implant System 
Manufacturer 
Journey II Unicompartamental Knee System
Smith & Nephew, Inc. 
Journey Uni
Smith & Nephew, Inc. 
CORI is comprised of a console control unit, optical tracking camera, primary and 
secondary input displays (tablet and optional display monitor), instrument trays and 
foot pedal (Figure 6.1-6-1). CORI software consists of a patient and user 
management module, a surgical planner, and an intra-operative cutting module. 
The system uses the tracked position of the surgical bur to control its cutting 
engagement to the bone that is intended to be removed. This cutting control is 
based on the bur’s proximity to the planned target surface of the bone. 
CORI incorporates a detailed user interface that provides procedure setup, tracking 
status, visual indicators, and real-time cutting progress during the procedure. The 
system uses the tracked position of the surgical bur to control its cutting 
engagement to the bone that is intended to be removed. The cutting control is 
based on the bur’s proximity to the planned target surface of the bone. CORI 

Clinical Protocol 
Study Number: CORI.2019.06
A Prospective, Multi-center, Randomized 
Controlled Study to Evaluate the Safety and 
Effectiveness of REAL INTELLIGENCE™ CORI™ in 
unicondylar knee arthroplasty (UKA) Procedure
Version: 4.0-Master, 07 Sep 
2022
Page: 38 of 167
CONFIDENTIAL AND PROPRIETARY
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. 
and is intended for use only by Smith+Nephew and its manufacturer. It shall not be reproduced or copied in whole or in 
part, nor shall the contents be disclosed by any means without prior written permission from Smith+Nephew, nor shall 
anyone make any use of it that is contrary to the expressed or implied wishes of Smith+Nephew.
TMP-CD-05-01 Clinical Protocol - Device – Revision D; SOP-CD-05 Clinical Protocol
software controls the cutting engagement of the surgical bur based on its proximity 
to the planned target surface. The cutting control is achieved with two modes: 
Exposure control adjusts the bur's exposure with respect to a guard. If the 
surgeon encroaches on a portion of bone that is not to be cut, CORI retracts 
the bur inside the guard, disabling cutting.
Speed control regulates the signal going to the drill motor controller itself and 
limits the speed of the drill if the target surface is approached. This mode of 
operation is useful in shaping surfaces of the condyle as well as placing post 
holes and fixation features for femoral and tibial cut guides.
The surgeon can disable both controls and operate CORI robotic drill as a standard 
navigated surgical drill.
Figure 6.1-6-1 CORI
Instrument Tray
Console: It houses the robotic drill tool control, power management, video and 
audio distribution, central processing unit, and irrigation pump/control.
Display Monitor
Optical Tracking Camera 
Console
Foot Pedal
Cart
Tablet

Clinical Protocol 
Study Number: CORI.2019.06
A Prospective, Multi-center, Randomized 
Controlled Study to Evaluate the Safety and 
Effectiveness of REAL INTELLIGENCE™ CORI™ in 
unicondylar knee arthroplasty (UKA) Procedure
Version: 4.0-Master, 07 Sep 
2022
Page: 39 of 167   
 
CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. 
and is intended for use only by Smith+Nephew and its manufacturer. It shall not be reproduced or copied in whole or in 
part, nor shall the contents be disclosed by any means without prior written permission from Smith+Nephew, nor shall 
anyone make any use of it that is contrary to the expressed or implied wishes of Smith+Nephew. 
TMP-CD-05-01 Clinical Protocol - Device – Revision D; SOP-CD-05 Clinical Protocol
 
Optical Tracking Camera: It is used to determine the position of the surgical 
bur tip and point probe relative to the position of the tibia and femur tracker 
frames. The position is determined using reflective markers affixed to the 
robotic drill, point probe, and tibia and femur frames. 
 
Foot Pedal: The left foot pedal allows variable input for robotic drill speed 
control and provides navigation or confirmation action in certain situations. The 
right pedal and small circular buttons are used to navigate forward and 
backward in the workflow and dismiss error messages. 
 
Tablet: The wired display monitor provides a touchscreen interface for the user 
to interact with the system. 
 
Display Monitor: It provides duplicate display and control of the system user 
interface. 
 
Cart: It provides a location for the system console, mounting for the optical 
tracking camera and display monitor, and storage for the foot pedal, tablet, 
and power cords. 
 
CORI Instrument Trays UKA & TKA: There are two instrument trays, one 
for unicondylar knee arthroplasty (UKA) and for total knee arthroplasty (TKA) 
procedures. Both CORI instrument trays contain reusable, re-sterilizable tools 
to assist in surgical site preparation, implant placement planning, and bone 
removal. The tray is comprised of two levels. 
*Only UKA related components will be used for the study. 
CORI also includes specific reusable instruments as shown in Figure 6.1-6-2. 
 
 

Clinical Protocol 
Study Number: CORI.2019.06
A Prospective, Multi-center, Randomized 
Controlled Study to Evaluate the Safety and 
Effectiveness of REAL INTELLIGENCE™ CORI™ in 
unicondylar knee arthroplasty (UKA) Procedure
Version: 4.0-Master, 07 Sep 
2022
Page: 40 of 167
CONFIDENTIAL AND PROPRIETARY
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. 
and is intended for use only by Smith+Nephew and its manufacturer. It shall not be reproduced or copied in whole or in 
part, nor shall the contents be disclosed by any means without prior written permission from Smith+Nephew, nor shall 
anyone make any use of it that is contrary to the expressed or implied wishes of Smith+Nephew.
TMP-CD-05-01 Clinical Protocol - Device – Revision D; SOP-CD-05 Clinical Protocol
Figure 6.1-6-2 CORI Reusable Instruments
Point Proble
Femur & Tibia Trackers
CORI Robotic Drill
Checkpoint Pins
Bone Screw
CORI Robotic Drill: Controls the position and speed of the bur. It is intended 
for 75 uses and is able to be autoclaved, auto washed, and disinfected.
Point Probe: Tracked instrument used in robotic drill calibration, and bone 
registration, checkpoint verification.
Femur & Tibia Trackers: Rigid arrays placed on the femur and tibia to track 
the relative position of bones to point probe and robotic drill tools using 
reflective markers.
Checkpoint Pins: placed in femur and tibia and checked periodically with the 
point probe to verify that the tibia and femur tracking arrays have not moved 
during the procedure.
Details on single use instruments of CORI can be found in Section 22.3.
CORI, as well as the single use components, are manufactured by Smith+Nephew, 
Blue Belt Technologies, 2905 Northwest Blvd. Suite 40, Plymouth, MN 55441, USA 
6.1.2 Comparator Treatment
CORI will be compared to conventional manual instrumentation currently available 
in Australia, China (Hong Kong), New Zealand, South Korea, and China Mainland.

Clinical Protocol 
Study Number: CORI.2019.06
A Prospective, Multi-center, Randomized 
Controlled Study to Evaluate the Safety and 
Effectiveness of REAL INTELLIGENCE™ CORI™ in 
unicondylar knee arthroplasty (UKA) Procedure
Version: 4.0-Master, 07 Sep 
2022
Page: 41 of 167
CONFIDENTIAL AND PROPRIETARY
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. 
and is intended for use only by Smith+Nephew and its manufacturer. It shall not be reproduced or copied in whole or in 
part, nor shall the contents be disclosed by any means without prior written permission from Smith+Nephew, nor shall 
anyone make any use of it that is contrary to the expressed or implied wishes of Smith+Nephew.
TMP-CD-05-01 Clinical Protocol - Device – Revision D; SOP-CD-05 Clinical Protocol
Arthroplasty has traditionally used conventional manual instruments to guide 
placement of the implant and determine bone resection in reference to anatomical 
landmarks. Manual instruments include intramedullary or extramedullary rods that 
centralize and align the components according to the surgical plan as shown in 
Figure 6.1-6-3 & Figure 6.1-6-4.
Figure 6.1-6-3 Extramedullary rod
Figure 6.1-6-4 Intramedullary rod
6.1.3 Ancillary Product(s)
Not applicable.
6.2 PRODUCT USE
CORI has a user’s manual (Document ID: 500230, REAL INTELLIGENCE™ CORI™ 
for Knee Arthroplasty). The purpose of this user’s manual is to serve as the master 
reference document for properly trained users in the function and operation of CORI 
and its accessories.
In addition, the following devices are packaged with an IFU to ensure that the 
device is used properly and for the intended purposes:

Clinical Protocol 
Study Number: CORI.2019.06
A Prospective, Multi-center, Randomized 
Controlled Study to Evaluate the Safety and 
Effectiveness of REAL INTELLIGENCE™ CORI™ in 
unicondylar knee arthroplasty (UKA) Procedure
Version: 4.0-Master, 07 Sep 
2022
Page: 42 of 167   
 
CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. 
and is intended for use only by Smith+Nephew and its manufacturer. It shall not be reproduced or copied in whole or in 
part, nor shall the contents be disclosed by any means without prior written permission from Smith+Nephew, nor shall 
anyone make any use of it that is contrary to the expressed or implied wishes of Smith+Nephew. 
TMP-CD-05-01 Clinical Protocol - Device – Revision D; SOP-CD-05 Clinical Protocol
 
IFU REAL INTELLIGENCE™ CORI™ Burs (Document ID: 500172) 
 
IFU REAL INTELLIGENCE™ CORI™ Flat Markers (Document ID: 500198) 
 
IFU REAL INTELLIGENCE™ CORI™ Irrigation (Document ID: 500173) 
 
IFU REAL INTELLIGENCE™ CORI™ Instrumentation Tray (Document ID: 
500229) 
For Australia, Hong Kong, South Korea, and New Zealand the list of reference 
documents can be found in Appendix Section 22.3Instruction For Use & User 
Manual. 
For China mainland, details of the use of CORI can be found in the Investigator’s 
Brochure. 
6.3 PACKAGING AND LABELLING
Packaging and labeling are prepared to meet regulatory requirements. Package 
integrity and labelling should be verified prior to use of the product and confirmed in 
the eCRF. 
6.3.1 Labelling of Investigational Product  
All product components of the CORI System are commercial products in the 
Australia, China(Hong Kong), South Korea, and New Zealand and are being used as 
approved. Labeling is done as per the standard commercial packaging. 
In China mailand, CORI is a an investigational product. The standard commercial 
packaging as marketed in the US is used. However, additional labels will be included 
on the commercial packaging to meet the regulatory requirements for 
investigational devices in countries where the devices are not approved for 
marketing.  

Clinical Protocol 
Study Number: CORI.2019.06
A Prospective, Multi-center, Randomized 
Controlled Study to Evaluate the Safety and 
Effectiveness of REAL INTELLIGENCE™ CORI™ in 
unicondylar knee arthroplasty (UKA) Procedure
Version: 4.0-Master, 07 Sep 
2022
Page: 43 of 167   
 
CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. 
and is intended for use only by Smith+Nephew and its manufacturer. It shall not be reproduced or copied in whole or in 
part, nor shall the contents be disclosed by any means without prior written permission from Smith+Nephew, nor shall 
anyone make any use of it that is contrary to the expressed or implied wishes of Smith+Nephew. 
TMP-CD-05-01 Clinical Protocol - Device – Revision D; SOP-CD-05 Clinical Protocol
Compatible S+N Knee Implant Systems are commercial products in Australia, China 
(Hong Kong), New Zealand, and China mainland and are being used as approved. 
6.3.2 Comparator Product 
Conventional approach with conventional manual instrumentation will be used as 
the comparison group and there will be no packaging involved with the conventional 
approach.  
S+N Knee Implant Systems are commercial products in Australia, Hong Kong, New 
Zealand, South Korea, and China mainland and are being used as approved. 
6.4 PRODUCT ACCOUNTABILITY PROCEDURES  
This study is a post-market study in Australia, Hong Kong, South Korea, and New 
Zealand. However, the sponsor provides the study sites with CORI System (Console, 
Optical Tracking Camera, Foot Pedal, Tablet, Display Monitor, Cart, CORI 
Instrument Trays UKA) as well as with reusable instrumentation (CORI robotic Drill, 
Point Probe, Femur & Tibia Trackers, Checkpoint Pins). Therefore, the following 
product accountability procedures will be applied for CORI at all study sites.  
The investigational site will maintain an inventory of the investigational product. The 
Sponsor or its designee will provide a log(s) to facilitate IP inventory control. The log 
will contain details of receipt, use, returns etc. of IP. All IP accountability logs must 
be retained in the Investigator Site File (ISF). These records must be available for 
inspection by the Sponsor, its designees, or by regulatory agencies at any time. 
The Study Monitor will ensure that the procedures and records are in place for the 
appropriate reconciliation of all IP. As part of monitoring, the Study Monitor will check 
that site personnel are following the proper procedures for accountability and 
completing all necessary documentation. 

Clinical Protocol 
Study Number: CORI.2019.06
A Prospective, Multi-center, Randomized 
Controlled Study to Evaluate the Safety and 
Effectiveness of REAL INTELLIGENCE™ CORI™ in 
unicondylar knee arthroplasty (UKA) Procedure
Version: 4.0-Master, 07 Sep 
2022
Page: 44 of 167   
 
CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. 
and is intended for use only by Smith+Nephew and its manufacturer. It shall not be reproduced or copied in whole or in 
part, nor shall the contents be disclosed by any means without prior written permission from Smith+Nephew, nor shall 
anyone make any use of it that is contrary to the expressed or implied wishes of Smith+Nephew. 
TMP-CD-05-01 Clinical Protocol - Device – Revision D; SOP-CD-05 Clinical Protocol
No product accountability procedures will be applied for the S+N Knee Implant 
Systems as these are commercially available products. 
For details on CORI and reusable instrumetation please refer to Section 6.1.1 
Investigational Product. 
6.5 SURGICAL TECHNIQUE
All study related procedures with CORI must be performed according to the user’s 
manual (Document ID: 500230 CORI Robotics for Knee Arthroplasty for Australia, 
Hong Kong, South Korea, and New Zealand, as well as Investigator’s Brochure for 
China) and according to the according to the surgical technique and IFU of the 
specific S+N Implant System. 
Surgeons selected to participate in this study will be familiar with CORI and have 
written evidence of training and expertise in the study procedure. The Surgeon will 
conduct Pre-study in order to establish the expertise of the individual surgeons.  
The exact number of pre-study cases may be adjusted depending on the level of the 
individual experience of the surgeon.  
CORI Case Reports Forms of the non-randomized cases will be collected as proof of 
surgeons’ experience and for inclusion in the safety analysis set (applicable only at 
sites in China). 
6.6 MEDICAL PROCEDURE 
There are 3 basic steps in unicondylar knee arthroplasty. The first step is preparing 
the bone and removing the cartridge from the damaged knee compartment. This will 
be completed using either the CORI robotic drill or an oscillating saw. The surgeon 
will then position the metal implants on the damaged side of the femur and tibia using 
several orthopaedic tools. Finally, a spacer will be inserted between the metal 
implants to reduce friction when the knee flexes and extends. At various times during 

Clinical Protocol 
Study Number: CORI.2019.06
A Prospective, Multi-center, Randomized 
Controlled Study to Evaluate the Safety and 
Effectiveness of REAL INTELLIGENCE™ CORI™ in 
unicondylar knee arthroplasty (UKA) Procedure
Version: 4.0-Master, 07 Sep 
2022
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CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. 
and is intended for use only by Smith+Nephew and its manufacturer. It shall not be reproduced or copied in whole or in 
part, nor shall the contents be disclosed by any means without prior written permission from Smith+Nephew, nor shall 
anyone make any use of it that is contrary to the expressed or implied wishes of Smith+Nephew. 
TMP-CD-05-01 Clinical Protocol - Device – Revision D; SOP-CD-05 Clinical Protocol
the procedure, the hip-knee-ankle angle (HKA) will be checked using the CORI 
advanced tracking system or via the use of intramedullary and / or extramedullary 
rods. How the angle is measured will depend on which treatment arm the subject is 
randomized to receive. All unicondylar knee arthroplasty is completed using general 
anaesthetic by a surgical team trained in both the CORI system and the use of 
standard manual instrumentation. 
7 
SUBJECT ENROLLMENT AND WITHDRAWAL 
7.1 SUBJECT POPULATION 
At least 145 subjects will be enrolled into the study. At least 5 of these subjects will 
be treated with CORI directly to fulfil the learning needs of the surgeons prior to 
enrolling, a further 140 subjects who will be enrolled in the randomized stage of the 
study in up to 8 sites in Australia, Hong Kong, New Zealand, South Korea, and 
China mainland. Seventy (70) subjects will be enrolled for UKA with the use of the 
CORI and 70 subjects will be enrolled for UKA with the use of conventional manual 
instrumentation. Vulnerable subjects will not be enrolled in this study.  
 
 
 

Clinical Protocol 
Study Number: CORI.2019.06
A Prospective, Multi-center, Randomized 
Controlled Study to Evaluate the Safety and 
Effectiveness of REAL INTELLIGENCE™ CORI™ in 
unicondylar knee arthroplasty (UKA) Procedure
Version: 4.0-Master, 07 Sep 
2022
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CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. 
and is intended for use only by Smith+Nephew and its manufacturer. It shall not be reproduced or copied in whole or in 
part, nor shall the contents be disclosed by any means without prior written permission from Smith+Nephew, nor shall 
anyone make any use of it that is contrary to the expressed or implied wishes of Smith+Nephew. 
TMP-CD-05-01 Clinical Protocol - Device – Revision D; SOP-CD-05 Clinical Protocol
7.2 INCLUSION CRITERIA
Subjects will be considered qualified for enrollment if they meet the following 
criteria: 
1
Subject is a suitable candidate for a UKA procedure using CORI and a
compatible S+N Knee Implant System.
2
Subject requires a cemented UKA as a primary indication that meets any of 
the following conditions: 
a) Non-inflammatory degenerative joint disease, including osteoarthritis 
b) Avascular necrosis 
c) Requires correction of functional deformity 
d) Requires treatment of fractures that were unmanageable using other 
techniques 
3
years of age at the time of surgery)  
4
Subject agrees to consent to and to follow the study visit schedule (as defined 
in the study protocol and informed consent form), by signing the Ethics
Committee (EC) or Institutional Review Board (IRB) approved informed consent 
form. 
5
Subject plans to be available through one (1) year postoperative follow-up. 
6
Applicable routine radiographic assessment is possible. 
7.3 EXCLUSION CRITERIA 
Any one (1) of the following criteria will disqualify a potential subject from 
participation in the study: 

Clinical Protocol 
Study Number: CORI.2019.06
A Prospective, Multi-center, Randomized 
Controlled Study to Evaluate the Safety and 
Effectiveness of REAL INTELLIGENCE™ CORI™ in 
unicondylar knee arthroplasty (UKA) Procedure
Version: 4.0-Master, 07 Sep 
2022
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CONFIDENTIAL AND PROPRIETARY 
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and is intended for use only by Smith+Nephew and its manufacturer. It shall not be reproduced or copied in whole or in 
part, nor shall the contents be disclosed by any means without prior written permission from Smith+Nephew, nor shall 
anyone make any use of it that is contrary to the expressed or implied wishes of Smith+Nephew. 
TMP-CD-05-01 Clinical Protocol - Device – Revision D; SOP-CD-05 Clinical Protocol
1
Subject receives a UKA on the index joint as a revision for a previously failed 
surgery, or need for complex implants, or any other implant than a standard 
UKA (e.g. stems, augments, or custom made devices). 
2
Subject has been diagnosed with post-traumatic arthritis 
3
Subject receives simultaneous bilateral UKA OR a unilateral UKA with 
contralateral TKA.
4
Subject has one or more of the following arthroplasties that are not fully 
healed and well-functioning, as determined by the investigator:
-Contralateral primary TKA or UKA, however, the subject can only have 
one knee enrolled in the study. 
 
5
Subject does not understand the language used in the Informed Consent 
Form. 
6
Subject does not meet the indication or is contraindicated for UKA according 
to specific S+N knee system’s Instructions for Use (IFU). 
7
Subject has active infection or sepsis (treated or untreated). 
8
Subject is morbidly obese with a body mass index (BMI) greater than 40.
9
Subject is pregnant or breast feeding at the time of surgery. 
10
Subject, in the opinion of the Investigator, has advanced osteoarthritis or 
joint disease at the time of surgery and was better suited for an alternate 
procedure. 
11
Subject currently enrolled in another orthopedic clinical trial study.

Clinical Protocol 
Study Number: CORI.2019.06
A Prospective, Multi-center, Randomized 
Controlled Study to Evaluate the Safety and 
Effectiveness of REAL INTELLIGENCE™ CORI™ in 
unicondylar knee arthroplasty (UKA) Procedure
Version: 4.0-Master, 07 Sep 
2022
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CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. 
and is intended for use only by Smith+Nephew and its manufacturer. It shall not be reproduced or copied in whole or in 
part, nor shall the contents be disclosed by any means without prior written permission from Smith+Nephew, nor shall 
anyone make any use of it that is contrary to the expressed or implied wishes of Smith+Nephew. 
TMP-CD-05-01 Clinical Protocol - Device – Revision D; SOP-CD-05 Clinical Protocol
12
Subject has a condition(s) that may interfere with the UKA survival or 
outcome (i.e., Paget’s or Charcot’s disease, vascular insufficiency, muscular 
atrophy, uncontrolled diabetes, moderate to severe renal insufficiency or 
neuromuscular disease, or an active, local infection).
13
Subject in the opinion of the Investigator, has an emotional or neurological 
condition that would pre-empt their ability or willingness to participate in 
the study including mental illness, intellectual disability, drug or alcohol 
abuse.
14
Subject, in the opinion of the Investigator, has a neuromuscular disorder 
that prohibited control of the index joint. 
15
Subject is a prisoner or meets the definition of a Vulnerable Subject per ISO 
14155:2020 Section 3.55.1
 
1 ISO 14155:2020 Section 3.55 States: Vulnerable subject – Individuals who are unable to fully understand all 
aspects of the investigation that are relevant to the decision to participate, or who could be manipulated or unduly 
influenced as a result of a compromised position, expectation of benefits or fear of retaliatory response  

Clinical Protocol 
Study Number: CORI.2019.06
A Prospective, Multi-center, Randomized 
Controlled Study to Evaluate the Safety and 
Effectiveness of REAL INTELLIGENCE™ CORI™ in 
unicondylar knee arthroplasty (UKA) Procedure
Version: 4.0-Master, 07 Sep 
2022
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CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. 
and is intended for use only by Smith+Nephew and its manufacturer. It shall not be reproduced or copied in whole or in 
part, nor shall the contents be disclosed by any means without prior written permission from Smith+Nephew, nor shall 
anyone make any use of it that is contrary to the expressed or implied wishes of Smith+Nephew. 
TMP-CD-05-01 Clinical Protocol - Device – Revision D; SOP-CD-05 Clinical Protocol
7.4 SCREENING 
Investigators should consecutively screen all subjects presenting with degenerative 
joint disease of the knee, requiring correction of functional deformity, or treatment 
of fractures that were unmanageable using other techniques to determine whether 
they meet all inclusion and none of the exclusion criteria. 
Participating study sites are required to document all screened subjects considered 
for inclusion in this study. If a subject is excluded from the study, the reasons for 
exclusion will be documented in the subject's source documents and noted on the 
Screening and Enrollment Log. All screening activities that occur prior to consent 
shall be referred to as pre-screening.  
In China sites, part of the screening process will include documentation of women’s 
childbearing potential. If the woman is not of childbearing potential this should be 
documented in the medical history (e.g., surgically postmenopausal, 
postmenopausal [i.e., at least one year without menses]). For women of 
childbearing potential, their method of birth control should be documented in the 
source.   
 
7.5 INFORMED CONSENT
Before conducting any study procedures or examinations, the purpose and nature of 
the study should be explained to the subject in their native language.  
The subject, or their legally authorized representative (if applicable), will then read, 
sign, and personally date the IRB/IEC-approved informed consent document(s) 
(see below for difficulties with reading and writing). Additionally, the individual who 
obtains consent from the subject will sign and date the informed consent document. 

Clinical Protocol 
Study Number: CORI.2019.06
A Prospective, Multi-center, Randomized 
Controlled Study to Evaluate the Safety and 
Effectiveness of REAL INTELLIGENCE™ CORI™ in 
unicondylar knee arthroplasty (UKA) Procedure
Version: 4.0-Master, 07 Sep 
2022
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CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. 
and is intended for use only by Smith+Nephew and its manufacturer. It shall not be reproduced or copied in whole or in 
part, nor shall the contents be disclosed by any means without prior written permission from Smith+Nephew, nor shall 
anyone make any use of it that is contrary to the expressed or implied wishes of Smith+Nephew. 
TMP-CD-05-01 Clinical Protocol - Device – Revision D; SOP-CD-05 Clinical Protocol
A copy of the signed informed consent document will be provided to the subject, a 
copy will be placed in the subject’s medical record, with the original filed in the ISF. 
If the subject is unable to read, the informed consent document and associated 
study information may be read aloud to the subject in the presence of an impartial 
witness. If possible, the subject shall sign and personally date the Informed Consent 
Form (ICF). Where this is not possible, due to difficulties in writing, the subject shall 
provide verbal consent to participate in the study. The witness shall then personally 
sign and date the informed consent form, attesting that the information was 
accurately explained and that the informed consent was freely given. 
ICFs will comply with applicable laws and regulations in Australia (Privacy Act 
1988), China, South Korea, and New Zealand (Privacy Act 1993). If new information 
becomes available during the course of the study that can significantly affect a 
subject’s future health and medical care, Smith + Nephew will ensure that 
information shall be provided to the subject(s) affected in written form and if 
relevant, all affected subjects shall be asked to confirm their continuing consent in 
writing.  
7.6 ENROLMENT
Subjects for whom the consent process has been completed and have been treated 
with the study product are considered enrolled.  
Subjects that provided informed consent but do not receive the study treatment for 
any reason will be considered as screen failure. 
7.7 LOST TO FOLLOW-UP 
A subject will be considered lost to follow-up if he/she does not appear for the 
scheduled study visit for two (2) consecutive visits, and study personnel is unable to 
contact the subject. 

Clinical Protocol 
Study Number: CORI.2019.06
A Prospective, Multi-center, Randomized 
Controlled Study to Evaluate the Safety and 
Effectiveness of REAL INTELLIGENCE™ CORI™ in 
unicondylar knee arthroplasty (UKA) Procedure
Version: 4.0-Master, 07 Sep 
2022
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CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. 
and is intended for use only by Smith+Nephew and its manufacturer. It shall not be reproduced or copied in whole or in 
part, nor shall the contents be disclosed by any means without prior written permission from Smith+Nephew, nor shall 
anyone make any use of it that is contrary to the expressed or implied wishes of Smith+Nephew. 
TMP-CD-05-01 Clinical Protocol - Device – Revision D; SOP-CD-05 Clinical Protocol
Some actively enrolled subjects will not return for follow-up exams on time. Study 
personnel must make a reasonable effort to contact the subject and document the 
following contact attempts before declaring a subject to be lost to follow-up: the 
subject has been contacted according to the site's policies, but no fewer than two 
documented phone contacts and one certified letter without response. Copies of all 
attempts to reach the subjects by mail or email and/or the attempts to contact the 
subject via other means should be documented, and that documentation should be 
kept with the subject’s source documents. 
7.8 WITHDRAWAL 
7.8.1 Withdrawal from Treatment 
Subjects may be withdrawn early from having the study treatment at a date close 
to surgery or during surgery for the following reasons: 
 
At the discretion of the Investigator due to: 
o A change in treatment is clinically warranted 
o An adverse event 
o Any other significant reason identified by the Investigator 
7.8.2 Withdrawal from Study 
The Investigator may withdraw subjects from the study for many reasons, including 
but not limited to the following: 
 
Subject noncompliance (e.g., did not follow instructions, took disallowed 
medications) 
 
Subject is lost to follow-up 
 
The Investigator or the Sponsor terminates the study for any reason  
 
Concurrent illness 
 
Adverse Events/Adverse Device Effects 

Clinical Protocol 
Study Number: CORI.2019.06
A Prospective, Multi-center, Randomized 
Controlled Study to Evaluate the Safety and 
Effectiveness of REAL INTELLIGENCE™ CORI™ in 
unicondylar knee arthroplasty (UKA) Procedure
Version: 4.0-Master, 07 Sep 
2022
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CONFIDENTIAL AND PROPRIETARY 
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and is intended for use only by Smith+Nephew and its manufacturer. It shall not be reproduced or copied in whole or in 
part, nor shall the contents be disclosed by any means without prior written permission from Smith+Nephew, nor shall 
anyone make any use of it that is contrary to the expressed or implied wishes of Smith+Nephew. 
TMP-CD-05-01 Clinical Protocol - Device – Revision D; SOP-CD-05 Clinical Protocol
 
Any other significant reason identified by the Investigator 
For each case, the information will be recorded in the subject’s source document 
and the electronic Case Report Form (eCRF), detailing circumstances leading to the 
withdrawal.  
Subjects who withdraw or are withdrawn by the investigator cannot be re-enrolled 
in the study. Withdrawn subjects will not be replaced.  
If at any point during the study, the unicondylar prosthesis needs to be revised for 
any reason the following will apply: Subjects shall continue to have follow-up visits 
in order to monitor the subject’s health status. Potential data following the revision 
surgery will not be included as study data but presented separately as safety data.  
For minor revisions, where not the whole knee implant system is replaced (e.g. 
replacement of inserts) the subject shall continue with the study specific schedule 
and data will be presented. 
7.8.3 Subject’s Withdrawal of Consent to Participate in the Study 
Study participation is voluntary, and subjects may withdraw from the study at any 
time. Where subjects withdraw consent, the Investigator should make a reasonable 
effort to ascertain the reason(s), while fully respecting the subject’s right to privacy. 
The reason for withdrawal will be recorded in the eCRF and source documents. 
7.8.4 Use of Data Following Withdrawal 
In cases where the subject withdraws consent, the data collected up to the point of 
withdrawal may be used, but no additional data for that subject may be collected.  
 
 

Clinical Protocol 
Study Number: CORI.2019.06
A Prospective, Multi-center, Randomized 
Controlled Study to Evaluate the Safety and 
Effectiveness of REAL INTELLIGENCE™ CORI™ in 
unicondylar knee arthroplasty (UKA) Procedure
Version: 4.0-Master, 07 Sep 
2022
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CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. 
and is intended for use only by Smith+Nephew and its manufacturer. It shall not be reproduced or copied in whole or in 
part, nor shall the contents be disclosed by any means without prior written permission from Smith+Nephew, nor shall 
anyone make any use of it that is contrary to the expressed or implied wishes of Smith+Nephew. 
TMP-CD-05-01 Clinical Protocol - Device – Revision D; SOP-CD-05 Clinical Protocol
8
STUDY DESIGN
8.1 STUDY DESIGN 
This study is a prospective, multi-center, randomized controlled, non-blinded follow-
up study to evaluate the use of CORI in UKA procedure in achieving post-operative 
leg alignment. Up to 8 sites will participate within Australia, China (Hong Kong), 
New Zealand, South Korea, and China Mainland. 
The pre-randomized stage of the study will comprise of at least 5 subjects enrolled 
and treated with CORI directly in order to fulfil the learning needs of the surgeons. 
Subjects who will comprise the randomized stage of the study will be enrolled and 
randomized into one of two (2) groups, as shown in Table 8.1-8-1.  
All groups are treated with knee arthroplasty with a S+N Knee Implant System. 
(The implant system will be selected according to the registration status in each 
country). 
Table 8.1- 8-1 Overview of Study Groups 
Surgery 
Knee Implant system 
Surgical Technique
(Groups)
Number of 
Subjects
Primary UKA 
 
S+N UKA Implant 
System (Journey II 
Unicompartamental Knee 
System, Journey Uni) 
CORI  
70 
Conventional manual 
instrumentation 
70 
 
 

Clinical Protocol 
Study Number: CORI.2019.06
A Prospective, Multi-center, Randomized 
Controlled Study to Evaluate the Safety and 
Effectiveness of REAL INTELLIGENCE™ CORI™ in 
unicondylar knee arthroplasty (UKA) Procedure
Version: 4.0-Master, 07 Sep 
2022
Page: 54 of 167
CONFIDENTIAL AND PROPRIETARY
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. 
and is intended for use only by Smith+Nephew and its manufacturer. It shall not be reproduced or copied in whole or in 
part, nor shall the contents be disclosed by any means without prior written permission from Smith+Nephew, nor shall 
anyone make any use of it that is contrary to the expressed or implied wishes of Smith+Nephew.
TMP-CD-05-01 Clinical Protocol - Device – Revision D; SOP-CD-05 Clinical Protocol
Figure 8.1-8-1 Study Recruitment Timeline
The study is expected to enroll all subjects within a 12-month timeframe. Subjects
will be followed-up for a time period of 12 months after surgery.  Figure 8.1-8-1 
details the Study Recruitment timeline.
This study is being conducted in parallel to a global cohort study titled: “A 
Prospective, Multi-center Study to Evaluate the Safety and Effectiveness of REAL 
INTELLIGENCE™ CORI™ in unicondylar knee arthroplasty (UKA) and total knee 
arthroplasty (TKA) Procedures” (Protocol ID: CORI.2019.07). The study data may 
be combined for analysis. Further details are described in Section 10 Statistical 
Design and the Statistical Analysis Plan (SAP).
Figure 8.1-8-2 details the different steps of study conduct from screening to 
enrollment and follow-up.
Subjects may be assigned a subject ID, but then not enrolled in the study (e.g. did 
not receive the study device or decided not to participate in the study).
Enrolment
Training & 
Pre-study Cases
USA Market Access
Follow-up
August             March                  April                         March               April
2020                 2022                  2022                          2024               2025

Clinical Protocol 
Study Number: CORI.2019.06
A Prospective, Multi-center, Randomized 
Controlled Study to Evaluate the Safety and 
Effectiveness of REAL INTELLIGENCE™ CORI™ in 
unicondylar knee arthroplasty (UKA) Procedure
Version: 4.0-Master, 07 Sep 
2022
Page: 55 of 167
CONFIDENTIAL AND PROPRIETARY
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. 
and is intended for use only by Smith+Nephew and its manufacturer. It shall not be reproduced or copied in whole or in 
part, nor shall the contents be disclosed by any means without prior written permission from Smith+Nephew, nor shall 
anyone make any use of it that is contrary to the expressed or implied wishes of Smith+Nephew.
TMP-CD-05-01 Clinical Protocol - Device – Revision D; SOP-CD-05 Clinical Protocol
Figure 8.1-8-2 Study Flowchart
8.2 ALLOCATION AND BLINDING
8.2.1 Treatment Allocation
Subjects will be randomly assigned to the CORI navigational or conventional manual 
instrumentation groups according to a balanced randomization procedure using a 
1:1 allocation ratio. To ensure balanced group assignment within each 
investigational site, a block (by investigational site) randomization schedule will be 
generated. Only sites will be included that are willing to perform both, CORI 
Navigated and conventional instrumentation UKA procedures. Subjects who satisfy 
all inclusion and exclusion criteria will be randomized in a 1:1 randomization 
allocation ratio. The block size should be sufficiently small to allow approximately 
equal allocation of subjects in each group should the study be terminated 
prematurely whilst also being large enough so as the next treatment cannot be 
guessed.

Clinical Protocol 
Study Number: CORI.2019.06
A Prospective, Multi-center, Randomized 
Controlled Study to Evaluate the Safety and 
Effectiveness of REAL INTELLIGENCE™ CORI™ in 
unicondylar knee arthroplasty (UKA) Procedure
Version: 4.0-Master, 07 Sep 
2022
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and is intended for use only by Smith+Nephew and its manufacturer. It shall not be reproduced or copied in whole or in 
part, nor shall the contents be disclosed by any means without prior written permission from Smith+Nephew, nor shall 
anyone make any use of it that is contrary to the expressed or implied wishes of Smith+Nephew. 
TMP-CD-05-01 Clinical Protocol - Device – Revision D; SOP-CD-05 Clinical Protocol
8.2.2 Blinding
The study is non-blinded. 
8.3 DATA MANAGEMENT
This study utilizes a validated, encrypted electronic data capture system that is 21 
CFR Part 11 compliant. Access to the electronic data capture system is restricted by 
study role in accordance with Smith and Nephew procedures.  
A Data Management Plan (DMP) is written according to Smith and Nephew procedures 
containing details of the data management process. The following is a brief description 
of the key points detailed in this plan. 
8.3.1 Data Review and Quality Assurance  
Data will be transcribed from the data source to an electronic Case Report Form 
(eCRF). All data requested on the eCRFs are considered required. Data points not 
collected and/or recorded will be considered deviations unless otherwise specified.  
Data collection is the responsibility of the clinical trial staff at the site under the 
supervision of the Principal Investigator. The Principal Investigator is responsible for 
ensuring the accuracy, completeness, legibility, and timeliness of the data reported. 
The Principal Investigator must provide his/her electronic signature on the 
appropriate eCRFs to be documented in compliance with local regulations. Changes 
to data previously submitted to the sponsor will require a new signature by the 
Investigator to acknowledge/approve the changes.  
Visual and computer data review will be performed in line with Smith and Nephew 
procedures to identify possible data discrepancies. Manual and automatic queries will 
be created within the electronic data capture system, and will be issued by Smith and 
Nephew to the site for appropriate response. Site staff are responsible for resolving 
all queries in the electronic data capture system.  

Clinical Protocol 
Study Number: CORI.2019.06
A Prospective, Multi-center, Randomized 
Controlled Study to Evaluate the Safety and 
Effectiveness of REAL INTELLIGENCE™ CORI™ in 
unicondylar knee arthroplasty (UKA) Procedure
Version: 4.0-Master, 07 Sep 
2022
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CONFIDENTIAL AND PROPRIETARY 
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and is intended for use only by Smith+Nephew and its manufacturer. It shall not be reproduced or copied in whole or in 
part, nor shall the contents be disclosed by any means without prior written permission from Smith+Nephew, nor shall 
anyone make any use of it that is contrary to the expressed or implied wishes of Smith+Nephew. 
TMP-CD-05-01 Clinical Protocol - Device – Revision D; SOP-CD-05 Clinical Protocol
8.3.2 Retention Period
All eCRFs will be archived once the study is completed and will kept for a period of no 
less than five years after the later of the following dates: the date of which the study 
is terminated or completed or; the date that the records are no longer required 
supporting marketing applications. 
8.4 STUDY ENDPOINTS
8.4.1 Primary Endpoint
The primary endpoint of this study is defined as the evaluation of the proportion of 
subjects achieving planned post-operative leg alignment. Achieved leg alignment is 
defined as ± 3° from the subject’s specific target in comparison with conventional 
manual instrumentation.   
8.4.2 Secondary Endpoints  
The following secondary endpoints have been defined for this study in order to 
evaluate the safety and performance of CORI in comparison with conventional 
manual instrumentation up to 12 months post-operatively: 
 
Component Alignment 
 
Radiographic assessment (Presence of radiolucent lines, osteolysis & implant 
migration) 
 
2011 Knee Society Score (2011 KSS) 
 
Oxford Knee Score (OKS) 
 
Forgotten Joint Score (FJS-12) 
 
Five-level EuroQol five-dimensional (EQ-5D-5L) VAS & index scores 
8.4.3 Other Endpoints 
The following additional endpoints have been defined for this study: 

Clinical Protocol 
Study Number: CORI.2019.06
A Prospective, Multi-center, Randomized 
Controlled Study to Evaluate the Safety and 
Effectiveness of REAL INTELLIGENCE™ CORI™ in 
unicondylar knee arthroplasty (UKA) Procedure
Version: 4.0-Master, 07 Sep 
2022
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and is intended for use only by Smith+Nephew and its manufacturer. It shall not be reproduced or copied in whole or in 
part, nor shall the contents be disclosed by any means without prior written permission from Smith+Nephew, nor shall 
anyone make any use of it that is contrary to the expressed or implied wishes of Smith+Nephew. 
TMP-CD-05-01 Clinical Protocol - Device – Revision D; SOP-CD-05 Clinical Protocol
 
Leg alignment pre- and post-cementation for CORI UKA  
 
Navigations System time as extracted from the Subject’s CORI Case Report 
generated by the CORI Software. 
 
Cutting time of the robotic drills extracted from the Subject’s CORI Case 
Report, generated by the CORI Software. 
8.4.4 Safety Endpoints 
Safety endpoints include the collection of the following events: 
 
All adverse events (AEs) and complications occurring from the time of subject 
enrollment until study termination or study completion including intra-
operative adverse events and complications.  
 
Device related re-intervention 
 
Device Deficiencies 
 
Knee implant revision rate 
8.5 METHODS USED TO MINIMIZE BIAS AND MAXIMIZE VALIDITY
8.5.1 Multiple sites 
After fulfillment of all eligibility criteria (including informed consent), subjects will be 
enrolled and randomized at multiple sites, utilizing up to 8 sites in total for the 
study. Subject enrollment will continue until the completion of recruitment of a 
minimum of 140 subjects. File records and enrollment registration forms for 
screening work must be retained and submitted to the Sponsor as needed. 
8.5.2 Prospective Consecutive Enrolment 
Subjects meeting all inclusion/exclusion criteria will be randomly allocated to one of 
two treatment groups (CORI Navigational versus conventional manual 
instrumentation) in a 1:1 allocation ratio. Blocked randomization to balance this 
allocation ratio by investigational site and overall will be implemented through a 

Clinical Protocol 
Study Number: CORI.2019.06
A Prospective, Multi-center, Randomized 
Controlled Study to Evaluate the Safety and 
Effectiveness of REAL INTELLIGENCE™ CORI™ in 
unicondylar knee arthroplasty (UKA) Procedure
Version: 4.0-Master, 07 Sep 
2022
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part, nor shall the contents be disclosed by any means without prior written permission from Smith+Nephew, nor shall 
anyone make any use of it that is contrary to the expressed or implied wishes of Smith+Nephew. 
TMP-CD-05-01 Clinical Protocol - Device – Revision D; SOP-CD-05 Clinical Protocol
network-based randomization system. A randomization number is allocated only 
when subjects have signed the Informed Consent Form and satisfy all study 
eligibility criteria. 
8.5.3 Subject Attrition  
Subject attrition for the sample size has been accounted for in the sample size 
estimation. 
8.5.4 Pre-specification of Statistical Analysis 
The primary outcome measure has been pre-specified as well as the type of statistical 
analysis to be performed in order to evaluate this outcome. The details of all analyses 
to be performed will further be pre-specified in the Statistical Analysis Plan (SAP) so 
as to minimize any threats to external validity and yield clinically relevant estimates 
of effects and precision. 
9 
STUDY PROCEDURES
9.1 VISITS AND EXAMINATIONS 
9.1.1 Summary 
For a summary of the required procedures by visit, refer to the Study Schematic 
Table 9.1.1-9-1 Study Procedures by Visit. 
 
 

Clinical Protocol 
Study Number: CORI.2019.06
A Prospective, Multi-center, Randomized 
Controlled Study to Evaluate the Safety and 
Effectiveness of REAL INTELLIGENCE™ CORI™ in 
unicondylar knee arthroplasty (UKA) Procedure
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anyone make any use of it that is contrary to the expressed or implied wishes of Smith+Nephew. 
TMP-CD-05-01 Clinical Protocol - Device – Revision D; SOP-CD-05 Clinical Protocol
Table 9.1.1-9-1 Study Procedures by Visit 
Schedule of events 
Pre-
Operative
Data
-90 to 0 
days
Operative 
Data 
& 
Discharge
Day 1 (+ 
up 
to 
9 
days)
6 weeks
 
42 ± 14 
days
6 months
 
185 ± 14 
days
12 
months
 
365 ± 30 
days
Informed Consent
x
 
 
 
Demographics/ 
Medical  History 
x
 
 
 
Inclusion/Exclusion  
x
 
 
 
Preoperative 
Examinations 
(eg.
ECG, Blood Routine 
Examination, 
Biochemical 
Examination, 
Coagulation 
Examination)1
x
 
 
 
Pregnancy Test2
x
 
 
 
Concomitant 
Medication
x
 
 
 
Concomitant 
Medication Update
x 
x
x
x
Operative 
Data 
Collection
x 
 
 
 
CORI 
Case 
Report 
(System 
time 
& 
cutting time) 
x 
 
 
 
Discharge 
Data 
Collection
x 
 
 
 
Leg alignment Long 
leg X-ray AP3 
x
(x)4
x
 
(x)5
Standard Lateral X-
ray
(x)4
x
 
x
Standard A/P X-ray 
 
 
x

Clinical Protocol 
Study Number: CORI.2019.06
A Prospective, Multi-center, Randomized 
Controlled Study to Evaluate the Safety and 
Effectiveness of REAL INTELLIGENCE™ CORI™ in 
unicondylar knee arthroplasty (UKA) Procedure
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anyone make any use of it that is contrary to the expressed or implied wishes of Smith+Nephew. 
TMP-CD-05-01 Clinical Protocol - Device – Revision D; SOP-CD-05 Clinical Protocol
KSS
x
x
x
x
OKS
x
x
x
x
FJS-12 
x
x
x
EQ-5D-5L
x
x
x
x
Safety Assessment
x 
x
x
x
End of Study/Exit  
(x)6 
(x)6 
x
1
Only applicable at sites in China
2
Only Applicable at site in China
3
Pre-operative long leg X-rays (A/P) collected 6-months prior to the date of surgery is 
admissible 
4
Post-operative standing weight bearing long leg X-rays (A/P) and standard lateral X-rays may 
be taken at discharge.  
5
Only if standing weight bearing long leg A/P X-ray is taken as a standard of care at 12 months. 
6
Exit form to be completed at the point of withdrawal if the study is not completed.

Clinical Protocol 
Study Number: CORI.2019.06
A Prospective, Multi-center, Randomized 
Controlled Study to Evaluate the Safety and 
Effectiveness of REAL INTELLIGENCE™ CORI™ in 
unicondylar knee arthroplasty (UKA) Procedure
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TMP-CD-05-01 Clinical Protocol - Device – Revision D; SOP-CD-05 Clinical Protocol
9.1.2 Screening/Pre-operative Visit 
1.
Obtain written informed consent from the subject as detailed in Section 7.5. 
----- Do not proceed until the consent has been obtained ----- 
2.
Obtain demographic information and medical history, including information on 
all concomitant medications/therapies. 
3.
Screen the subject for protocol inclusion/exclusion criteria.
4.
The eCRF will assign the subject a study number. The subject identification log 
shall be completed accordingly. 
5.
Instruct the subject on treatment procedures.
6.
Collect radiographic images of the affected knee for evaluation of leg alignment
(Standing weight bearing A/P long leg X-ray). 
7.
Collect the 2011 KSS score objective measures (joint alignment, instability, 
motions & symptoms). 
8.
Have the subject complete the 2011 KSS score subject questions.
9.
Have the subject complete the OKS patient-reported outcome measure. 
10. Have the subject complete the EQ-5D-5L patient-reported outcome measure. 
11. The subject will be randomized to treatment group (CORI or Manual 
conventional instrumentation). 
12. Subjects will be instructed to return for the Operation Visit on a scheduled date.
9.1.3 Operation Visit & Discharge (Day 1+up to 9 days)  
1. 
Prior to surgery, check if there is any change in eligibility of the subject since 
the pre-operative visit. If the subject is no longer eligible, document as 
screening failure. 

Clinical Protocol 
Study Number: CORI.2019.06
A Prospective, Multi-center, Randomized 
Controlled Study to Evaluate the Safety and 
Effectiveness of REAL INTELLIGENCE™ CORI™ in 
unicondylar knee arthroplasty (UKA) Procedure
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anyone make any use of it that is contrary to the expressed or implied wishes of Smith+Nephew.
TMP-CD-05-01 Clinical Protocol - Device – Revision D; SOP-CD-05 Clinical Protocol
2.
Query subject regarding any changes in general health and the use of 
concomitant medications/therapies.
3.
Collect data on the surgical plan: Target Leg alignment.
4.
Perform surgery and collect intra-operative data on the appropriate eCRF. 
This includes but is not limited to the following information:
Knee Implant Data
Surgical data (e.g. duration, blood loss, surgical approach)
Collect pre- (with the trial implant in place) and post cementation 
alignment with the use of CORI.
Collect the Subject’s CORI Case Report, generated CORI Software 
(System time, cutting time) for CORI group.
5.
Complete discharge eCRF.
6.
If any adverse device effects or device deficiencies are observed or reported, 
they must be recorded as instructed in Section 12 - Adverse Events and 
Device Deficiencies.
7.
Instruct the subject on proper postoperative care/procedures.
8.
Instruct the subject returning to the site for the next follow up visit 6 weeks 
(42 ± 14 days) after the surgery date.
9.1.4 Follow-up visits at 6 weeks (42 ± 14 days) 
Query subject regarding any changes in general health and the use of 
concomitant medications/therapies.
If any adverse device effects or device deficiencies are observed or reported, 
they must be recorded as instructed in Section 12 - Adverse Events and Device 
Deficiencies.

Clinical Protocol 
Study Number: CORI.2019.06
A Prospective, Multi-center, Randomized 
Controlled Study to Evaluate the Safety and 
Effectiveness of REAL INTELLIGENCE™ CORI™ in 
unicondylar knee arthroplasty (UKA) Procedure
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part, nor shall the contents be disclosed by any means without prior written permission from Smith+Nephew, nor shall 
anyone make any use of it that is contrary to the expressed or implied wishes of Smith+Nephew.
TMP-CD-05-01 Clinical Protocol - Device – Revision D; SOP-CD-05 Clinical Protocol
Verify with the subject if any revision has occurred since the last visit. If any 
revision is observed or reported, it must be recorded as instructed in Section 
12 - Adverse Events and Device Deficiencies.
Collect the 2011 KSS score objective measures (joint alignment, instability, 
motions & symptoms).
Have the subject complete the 2011 KSS score subject questions.
Have the subject complete the OKS patient-reported outcome measure
Have the subject complete the EQ-5D-5L patient-reported outcome measure.
Have the subject complete the FJS-12 patient-reported outcome measure.
Collect the standing weight bearing long leg (A/P) and standard lateral (non-
weight bearing) radiographic images of the affected knee. Review the images 
to complete the appropriate eCRF for leg alignment and component alignment. 
Instruct the subject on follow-up procedures, including returning to the site 
for the next follow-up visit in 6 months (185 ± 14 days) after the surgery 
date.
9.1.5 6 months (185 ± 14 days) after surgery
1.
Query subject regarding any changes in general health and the use of 
concomitant medications/therapies.
2.
If any adverse device effects or device deficiencies are observed or reported, 
they must be recorded as instructed in Section 12 - Adverse Events and Device 
Deficiencies.
3.
Verify with the subject if any revision has occurred since the last visit. If any 
revision is observed or reported, it must be recorded as instructed in Section 
12 - Adverse Events and Device Deficiencies.

Clinical Protocol 
Study Number: CORI.2019.06
A Prospective, Multi-center, Randomized 
Controlled Study to Evaluate the Safety and 
Effectiveness of REAL INTELLIGENCE™ CORI™ in 
unicondylar knee arthroplasty (UKA) Procedure
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part, nor shall the contents be disclosed by any means without prior written permission from Smith+Nephew, nor shall 
anyone make any use of it that is contrary to the expressed or implied wishes of Smith+Nephew. 
TMP-CD-05-01 Clinical Protocol - Device – Revision D; SOP-CD-05 Clinical Protocol
4.
Collect the 2011 KSS score objective measures (joint alignment, instability, 
motions & symptoms).
5.
Have the subject complete the 2011 KSS score subject questions.
6.
Have the subject complete the OKS patient-reported outcome measure 
7.
Have the subject complete the EQ-5D-5L patient-reported outcome measure. 
8.
Have the subject complete the FJS-12 patient-reported outcome measure. 
9.
Instruct the subject on follow-up procedures, including returning to the site for 
the next follow-up visit 12 months (365 ± 30 days) after the surgery date. 
9.1.6 Exit visit 12 months (365 ± 30 days) after surgery 
1.
Query subject regarding any changes in general health and the use of 
concomitant medications/therapies. 
2.  
If any adverse device effects or device deficiencies are observed or reported, 
they must be recorded as instructed in Section 12 - Adverse Events and Device 
Deficiencies. 
3.
Verify with the subject if any revision has occurred since the last visit. If any 
revision is observed or reported, it must be recorded as instructed in Section 
12 - Adverse Events and Device Deficiencies. 
4.
Collect standard A/P and lateral radiographic images of the affected knee. 
Review the images to complete the appropriate eCRF for standard 
radiographic evaluation (presence of radiolucent lines, osteolysis and implant 
migration).  
5.
In case a standing long leg X-ray is taken as a standard of care, please 
complete the respective leg alignment eCRF (optional). 

Clinical Protocol 
Study Number: CORI.2019.06
A Prospective, Multi-center, Randomized 
Controlled Study to Evaluate the Safety and 
Effectiveness of REAL INTELLIGENCE™ CORI™ in 
unicondylar knee arthroplasty (UKA) Procedure
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part, nor shall the contents be disclosed by any means without prior written permission from Smith+Nephew, nor shall 
anyone make any use of it that is contrary to the expressed or implied wishes of Smith+Nephew. 
TMP-CD-05-01 Clinical Protocol - Device – Revision D; SOP-CD-05 Clinical Protocol
6.
Collect the 2011 KSS score objective measures (joint alignment, instability, 
motions & symptoms).
7. 
Have the subject complete the 2011 KSS score subject questions.
8.
Have the subject complete the OKS patient-reported outcome measure 
9.
Have the subject complete the EQ-5D-5L patient-reported outcome measure.
10.
Have the subject complete the FJS-12 patient-reported outcome measure. 
11.
Complete Exit Visit eCRF.
9.1.7 Unscheduled Visits  
Unscheduled examinations may be conducted at the discretion of the Investigator 
with all obtained information recorded in the source documents and on the 
appropriate eCRF. The subject should be scheduled to return for the next scheduled 
study visit within the acceptable time window. 
9.1.8 Concomitant Medications and Therapies 
Concomitant medications and concomitant therapies (e.g., physical therapy, pain 
medication) are recorded at any time from enrollment into the study through the 
subject’s last study visit.  
Concomitant Medications 
Excluded Concomitant Medications 
There are no restrictions on concomitant medications for this study. 
Recording Concomitant Medications in the eCRF 
Only medications related to the study treatment and medications used to treat an 
adverse event related to the study device and device deficiency will be recorded in 

Clinical Protocol 
Study Number: CORI.2019.06
A Prospective, Multi-center, Randomized 
Controlled Study to Evaluate the Safety and 
Effectiveness of REAL INTELLIGENCE™ CORI™ in 
unicondylar knee arthroplasty (UKA) Procedure
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part, nor shall the contents be disclosed by any means without prior written permission from Smith+Nephew, nor shall 
anyone make any use of it that is contrary to the expressed or implied wishes of Smith+Nephew. 
TMP-CD-05-01 Clinical Protocol - Device – Revision D; SOP-CD-05 Clinical Protocol
the eCRF. Reference the eCRF Completion Guidelines for how medications are 
recorded.    
Concomitant Therapies 
Therapies Prohibited During the Study 
There are no restrictions on concomitant therapies for this study.
Recording Concomitant Therapies in the eCRF 
Only therapies related to the study treatment and therapies used to treat an 
adverse event related to the study device and device deficiency will be recorded in 
the eCRF. Reference the eCRF Completion Guidelines for how therapies are 
recorded.     
9.1.9 Discontinued Subjects 
Discontinued subjects are those who voluntarily discontinue participation, who are 
withdrawn for reasons of safety or use of prohibited concomitant 
medications/therapies, who are lost to follow-up, refer to Section 7.8 for further 
details. Where possible, the next scheduled study visit should be completed for all 
subjects who discontinue the study early. Where consent is withdrawn, the date and 
any reason given for discontinuation should be captured, at a minimum (see Section 
7.8.3). 
Finally, if appropriate, the Investigator will also advise the subject of subsequent 
therapy and/or procedures necessary for their medical condition.  
9.1.10 Subject Pregnancy 
Women of child-bearing potential are not excluded from the study. However, if a 
woman becomes pregnant during the study, S+N must be contacted immediately 

Clinical Protocol 
Study Number: CORI.2019.06
A Prospective, Multi-center, Randomized 
Controlled Study to Evaluate the Safety and 
Effectiveness of REAL INTELLIGENCE™ CORI™ in 
unicondylar knee arthroplasty (UKA) Procedure
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part, nor shall the contents be disclosed by any means without prior written permission from Smith+Nephew, nor shall 
anyone make any use of it that is contrary to the expressed or implied wishes of Smith+Nephew. 
TMP-CD-05-01 Clinical Protocol - Device – Revision D; SOP-CD-05 Clinical Protocol
once the investigator is made aware of the pregnancy. All study procedures that are 
contraindicated during pregnancy and/or lactation (e.g., x-rays) will not be 
required. A decision will be made regarding the continuation in the study of the 
pregnant woman. Pregnancy is not an adverse event; however, complications 
related to the pregnancy may be reportable as determined on a case-by-case basis. 
Pregnancy-related information will be collected until the end of the pregnancy. 
 
 

Clinical Protocol 
Study Number: CORI.2019.06
A Prospective, Multi-center, Randomized 
Controlled Study to Evaluate the Safety and 
Effectiveness of REAL INTELLIGENCE™ CORI™ in 
unicondylar knee arthroplasty (UKA) Procedure
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2022
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and is intended for use only by Smith+Nephew and its manufacturer. It shall not be reproduced or copied in whole or in 
part, nor shall the contents be disclosed by any means without prior written permission from Smith+Nephew, nor shall 
anyone make any use of it that is contrary to the expressed or implied wishes of Smith+Nephew.
TMP-CD-05-01 Clinical Protocol - Device – Revision D; SOP-CD-05 Clinical Protocol
9.2 STUDY METHODS AND MEASUREMENTS
9.2.1 Leg alignment
The leg alignment should be measured from an antero-posterior (A/P) view standing 
weight bearing full leg (‘long leg’) x-ray. The following axes shall be identified:
Mechanical Axis of the femur: Axis from the center of the femoral head to the 
center of the distal femur.
Mechanical Axis of the tibia: Axis from the center of the proximal to the center 
of the distal tibia.
The angular deviation from the neutral position (180°) shall be measured as shown 
as “E” in Figure 9.2-9-1. The angular deviation from the neutral position shall be 
recorded in the eCRF. 
Figure 9.2-9-1 Leg alignment
Red: Mechanical Axis of Femur: Axis from the 
center of the femoral head to the center of the 
distal femur
Yellow: Mechanical Axis of Tibia: Axis from the 
center of the proximal to the center of the distal 
center of the tibia.
Blue: Neutral position axis (180°).
E: Deviation angle from the neutral position.

Clinical Protocol 
Study Number: CORI.2019.06
A Prospective, Multi-center, Randomized 
Controlled Study to Evaluate the Safety and 
Effectiveness of REAL INTELLIGENCE™ CORI™ in 
unicondylar knee arthroplasty (UKA) Procedure
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part, nor shall the contents be disclosed by any means without prior written permission from Smith+Nephew, nor shall 
anyone make any use of it that is contrary to the expressed or implied wishes of Smith+Nephew. 
TMP-CD-05-01 Clinical Protocol - Device – Revision D; SOP-CD-05 Clinical Protocol
Pre-Operative Leg alignment 
The pre-operative leg alignment evaluated from a standing weight bearing long leg 
standing A/P shall be recorded. 
Target Leg alignment (Surgical Plan) 
The operative plan for leg alignment as entered in CORI shall be recorded in the 
eCRF for each subject. The planned leg alignment serves as the target for post-
operative leg alignment. This may not be a neutral position. 
Pre- & Post-Cementation Leg alignment (for CORI UKA only) 
The pre-cementation leg alignment shall be recorded with the use of CORI (manual 
screenshot to be taken) with the trials implant is placed. 
Once the final implant has been cemented the post-cementation leg alignment shall 
be recorded with CORI (manual screenshot to be taken). 
Post-Operative Leg alignment 
The leg alignment shall be assessed post-operatively and 6 weeks after surgery on 
standing weight bearing long leg A/P X-ray and lateral X-ray. Optionally, leg 
alignment can be assessed optionally at 12 months, in case a standing weight 
bearing long leg A/P X-ray is taken at 12 months. 
Post-operative leg alignment is achieved when the deviation from the subject 
specific target does not exceed ±3 degrees. 
All leg alignment measures will be added to the eCRF. 

Clinical Protocol 
Study Number: CORI.2019.06
A Prospective, Multi-center, Randomized 
Controlled Study to Evaluate the Safety and 
Effectiveness of REAL INTELLIGENCE™ CORI™ in 
unicondylar knee arthroplasty (UKA) Procedure
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part, nor shall the contents be disclosed by any means without prior written permission from Smith+Nephew, nor shall 
anyone make any use of it that is contrary to the expressed or implied wishes of Smith+Nephew.
TMP-CD-05-01 Clinical Protocol - Device – Revision D; SOP-CD-05 Clinical Protocol
9.2.2 Component Alignment
Component alignment will be assessed on long leg standing A/P X-rays and 
standard non-weight bearing lateral X-rays taken 6 weeks after surgery (or at 
discharge). The following angles will be evaluated on the X-rays and recorded in the 
eCRF:
A/P View
Femoral
A/P 
Angle: 
From 
the
A/P 
radiograph, the femoral flexion angle is to be 
obtained using standard radiographic tools. 
Femoral flexion angle is defined as the angle 
formed between a line across the base of the 
femoral condyles and a line that is centered 
along the femoral canal
Tibial A/P Angle: From the A/P radiograph, 
the tibial angle denotes the angle formed on 
the medial side of the knee from intersecting 
lines parallel to the tibial base plate and a line 
drawn parallel to the tibial canal (Figure 9.2-9-
2).
Total Valgus Angle: Is the sum of the femoral 
flexion angle and the tibial angle.
Figure 9.2.2-9-2 A/P 
View
A: Femoral A/P Angle 
B: Tibial A/P Angle
A+B: Total Valgus Angle
Lateral View
Femoral Flexion Angle: The lateral view 
femoral flexion angle is obtained from the 
intersection of a line from the center of the 
femoral implant to the top of the femur with a 

Clinical Protocol 
Study Number: CORI.2019.06
A Prospective, Multi-center, Randomized 
Controlled Study to Evaluate the Safety and 
Effectiveness of REAL INTELLIGENCE™ CORI™ in 
unicondylar knee arthroplasty (UKA) Procedure
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part, nor shall the contents be disclosed by any means without prior written permission from Smith+Nephew, nor shall 
anyone make any use of it that is contrary to the expressed or implied wishes of Smith+Nephew.
TMP-CD-05-01 Clinical Protocol - Device – Revision D; SOP-CD-05 Clinical Protocol
line through the femoral canal. The angle is 
measured on the proximal side of the 
intersection
Tibial Lateral Angle: The lateral view tibial 
angle 
is 
the 
angle 
obtained 
from 
the 
intersection of a line drawn parallel to the 
bottom of the tibial base insert and a line 
through the center of the tibial base and the 
tibial canal.
Figure 9.2.2-9-3 
Lateral View
X: Femoral Flexion Angle
Y: Tibial Lateral Angle
9.2.3 Standard Radiographic Evaluation
Standard radiographic evaluation on antero-posterior (A/P) and lateral views shall 
be performed 12 months after surgery in order to identify any radiographic 
observations such as radiolucent lines around the implant components. The 
presence of radiolucent lines, osteolysis & implant migration shall be recorded in the 
eCRF.
9.2.4 2011 Knee Society Score (2011 KSS)
The 2011 Knee Society Score will be collected at the pre-operative visit and 6 
weeks, 6- and 12-months after surgery. 
The 2011 KSS is a validated tool that combines an objective physician-derived 
component with a subjective subject-derived component [45, 46]. The 2011 KSS 
consists of 34 questions and provides sub-scores across 4 dimensions as shown in 
Table 9.2.4-9-2. 
Table 9.2.4-9-2 2011 Knee Society Score 
# 
Sub-Score
# Questions
Completion by
1
Objective Knee Score
4
Surgeon

Clinical Protocol 
Study Number: CORI.2019.06
A Prospective, Multi-center, Randomized 
Controlled Study to Evaluate the Safety and 
Effectiveness of REAL INTELLIGENCE™ CORI™ in 
unicondylar knee arthroplasty (UKA) Procedure
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part, nor shall the contents be disclosed by any means without prior written permission from Smith+Nephew, nor shall 
anyone make any use of it that is contrary to the expressed or implied wishes of Smith+Nephew. 
TMP-CD-05-01 Clinical Protocol - Device – Revision D; SOP-CD-05 Clinical Protocol
2
Symptoms
3
Subject
2 
Subject Satisfaction 
Score 
5 
Subject 
3 
Subject Expectation
3 
Subject 
4 
Functional Knee Score 
19
Subject 
The Objective Knee Score is rated by the clinician and assesses a range of clinical 
outcomes: UKA alignment, stability, ROM and symptoms. The Subject Satisfaction 
Score assesses the satisfaction with 5 daily activities (sitting, lying in bed, getting 
out of bed, light household duties, and leisure activities). The Subject Expectation 
Score evaluates the subject’s expectations prior to surgery. The post-operative 
questions differ from the pre-operative questions and ask if the subject’s pre-
operative expectations have been met. As the pre- and post-operative scores are 
based on different questions, they cannot be directly compared. The Functional 
Knee Score is derived from assessments of walking and standing, standard 
activities, advanced activities, and discretionary activities. 
A paper questionnaire will be provided by the Sponsor to be completed by the subject. 
Responses for the 2011 KSS will then be recorded in the eCRF. 
9.2.5 Oxford Knee Score (OKS) 
The OKS will be collected at the pre-operative visit and 6 weeks, 6- and 12-months 
after surgery. 
The OKS is a Patient Reported Outcome questionnaire that was developed to 
specifically assess the patient's perspective of outcome following Total Knee 
Arthroplasty. The OKS is a patient self-completion PRO containing 12 equally 
weighted questions on activities of daily living. The OKS has been developed and 
validated specifically to assess perceived function and pain answered on a Likert scale 
after TKA [47, 48]. Responses to each question ranges from 0-4 with a range of a 

Clinical Protocol 
Study Number: CORI.2019.06
A Prospective, Multi-center, Randomized 
Controlled Study to Evaluate the Safety and 
Effectiveness of REAL INTELLIGENCE™ CORI™ in 
unicondylar knee arthroplasty (UKA) Procedure
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part, nor shall the contents be disclosed by any means without prior written permission from Smith+Nephew, nor shall 
anyone make any use of it that is contrary to the expressed or implied wishes of Smith+Nephew. 
TMP-CD-05-01 Clinical Protocol - Device – Revision D; SOP-CD-05 Clinical Protocol
possible overall score from 0-48. A score of 0 is the worst possible outcome while a 
score of 48 is the best possible outcome. The benefit to this questionnaire is that it is 
short, practical, reliable, valid and sensitive to clinically important changes over time.  
A paper questionnaire will be provided by the Sponsor to be completed by the subject. 
Responses for the OKS will then be recorded in the eCRF. 
9.2.6 Forgotten Joint Score (FJS-12) 
The FJS-12will be collected at 6 weeks, 6- and 12-months after surgery. A paper 
questionnaire will be provided by the Sponsor to be completed by the subject. 
The FJS-12 comprises measures for the assessment of joint-specific patient 
reported outcomes. This questionnaire focuses on the study subject’s awareness of 
the partially or fully replaced knee joint in everyday life. Joint awareness can be 
simply defined as any unintended perception of a joint [49]. Subjects are asked to 
rate their awareness of their knee arthroplasty in 12 questions with a five point 
Likert response format: “Never”, “almost never”, “seldom”, “sometimes” and 
“mostly”. The item scores are summed and linearly transformed in a 0 to 100 scale 
with a high value reflecting the ability of the subject to forget about the replaced 
knee joint during the activities of daily living.  
A paper questionnaire will be provided by the Sponsor to be completed by the 
subject. Responses for the FJS-12 will then be recorded in the eCRF. 
9.2.7 CORI System Time & Cutting Time 
CORI System Time and the Cutting Time of the robotic drill shall be collected post-
operatively.  
CORI Case Report, including case logs, will be extracted from CORI via USB and 
time data will be extracted for CORI System Time and the Cutting Time  

Clinical Protocol 
Study Number: CORI.2019.06
A Prospective, Multi-center, Randomized 
Controlled Study to Evaluate the Safety and 
Effectiveness of REAL INTELLIGENCE™ CORI™ in 
unicondylar knee arthroplasty (UKA) Procedure
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part, nor shall the contents be disclosed by any means without prior written permission from Smith+Nephew, nor shall 
anyone make any use of it that is contrary to the expressed or implied wishes of Smith+Nephew. 
TMP-CD-05-01 Clinical Protocol - Device – Revision D; SOP-CD-05 Clinical Protocol
In the case logs, the following time stamps will be recorded in the log file of the 
CORI Case Report: 
1. State-Machine transition : [ Adjust Camera ] --> [ Checkpoint Definition ]  
2. State-Machine transition : [ Checkpoint Verification ] --> [ Remove Bone ]  
3. State-Machine transition : [ Remove Bone ] --> [ Baseline Stress ROM 
Collection ]  
CORI System Time  
CORI System starts with the checkpoint definition until the bone is removed. This is 
calculated by the time difference between #3 and #1. 
Cutting Time 
The Cutting Time of the robotic drill is the time from the start until the end of bone 
removal and is calculated by the time difference between #3 and #2. 
The CORI System time and the cutting time of the robotic drill will not be recorded 
in the eCRF as they will be extracted directly from the CORI Case Report. 
9.3 HEALTH ECONOMICS/QUALITY OF LIFE 
9.3.1 EQ-5D-5L 
The EQ-5D-5L questionnaire will be collected at the pre-operative visit as well as 6 
weeks, 6- and 12-months after surgery. A paper questionnaire will be provided by 
the Sponsor to be completed by the subject.  
The EQ-5D-5L essentially consists of 2 pages: the EQ-5D descriptive system and the 
EQ visual analogue scale (EQ VAS). 

Clinical Protocol 
Study Number: CORI.2019.06
A Prospective, Multi-center, Randomized 
Controlled Study to Evaluate the Safety and 
Effectiveness of REAL INTELLIGENCE™ CORI™ in 
unicondylar knee arthroplasty (UKA) Procedure
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part, nor shall the contents be disclosed by any means without prior written permission from Smith+Nephew, nor shall 
anyone make any use of it that is contrary to the expressed or implied wishes of Smith+Nephew. 
TMP-CD-05-01 Clinical Protocol - Device – Revision D; SOP-CD-05 Clinical Protocol
The descriptive system is used to describe the subject’s health state and consists of 
five dimensions: mobility, self-care, usual activities, pain/discomfort, and 
anxiety/depression. Each dimension has 5 levels to choose the most appropriate 
answer: no problems, slight problems, moderate problems, severe problems, and 
extreme problems. The subject is asked to indicate his/her health state by marking 
the most appropriate statement in each of the five areas [50].  
The EQ VAS records the subject’s self-rated health on a vertical visual analogue 
scale. The endpoints on the scale are labelled “The best health you can imagine” 
and “The worst health you can imagine”. The VAS can be used as a quantitative 
measure of health outcome as judged by the individual respondents. 
A paper questionnaire will be provided by the Sponsor to be completed by the subject. 
Responses for the EQ-5D-5L Score will then be recorded in the eCRF.  
 
 

Clinical Protocol 
Study Number: CORI.2019.06
A Prospective, Multi-center, Randomized 
Controlled Study to Evaluate the Safety and 
Effectiveness of REAL INTELLIGENCE™ CORI™ in 
unicondylar knee arthroplasty (UKA) Procedure
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part, nor shall the contents be disclosed by any means without prior written permission from Smith+Nephew, nor shall 
anyone make any use of it that is contrary to the expressed or implied wishes of Smith+Nephew. 
TMP-CD-05-01 Clinical Protocol - Device – Revision D; SOP-CD-05 Clinical Protocol
10 STATISTICAL DESIGN
A Statistical Analysis Plan (SAP) will be written and finalized prior to database lock. 
The following is a brief description of the analyses to be described in this plan.  
10.1 GENERAL
S+N’s Global Biostatistics group will conduct the statistical analysis for this study. 
Unless otherwise stated, all significance tests and hypothesis testing will be two-
sided, performed at the 5% significance level. Resulting p-values will be quoted and 
95% two-sided confidence intervals will be generated where appropriate. Where data 
summaries are specified, categorical and ordinal variables will be summarized with 
frequencies and percentages. Continuous variables will be summarized with the 
following summary statistics: the number of observations, mean, median, standard 
deviation, minimum and maximum values. 
 
All statistical comparisons of data will describe the test statistic used as well as its 
distributional assumptions. For continuous variables, in an event of marked deviation 
from normality assumption, a commensurate non-parametric test would be used as 
an alternative thereby eliminating the possibility of violation of normality assumptions. 
All analyses will be performed using SAS version 9.3 (or a later version).
10.2 ANALYSIS POPULATIONS
The following are the analysis populations:
 
Enrolled Population: This is defined as subjects enrolled and/or  randomized 
to either CORI or Conventional manual instrumentation groups. A total of 140 
patients will be competitively enrolled and or/randomized in the study across 
all the sites including the sites in China.   
 
Safety Population (SAF): This is defined as all subjects who were treated for 
UKA (include non-randomized subjects in China as CORI is a pre-market 

Clinical Protocol 
Study Number: CORI.2019.06
A Prospective, Multi-center, Randomized 
Controlled Study to Evaluate the Safety and 
Effectiveness of REAL INTELLIGENCE™ CORI™ in 
unicondylar knee arthroplasty (UKA) Procedure
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part, nor shall the contents be disclosed by any means without prior written permission from Smith+Nephew, nor shall 
anyone make any use of it that is contrary to the expressed or implied wishes of Smith+Nephew. 
TMP-CD-05-01 Clinical Protocol - Device – Revision D; SOP-CD-05 Clinical Protocol
product in China) with the use of CORI or conventional manual 
instrumentation. 
 
Intent-to-Treat Population (ITT): The ITT population is a subset of the 
randomized population which is defined as subjects randomized to either 
CORI or conventional manual instrumentation groups who have at least one 
post-operative assessment on any of the effectiveness endpoints or health-
related quality of life (HRQoL) endpoints. Data summarized on the ITT 
population will be based on the intervention the subject was randomized to 
receive which may be different from the intervention the subject actually 
received.  
 
Per-Protocol Population (PP): The PP population is a subset of subjects in the 
FAS population who do not have major protocol deviations and who satisfied 
all enrollment eligibility criteria. Major protocol deviations will include but not 
only restricted to subjects enrolled who do not satisfy the study entry eligibility 
criteria. All other criteria that will be categorized as major deviations will be 
formally classified on a case-by-case basis prior to the final study database 
lock.  
10.3 BASELINE DATA 
All observations available prior to the operative date will be defined as baseline (or 
preoperative) data. All demographic and pre-operative characteristics data will be 
summarized at baseline. All demographic and baseline characteristics will be 
summarized using the enrolled SAF, ITT and PP analysis populations. 
10.4 EFFECTIVENESS ANALYSIS 
10.4.1  Analysis of Primary Endpoint 
Leg alignment 

Clinical Protocol 
Study Number: CORI.2019.06
A Prospective, Multi-center, Randomized 
Controlled Study to Evaluate the Safety and 
Effectiveness of REAL INTELLIGENCE™ CORI™ in 
unicondylar knee arthroplasty (UKA) Procedure
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part, nor shall the contents be disclosed by any means without prior written permission from Smith+Nephew, nor shall 
anyone make any use of it that is contrary to the expressed or implied wishes of Smith+Nephew. 
TMP-CD-05-01 Clinical Protocol - Device – Revision D; SOP-CD-05 Clinical Protocol
The primary endpoint, the proportion of knees achieving post-operative leg 
alignment, defined as ±3° from the target (pre-operative planned leg alignment) 
assessed at the 6 weeks study visit in CORI 
1) and conventional manual 
instrumentation 
0) groups. 
The hypotheses are as follows: 
 
H0
1
0 versus
 
H1 (alternate
1 
0. 
The proportions as described above will be supported with the use of a two-sided 
95% confidence intervals (CI), estimated using exact binomial methods. 
Superiority 
1
0 will be inferred if and only if the lower limit of the 95% CI 
1 is greater than the upper limit of the 
0 . 
As supportive analysis on the primary endpoint, the difference between the target 
and actual leg alignment achieved postoperatively will be summarized for each 
group (i.e. CORI UKA and the Conventional manual instrumentation UKA) using 
summary statistics for continuous variables. Ninety-five (95) % CIs based on the 
Student’s t-distribution will be calculated for the means.   
The primary endpoint and the supportive analysis will be summarized using the FAS 
analysis population as primary and then PP analysis population for sensitivity. 
For missing primary endpoint data, the Missing Value Treated as Failure (MVTF) 
missing value imputation method will be used. This is considered a conservative 
imputation method as all missing data on the primary endpoint will be considered as 
a failure, i.e. not attaining the pre-specified target alignment. More specific details of 
this imputation method will be included in the SAP. 

Clinical Protocol 
Study Number: CORI.2019.06
A Prospective, Multi-center, Randomized 
Controlled Study to Evaluate the Safety and 
Effectiveness of REAL INTELLIGENCE™ CORI™ in 
unicondylar knee arthroplasty (UKA) Procedure
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part, nor shall the contents be disclosed by any means without prior written permission from Smith+Nephew, nor shall 
anyone make any use of it that is contrary to the expressed or implied wishes of Smith+Nephew. 
TMP-CD-05-01 Clinical Protocol - Device – Revision D; SOP-CD-05 Clinical Protocol
10.4.2 Analysis of Secondary Endpoints
Component Alignment 
Femoral components (internal rotation, valgus and anterior tilt) and tibial 
components (internal rotation, valgus, and posterior slope) will be summarized 
using descriptive summary characteristics for continuous variables.  These would 
additionally be stratified by surgical technique within each group (CORI Navigational 
versus Conventional Manual Instrumentation). 
 

Clinical Protocol 
Study Number: CORI.2019.06
A Prospective, Multi-center, Randomized 
Controlled Study to Evaluate the Safety and 
Effectiveness of REAL INTELLIGENCE™ CORI™ in 
unicondylar knee arthroplasty (UKA) Procedure
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part, nor shall the contents be disclosed by any means without prior written permission from Smith+Nephew, nor shall 
anyone make any use of it that is contrary to the expressed or implied wishes of Smith+Nephew. 
TMP-CD-05-01 Clinical Protocol - Device – Revision D; SOP-CD-05 Clinical Protocol
Standard Radiographic Assessment 
The presence of radiographic observations: implant loosening, implant migration, 
and osteolysis and other pertinent radiographic findings will be summarized as 
counts (n) and percentages (%) by visit. These would additionally be stratified by 
surgical technique within each group (CORI Navigational versus Conventional 
Manual Instrumentation). 
Radiolucent lines (mm) by zone and visit will be summarized using descriptive 
statistics for continuous variables. These would additionally be stratified by surgical 
technique within each group (CORI Navigational versus Conventional Manual 
Instrumentation). 
2011 Knee Society Score (KSS) 
The 2011 KSS objective, function and satisfaction scores will be summarized at the 
pre-operative and postoperative visits using continuous summary characteristics. 
For each of these 3 KSS scores, independent repeated measures Analysis of 
Covariance (ANCOVA) models (to account for the correlation between subjects with 
bilateral knees) will be used to model the change from preoperative to 
postoperative KSS scores as the dependent variable. As a minimum, each model will 
contain a group (pre-operative and postoperative) and the investigational site as a 
fixed term with a repeated specification for the knee.  Pre-operative prognostic and 
demographic variables not only restricted to age, BMI and sex, but that can also be 
ascertained to have an impact on the KSS scores will be introduced as covariates in 
the final model. These covariates will be added to the model using a stepwise 
approach and a covariate is retained in the final model if and only if its associated p-
value 
 0.1. Model based means (adjusted means or Least Square Means, 
LSMeans) and corresponding standard errors associated with each change from 
preoperative to postoperative KSS score will be presented by group. Model based 

Clinical Protocol 
Study Number: CORI.2019.06
A Prospective, Multi-center, Randomized 
Controlled Study to Evaluate the Safety and 
Effectiveness of REAL INTELLIGENCE™ CORI™ in 
unicondylar knee arthroplasty (UKA) Procedure
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part, nor shall the contents be disclosed by any means without prior written permission from Smith+Nephew, nor shall 
anyone make any use of it that is contrary to the expressed or implied wishes of Smith+Nephew. 
TMP-CD-05-01 Clinical Protocol - Device – Revision D; SOP-CD-05 Clinical Protocol
differences (and corresponding standard errors) between the CORI Navigational and 
Conventional manual instrumentation groups and their corresponding 95% CIs will 
additionally be summarized. If the p-value associated with the group term in the 
model is significant (i.e. p < 0.05), then the 95% CIs corresponding to the model 
based differences between the CORI Navigational and Conventional manual 
instrumentation groups will additionally be presented.   
The 2011 KSS subject expectation score will be summarized at the pre-operative 
and postoperative follow-up visits using descriptive characteristics for continuous 
variables. 
Oxford Knee Score (OKS) 
The OKS (0-48) will be summarized at the preoperative and postoperative visits 
using continuous summary characteristics. Change from preoperative to 
postoperative visits will also be summarized. The repeated measures ANCOVA 
model to account for the correlation between subjects in case of bilateral knees 
analogous to that specified for the 2011 KSS will be used. 
Forgotten Joint Score (FJS-12) 
The transformed FJS-12 score (0-100) will be summarized at the postoperative 
visits using continuous summary characteristics. Change from preoperative to 
postoperative visits will also be summarized. The repeated measures ANCOVA 
model to account for the correlation between subjects in case of bilateral knees 
analogous to that specified for the 2011 KSS will be used. 
EQ-5D-5L Score 
The HRQoL Index score and VAS score will be summarized using summary statistics 
for continuous variables pre-operatively and at all postoperative visits. Change from 

Clinical Protocol 
Study Number: CORI.2019.06
A Prospective, Multi-center, Randomized 
Controlled Study to Evaluate the Safety and 
Effectiveness of REAL INTELLIGENCE™ CORI™ in 
unicondylar knee arthroplasty (UKA) Procedure
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part, nor shall the contents be disclosed by any means without prior written permission from Smith+Nephew, nor shall 
anyone make any use of it that is contrary to the expressed or implied wishes of Smith+Nephew. 
TMP-CD-05-01 Clinical Protocol - Device – Revision D; SOP-CD-05 Clinical Protocol
preoperative to postoperative visits will also be summarized. In the case of bilateral 
knees, repeated measures ANCOVA models will account for correlation between 
subjects with bilateral knees each for the index score and VAS analogous to that 
specified for the 2011 KSS will be used.  
The 2011 KSS, transformed FJS-12 and EQ-5D-5L scores will additionally be 
summarized by group (i.e. the CORI Navigational and Conventional manual 
instrumentation groups) and visit using descriptive statistics for continuous 
variables.  
The Multiple Imputation (MI) missing value imputation method will be used as the 
imputation method for missing 2011 KSS, FJS-12, OKS, and EQ-5D-5L endpoints. 
Details of the MI method will be included in the SAP. 
All secondary endpoints will be summarized using the FAS analysis population. 
10.4.3  Analysis of Other Endpoint(s) 
The analyses for other endpoints (will be summarized separately in the CORI 
Navigational and Conventional manual instrumentation groups). 
Leg alignment pre- and post-cementation (CORI UKA only) 
Leg alignment is classified as normal, varus deformity and valgus deformity. Shift 
tables to summarize the changes from pre- to post-cementation will be created.  
CORI System Time & Cutting Time 
CORI System and cutting times will be summarized using summary statistics for 
continuous variables. The average operating and cutting times summarized using 
summary statistics for continuous variables. Additionally, 95% CIs based on the t-
statistic will be presented.  

Clinical Protocol 
Study Number: CORI.2019.06
A Prospective, Multi-center, Randomized 
Controlled Study to Evaluate the Safety and 
Effectiveness of REAL INTELLIGENCE™ CORI™ in 
unicondylar knee arthroplasty (UKA) Procedure
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part, nor shall the contents be disclosed by any means without prior written permission from Smith+Nephew, nor shall 
anyone make any use of it that is contrary to the expressed or implied wishes of Smith+Nephew. 
TMP-CD-05-01 Clinical Protocol - Device – Revision D; SOP-CD-05 Clinical Protocol
All other endpoints will be summarized using the FAS analysis population. 
10.5 SAFETY ANALYSES 
All safety analyses will be summarized separately for each of the groups (i.e. CORI 
Navigational and Conventional manual instrumentation groups) as follows: 
 
 
The number of adverse events will be reported by seriousness, relationship to 
study device and anticipation. 
 
The number of subjects experiencing adverse events will be summarised by 
seriousness, relationship to study device and anticipation. 
 
An overall AE summary table that will summarize as number (n) and 
percentages (%), the overall incidence according to subjects with at least one 
AE; subjects with at least one AE by worst severity (mild, moderate, or severe); 
subjects with at least one AE by worst outcome (resolved, ongoing/unresolved, 
or death); subjects with an AE that led to study discontinuation) and; subjects 
with at least one AE by worse relatedness to device. Other events such as SAEs, 
ADEs, SADEs or UADEs will also be similarly summarized using the number (n) 
and percentages (%).  
 
Incidence of device-related re-interventions that occur on-study will be 
summarized as number (n) and percentages as well as by type. 
 
A listing of device deficiencies that occur on-study will be provided. 
 
Knee implant revision rate will be summarized as proportions with 95% CIs 
estimated using exact binomial methods.  
All safety endpoints will be summarized using the SAF analysis population. 
10.6 INTERIM ANALYSES
A first interim analysis is planned for after completion of the 6 weeks visit in order 
to support the China NMPA registration. More specific details on the interim analyses 
will be included in the SAP. 

Clinical Protocol 
Study Number: CORI.2019.06
A Prospective, Multi-center, Randomized 
Controlled Study to Evaluate the Safety and 
Effectiveness of REAL INTELLIGENCE™ CORI™ in 
unicondylar knee arthroplasty (UKA) Procedure
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part, nor shall the contents be disclosed by any means without prior written permission from Smith+Nephew, nor shall 
anyone make any use of it that is contrary to the expressed or implied wishes of Smith+Nephew. 
TMP-CD-05-01 Clinical Protocol - Device – Revision D; SOP-CD-05 Clinical Protocol
11 SAMPLE SIZE JUSTIFICATION
Parratte et al.[51] looked at the effects of postoperative mechanical axis alignment 
on the survival of TKAs. They found that of the 398 TKAs reviewed in the paper 
there were 292 (73.4%) which post-operatively were defined as mechanically 
aligned (i.e. with a mechanical axis of 0° ± 3°).  
This study is designed to demonstrate superiority in the proportion of knees 
achieving post-operative leg alignment in the CORI Navigational group over the 
Conventional manual instrumentation group. 
The proportion of mechanically aligned TKAs using NAVIO from a recent analysis 
was estimated to be 92.1% [52]. This proportion is expected to be equivalent if 
NAVIO was used to determine the proportion of mechanically aligned UKAs. Using 
these assumptions, enrollment of 63 UKAs per group will provide 80% power to 
show that the lower limit of the two-sided 95% confidence interval for the 
proportion of mechanically aligned UKAs is greater than that obtained from 
literature. To account for up to a 10% attrition rate in knees enrolled, 70 knees in 
each group (140 knees combined) will be enrolled into the randomized stage of the 
study. A minimum of an additional 5 subjects who will be treated with CORI directly 
to fulfil the learning needs of the surgeons will be enrolled at the pre-randomized 
study stage, thus leading to a minimum total study enrollment of 145 subjects. 
 
 

Clinical Protocol 
Study Number: CORI.2019.06
A Prospective, Multi-center, Randomized 
Controlled Study to Evaluate the Safety and 
Effectiveness of REAL INTELLIGENCE™ CORI™ in 
unicondylar knee arthroplasty (UKA) Procedure
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part, nor shall the contents be disclosed by any means without prior written permission from Smith+Nephew, nor shall 
anyone make any use of it that is contrary to the expressed or implied wishes of Smith+Nephew. 
TMP-CD-05-01 Clinical Protocol - Device – Revision D; SOP-CD-05 Clinical Protocol
12 ADVERSE EVENTS AND DEVICE DEFICIENCIES
12.1 DEFINITIONS
The categories of adverse events are shown in Table 12.1-12-1. The definitions for 
each of these categories are given in the subsequent sections. 
 
Table 12.1-12-1 Categories of Adverse Event 
 
NOT DEVICE- 
RELATED 
DEVICE- OR PROCEDURE-RELATED 
NON-
SERIOUS
ADVERSE EVENT 
(AE) 
ADVERSE DEVICE EFFECT 
(ADE)  
SERIOUS
SERIOUS ADVERSE 
EVENT  
(SAE)  
SERIOUS ADVERSE DEVICE EFFECT 
(SADE) (SEE 12.1.3) 
ANTICIPATED 
UNANTICIPATED
ANTICIPATED SERIOUS 
ADVERSE DEVICE EFFECT  
(ASADE)
UNANTICIPATED SERIOUS 
ADVERSE DEVICE EFFECT  
(USADE)

Clinical Protocol 
Study Number: CORI.2019.06
A Prospective, Multi-center, Randomized 
Controlled Study to Evaluate the Safety and 
Effectiveness of REAL INTELLIGENCE™ CORI™ in 
unicondylar knee arthroplasty (UKA) Procedure
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part, nor shall the contents be disclosed by any means without prior written permission from Smith+Nephew, nor shall 
anyone make any use of it that is contrary to the expressed or implied wishes of Smith+Nephew. 
TMP-CD-05-01 Clinical Protocol - Device – Revision D; SOP-CD-05 Clinical Protocol
12.1.1 Adverse Event
An Adverse Event (AE) is any untoward medical occurrence, unintended disease or 
injury or untoward clinical signs (including abnormal laboratory findings) in 
subjects, users or other persons, whether or not related to the investigational 
medical device and whether anticipated or unanticipated.  
Note 1: This definition includes events related to the investigational medical device 
or the comparator.  
Note 2: This definition includes events related to the procedures involved.  
Note 3: For users or other persons, this definition is restricted to events related to 
the use of investigational medical devices. 
AE is used both to refer to AE which do not meet the definitions of Adverse Device 
Effects or Serious Adverse Events and as an umbrella term referring to adverse 
events of all classifications.  
An AE can be any unfavorable and unintended sign (for example, an abnormal 
laboratory finding), symptom, or disease. For reporting purposes, emphasis is 
placed first and foremost on whether or not the event constitutes an untoward 
medical occurrence. 
12.1.2  Adverse Device Effect 
An Adverse Device Effect (ADE) is an adverse event related to the use of an 
investigational medical device.  
Note 1: This definition includes adverse events resulting from insufficient or 
inadequate instructions for use, deployment, implantation, installation or operation, 
or any malfunction of the investigational medical device.  
Note 2: This definition includes any event resulting from use error or from 
intentional misuse of the investigational medical device.  
Note 3: This includes "comparator" if the comparator is a medical device. 
Not Related - An AE is considered to be not related to the use of an IP or the 
procedure when the effect is DEFINITELY UNRELATED to have any relationship to 
the use of the IP or the procedure. 

Clinical Protocol 
Study Number: CORI.2019.06
A Prospective, Multi-center, Randomized 
Controlled Study to Evaluate the Safety and 
Effectiveness of REAL INTELLIGENCE™ CORI™ in 
unicondylar knee arthroplasty (UKA) Procedure
Version: 4.0-Master, 07 Sep 
2022
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CONFIDENTIAL AND PROPRIETARY 
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and is intended for use only by Smith+Nephew and its manufacturer. It shall not be reproduced or copied in whole or in 
part, nor shall the contents be disclosed by any means without prior written permission from Smith+Nephew, nor shall 
anyone make any use of it that is contrary to the expressed or implied wishes of Smith+Nephew. 
TMP-CD-05-01 Clinical Protocol - Device – Revision D; SOP-CD-05 Clinical Protocol
Related – An AE is considered to be related to the use of an IP or the procedure 
when there is a POSSIBLE, or DEFINITE relationship between the AE and the use of 
the IP or the procedure. 
An ADE is further categorized depending on whether the criteria in section 12.1.3 
and 12.1.4 are met. 
12.1.3  Related Serious Adverse Events and Serious Adverse Device 
Effects  
An AE or ADE is considered a Serious Adverse Event (SAE) or Serious Adverse 
Device Effects (SADE) if, it led to any of the following: 
a) Death, 
b) Serious deterioration in the health of the subject, users or other persons as 
defined by one or more of the following:  
1) Alife-threatening illness or injury, or 
2) A permanent impairment of a body structure or a body function 
including chronic diseases, or 
3) In-patient or prolonged hospitalization, or 
4) -Medical or surgical intervention to prevent life-threatening illness or 
injury or permanent impairment to a body structure or a body function, 
c) Fetal distress, fetal death or a congenital abnormality or birth defect 
including physical or mental impairment 
Note 1: Planned hospitalization for a pre-existing condition, or a procedure required 
by the study protocol, without serious deterioration in health, is not considered a 
serious adverse event. 
12.1.4  Anticipated/Unanticipated Serious Adverse Device Effect 
An Unanticipated Serious Adverse Device Effect (USADE) is a serious ADE which by 
its nature, incidence, severity or outcome has not been identified in the current 
version of the risk assessment.  
Note 1: Anticipated serious adverse device effect (ASADE) is an effect which by its 
nature, incidence, severity or outcome has been identified in the risk assessment. 
A list of potential ASADE for CORI is provided in Table 12.1.4-12-2. Please also refer 
to Section 4.4.5 Potential Adverse Effects. 

Clinical Protocol 
Study Number: CORI.2019.06
A Prospective, Multi-center, Randomized 
Controlled Study to Evaluate the Safety and 
Effectiveness of REAL INTELLIGENCE™ CORI™ in 
unicondylar knee arthroplasty (UKA) Procedure
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2022
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and is intended for use only by Smith+Nephew and its manufacturer. It shall not be reproduced or copied in whole or in 
part, nor shall the contents be disclosed by any means without prior written permission from Smith+Nephew, nor shall 
anyone make any use of it that is contrary to the expressed or implied wishes of Smith+Nephew. 
TMP-CD-05-01 Clinical Protocol - Device – Revision D; SOP-CD-05 Clinical Protocol
Table 12.1.4-12-2 Potential Anticipated Serious Adverse Device Effects 
(ASADE) 
# 
Potential Harm 
Description 
1 
Allergic Reaction 
to Materials 
Hypersensitivity caused by exposure to material constituents of 
the product that leads to local inflammatory reaction and tissue 
damage. Contact with an allergen may cause swelling and 
redness of the skin in minor cases. A severe anaphylactic reaction 
may occur. 
2 
Bone Fracture 
Any break or fracture to any bone. (Applicable to displaced and 
non-displaced fractures) 
The bone break could be reduced (set) and immobilized during 
the same surgery during which it occurred if it is detected. If the 
fracture occurs after the surgery, additional medical attention 
would be required. Subsequent healing returns normal body 
function for the subject. 
3 
Burn 
3rd degree burn extending through the dermis which requires 
excision. 4th degree burn extending into the subcutaneous tissue, 
muscle and bone with eschar formation. Burns may be caused by 
thermal or chemical burns. 
4 
Cardiac 
Arrhythmia - 
symptomatic 
Variation from the normal heart rhythm symptomatic. 
5 
Cement Leakage 
Cement can end up in an unintended location in the joint. Cement 
leakage may cause early wear of poly or pain to the subject and 
may require revision surgery. 
6 
Unstable knee 
joint 
The implant components are placed in such a way that there is 
too much laxity in the ligaments. The subject experiences 
instability throughout the range of motion, There is an increased 
risk of early loosening/ wear of the implant. This may impact the 
stability and wear of implant components.  
Implants loosening could lead to early revision surgery. 
7 
Restricted Range 
of Motion 
The implants are placed in such a way that excessive forces are 
placed on the ligaments (ACL, PCL, MCL, and LCL). This leads to 
an unintended reduction in the range of motion or progression of 
disease in a non- operative compartment. This may be serious, if 
the subject's range of motion has been worsened compared to the 
range of motion prior to surgery, or it has been restored sub-
optimally. 

Clinical Protocol 
Study Number: CORI.2019.06
A Prospective, Multi-center, Randomized 
Controlled Study to Evaluate the Safety and 
Effectiveness of REAL INTELLIGENCE™ CORI™ in 
unicondylar knee arthroplasty (UKA) Procedure
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and is intended for use only by Smith+Nephew and its manufacturer. It shall not be reproduced or copied in whole or in 
part, nor shall the contents be disclosed by any means without prior written permission from Smith+Nephew, nor shall 
anyone make any use of it that is contrary to the expressed or implied wishes of Smith+Nephew. 
TMP-CD-05-01 Clinical Protocol - Device – Revision D; SOP-CD-05 Clinical Protocol
#
Potential Harm
Description
8 
Infection 
Invasion and multiplication of microorganisms in body tissues, 
especially microorganisms causing local cellular injury due to 
competitive metabolism, toxins, intracellular replication, or 
antigen-antibody response. The infection may lead to a diseased 
state in the receiving host if the host has inadequate resistance 
and/or lacks immunity to overcome the invasion by the pathogen. 
Most typically, the resultant disease state can be treated through 
the use of antibiotics. When the pathogen is particularly virulent, 
or when the host has low resistance, the disease state may lead 
to a permanent impairment of some aspect of bodily function or, 
in extreme cases, to death. Infections caused by a transfer of 
body fluids during orthopedic surgery can in most cases be 
treated by a course of antibiotics. Severe infections that can occur 
by the transfer of body fluids during the procedure include HIV 
and hepatitis. 
9 
Delay  
A delay in the operation time exceeding 60 minutes of intra-
operative case time. A wound being open longer would more likely 
result in soft tissue edema, increased blood loss, muscle necrosis 
as a result of extended tourniquet time and a higher chance of 
infection. 
10 
Immature implant 
failure 
Implant components wear before their intended service life 
resulting in early revision surgery.  
11 
Neurological 
Injury 
Damage to the nerve systems of the subject's leg. A neurological 
injury could result in temporary or permanent paralysis. 
12 
Physical Injury - 
Serious
A physical injury that necessitates medical intervention. 
13 
Soft Tissue 
Damage 
Damage to ligaments or tendons leading to loss of stability in the 
knee joint. In severe cases of ligament damage, additional 
surgery may be required.
14 
Surgeon Operates 
on Wrong Part of 
Anatomy 
The clinical impacts of operating on the wrong subject anatomy 
relate to the resultant function of the skeletal element that was 
treated and the need to repeat treatment for the desired skeletal 
element. The impact on the subject may be additional surgery 
under full anesthesia.  
15 
Vascular Injury - 
Main Low-
extremity vessels 
Damage to the vascular systems of the subject's leg. 
In severe cases, dis-vascularization occurs that is, the subject 
loses blood flow to the leg when a clot forms in significant arteries 
of the leg. Additional surgery would be required to correct blood 

Clinical Protocol 
Study Number: CORI.2019.06
A Prospective, Multi-center, Randomized 
Controlled Study to Evaluate the Safety and 
Effectiveness of REAL INTELLIGENCE™ CORI™ in 
unicondylar knee arthroplasty (UKA) Procedure
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and is intended for use only by Smith+Nephew and its manufacturer. It shall not be reproduced or copied in whole or in 
part, nor shall the contents be disclosed by any means without prior written permission from Smith+Nephew, nor shall 
anyone make any use of it that is contrary to the expressed or implied wishes of Smith+Nephew. 
TMP-CD-05-01 Clinical Protocol - Device – Revision D; SOP-CD-05 Clinical Protocol
#
Potential Harm
Description
flow. If blood flow to the leg is not restored, the patient's leg may 
need to be amputated.
 
12.1.5  Guidance Regarding the Determination of Unanticipated 
Events: 
During causality assessment activity, clinical judgement shall be used and the 
relevant documents, such as the Investigator’s Brochure, the Clinical Protocol or the 
Risk Analysis Report shall be consulted, as all the foreseeable serious adverse 
events and the potential risks are listed and assessed there. The presence of 
confounding factors, such as concomitant medication/treatment, the natural history 
of the underlying disease, other concurrent illness or risk factors shall also be 
considered [MEDDEV 2.7/3 Rev 3 Sec 8]. 
12.1.6  Severity  
The severity of every AE will be assessed by the PI or medically qualified site staff 
to whom the responsibility has been delegated and documented on the delegation of 
authority log. AE should be classified as mild, moderate, or severe, regardless of 
whether or not the AE are considered to be serious or non-serious. The classification 
should be based on the following definitions: 
Mild  
- 
An event is mild if the subject is aware of, but can easily tolerate the 
sign or symptom. 
Moderate - An event is moderate if the sign or symptom results in discomfort 
significant enough to cause interference with the subject’s usual 
activities. 
 

Clinical Protocol 
Study Number: CORI.2019.06
A Prospective, Multi-center, Randomized 
Controlled Study to Evaluate the Safety and 
Effectiveness of REAL INTELLIGENCE™ CORI™ in 
unicondylar knee arthroplasty (UKA) Procedure
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and is intended for use only by Smith+Nephew and its manufacturer. It shall not be reproduced or copied in whole or in 
part, nor shall the contents be disclosed by any means without prior written permission from Smith+Nephew, nor shall 
anyone make any use of it that is contrary to the expressed or implied wishes of Smith+Nephew. 
TMP-CD-05-01 Clinical Protocol - Device – Revision D; SOP-CD-05 Clinical Protocol
Severe -    An event is severe if the sign or symptom is incapacitating and results 
in the subject’s inability to work or engage in their usual activities. 
12.1.7  Device Deficiency 
A Device Deficiency (DD) is an inadequacy of a medical device with respect to its 
identity, quality, durability, reliability, safety or performance. DD includes 
malfunctions, use errors and inadequate labeling.  
Note 1: DD includes malfunctions, use errors and inadequacy in the information 
supplied by the manufacturer including labelling.  
Note 2: This definition includes device deficiencies related to the investigational 
medical device or the comparator. 
Device deficiencies that did not lead to an adverse event but could have led to a 
medical occurrence  
a) if either suitable action had not been taken,  
b) if intervention had not been made, or  
c) if circumstances had been less fortunate,  
are considered Device Deficiencies with potential to cause SADE and shall be 
reported as specified in section 12.3. 
12.2 AE CODING DICTIONARY  
Coding for this study will be done per International Medical Device Regulators 
Forum (IMDRF) AE Terminology Annex E – Clinical signs, symptoms, and conditions. 
 
 

Clinical Protocol 
Study Number: CORI.2019.06
A Prospective, Multi-center, Randomized 
Controlled Study to Evaluate the Safety and 
Effectiveness of REAL INTELLIGENCE™ CORI™ in 
unicondylar knee arthroplasty (UKA) Procedure
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and is intended for use only by Smith+Nephew and its manufacturer. It shall not be reproduced or copied in whole or in 
part, nor shall the contents be disclosed by any means without prior written permission from Smith+Nephew, nor shall 
anyone make any use of it that is contrary to the expressed or implied wishes of Smith+Nephew. 
TMP-CD-05-01 Clinical Protocol - Device – Revision D; SOP-CD-05 Clinical Protocol
12.3 REPORTING PROCEDURES
AE of any kind and DD will be recorded in the applicable CRF and source notes to 
include the date of occurrence, treatment and the details resolution. The 
Investigator will evaluate all AE for relationship to the device and procedure, 
seriousness, and severity (if applicable). DD will be evaluated for potential to cause 
SADE.  The following timescales should be followed for the AE/DD information to be 
submitted/entered into the CRF and reported to the Sponsor or designee (see figure 
12.2-1): 
 
ADE and DD – without unreasonable delay 
 
SAE, SADE and DD with potential to cause SADE – immediately (i.e. within 24 
hours of the investigator being informed about the event) 
 
All other events – according to usual timescales 
In addition to inputting SAE and SADE information within 24 hours of being aware of 
the event, the investigator should email Clinical.safety@Smith-nephew.com to alert 
the safety representative of the events existence and to clarify details if necessary. 
For ADE and DD, date of occurrence, and details of the product/procedure related to 
the event will be included and where applicable, pictures taken of the device. The 
deficient product should be retained for return to S+N unless it is contaminated 
(e.g., used dressings must not be retained). Updates to submitted information will 
be recorded in the CRF according to the timescales above. 
All adverse events will be reviewed by a medically qualified person appointed by the 
Sponsor to determine which, if any, meet criteria for expedited reporting to the 
regulatory authorities.  
The investigator will inform the regulatory agency and IRB/IEC of adverse events as 
per the requirements listed below: -  

Clinical Protocol 
Study Number: CORI.2019.06
A Prospective, Multi-center, Randomized 
Controlled Study to Evaluate the Safety and 
Effectiveness of REAL INTELLIGENCE™ CORI™ in 
unicondylar knee arthroplasty (UKA) Procedure
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CONFIDENTIAL AND PROPRIETARY 
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and is intended for use only by Smith+Nephew and its manufacturer. It shall not be reproduced or copied in whole or in 
part, nor shall the contents be disclosed by any means without prior written permission from Smith+Nephew, nor shall 
anyone make any use of it that is contrary to the expressed or implied wishes of Smith+Nephew. 
TMP-CD-05-01 Clinical Protocol - Device – Revision D; SOP-CD-05 Clinical Protocol
The investigator should inform the regulatory agency and IRB/IEC of adverse events 
as per the requirements of each site. The detailed information is described in Safety 
Monitoring Plan. 
All other events will be reported on a periodic/annual basis. 
Depending on the nature of the adverse event, S+N may request copies of the 
subject’s medical records, Imaging, Operative notes, as well as results of any 
relevant laboratory tests performed or other documentation related to the AE. If the 
subject was hospitalized, a copy of the discharge summary may be requested by 
S+N and should be forwarded as soon as it becomes available. In certain cases, 
S+N also may request a letter from the Investigator that summarizes the events 
related to the case. Refer to the ISF Sponsor Contact Information Sheet to report 
SAE, unanticipated SADE, anticipated SADE, and DD. 

Clinical Protocol 
Study Number: CORI.2019.06
A Prospective, Multi-center, Randomized 
Controlled Study to Evaluate the Safety and 
Effectiveness of REAL INTELLIGENCE™ CORI™ in 
unicondylar knee arthroplasty (UKA) Procedure
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2022
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and is intended for use only by Smith+Nephew and its manufacturer. It shall not be reproduced or copied in whole or in 
part, nor shall the contents be disclosed by any means without prior written permission from Smith+Nephew, nor shall 
anyone make any use of it that is contrary to the expressed or implied wishes of Smith+Nephew. 
TMP-CD-05-01 Clinical Protocol - Device – Revision D; SOP-CD-05 Clinical Protocol
Figure 12.3-12-1 Evaluation and Reporting of AE 
Site 
aware 
of AE
Investigator 
assesses 
seriousness 
Serious
Investigator 
assesses device 
relationship
Related 
Investigator 
assesses whether 
SADE is 
anticipated
Not Related
Serious Adverse 
Event (SAE)
unanticipated
Unanticpated 
Serious Adverse 
Device Effect 
(USADE)
Anticipated 
Serious Adverse 
Device Effect 
(ASADE)
Investigator 
assesses device 
relationship
Non-serious
Related
Adverse Device 
Effect (ADE)
Not Related
Adverse Event 
(AE)
Complete CRF 
and alert S&N 
IMMEDIATELY  
Record 
information in 
patient CRF 
according to 
usual 
timescales.
Complete CRF 
and alert S&N 
without 
unreasonable 
delay. 
Record 
details in 
subject’s 
medical 
records
 
 
 

Clinical Protocol 
Study Number: CORI.2019.06
A Prospective, Multi-center, Randomized 
Controlled Study to Evaluate the Safety and 
Effectiveness of REAL INTELLIGENCE™ CORI™ in 
unicondylar knee arthroplasty (UKA) Procedure
Version: 4.0-Master, 07 Sep 
2022
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CONFIDENTIAL AND PROPRIETARY 
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and is intended for use only by Smith+Nephew and its manufacturer. It shall not be reproduced or copied in whole or in 
part, nor shall the contents be disclosed by any means without prior written permission from Smith+Nephew, nor shall 
anyone make any use of it that is contrary to the expressed or implied wishes of Smith+Nephew. 
TMP-CD-05-01 Clinical Protocol - Device – Revision D; SOP-CD-05 Clinical Protocol
Figure 12.3-12-2 Evaluation and Reporting of DD 
Site aware 
of DD
Investigator 
assesses whether 
could have led to 
SADE 
Potential to cause SADE
No potential to cause SADE
Complete CRF and alert S&N 
IMMEDIATELY  
Record information in patient 
CRF according to usual 
timescales.
Record details in subject’s 
medical records
12.4 UNBLINDING OF INVESTIGATIONAL PRODUCT 
Not applicable. 
12.5 FOLLOW-UP OF SUBJECTS WITH ADVERSE EVENTS
For subjects who are experiencing ongoing unresolved AE at the time of their study 
completion or early discontinuation from the study, it is recommended that the 
Investigator schedule an appropriate follow-up visit to determine the outcome of the 
event.  
Any additional data must be documented and available to the Sponsor who will 
determine whether the data need to be documented in the eCRF or the Clinical 
Study Report. 

Clinical Protocol 
Study Number: CORI.2019.06
A Prospective, Multi-center, Randomized 
Controlled Study to Evaluate the Safety and 
Effectiveness of REAL INTELLIGENCE™ CORI™ in 
unicondylar knee arthroplasty (UKA) Procedure
Version: 4.0-Master, 07 Sep 
2022
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CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. 
and is intended for use only by Smith+Nephew and its manufacturer. It shall not be reproduced or copied in whole or in 
part, nor shall the contents be disclosed by any means without prior written permission from Smith+Nephew, nor shall 
anyone make any use of it that is contrary to the expressed or implied wishes of Smith+Nephew. 
TMP-CD-05-01 Clinical Protocol - Device – Revision D; SOP-CD-05 Clinical Protocol
12.5.1 Ongoing Adverse Events at Study Discontinuation
Adverse events which are related to a study procedure or S+N IP and are ongoing 
at the end of subject’s participation: The event should be followed until it is either 
resolved or until the event has become chronic and is not expected to further 
improve based on Investigator’s review of the event. 
Adverse events that are not related to a study procedure or S+N IP and are 
ongoing at the end of subject’s participation should be followed for 30 days after 
discontinuation or if the AE is resolved, whichever is sooner. 
At the time of data analysis (e.g., interim or final), an evaluation of ongoing events 
should take place and be listed as ongoing in the safety table. 
13 INVESTIGATOR OBLIGATIONS
The Principal Investigator will comply with the commitments outlined in the in the 
Statement of Investigator, provided by the Sponsor, and with Good Clinical Practice 
(GCP), and all applicable regulatory requirements as outlined in Appendix-Principal 
Investigator Obligations as well as all applicable local laws and regulations. 
In addition, the PI will ensure that the Financial Disclosure Statements will be 
completed by the PI and the Sub-Investigator upon entry into the study and any 
changes that affect their financial disclosure status occur during the course of the 
study and up to one year after study completion. 
14 SPONSOR AND MONITOR RESPONSIBILITIES 
The Sponsor will designate a monitor to conduct the appropriate site visits at the 
appropriate intervals. The clinical investigation will be monitored to ensure that: the 
rights and wellbeing of the subjects are protected; the reported data are accurate, 
complete, and verifiable from the source documents; and the study is conducted in 

Clinical Protocol 
Study Number: CORI.2019.06
A Prospective, Multi-center, Randomized 
Controlled Study to Evaluate the Safety and 
Effectiveness of REAL INTELLIGENCE™ CORI™ in 
unicondylar knee arthroplasty (UKA) Procedure
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2022
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and is intended for use only by Smith+Nephew and its manufacturer. It shall not be reproduced or copied in whole or in 
part, nor shall the contents be disclosed by any means without prior written permission from Smith+Nephew, nor shall 
anyone make any use of it that is contrary to the expressed or implied wishes of Smith+Nephew. 
TMP-CD-05-01 Clinical Protocol - Device – Revision D; SOP-CD-05 Clinical Protocol
compliance with the currently approved protocol and amendment(s), if applicable, 
with GCP regulations, and with applicable regulatory requirements. 
Detailed monitoring requirements will be documented in the Clinical Monitoring Plan 
for this study.  
14.1 CONTRACT RESEARCH ORGANIZATION
The Sponsor has engaged Contract Research Organization (CRO) to assist in 
conducting this study. When appropriate, the CRO is referred to in study documents 
as “Sponsor’s agent.” 
14.2 SITE QUALIFICATION VISIT 
A site qualification visit may be performed by the Sponsor prior to the execution of 
a clinical agreement to ensure that all Investigators have the appropriate training, 
staff, facilities, and resources to adequately conduct the study. 
14.3 SITE INITIATION VISIT 
A site initiation visit to provide training on the specifics of the study, site obligations 
and expectations of study conduct will be performed by the Sponsor or qualified 
person designated by the Sponsor following the execution of the Clinical Trial 
Agreement (CTA) and documented IRB/IEC approval.  
14.4 INTERIM MONITORING VISIT 
Regular interim monitoring visits will be performed by the Sponsor or qualified 
person designated by the Sponsor. 
14.5 SPONSOR AUDITS AND REGULATORY INSPECTION
Quality Assurance auditors, whether an employee of the Sponsor or its designee, 
may evaluate study conduct at the study sites. These parties must have access to 

Clinical Protocol 
Study Number: CORI.2019.06
A Prospective, Multi-center, Randomized 
Controlled Study to Evaluate the Safety and 
Effectiveness of REAL INTELLIGENCE™ CORI™ in 
unicondylar knee arthroplasty (UKA) Procedure
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2022
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part, nor shall the contents be disclosed by any means without prior written permission from Smith+Nephew, nor shall 
anyone make any use of it that is contrary to the expressed or implied wishes of Smith+Nephew. 
TMP-CD-05-01 Clinical Protocol - Device – Revision D; SOP-CD-05 Clinical Protocol
any and all study reports and source documentation, regardless of location and 
format.   
14.6 CLOSE-OUT VISIT
A study close-out visit will be performed by the Sponsor or designee to retrieve and 
account for all remaining clinical data and to resolve outstanding queries. During 
study close-out, the monitor will review investigator files to ensure required 
documents and records are on file, confirm the disposition of any other ancillary 
items used for the study, and review regulatory requirements regarding records 
retention and IRB or IEC reporting requirements.  When no subjects have been 
included, a remote close-out visit may be conducted.  
15 PROTOCOL DEVIATIONS 
An Investigator must not make any changes or deviate from this protocol, except to 
protect the life and physical well-being of a subject in an emergency. Protocol 
deviations reported by the Investigator or discovered during monitoring visits will be 
compiled in a Protocol / GCP Deviation Log (TMP-CD-31-02 Protocol/GCP Deviation 
Log). Significant and/or recurrent protocol/GCP deviations will be documented on a 
protocol deviation form (TMP-CD-31-01 Protocol/GCP Deviation) including identified 
root cause and, as necessary, appropriate corrective and preventive actions will be 
put in place and and signed off by the study personnel. 
16 PROTOCOL AMENDMENTS 
Amendments should be made only in necessary cases once the study has started. 
Protocol amendments must be approved by the protocol signatories prior to 
submission to the IRB or IEC. Protocol amendments need to be approved by the IRB 
or IEC, according to the applicable requirements prior to implementation at the site. 
 

Clinical Protocol 
Study Number: CORI.2019.06
A Prospective, Multi-center, Randomized 
Controlled Study to Evaluate the Safety and 
Effectiveness of REAL INTELLIGENCE™ CORI™ in 
unicondylar knee arthroplasty (UKA) Procedure
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part, nor shall the contents be disclosed by any means without prior written permission from Smith+Nephew, nor shall 
anyone make any use of it that is contrary to the expressed or implied wishes of Smith+Nephew. 
TMP-CD-05-01 Clinical Protocol - Device – Revision D; SOP-CD-05 Clinical Protocol
17 CONFIDENTIALITY OF THE STUDY
The confidentiality of this study and associated documents is governed by the terms 
of the Clinical Trial Agreement (CTA). 
18 STATEMENTS OF COMPLIANCE
This clinical study will be performed in compliance with the ethical principles of the 
Declaration of Helsinki; and ISO 14155: Clinical investigation of medical devices – 
Good Clinical Practice. 
This clinical study will not commence until the required approval/favorable opinion 
from the IRB/IEC or regulatory authority has been obtained. Any additional 
requirements imposed by the IRB/IEC or regulatory authority will be followed.  
Public/Products Liability Insurance has been purchased by Smith & Nephew plc. 
Worldwide and incorporates coverage for personal injury in respect of clinical 
studies. The Sponsor agrees to operate in good faith and in accordance with the 
local guidelines regarding compensation for injury resulting from participation in an 
industry-sponsored clinical trial. 
19 END OF STUDY
The end of this study is defined by the last follow-up visit that occurs in the whole 
study population. Due to defined visit windows, the last follow-up visit must not 
necessarily be of the last subject treated. 
Should circumstances arise which require the termination of the entire study prior to 
its planned completion (e.g., safety concerns) or circumstances arise which mean 
the end of the participation of an individual site (e.g., departure of Investigator, 
non-compliance), then this will be undertaken according to the SOPs of the Sponsor. 
The requirement for subject follow up in these instances will be considered as part 

Clinical Protocol 
Study Number: CORI.2019.06
A Prospective, Multi-center, Randomized 
Controlled Study to Evaluate the Safety and 
Effectiveness of REAL INTELLIGENCE™ CORI™ in 
unicondylar knee arthroplasty (UKA) Procedure
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part, nor shall the contents be disclosed by any means without prior written permission from Smith+Nephew, nor shall 
anyone make any use of it that is contrary to the expressed or implied wishes of Smith+Nephew. 
TMP-CD-05-01 Clinical Protocol - Device – Revision D; SOP-CD-05 Clinical Protocol
of these processes. The sponsor may decide to discontinue a specific study site 
under the following conditions: 
 
Non-compliance to GCP or study protocol 
 
Failure to enroll in subjects 
 
Unsafe or unethical practices 
20 PUBLICATION POLICY 
20.1 PUBLICATION OF STUDY DATA
The preparation and submission for publication of manuscripts containing the study 
results shall be in accordance with a process determined by the Clinical Trial 
Agreements between the study Sponsor and participating institutions. The 
publication or presentation of any study results shall comply with all applicable 
privacy laws.  
20.2 DATA SHARING 
Smith+Nephew is committed to upholding the highest ethical and legal standards 
involved in conducting clinical trials. Smith & Nephew, therefore, supports the data 
sharing requirements of The International Committee of Medical Journal Editors 
(ICMJE) published on the 6th June 2017. In accordance, Smith+Nephew will 
consider requests to share individual (de-identified) participant data that underlie 
the results of any interventional clinical trial, as presented from the 1st July 2018 
within an ICMJE associated journal. Requests made by researchers who provide a 
methodologically sound proposal will be considered. Requests may include data that 
underlie results presented in text, tables, figures, and appendices, together with 
data dictionaries. The availability of these data will begin nine months and end 36 
months after article publication. Data supplied may only be used by the 
researcher(s) named in the approved research proposal for the purposes of 
achieving the aims of the analyses specified therein. All proposals should be 

Clinical Protocol 
Study Number: CORI.2019.06
A Prospective, Multi-center, Randomized 
Controlled Study to Evaluate the Safety and 
Effectiveness of REAL INTELLIGENCE™ CORI™ in 
unicondylar knee arthroplasty (UKA) Procedure
Version: 4.0-Master, 07 Sep 
2022
Page: 102 of 167   
 
CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. 
and is intended for use only by Smith+Nephew and its manufacturer. It shall not be reproduced or copied in whole or in 
part, nor shall the contents be disclosed by any means without prior written permission from Smith+Nephew, nor shall 
anyone make any use of it that is contrary to the expressed or implied wishes of Smith+Nephew. 
TMP-CD-05-01 Clinical Protocol - Device – Revision D; SOP-CD-05 Clinical Protocol
directed to datasharing.gcs@smith-nephew.com. To gain access, data requestors 
will need to sign a data access agreement.

Clinical Protocol 
Study Number: CORI.2019.06
A Prospective, Multi-center, Randomized 
Controlled Study to Evaluate the Safety and 
Effectiveness of REAL INTELLIGENCE™ CORI™ in 
unicondylar knee arthroplasty (UKA) Procedure
Version: 4.0-Master, 07 Sep 
2022
Page: 103 of 167   
 
CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. 
and is intended for use only by Smith+Nephew and its manufacturer. It shall not be reproduced or copied in whole or in 
part, nor shall the contents be disclosed by any means without prior written permission from Smith+Nephew, nor shall 
anyone make any use of it that is contrary to the expressed or implied wishes of Smith+Nephew. 
TMP-CD-05-01 Clinical Protocol - Device – Revision D; SOP-CD-05 Clinical Protocol
21 REFERENCES
1. 
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Cutolo, M., et al., Commentary on recent therapeutic guidelines for osteoarthritis. 
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3. 
Arora, S., A. Rafiq, and M. Jolly, Management of rheumatoid arthritis: Review of 
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4. 
Saxby, D.J. and D.G. Lloyd, Osteoarthritis year in review 2016: mechanics. 
Osteoarthritis Cartilage, 2017. 25(2): p. 190-198. 
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following arthroscopic surgery for osteoarthritis: a systematic review. BMC 
Musculoskelet Disord, 2017. 18(1): p. 408. 
12. 
Hofstede, S.N., et al., Mobile bearing vs fixed bearing prostheses for posterior 
cruciate retaining total knee arthroplasty for postoperative functional status in 
patients with osteoarthritis and rheumatoid arthritis. Cochrane Database Syst Rev, 
2015(2): p. Cd003130. 

Clinical Protocol 
Study Number: CORI.2019.06
A Prospective, Multi-center, Randomized 
Controlled Study to Evaluate the Safety and 
Effectiveness of REAL INTELLIGENCE™ CORI™ in 
unicondylar knee arthroplasty (UKA) Procedure
Version: 4.0-Master, 07 Sep 
2022
Page: 104 of 167   
 
CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. 
and is intended for use only by Smith+Nephew and its manufacturer. It shall not be reproduced or copied in whole or in 
part, nor shall the contents be disclosed by any means without prior written permission from Smith+Nephew, nor shall 
anyone make any use of it that is contrary to the expressed or implied wishes of Smith+Nephew. 
TMP-CD-05-01 Clinical Protocol - Device – Revision D; SOP-CD-05 Clinical Protocol
13. 
Evans, J.T., et al., How long does a knee replacement last? A systematic review and 
meta-analysis of case series and national registry reports with more than 15 years of 
follow-up. The Lancet, 2019. 393(10172): p. 655-663. 
14. 
Aujla, R.S. and C.N. Esler, Total Knee Arthroplasty for Osteoarthritis in Patients Less 
Than Fifty-Five Years of Age: A Systematic Review. J Arthroplasty, 2017. 32(8): p. 
2598-2603.e1. 
15. 
Yoon, C., et al., Does unicompartmental knee arthroplasty have worse outcomes in 
spontaneous osteonecrosis of the knee than in medial compartment osteoarthritis? A 
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393-403. 
16. 
Yue, J., L. Zhang, and C. Yang, The impact of patellofemoral arthritis on 
unicompartmental knee arthroplasty. Acta Orthop Belg, 2015. 81(4): p. 587-93. 
17. 
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Wales, Northern Ireland. 
18. 
(AOANJRR), A.O.A.N.J.R.R., Hip, Knee & Shoulder Arthroplasty: 2019 Annual Report. 
. Adelaide: AOA, 2019, 2019. 
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literature review. Musculoskelet Surg, 2015. 99(1): p. 11-8. 
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Confalonieri, N., et al., Navigated "small implants" in knee reconstruction. Knee Surg 
Sports Traumatol Arthrosc, 2016. 24(11): p. 3507-3516. 
21. 
Burnett, R.S. and R.L. Barrack, Computer-assisted total knee arthroplasty is currently 
of no proven clinical benefit: a systematic review. Clin Orthop Relat Res, 2013. 
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22. 
van der List, J.P., et al., Current state of computer navigation and robotics in 
unicompartmental and total knee arthroplasty: a systematic review with meta-
analysis. Knee Surg Sports Traumatol Arthrosc, 2016. 24(11): p. 3482-3495. 
23. 
Roche, M., L. Elson, and C. Anderson, Dynamic soft tissue balancing in total knee 
arthroplasty. Orthopedic Clinics of North America, 2014. 45(2): p. 157-165. 
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Mayman, D., Handheld navigation in total knee arthroplasty. Orthop Clin North Am, 
2014. 45(2): p. 185-90. 
25. 
van der List, J.P., H. Chawla, and A.D. Pearle, Robotic-Assisted Knee Arthroplasty: An 
Overview. Am J Orthop (Belle Mead NJ), 2016. 45(4): p. 202-11. 

Clinical Protocol 
Study Number: CORI.2019.06
A Prospective, Multi-center, Randomized 
Controlled Study to Evaluate the Safety and 
Effectiveness of REAL INTELLIGENCE™ CORI™ in 
unicondylar knee arthroplasty (UKA) Procedure
Version: 4.0-Master, 07 Sep 
2022
Page: 105 of 167   
 
CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. 
and is intended for use only by Smith+Nephew and its manufacturer. It shall not be reproduced or copied in whole or in 
part, nor shall the contents be disclosed by any means without prior written permission from Smith+Nephew, nor shall 
anyone make any use of it that is contrary to the expressed or implied wishes of Smith+Nephew. 
TMP-CD-05-01 Clinical Protocol - Device – Revision D; SOP-CD-05 Clinical Protocol
26. 
Clayton, A.W., et al., Does the use of navigation in total knee arthroplasty affect 
outcomes? J Knee Surg, 2014. 27(3): p. 171-5. 
27. 
Abdel, M.P., et al., Coronal alignment in total knee replacement: historical review, 
contemporary analysis, and future direction. Bone Joint J, 2014. 96-b(7): p. 857-62. 
28. 
Nair, R., G. Tripathy, and G.R. Deysine, Computer navigation systems in 
unicompartmental knee arthroplasty: a systematic review. Am J Orthop (Belle Mead 
NJ), 2014. 43(6): p. 256-61. 
29. 
Banerjee, S., et al., Robotic-assisted knee arthroplasty. Expert Review of Medical 
Devices, 2015. 12(6): p. 727-735. 
30. 
Nodzo, S.R., K.M. Carroll, and D.J. Mayman, Disposable Navigation for Total Knee 
Arthroplasty. Am J Orthop (Belle Mead NJ), 2016. 45(4): p. 240-5. 
31. 
Blakeney, W., et al., Kinematic alignment in total knee arthroplasty better reproduces 
normal gait than mechanical alignment. Knee Surg Sports Traumatol Arthrosc, 2019. 
27(5): p. 1410-1417. 
32. 
Lonner, J.H. and V.M. Moretti, The Evolution of Image-Free Robotic Assistance in 
Unicompartmental Knee Arthroplasty. Am J Orthop (Belle Mead NJ), 2016. 45(4): p. 
249-54. 
33. 
Khlopas, A., et al., Robotic Arm-Assisted Total Knee Arthroplasty. J Arthroplasty, 
2018. 33(7): p. 2002-2006. 
34. 
Robinson, P.G., et al., A systematic review of robotic-assisted unicompartmental knee 
arthroplasty: prosthesis design and type should be reported. Bone Joint J, 2019. 
101-b(7): p. 838-847. 
35. 
Jacofsky, D.J. and M. Allen, Robotics in Arthroplasty: A Comprehensive Review. J 
Arthroplasty, 2016. 31(10): p. 2353-63. 
36. 
Thein, R., et al., Lateral Robotic Unicompartmental Knee Arthroplasty. Sports 
Medicine and Arthroscopy Review, 2014. 22(4): p. 223-228. 
37. 
Roche, M., Robotic-assisted unicompartmental knee arthroplasty: the MAKO 
experience. Orthop Clin North Am, 2015. 46(1): p. 125-31. 
38. 
Batailler, C., et al., Improved implant position and lower revision rate with robotic-
assisted unicompartmental knee arthroplasty. Knee surgery, sports traumatology, 
arthroscopy : official journal of the ESSKA, 2019. 27(4): p. 1232-1240. 

Clinical Protocol 
Study Number: CORI.2019.06
A Prospective, Multi-center, Randomized 
Controlled Study to Evaluate the Safety and 
Effectiveness of REAL INTELLIGENCE™ CORI™ in 
unicondylar knee arthroplasty (UKA) Procedure
Version: 4.0-Master, 07 Sep 
2022
Page: 106 of 167   
 
CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. 
and is intended for use only by Smith+Nephew and its manufacturer. It shall not be reproduced or copied in whole or in 
part, nor shall the contents be disclosed by any means without prior written permission from Smith+Nephew, nor shall 
anyone make any use of it that is contrary to the expressed or implied wishes of Smith+Nephew. 
TMP-CD-05-01 Clinical Protocol - Device – Revision D; SOP-CD-05 Clinical Protocol
39. 
Battenberg, A.K., N.A. Netravali, and J.H. Lonner, A novel handheld robotic-assisted 
system for unicompartmental knee arthroplasty: surgical technique and early 
survivorship. J Robot Surg, 2019. 
40. 
Canetti, R., et al., Faster return to sport after robotic-assisted lateral 
unicompartmental knee arthroplasty: a comparative study. Archives of orthopaedic 
and trauma surgery, 2018. 138(12): p. 1765-1771. 
41. 
Gregori, A., F. Picard, and J. Lonner, ACCURACY OF IMAGELESS ROBOTICALLY 
ASSISTED UNICONDYLAR KNEE ARTHROPLASTY. Bone Joint J, 2016. 98(SUPP 5): p. 
33-33. 
42. 
Herry, Y., et al., Improved joint-line restitution in unicompartmental knee 
arthroplasty using a robotic-assisted surgical technique. International Orthopaedics, 
2017. 41(11): p. 2265-2271. 
43. 
Vega Parra, P.D., et al., Robotic-assisted unicompartmental knee replacement with 
navio surgical system: Outcome Evaluation using the Knee Injury Osteoarthritis 
Outcome Score. Revista Chilena de Ortopedia y Traumatologia, 2017. 58(1): p. 7-12. 
44. 
Sephton, B.M., et al., Predictors of extended length of stay after unicompartmental 
knee arthroplasty. Journal of Clinical Orthopaedics and Trauma, 2019. 
45. 
Asif, S. and D.S. Choon, Midterm results of cemented Press Fit Condylar Sigma total 
knee arthroplasty system. J Orthop Surg (Hong Kong), 2005. 13(3): p. 280-4. 
46. 
Insall, J.N., et al., Rationale of the Knee Society clinical rating system. Clin Orthop 
Relat Res, 1989(248): p. 13-4. 
47. 
Dawson, J., et al., Questionnaire on the perceptions of patients about total knee 
replacement. J Bone Joint Surg Br, 1998. 80(1): p. 63-9. 
48. 
Murray, D.W., et al., The use of the Oxford hip and knee scores. J Bone Joint Surg Br, 
2007. 89(8): p. 1010-4. 
49. 
Behrend, H., et al., The "forgotten joint" as the ultimate goal in joint arthroplasty: 
validation of a new patient-reported outcome measure. J Arthroplasty, 2012. 27(3): 
p. 430-436.e1. 
50. 
Janssen, M.F., et al., Measurement properties of the EQ-5D-5L compared to the EQ-
5D-3L across eight patient groups: a multi-country study. Qual Life Res, 2013. 
22(7): p. 1717-27. 
51. 
Parratte, S., et al., Effect of postoperative mechanical axis alignment on the fifteen-
year survival of modern, cemented total knee replacements. J Bone Joint Surg Am, 
2010. 92(12): p. 2143-9. 

Clinical Protocol 
Study Number: CORI.2019.06
A Prospective, Multi-center, Randomized 
Controlled Study to Evaluate the Safety and 
Effectiveness of REAL INTELLIGENCE™ CORI™ in 
unicondylar knee arthroplasty (UKA) Procedure
Version: 4.0-Master, 07 Sep 
2022
Page: 107 of 167   
 
CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. 
and is intended for use only by Smith+Nephew and its manufacturer. It shall not be reproduced or copied in whole or in 
part, nor shall the contents be disclosed by any means without prior written permission from Smith+Nephew, nor shall 
anyone make any use of it that is contrary to the expressed or implied wishes of Smith+Nephew. 
TMP-CD-05-01 Clinical Protocol - Device – Revision D; SOP-CD-05 Clinical Protocol
52. 
Nephew, S., Clinical Study Report 6-month Follow-up: "Clinical, Radiographic and 
Patient-reported Outcomes Associated with the Use of the NAVIO™ Robotic-assisted 
Surgical System in Total Knee Arthroplasty", 2019. 
 
 
 

Clinical Protocol 
Study Number: CORI.2019.06
A Prospective, Multi-center, Randomized 
Controlled Study to Evaluate the Safety and 
Effectiveness of REAL INTELLIGENCE™ CORI™ in 
unicondylar knee arthroplasty (UKA) Procedure
Version: 4.0-Master, 07 Sep 
2022
Page: 108 of 167   
 
CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. 
and is intended for use only by Smith+Nephew and its manufacturer. It shall not be reproduced or copied in whole or in 
part, nor shall the contents be disclosed by any means without prior written permission from Smith+Nephew, nor shall 
anyone make any use of it that is contrary to the expressed or implied wishes of Smith+Nephew. 
TMP-CD-05-01 Clinical Protocol - Device – Revision D; SOP-CD-05 Clinical Protocol
22 APPENDICES
22.1 PROTOCOL AMENDMENT  
22.1.1  General Purpose 
The purpose of the protocol amendment is to meet the requirements of the Hongkong 
site during the EC approval session. The protocol amendment for version 2.1 is minor. 
The purpose to have the 2nd protocol amendment into version 3.0-Master is to update 
the protocol from Template B into Template D and also update the information within 
the protocol.  
The purpose of amending version 3.0 to version 4.0-Master is to expand the pre-
surgery visit window from -28 to -90 days. South Korea has also been added as a 
location for where the study will be conducted and staged bilateral subjects can now 
be enrolled. Subject has one or more of the following arthroplasties that are not fully 
healed and well-functioning, as determined by the investigator: Contralateral primary 
TKA or UKA, however, the subject can only have one knee enrolled in this study. 
. An additional exclusion was added to restrict the enrolment of subjects who 
currently enrolled in another study orthopaedic clinical trial study at least 1 year 
prior to screening.  Some of the changes in this version are being made to maintain 
alignment with the changes required by the regulatory authorities in China. 
22.1.2 Rationale 
The rationale to 1st time updates the protocol is due to the protocol title inconsistency 
with other documents. Since the amendment is change that do not materially affect 
the study which is simply update the protocol title from “procedures” into “Procedure”.  
 
The rationale to 2nd time updates the protocol is due to the protocol template updated 
from version B to version D. And also, the information inside of the protocol need to 
be further updated. 

Clinical Protocol 
Study Number: CORI.2019.06
A Prospective, Multi-center, Randomized 
Controlled Study to Evaluate the Safety and 
Effectiveness of REAL INTELLIGENCE™ CORI™ in 
unicondylar knee arthroplasty (UKA) Procedure
Version: 4.0-Master, 07 Sep 
2022
Page: 109 of 167   
 
CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. 
and is intended for use only by Smith+Nephew and its manufacturer. It shall not be reproduced or copied in whole or in 
part, nor shall the contents be disclosed by any means without prior written permission from Smith+Nephew, nor shall 
anyone make any use of it that is contrary to the expressed or implied wishes of Smith+Nephew. 
TMP-CD-05-01 Clinical Protocol - Device – Revision D; SOP-CD-05 Clinical Protocol
 
The rationale to 3rd time update is to allow more patient to enrol in the study and 
update the information based on ISO14155 2020 and to maintain alignment with the 
changes required by the regulatory authorities in China.  
 
22.1.3  Effect on Study Status 
Not applicable. The amendment in version 2.0, 2.1 and 3.0-Master was in effect and 
implemented prior to subject enrolment. 
The amendment in Version 4.0-Master will not impact the status of study, however, 
patient enrolment may improve.  
 
22.1.4  Details 
1st Update from Version 2.0 to Version 2.1 
Section 
Current Text
Version 2.0 (04SEP2020) 
Revised Text 
Version 2.1 (14JAN2021) 
header 
A 
Prospective, 
Multi-center, 
Randomized Controlled Study to 
Evaluate 
the 
Safety 
and 
Effectiveness 
of 
REAL 
INTELLIGENCE™ 
CORI™ 
in 
unicondylar knee arthroplasty 
(UKA) procedures  
Version: 2.0, 04SEP2020 
A 
Prospective, 
Multi-center, 
Randomized Controlled Study to 
Evaluate 
the 
Safety 
and 
Effectiveness 
of 
REAL 
INTELLIGENCE™ 
CORI™ 
in 
unicondylar knee arthroplasty (UKA) 
Procedure 
Version: 2.1, 14JAN2021 
Section 
1.2.1&1.2.2 
A 
Prospective, 
Multi-center, 
Randomized Controlled Study to 
Evaluate 
the 
Safety 
and 
Effectiveness 
of 
REAL 
A 
Prospective, 
Multi-center, 
Randomized Controlled Study to 
Evaluate 
the 
Safety 
and 
Effectiveness 
of 
REAL 

Clinical Protocol 
Study Number: CORI.2019.06
A Prospective, Multi-center, Randomized 
Controlled Study to Evaluate the Safety and 
Effectiveness of REAL INTELLIGENCE™ CORI™ in 
unicondylar knee arthroplasty (UKA) Procedure
Version: 4.0-Master, 07 Sep 
2022
Page: 110 of 167   
 
CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. 
and is intended for use only by Smith+Nephew and its manufacturer. It shall not be reproduced or copied in whole or in 
part, nor shall the contents be disclosed by any means without prior written permission from Smith+Nephew, nor shall 
anyone make any use of it that is contrary to the expressed or implied wishes of Smith+Nephew. 
TMP-CD-05-01 Clinical Protocol - Device – Revision D; SOP-CD-05 Clinical Protocol
INTELLIGENCE™ 
CORI™ 
in 
unicondylar knee arthroplasty 
(UKA) procedures”, version 2.0, 
dated 04SEP2020
INTELLIGENCE™ 
CORI™ 
in 
unicondylar knee arthroplasty (UKA) 
Procedure”, 
version 
2.1, 
dated 
14JAN2021
Synopsis
A Prospective, Multi-center, 
Randomized Controlled Study to 
Evaluate the Safety and 
Effectiveness of REAL 
INTELLIGENCE™ CORI™ in 
unicondylar knee arthroplasty 
(UKA) procedures 
A Prospective, Multi-center, 
Randomized Controlled Study to 
Evaluate the Safety and 
Effectiveness of REAL 
INTELLIGENCE™ CORI™ in 
unicondylar knee arthroplasty 
(UKA) Procedure 
 
2nd Update from Version 2.1 to Version 3.0-Master 
Section 
Current Text 
Version 2.1 (14JAN2021) 
Revised Text 
Version 3.0-Master (03MAR2021) 
Cover 
Page 
Original Text
Added “Single Identification Number 
of 
Clinical 
Investigation: 
CORI.2019.06” 
Cover 
Page 
Protocol Author(s):
Rahel Meister, Senior Clinical 
Study Manager 
Babajide 
Olayinka, 
Senior 
Biostatistician 
Protocol Author(s):
Michelle Li, Associate Clinical Study 
Manager 
Rahel Meister, Senior Clinical Study 
Manager 
Babajide 
Olayinka, 
Senior 
Biostatistician 
Header  
Version: 2.1, Date: 14JAN2021
Version: 
3.0-Master, 
Date: 
03MAR2021 

Clinical Protocol 
Study Number: CORI.2019.06
A Prospective, Multi-center, Randomized 
Controlled Study to Evaluate the Safety and 
Effectiveness of REAL INTELLIGENCE™ CORI™ in 
unicondylar knee arthroplasty (UKA) Procedure
Version: 4.0-Master, 07 Sep 
2022
Page: 111 of 167   
 
CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. 
and is intended for use only by Smith+Nephew and its manufacturer. It shall not be reproduced or copied in whole or in 
part, nor shall the contents be disclosed by any means without prior written permission from Smith+Nephew, nor shall 
anyone make any use of it that is contrary to the expressed or implied wishes of Smith+Nephew. 
TMP-CD-05-01 Clinical Protocol - Device – Revision D; SOP-CD-05 Clinical Protocol
Footer 
TMP-CD-05-01 
– 
Clinical 
Protocol-Device –
Revision B; 
SOP-CD-05 Clinical Protocols 
TMP-CD-05-01 – Clinical Protocol-
Device –
Revision D; SOP-CD-05 
Clinical Protocols 
Section 
1.1 &1.2 
Protocol
Version: 2.1, Date: 
14JAN2021 
Protocol Version: 3.0-Master, Date: 
03MAR2021 
Merge the Signature and Date into 
same column 
Section 1.1 
I agree to comply with the 
Investigator’s 
Obligations 
stipulated 
in 
Section 
22.5
Principal Investigator Obligations 
according to ISO 14155:2011. 
and 
applicable 
laws 
and 
regulation in China (NMPA) of 
the protocol. 
I 
agree 
to 
comply 
with 
the 
Investigator’s Obligations stipulated 
in Section 6 Principal Investigator 
Obligations 
according 
to 
ISO 
14155:2011 and all applicable local 
legislation and regulations 
Section 1.2 
Refer to version 2.0 for full 
sponsor approval. Approval of 
the 
head 
of 
China 
clinical 
operations 
indicates 
approval 
both of the changes to the 
protocol and of the changes 
being processed and approved 
as a minor amendment. 
Astrid Yung 
Associate 
Director, 
Clinical 
Strategy and Operations 
Full stakeholders signature list 

Clinical Protocol 
Study Number: CORI.2019.06
A Prospective, Multi-center, Randomized 
Controlled Study to Evaluate the Safety and 
Effectiveness of REAL INTELLIGENCE™ CORI™ in 
unicondylar knee arthroplasty (UKA) Procedure
Version: 4.0-Master, 07 Sep 
2022
Page: 112 of 167   
 
CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. 
and is intended for use only by Smith+Nephew and its manufacturer. It shall not be reproduced or copied in whole or in 
part, nor shall the contents be disclosed by any means without prior written permission from Smith+Nephew, nor shall 
anyone make any use of it that is contrary to the expressed or implied wishes of Smith+Nephew. 
TMP-CD-05-01 Clinical Protocol - Device – Revision D; SOP-CD-05 Clinical Protocol
Sections 2 
and 7.3 
11. Subject in the opinion of the 
Investigator has an emotional or 
neurological condition that would 
pre-empt 
their 
ability 
or 
willingness to participate in the 
study including mental illness, 
mental 
retardation, 
drug 
or 
alcohol abuse. 
11. Subject in the opinion of the 
Investigator has an emotional or 
neurological condition that would pre-
empt their ability or willingness to 
participate in the study including 
mental illness, intellectual disability, 
or drug or alcohol abuse.
Section 2 
Study Duration: 
Estimated timeline: 
•Study period: 25 months (12 
months enrolment) 
•Start 
enrolment: 
December 
2020 
•Last subject first visit: February 
2022 
•Last subject last visit: April 
2020 
Study Duration: 
Estimated timeline: 
•Study period: 25 months (12 months 
enrolment) 
•Start enrolment: March 2021 
•Last subject first visit: March 2022 
•Last subject last visit: May 2023 
Section 2 
Safety Data: 
All AEs will be categorized in 
terms 
of 
seriousness 
and 
relatedness to the study device 
or to the surgical procedure 
(Adverse 
Events, 
Serious 
Adverse Events, Adverse Device 
Effects, Serious Adverse Device 
effects). All Serious Adverse 
Device Effects will be further 
categorized as Anticipated or 
Safety Data: 
All AEs will be categorized in terms of 
seriousness and relatedness to the 
study device or to the surgical 
procedure (Adverse Events, Serious 
Adverse 
Events, 
Adverse 
Device 
Effects, 
Serious 
Adverse 
Device 
effects). All Serious Adverse Device 
Effects will be further categorized as 
Anticipated or Unanticipated. The 
definitions 
for 
each 
of 
these 

Clinical Protocol 
Study Number: CORI.2019.06
A Prospective, Multi-center, Randomized 
Controlled Study to Evaluate the Safety and 
Effectiveness of REAL INTELLIGENCE™ CORI™ in 
unicondylar knee arthroplasty (UKA) Procedure
Version: 4.0-Master, 07 Sep 
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and is intended for use only by Smith+Nephew and its manufacturer. It shall not be reproduced or copied in whole or in 
part, nor shall the contents be disclosed by any means without prior written permission from Smith+Nephew, nor shall 
anyone make any use of it that is contrary to the expressed or implied wishes of Smith+Nephew. 
TMP-CD-05-01 Clinical Protocol - Device – Revision D; SOP-CD-05 Clinical Protocol
Unanticipated. The definitions for 
each of these categories are 
based on ISO 14155:2011 and 
applicable 
local 
laws 
and 
regulations. in China.
(Including 
hardware 
and 
instrumentation), complications, 
and revisions. 
categories 
are 
based 
on 
ISO 
14155:2011 and applicable local laws 
and regulations.  
Section 3.1 
&3.2 & 3.3 
Original Table of Content, List of 
Tables & List of Figures 
Updated Table of Content, List of 
Tables & List of Figures 
Numbering updated for all tables and 
figures throughout the protocol 
Section 3.4 
KSS - Knee Society Score
2011 KSS - Knee Society Score, 2011
HKA – Hip-Knee-Ankle 
Section 5.1 
The primary objective of this 
study is to evaluate the use of 
CORI in UKA procedures in 
achieving 
post-operative 
leg 
alignment 
as 
compared 
to 
procedures 
using 
standard 
instruments.
The primary objective of this study is 
to evaluate the use of CORI in UKA 
procedures 
in 
achieving 
post-
operative leg alignment as compared 
to procedures using conventional 
manual instruments.
Section 5.2 
The secondary objective of this 
study is to assess the safety and 
performance of CORI up to 12 
months 
after 
surgery 
as 
compared to procedures using 
conventional 
manual 
instruments. 
The secondary objective of this study 
is to generate safety and performance 
evidence supporting the use of CORI 
procedures. To assess the safety and 
performance of CORI up to 12 months 
after 
surgery 
as 
compared 
to 
procedures 
using 
conventional 
manual instruments. 

Clinical Protocol 
Study Number: CORI.2019.06
A Prospective, Multi-center, Randomized 
Controlled Study to Evaluate the Safety and 
Effectiveness of REAL INTELLIGENCE™ CORI™ in 
unicondylar knee arthroplasty (UKA) Procedure
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and is intended for use only by Smith+Nephew and its manufacturer. It shall not be reproduced or copied in whole or in 
part, nor shall the contents be disclosed by any means without prior written permission from Smith+Nephew, nor shall 
anyone make any use of it that is contrary to the expressed or implied wishes of Smith+Nephew. 
TMP-CD-05-01 Clinical Protocol - Device – Revision D; SOP-CD-05 Clinical Protocol
Section 
5.3 
Other 
objectives 
are 
to 
determine the system time and 
cutting time of the robotic drill of 
UKA procedures with CORI. 
Other objectives are to collect the 
system time and cutting time of the 
robotic drill from the CORI Case 
Report.
Section 6 
Title: 
NVESTIGATIONAL 
PRODUCT(S) 
Title: NVESTIGATIONAL PRODUCT(S) 
AND COMPARATOR
Section 
6.1.1 
Figure 
6.1-6-1 
CORI 
Reusable Instruments
CORI Robotic Drill: Controls 
the position and speed of the 
bur. It is intended for 5 uses and 
is able to be autoclaved, auto 
washed, and disinfected.
Figure 6.1-6-2 CORI Reusable 
Instruments
CORI Robotic Drill: Controls the 
position and speed of the bur. It is 
intended for 75 uses and is able to be 
autoclaved, 
auto 
washed, 
and 
disinfected.
Section 
6.1.3 
Not Exist 
Added 
new 
section 
“Ancillary 
Product(s)->Not applicable. 
Section 
6.2 
For Australia, Hong Kong and 
New Zealand the list of reference 
documents can be found in 
Appendix 
Section 
22.2 
Instruction For Use & User 
Manual. 
For Australia, Hong Kong and New 
Zealand 
the 
list 
of 
reference 
documents can be found in Appendix 
Section 22.3 Instruction For Use & 
User Manual. 
Section 
6.3.1 
The 
standard 
commercial 
pacaing as marketed in the US is 
used. However, additional labels 
will 
be 
included 
on 
the 
commercial packaing to meet the 
regulatory 
requirements 
for 
investational devices in countries 
The standard commercial packaging 
as marketed in the US is used. 
However, additional labels will be 
included 
on 
the 
commercial 
packaging to meet the regulatory 
requirements 
for 
investigational 
devices 
in 
countries 
where 
the 

Clinical Protocol 
Study Number: CORI.2019.06
A Prospective, Multi-center, Randomized 
Controlled Study to Evaluate the Safety and 
Effectiveness of REAL INTELLIGENCE™ CORI™ in 
unicondylar knee arthroplasty (UKA) Procedure
Version: 4.0-Master, 07 Sep 
2022
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and is intended for use only by Smith+Nephew and its manufacturer. It shall not be reproduced or copied in whole or in 
part, nor shall the contents be disclosed by any means without prior written permission from Smith+Nephew, nor shall 
anyone make any use of it that is contrary to the expressed or implied wishes of Smith+Nephew. 
TMP-CD-05-01 Clinical Protocol - Device – Revision D; SOP-CD-05 Clinical Protocol
where 
the 
devices 
are 
not 
approved for marketing.
devices 
are 
not 
approved 
for 
marketing.
Section 
6.6 
Not Exist 
New 
added 
section 
“Medical 
Procedure-> There are 3 basic steps 
in unicondylar knee arthroplasty. The 
first step is preparing the bone and 
removing the cartridge from the 
damaged knee compartment. This will 
be completed using either the CORI 
robotic drill or an oscillating saw. The 
surgeon will then position the metal 
implants on the damaged side of the 
femur 
and 
tibia 
using 
several 
orthopaedic tools. Finally, a spacer 
will be inserted between the metal 
implants to reduce friction when the 
knee flexes and extends. At various 
times during the procedure, the hip-
knee-ankle 
angle 
(HKA) 
will 
be 
checked using the CORI advanced 
tracking system or via the use of 
intramedullary 
and 
/ 
or 
extramedullary rods. How the angle is 
measured will depend on which 
treatment 
arm 
the 
subject 
is 
randomized 
to 
receive. 
All 
unicondylar 
knee 
arthroplasty 
is 
completed using general anaesthetic 
by a surgical team trained in both the 

Clinical Protocol 
Study Number: CORI.2019.06
A Prospective, Multi-center, Randomized 
Controlled Study to Evaluate the Safety and 
Effectiveness of REAL INTELLIGENCE™ CORI™ in 
unicondylar knee arthroplasty (UKA) Procedure
Version: 4.0-Master, 07 Sep 
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and is intended for use only by Smith+Nephew and its manufacturer. It shall not be reproduced or copied in whole or in 
part, nor shall the contents be disclosed by any means without prior written permission from Smith+Nephew, nor shall 
anyone make any use of it that is contrary to the expressed or implied wishes of Smith+Nephew. 
TMP-CD-05-01 Clinical Protocol - Device – Revision D; SOP-CD-05 Clinical Protocol
CORI system and the use of standard 
manual instrumentation.
Section 
7.3 
Exclusion Criteria No. 1-7 
Exclusion Criteria No. 7-13 
Section 
7.5 
The subject, or their legally 
authorized representative  
The 
subject, 
or 
their 
legally 
authorized 
representative 
(if 
applicable) 
Section 
7.8.2 
Subject noncompliance (e.g., 
did not follow instructions, 
took disallowed medications) 
 
Subject lost to follow-up 
 
The 
Investigator 
or 
the 
Sponsor stops the study for 
any reason and decides to 
withdraw subject(s) from the 
study
 
Concurrent illness 
 
Adverse 
Events/Adverse 
Device Effects 
 
Any other significant reason 
identified by the Investigator
Subjects who drop out or are 
withdrawn will not be-re-entered 
into the study at a later date. 
 
Subject noncompliance (e.g., did 
not 
follow 
instructions, 
took 
disallowed medications) 
 
Subject is lost to follow-up 
 
The Investigator or the Sponsor 
terminates the study 
for any 
reason  
 
Concurrent illness 
 
Adverse 
Events/Adverse 
Device 
Effects 
 
Any 
other 
significant 
reason 
identified by the Investigator. 
 
Subjects 
who 
withdraw 
or 
are 
withdrawn by the Investigator cannot 
be-re-enrolled in the study.  
Section 
7.8.3 
Study participation is voluntary, 
and subjects may withdraw at 
any point during the study 
without giving their reason for 
Study participation is voluntary, and 
subjects may withdraw from the 
study at any time. Where subjects 
withdraw consent, the Investigator 

Clinical Protocol 
Study Number: CORI.2019.06
A Prospective, Multi-center, Randomized 
Controlled Study to Evaluate the Safety and 
Effectiveness of REAL INTELLIGENCE™ CORI™ in 
unicondylar knee arthroplasty (UKA) Procedure
Version: 4.0-Master, 07 Sep 
2022
Page: 117 of 167
CONFIDENTIAL AND PROPRIETARY
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. 
and is intended for use only by Smith+Nephew and its manufacturer. It shall not be reproduced or copied in whole or in 
part, nor shall the contents be disclosed by any means without prior written permission from Smith+Nephew, nor shall 
anyone make any use of it that is contrary to the expressed or implied wishes of Smith+Nephew.
TMP-CD-05-01 Clinical Protocol - Device – Revision D; SOP-CD-05 Clinical Protocol
doing 
so. 
Where 
subjects 
withdraw 
consent, 
the 
Investigator 
should 
make 
a 
reasonable effort to ascertain the 
reason(s), while fully respecting 
the subject’s privacy. The reason 
for withdrawal will be recorded in 
the eCRF and source documents.
should make a reasonable effort to 
ascertain the reason(s), while fully 
respecting the subject’s right to 
privacy. The reason for withdrawal 
will be recorded in the eCRF and 
source documents.
Section 
8.1-Figure 
8-1
Section 
8.2.1
Within the Primary UKA segment 
of the study, subjects will be 
randomly assigned to the CORI 
Navigational 
or 
Conventional 
manual instrumentation groups 
according 
to 
a 
balanced 
randomization procedure using a 
1:1 allocation ratio.
Subjects will be randomly assigned to 
the CORI navigational or conventional 
manual 
instrumentation 
groups 
according 
to 
a 
balanced 
randomization procedure using a 1:1 
allocation ratio.
Section 
8.3
Not Exist
New 
added 
section 
“DATA 
MANAGEMENT”
This 
study 
utilizes 
a 
validated, 
encrypted electronic data capture 
system that is 21 CFR Part 11 
compliant. Access to the electronic 
data capture system is restricted by 
study role in accordance with Smith 
and Nephew procedures. 

Clinical Protocol 
Study Number: CORI.2019.06
A Prospective, Multi-center, Randomized 
Controlled Study to Evaluate the Safety and 
Effectiveness of REAL INTELLIGENCE™ CORI™ in 
unicondylar knee arthroplasty (UKA) Procedure
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and is intended for use only by Smith+Nephew and its manufacturer. It shall not be reproduced or copied in whole or in 
part, nor shall the contents be disclosed by any means without prior written permission from Smith+Nephew, nor shall 
anyone make any use of it that is contrary to the expressed or implied wishes of Smith+Nephew. 
TMP-CD-05-01 Clinical Protocol - Device – Revision D; SOP-CD-05 Clinical Protocol
A Data Management Plan (DMP) is 
written 
according 
to 
Smith 
and 
Nephew procedures containing details 
of the data management process. The 
following is a brief description of the 
key points detailed in this plan.
8.3.1 Data 
Review 
and 
Quality 
Assurance  
Data will be transcribed from the data 
source to an electronic Case Report 
Form (eCRF). All data requested on 
the eCRFs are considered required. 
Data points not collected and/or 
recorded will be considered deviations 
unless otherwise specified.  
Data collection is the responsibility of 
the clinical trial staff at the site under 
the 
supervision 
of 
the 
Principal 
Investigator. 
The 
Principal 
Investigator 
is 
responsible 
for 
ensuring the accuracy, completeness, 
legibility, and timeliness of the data 
reported. The Principal Investigator 
must 
provide 
his/her 
electronic 
signature on the appropriate eCRFs to 
be documented in compliance with 
local regulations. Changes to data 

Clinical Protocol 
Study Number: CORI.2019.06
A Prospective, Multi-center, Randomized 
Controlled Study to Evaluate the Safety and 
Effectiveness of REAL INTELLIGENCE™ CORI™ in 
unicondylar knee arthroplasty (UKA) Procedure
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part, nor shall the contents be disclosed by any means without prior written permission from Smith+Nephew, nor shall 
anyone make any use of it that is contrary to the expressed or implied wishes of Smith+Nephew. 
TMP-CD-05-01 Clinical Protocol - Device – Revision D; SOP-CD-05 Clinical Protocol
previously submitted to the sponsor 
will require a new signature by the 
Investigator to acknowledge/approve 
the changes. 
Visual and computer data review will 
be performed in line with Smith and 
Nephew 
procedures 
to 
identify 
possible data discrepancies. Manual 
and automatic queries will be created 
within the electronic data capture 
system, and will be issued by Smith 
and 
Nephew 
to 
the 
site 
for 
appropriate response. Site staff are 
responsible for resolving all queries in 
the electronic data capture system.  
8.3.2 Retention Period 
All eCRFs will be archived once the 
study is completed and will kept for a 
period of no less than five years after 
the later of the following dates: the 
date of which the study is terminated 
or completed or; the date that the 
records 
are 
no 
longer 
required 
supporting marketing applications. 
Section 
8.4.3
robotic drills 
robotic drills 
Section 
8.5.1 
In order to eliminate selection 
bias, 
investigators 
will 
Original Sentence deleted 

Clinical Protocol 
Study Number: CORI.2019.06
A Prospective, Multi-center, Randomized 
Controlled Study to Evaluate the Safety and 
Effectiveness of REAL INTELLIGENCE™ CORI™ in 
unicondylar knee arthroplasty (UKA) Procedure
Version: 4.0-Master, 07 Sep 
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and is intended for use only by Smith+Nephew and its manufacturer. It shall not be reproduced or copied in whole or in 
part, nor shall the contents be disclosed by any means without prior written permission from Smith+Nephew, nor shall 
anyone make any use of it that is contrary to the expressed or implied wishes of Smith+Nephew. 
TMP-CD-05-01 Clinical Protocol - Device – Revision D; SOP-CD-05 Clinical Protocol
continuously 
screen 
eligible 
subjects.
Section 
8.5.2 
Subjects 
meeting 
all 
inclusion/exclusion criteria will 
be randomly allocated into any of 
two 
study 
groups 
(CORI 
Navigational versus conventional 
manual instrumentation groups) 
in a 1:1 allocation ratio.  
Subjects 
meeting 
all 
inclusion/exclusion criteria will be 
randomly allocated to one of two 
treatment groups (CORI Navigational 
versus 
conventional 
manual 
instrumentation) in a 1:1 allocation 
ratio.  
Section 
8.5.4 
The details of the analyses will 
further be pre-specified in the 
Statistical Analysis Plan (SAP) so 
as minimize any threats to 
external 
validity 
and 
yield 
clinically relevant estimates of 
effects and precision. 
The details of all analysis to be 
performed 
will 
further 
be 
pre-
specified in the Statistical Analysis 
Plan (SAP) so as to minimize any 
threats to external validity and yield 
clinically relevant estimates of effects 
and precision. 
Section 
9.1.2 
1.Obtain 
written 
informed 
consent from the subject as 
detailed in Section 7.5. Any 
subject who signs an informed 
consent but fails to meet the 
entry criteria is considered to be 
a 
Screen 
Failure. 
Their 
demographic information must 
be captured in the appropriate 
electronic Case Report Form 
(eCRF) with the reason for 
screen failure specified. 
1.Obtain written informed consent 
from the subject as detailed in 
Section 7.5. 

Clinical Protocol 
Study Number: CORI.2019.06
A Prospective, Multi-center, Randomized 
Controlled Study to Evaluate the Safety and 
Effectiveness of REAL INTELLIGENCE™ CORI™ in 
unicondylar knee arthroplasty (UKA) Procedure
Version: 4.0-Master, 07 Sep 
2022
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and is intended for use only by Smith+Nephew and its manufacturer. It shall not be reproduced or copied in whole or in 
part, nor shall the contents be disclosed by any means without prior written permission from Smith+Nephew, nor shall 
anyone make any use of it that is contrary to the expressed or implied wishes of Smith+Nephew. 
TMP-CD-05-01 Clinical Protocol - Device – Revision D; SOP-CD-05 Clinical Protocol
Section 
9.1.2 
Original text 
Add” No. 11- The subject will be 
randomized 
to 
treatment 
group 
(CORI 
or 
Manual 
conventional 
instrumentation).” 
Section 
9.1.3 
1. Check if there is any change in 
eligibility of the subject since the 
pre-operative visit. If the subject 
is no longer eligible, document 
as screening failure 
7. Instruct the subject on proper 
postoperative care/procedures, 
including 
any 
contraindicated 
treatments/medication(s). 
1. Prior to surgery, check if there is 
any change in eligibility of the subject 
since the pre-operative visit. If the 
subject 
is 
no 
longer 
eligible, 
document as screening failure. 
7. Instruct the subject on proper 
postoperative care/procedures. 
 
Remove Randomization procedure 
into Pre-op, which is mentioned 
above. 
Section 
9.1.9 
Where possible, a full Exit Visit 
should be completed for all 
subjects who discontinue the 
study early.  
Where possible, the next scheduled 
study visit should be completed for all 
subjects who discontinue the study 
early.  
Section 
9.2.3 
radiolucent lines,
osteolysis & 
implant migration)
radiolucent lines, osteolysis & implant 
migration
Section 
10.1 
All statistical comparisons of 
data would describe the test 
statistic used as well as its 
distributional assumptions. 
All statistical comparisons of data will 
describe the test statistic used as well 
as its distributional assumptions. 
Section 
10.2 
Original Text
Newly 
Added 
“Randomized 
Population: This is defined as subjects 
randomized 
to 
either 
CORI 
or 

Clinical Protocol 
Study Number: CORI.2019.06
A Prospective, Multi-center, Randomized 
Controlled Study to Evaluate the Safety and 
Effectiveness of REAL INTELLIGENCE™ CORI™ in 
unicondylar knee arthroplasty (UKA) Procedure
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part, nor shall the contents be disclosed by any means without prior written permission from Smith+Nephew, nor shall 
anyone make any use of it that is contrary to the expressed or implied wishes of Smith+Nephew. 
TMP-CD-05-01 Clinical Protocol - Device – Revision D; SOP-CD-05 Clinical Protocol
Conventional manual instrumentation 
groups.”
Section 
10.2 
The ITT population is defined as 
subjects randomized to either 
CORI or conventional manual 
instrumentation 
groups 
who 
have at least one post-operative 
assessment 
on 
any 
of 
the 
effectiveness 
endpoints 
or 
health-related 
quality 
of 
life 
(HRQoL) 
endpoints. 
Data 
summarized 
on 
the 
ITT 
population will be based on the 
implant 
the 
subject 
was 
randomized to receive which 
may be different from device the 
subject actually received. 
The ITT population is a subset of the 
randomized 
population 
which 
is 
defined as subjects randomized to 
either CORI or conventional manual 
instrumentation groups who have at 
least one post-operative assessment 
on any of the effectiveness endpoints 
or 
health-related 
quality 
of 
life 
(HRQoL) endpoints. Data summarized 
on the ITT population will be based on 
the intervention the subject was 
randomized to receive which may be 
different from the intervention the 
subject actually received. 
Section 
10.4.1 
Original Text  
New Added “For missing primary 
endpoint data, the Missing Value 
Treated as Failure (MVTF) missing 
value imputation method will be used. 
This is considered a conservative 
imputation method as all missing data 
on the primary endpoint will be 
considered as a failure, i.e. not 
attaining the pre-specified target 
alignment. More specific details of this 
imputation method will be included in 
the SAP.” 

Clinical Protocol 
Study Number: CORI.2019.06
A Prospective, Multi-center, Randomized 
Controlled Study to Evaluate the Safety and 
Effectiveness of REAL INTELLIGENCE™ CORI™ in 
unicondylar knee arthroplasty (UKA) Procedure
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and is intended for use only by Smith+Nephew and its manufacturer. It shall not be reproduced or copied in whole or in 
part, nor shall the contents be disclosed by any means without prior written permission from Smith+Nephew, nor shall 
anyone make any use of it that is contrary to the expressed or implied wishes of Smith+Nephew. 
TMP-CD-05-01 Clinical Protocol - Device – Revision D; SOP-CD-05 Clinical Protocol
Section 
10.4.2 
The transformed FJS-12 score 
(0-100) will be summarized at 
the 
preoperative 
and 
postoperative 
visits 
using 
continuous 
summary 
characteristics. 
The transformed FJS-12 score (0-
100) will be summarized at the 
postoperative visits using continuous 
summary characteristics.
Section 
12.1.1 
&12.1.2 
&12.1.3 
&12.1.4 
&12.1.7 & 
12.3
Original Text
Text Updated according to Protocol 
Template Rev D. 
Section 13 
The Principal Investigator will 
comply with the commitments 
outlined in the in the Statement 
of Investigator, provided by the 
Sponsor, and with Good Clinical 
Practice (GCP), and all applicable 
regulatory 
requirements 
as 
outlined in Appendix-Principal 
Investigator Obligations as well 
as 
applicable 
laws 
and 
regulations in China of this 
protocol. 
The Principal Investigator will comply 
with the commitments outlined in the 
in the Statement of Investigator, 
provided by the Sponsor, and with 
Good Clinical Practice (GCP), and all 
applicable regulatory requirements as 
outlined 
in 
Appendix-Principal 
Investigator Obligations as well as all 
applicable local laws and regulations. 
Section 
14.4 
Not Exist 
New 
added 
section 
”Interim 
Monitoring Visit->
Regular interim 
monitoring visits will be performed by 
the Sponsor or qualified person 
designated by the Sponsor.” 

Clinical Protocol 
Study Number: CORI.2019.06
A Prospective, Multi-center, Randomized 
Controlled Study to Evaluate the Safety and 
Effectiveness of REAL INTELLIGENCE™ CORI™ in 
unicondylar knee arthroplasty (UKA) Procedure
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and is intended for use only by Smith+Nephew and its manufacturer. It shall not be reproduced or copied in whole or in 
part, nor shall the contents be disclosed by any means without prior written permission from Smith+Nephew, nor shall 
anyone make any use of it that is contrary to the expressed or implied wishes of Smith+Nephew. 
TMP-CD-05-01 Clinical Protocol - Device – Revision D; SOP-CD-05 Clinical Protocol
Section 18
Public/Products 
Liability 
Insurance has been purchased 
by 
Smith 
& 
Nephew 
plc. 
Worldwide 
and 
incorporates 
coverage for personal injury in 
respect of clinical studies. The 
Sponsor agrees to operate in 
good faith and in accordance 
with ABHI (Association of British 
Healthcare Industries) guidelines 
regarding 
compensation 
for 
injury arising in the course of 
clinical studies. 
Public/Products Liability Insurance 
has been purchased by Smith & 
Nephew 
plc. 
Worldwide 
and 
incorporates coverage for personal 
injury in respect of clinical studies. 
The Sponsor agrees to operate in 
good faith and in accordance with the 
local 
guidelines 
regarding 
compensation for injury resulting 
from participation in an industry-
sponsored clinical trial. 
Section 19 
Should 
circumstances 
arise 
which require the termination of 
the entire study prior to its 
planned completion (e.g., safety 
concerns) or circumstances arise 
which mean the end of the 
participation of an individual site 
(e.g., departure of Investigator, 
non-compliance), then this will 
be undertaken according to the 
SOPs of the Sponsor. 
Should circumstances arise which 
require the termination of the entire 
study prior to its planned completion 
(e.g., 
safety 
concerns) 
or 
circumstances arise which mean the 
end 
of 
the 
participation 
of 
an 
individual site (e.g., departure of 
Investigator, non-compliance), then 
this will be undertaken according to 
the SOPs of the Sponsor. The 
requirement for subject follow up in 
these instances will be considered as 
part of these processes. 
Section 
20.2
S+N
Smith+Nephew

Clinical Protocol 
Study Number: CORI.2019.06
A Prospective, Multi-center, Randomized 
Controlled Study to Evaluate the Safety and 
Effectiveness of REAL INTELLIGENCE™ CORI™ in 
unicondylar knee arthroplasty (UKA) Procedure
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and is intended for use only by Smith+Nephew and its manufacturer. It shall not be reproduced or copied in whole or in 
part, nor shall the contents be disclosed by any means without prior written permission from Smith+Nephew, nor shall 
anyone make any use of it that is contrary to the expressed or implied wishes of Smith+Nephew. 
TMP-CD-05-01 Clinical Protocol - Device – Revision D; SOP-CD-05 Clinical Protocol
Section 
22.1.1 
The purpose to have the protocol 
amendment is to meet the 
requirements of the Hongkong 
site during the EC approval 
session. 
The 
protocol 
amendment for version 2.1 is 
minor.
The purpose to have the 1ST protocol 
amendment 
is 
to 
meet 
the 
requirements of the Hong Kong site 
during the EC approval session. The 
protocol amendment for version 2.1 is 
minor. 
The purpose to have the 2nd protocol 
amendment into version 3.0-Master is 
to update the protocol from Template 
B into Template D and also update the 
information within the protocol. 
Section 
22.1.2 
The rationale to update the 
protocol is due to the protocol 
title inconsistency with other 
documents. 
Since 
the 
amendment is change that do 
not materially affect the study 
which is simply update the 
protocol title from “procedures” 
into “Procedure”. Therefore, the 
amendment for version 2.1 is 
considered as minor. 
The rationale to 1ST time protocol 
update is due to the protocol title 
inconsistency with other documents. 
Since the amendment is change that 
do not materially affect the study 
which is simply update the protocol 
title 
from 
“procedures” 
into 
“Procedure”. 
Therefore, 
the 
amendment 
for 
version 
2.1 
is 
considered as minor. 
 
The rationale to 2nd time update the 
protocol is due to the protocol 
template updated from version B to 
version D. And also the information 
inside of the protocol need to be 
further updated. 

Clinical Protocol 
Study Number: CORI.2019.06
A Prospective, Multi-center, Randomized 
Controlled Study to Evaluate the Safety and 
Effectiveness of REAL INTELLIGENCE™ CORI™ in 
unicondylar knee arthroplasty (UKA) Procedure
Version: 4.0-Master, 07 Sep 
2022
Page: 126 of 167   
 
CONFIDENTIAL AND PROPRIETARY 
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and is intended for use only by Smith+Nephew and its manufacturer. It shall not be reproduced or copied in whole or in 
part, nor shall the contents be disclosed by any means without prior written permission from Smith+Nephew, nor shall 
anyone make any use of it that is contrary to the expressed or implied wishes of Smith+Nephew. 
TMP-CD-05-01 Clinical Protocol - Device – Revision D; SOP-CD-05 Clinical Protocol
Section 
22.1.4 
1ST Update from Version 2.0 to 
Version 2.1
2nd Update from Version 2.1 to 
Version 3.0-Master.
 
This table added 
Section 
22.2 
Not Exist 
New 
section 
added 
“Sponsor 
Details”->
Smith & Nephew, Inc., 
1450 E. Brooks Road, Memphis, TN 
38116, United States   
Section 
22.4 
Not applicable 
Refer to Section 9.2 & 9.3 for Quality-
of-Life measures. 
 
 
3rd Update from Version 3.0-Master to Version 4.0-Master 
 
Section 
Current Text
Version 3.0-Master (03 
MAR2021)
Revised Text 
Version 4.0-Master (07 Sep 2022) 
Throughout 
as 
applicable 
Writing acronymns out in full at first use and tidying up use of the 
acronym vs full term.  
Making use of S+N, Smith+Nephew, and Smith&Nephew more 
consistent. 
ISO 14155 
reference 
ISO reference changed from ISO 14155:2011 to ISO14155:2020 
throughout the study.  
Header 
Version: 
3.0-Master, 
03 
MAR2021 
Version: 4.0-Master, Date 07 Sep 2022 
Section 
1.1&1.2 
Protocol version and date:
3.0-Master, 03 MAR2021 
Version: 4.0-Master, Date 07 Sep 2022 
Cover Page 
Protocol Author(s):
Michelle Li, Associate Clinical 
Study Manager 
Protocol Author(s): 
Michelle Li, Associate Clinical Study 
Manager 

Clinical Protocol 
Study Number: CORI.2019.06
A Prospective, Multi-center, Randomized 
Controlled Study to Evaluate the Safety and 
Effectiveness of REAL INTELLIGENCE™ CORI™ in 
unicondylar knee arthroplasty (UKA) Procedure
Version: 4.0-Master, 07 Sep 
2022
Page: 127 of 167   
 
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and is intended for use only by Smith+Nephew and its manufacturer. It shall not be reproduced or copied in whole or in 
part, nor shall the contents be disclosed by any means without prior written permission from Smith+Nephew, nor shall 
anyone make any use of it that is contrary to the expressed or implied wishes of Smith+Nephew. 
TMP-CD-05-01 Clinical Protocol - Device – Revision D; SOP-CD-05 Clinical Protocol
Rahel Meister, Senior Clinical 
Study Manager
Babajide 
Olayinka, 
Senior 
Biostatistician
Sponsor Approval  
Kelli C. Armstrong,  
Clinical 
Strategy 
Director 
Robotics
 
Alan 
Rossington, 
Director 
Biostatistics 
& 
Data 
Management  
Rahel Meister, Senior Clinical Study 
Manager
Manvendra 
Saxena, 
Clinical 
Study 
Manager
Babajide 
Olayinka, 
Senior 
Biostatistician 
Sponsor Approval  
Julie Lankiewicz,  
Clinical Strategy Director Robotics 
 
Michael Robinson  
Independent Statistician 
Section 1.2 
Original Text- Coordinating 
Investigator Approval 
Update 
the 
section 
into 
Clinical 
Institution Approval page 
Section 1.3 
Full internal sponsor approval
Only China operation head approval
Synopsis-
Exclusion 
Criteria 
& 
Section 7.3 
Original Text 
a. Added 
“Targeted 
Global 
Region- Added South Korea 
b. Exclusion Criteria: Changed 
“point 3: Subject receives 
simultaneous bilateral UKA
OR a unilateral UKA with 
contralateral TKA.  
c. Added 
exclusion 
criteria 
“point 4: Subject has one or 
more 
of 
the 
following 
arthroplasties that are not 
fully 
healed 
and 
well-

Clinical Protocol 
Study Number: CORI.2019.06
A Prospective, Multi-center, Randomized 
Controlled Study to Evaluate the Safety and 
Effectiveness of REAL INTELLIGENCE™ CORI™ in 
unicondylar knee arthroplasty (UKA) Procedure
Version: 4.0-Master, 07 Sep 
2022
Page: 128 of 167   
 
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and is intended for use only by Smith+Nephew and its manufacturer. It shall not be reproduced or copied in whole or in 
part, nor shall the contents be disclosed by any means without prior written permission from Smith+Nephew, nor shall 
anyone make any use of it that is contrary to the expressed or implied wishes of Smith+Nephew. 
TMP-CD-05-01 Clinical Protocol - Device – Revision D; SOP-CD-05 Clinical Protocol
functioning, as determined 
by the investigator:
-Contralateral primary TKA or 
UKA, however, the subject 
can only have one knee 
enrolled in this study”. And 
“point 6: Subject currently 
enrolled in another orthopedic 
d. Study 
Duration 
Timeline 
updated  
e. Study Schedule 
Screening 
i. 
Visit Duration changed 
from -28 to 0 day to-
90 to 0 days.  
ii. 
Added subsection 1- 
pre-operative long leg 
X-rays (A/P) collected 
6-months prior to the 
date 
of 
surgery 
is 
admissible.
Study Duration 
Study period: 49 months  
Start enrollment: April 2022 
Last subject first visit: Feb 2024 
Last subject last visit: May 2026 

Clinical Protocol 
Study Number: CORI.2019.06
A Prospective, Multi-center, Randomized 
Controlled Study to Evaluate the Safety and 
Effectiveness of REAL INTELLIGENCE™ CORI™ in 
unicondylar knee arthroplasty (UKA) Procedure
Version: 4.0-Master, 07 Sep 
2022
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and is intended for use only by Smith+Nephew and its manufacturer. It shall not be reproduced or copied in whole or in 
part, nor shall the contents be disclosed by any means without prior written permission from Smith+Nephew, nor shall 
anyone make any use of it that is contrary to the expressed or implied wishes of Smith+Nephew. 
TMP-CD-05-01 Clinical Protocol - Device – Revision D; SOP-CD-05 Clinical Protocol
Study 
Schedule & 
Table 9.1.1-
9-1 
Original 
Study 
Schedule 
Table 
Schedu
le of 
events  
Pre-
Ope
rati
ve 
Dat
a 
 
-90 
to 0 
days
Oper
ativ
e 
Data 
& 
Disc
harg
e 
Day 
1 (+ 
up to 
9 
days
) 
6 
we
eks 
 
 
42 
± 
14 
day
s
6 
mo
nth
s 
180 
± 
14 
day
s
12 
mo
nth
s 
365 
± 
30 
day
s
Informe
d 
Consent
x 
 
 
 
 
Demogr
aphics/ 
Medical 
History
x 
 
 
 
 
Inclusio
n/Exclu
sion 
x 
 
 
 
 

Clinical Protocol 
Study Number: CORI.2019.06
A Prospective, Multi-center, Randomized 
Controlled Study to Evaluate the Safety and 
Effectiveness of REAL INTELLIGENCE™ CORI™ in 
unicondylar knee arthroplasty (UKA) Procedure
Version: 4.0-Master, 07 Sep 
2022
Page: 130 of 167   
 
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part, nor shall the contents be disclosed by any means without prior written permission from Smith+Nephew, nor shall 
anyone make any use of it that is contrary to the expressed or implied wishes of Smith+Nephew. 
TMP-CD-05-01 Clinical Protocol - Device – Revision D; SOP-CD-05 Clinical Protocol
Preoper
ative 
Examin
ations 
(eg. 
ECG, 
Blood 
Routine 
Examin
ation, 
Bioche
mical 
Examin
ation, 
Coagula
tion 
Examin
ation) (1)
x 
 
 
 
 
Pregnan
cy Test 
(2)
x 
 
 
 
 
Concom
itant 
Medicati
on
x 
 
 
 
 
Concom
itant 
Medicati
on 
Update
x 
x 
x 
x 
Operati
ve Data 
Collecti
on
 
x 
 
 
 

Clinical Protocol 
Study Number: CORI.2019.06
A Prospective, Multi-center, Randomized 
Controlled Study to Evaluate the Safety and 
Effectiveness of REAL INTELLIGENCE™ CORI™ in 
unicondylar knee arthroplasty (UKA) Procedure
Version: 4.0-Master, 07 Sep 
2022
Page: 131 of 167   
 
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part, nor shall the contents be disclosed by any means without prior written permission from Smith+Nephew, nor shall 
anyone make any use of it that is contrary to the expressed or implied wishes of Smith+Nephew. 
TMP-CD-05-01 Clinical Protocol - Device – Revision D; SOP-CD-05 Clinical Protocol
CORI 
Case 
Report 
(Syste
m time 
& 
cutting 
time) 
x
Dischar
ge Data 
Collecti
on
 
x 
 
 
 
Leg 
alignme
nt long 
leg X-
ray AP3 
x 
(x)4 
x 
 
(x)5
Standar
d 
Lateral 
X-ray: 
Knee      
 
(x)4 
x 
 
x 
Standar
d A/P 
X-ray: 
Knee
 
 
 
 
x 
KSS 
2011
 
 
 
 
 
OKS 
x 
 
x 
x 
x 
FJS
x 
 
x 
x 
x 
EQ-5D-
5L
 
 
x 
x 
x 
Safety 
Assess
ment
x 
 
x 
x 
x 
End of 
Study/E
xit   
 
x 
x 
x 
x 

Clinical Protocol 
Study Number: CORI.2019.06
A Prospective, Multi-center, Randomized 
Controlled Study to Evaluate the Safety and 
Effectiveness of REAL INTELLIGENCE™ CORI™ in 
unicondylar knee arthroplasty (UKA) Procedure
Version: 4.0-Master, 07 Sep 
2022
Page: 132 of 167   
 
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part, nor shall the contents be disclosed by any means without prior written permission from Smith+Nephew, nor shall 
anyone make any use of it that is contrary to the expressed or implied wishes of Smith+Nephew. 
TMP-CD-05-01 Clinical Protocol - Device – Revision D; SOP-CD-05 Clinical Protocol
 
(x)6 (x)6
(x)
1. 
Applicable, at China sites only 
2. 
Applicable, at China sites only. 
3. 
Pre-operative long leg X-rays 
(A/P) collected 6-months prior 
to the date of surgery is 
admissible.  
4. 
Post-operative standing weight 
bearing long leg X-rays (A/P) 
and standard lateral X-rays may 
be taken at discharge.  
5. 
To be performed, only if 
standing weight bearing long 
leg A/P X-ray is taken as a 
standard of care at 12 and 24 
months. 
6. 
Exit form to be completed at 
the point of withdrawal if the 
study is not completed. 
Region 
South Korea 
Not exist 
Added throughout the protocol 
where applicable.  
Section 6.5 
“Surgical 
Technique” 
 
Original Text 
All CORI study related procedures must 
be performed according to the User’s 
Manual (Document ID: 500230 CORI 
for Knee Arthroplasty for Australia, 
Hong Kong, South Korea, and New 
Zealand, as well as Investigator’s 
Brochure for China) and according to 
the according to the surgical technique 

Clinical Protocol 
Study Number: CORI.2019.06
A Prospective, Multi-center, Randomized 
Controlled Study to Evaluate the Safety and 
Effectiveness of REAL INTELLIGENCE™ CORI™ in 
unicondylar knee arthroplasty (UKA) Procedure
Version: 4.0-Master, 07 Sep 
2022
Page: 133 of 167   
 
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and is intended for use only by Smith+Nephew and its manufacturer. It shall not be reproduced or copied in whole or in 
part, nor shall the contents be disclosed by any means without prior written permission from Smith+Nephew, nor shall 
anyone make any use of it that is contrary to the expressed or implied wishes of Smith+Nephew. 
TMP-CD-05-01 Clinical Protocol - Device – Revision D; SOP-CD-05 Clinical Protocol
and IFU of the specific Smith+Nephew 
Implant System.
The primary endpoint of post-operative 
leg 
alignment 
is 
defined 
as 
the 
proportion of subjects achieving post-
operative leg alignment 6 weeks after 
surgery within ± 3° from target.  
Because this assessment is comparing 
the target alignment vs measured 
alignment from 6 weeks postoperative 
imaging, 
the 
defined 
method 
of 
preoperatively planning alignment is 
left up to the individual investigator’s 
discretion.  Each investigator is to plan 
according to their own techniques. 
For 
the 
analysis 
of 
the 
primary 
endpoint, X-ray or CT may be utilized. 
The recommended CORI bone removal 
technique is a “burr all” technique per 
the user’s manual (Document ID: 
500230 CORI Knee Arthroplasty for 
Australia, Hong Kong, South Korea, 
and 
New 
Zealand, 
as 
well 
as 
Investigator’s Brochure for China). 
However, a hybrid approach using 
“distal precision burring” may be used 
per surgeon’s discretion. This will be 

Clinical Protocol 
Study Number: CORI.2019.06
A Prospective, Multi-center, Randomized 
Controlled Study to Evaluate the Safety and 
Effectiveness of REAL INTELLIGENCE™ CORI™ in 
unicondylar knee arthroplasty (UKA) Procedure
Version: 4.0-Master, 07 Sep 
2022
Page: 134 of 167   
 
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part, nor shall the contents be disclosed by any means without prior written permission from Smith+Nephew, nor shall 
anyone make any use of it that is contrary to the expressed or implied wishes of Smith+Nephew. 
TMP-CD-05-01 Clinical Protocol - Device – Revision D; SOP-CD-05 Clinical Protocol
captured in the eCRF along with a 
rationale of why this approach was 
chosen.  
Resurfacing of the patella will be left up 
to the discretion of each investigator.  
This will be captured in the eCRF.
Surgeons selected to participate in this 
study will be familiar with CORI and 
have written evidence of training and 
expertise in the study procedure. The 
surgeons will conduct pre-study CORI 
cases, 
in 
order 
to 
establish 
the 
expertise of the individual surgeons. 
The exact number may be adjusted 
depending on the level of the individual 
experience of the surgeon, the subjects 
will not be randomized.  
CORI Case Report Forms of the non-
randomized cases will be collected as 
proof of surgeons’ experience and for 
inclusion in the safety analysis set 
(applicable only at sites in China). 
 
7.1 “Subject 
Population” 
Original Text  
“A total of 140 subjects will 
be enrolled in the study in up 
to 8 sites in Australia, Hong 
Changed to  
At least 145 subjects will be enrolled 
into the study. At least 5 of these 
subjects will be treated with CORI 

Clinical Protocol 
Study Number: CORI.2019.06
A Prospective, Multi-center, Randomized 
Controlled Study to Evaluate the Safety and 
Effectiveness of REAL INTELLIGENCE™ CORI™ in 
unicondylar knee arthroplasty (UKA) Procedure
Version: 4.0-Master, 07 Sep 
2022
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part, nor shall the contents be disclosed by any means without prior written permission from Smith+Nephew, nor shall 
anyone make any use of it that is contrary to the expressed or implied wishes of Smith+Nephew. 
TMP-CD-05-01 Clinical Protocol - Device – Revision D; SOP-CD-05 Clinical Protocol
Kong, New Zealand, and 
China Mainland”.
 
directly to fulfil the learning needs of 
the surgeons prior to enrolling, a 
further 140 subjects who will be 
enrolled in the randomized stage of the 
study in up to 8 sites in Australia, China 
(Hong Kong), New Zealand, South 
Korea, and China mainland. Seventy 
(70) subjects will be enrolled for UKA 
with the use of the CORI and 70 
subjects will be enrolled for UKA with 
the 
use 
of 
conventional 
manual 
instrumentation. Vulnerable subjects 
will not be enrolled in this study.  
 
Section 7.3 
“Exclusion 
Criteria” 
 
Added exclusion Criteria Point 10 
“Subject currently enrolled in another 
orthopedic clinical trial study 
 
Section 7.4 
“Screening” 
Original Text
“Investigators 
should 
consecutively 
screen 
all 
subjects 
presenting 
with 
degenerative joint disease of 
the knee, requiring correction 
of functional deformity, or 
treatment of fractures that 
were unmanageable using 
other 
techniques 
to 
determine whether they meet 
Changed To
“Investigators 
should 
consecutively 
screen all subjects presenting with 
degenerative joint disease of the knee, 
requiring 
correction 
of 
functional 
deformity, or treatment of fractures 
that were unmanageable using other 
techniques to determine whether they 

Clinical Protocol 
Study Number: CORI.2019.06
A Prospective, Multi-center, Randomized 
Controlled Study to Evaluate the Safety and 
Effectiveness of REAL INTELLIGENCE™ CORI™ in 
unicondylar knee arthroplasty (UKA) Procedure
Version: 4.0-Master, 07 Sep 
2022
Page: 136 of 167   
 
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part, nor shall the contents be disclosed by any means without prior written permission from Smith+Nephew, nor shall 
anyone make any use of it that is contrary to the expressed or implied wishes of Smith+Nephew. 
TMP-CD-05-01 Clinical Protocol - Device – Revision D; SOP-CD-05 Clinical Protocol
all inclusion and none of the 
exclusion criteria.
Participating study sites are 
required 
to 
document 
all 
screened subjects considered 
for inclusion in this study. If a 
subject is excluded from the 
study, 
the 
reasons 
for 
exclusion will be documented 
in 
the 
subject's 
source 
documents and noted on the 
Screening 
and 
Enrollment 
Log. All screening activities 
that occur prior to consent 
shall be referred to as pre-
screening”.
meet all inclusion and none of the 
exclusion criteria.
Participating study sites are required to 
document 
all 
screened 
subjects 
considered for inclusion in this study. If 
a subject is excluded from the study, 
the reasons for exclusion will be 
documented in the subject's source 
documents and noted on the Screening 
and Enrollment Log. All screening 
activities that occur prior to consent 
shall be referred to as pre-screening.  
In China sites, part of the screening 
process will include documentation of 
women’s childbearing potential. If the 
woman is not of childbearing potential 
this should be documented in the 
medical 
history 
(e.g., 
surgically 
postmenopausal, 
postmenopausal 
[i.e., 
at 
least 
one 
year 
without 
menses]). For women of childbearing 
potential, their method of birth control 
should be documented in the source”.
Section 7.5 
“Informed 
Consent” 
 Original Text 
“Before conducting any study 
procedures or examinations, 
the purpose and nature of the 
study should be explained to 
Changed To 
“Before 
conducting 
any 
study 
procedures 
or 
examinations, 
the 
purpose and nature of the study should 
be explained to the subject in their 
native language.  

Clinical Protocol 
Study Number: CORI.2019.06
A Prospective, Multi-center, Randomized 
Controlled Study to Evaluate the Safety and 
Effectiveness of REAL INTELLIGENCE™ CORI™ in 
unicondylar knee arthroplasty (UKA) Procedure
Version: 4.0-Master, 07 Sep 
2022
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part, nor shall the contents be disclosed by any means without prior written permission from Smith+Nephew, nor shall 
anyone make any use of it that is contrary to the expressed or implied wishes of Smith+Nephew. 
TMP-CD-05-01 Clinical Protocol - Device – Revision D; SOP-CD-05 Clinical Protocol
the subject in their native 
language. 
The subject, or their legally 
authorized representative (if 
applicable), will then read, 
sign, and personally date 
the 
IRB/IEC-approved 
informed 
consent 
document(s) (see below for 
difficulties with reading and 
writing). 
Additionally, 
the 
individual 
who 
obtains 
consent from the subject will 
sign and date the informed 
consent document. A copy of 
the signed informed consent 
document will be provided to 
the subject, a copy will be 
placed 
in 
the 
subject’s 
medical 
record, 
with 
the 
original filed in the ISF.
If the subject is unable to 
read, the informed consent 
document 
and 
associated 
study information may be 
read aloud to the subject in 
the presence of an impartial 
witness. 
If 
possible, 
the 
subject 
shall 
sign 
and 
The subject, or their legally authorized 
representative (if applicable), will then 
read, sign, and personally date the 
IRB/IEC-approved informed consent 
document(s) (see below for difficulties 
with reading and writing). Additionally, 
the individual who obtains consent 
from the subject will sign and date the 
informed consent document. A copy of 
the signed informed consent document 
will be provided to the subject, a copy 
will be placed in the subject’s medical 
record, with the original filed in the ISF. 
If the subject is unable to read, the 
informed 
consent 
document 
and 
associated study information may be 
read aloud to the subject in the 
presence of an impartial witness. If 
possible, the subject shall sign and 
personally date the Informed Consent 
Form (ICF). Where this is not possible, 
due to difficulties in writing, the subject 
shall 
provide 
verbal 
consent 
to 
participate in the study. The witness 
shall then personally sign and date the 
informed consent form, attesting that 
the 
information 
was 
accurately 
explained 
and 
that 
the 
informed 
consent was freely given. 

Clinical Protocol 
Study Number: CORI.2019.06
A Prospective, Multi-center, Randomized 
Controlled Study to Evaluate the Safety and 
Effectiveness of REAL INTELLIGENCE™ CORI™ in 
unicondylar knee arthroplasty (UKA) Procedure
Version: 4.0-Master, 07 Sep 
2022
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part, nor shall the contents be disclosed by any means without prior written permission from Smith+Nephew, nor shall 
anyone make any use of it that is contrary to the expressed or implied wishes of Smith+Nephew. 
TMP-CD-05-01 Clinical Protocol - Device – Revision D; SOP-CD-05 Clinical Protocol
personally date the Informed 
Consent Form (ICF). Where 
this is not possible, due to 
difficulties in writing, the 
subject shall provide verbal 
consent to participate in the 
study. The witness shall then 
personally sign and date the 
informed 
consent 
form, 
attesting that the information 
was accurately explained and 
that the informed consent 
was freely given. 
ICFs will comply with Health 
Information 
Portability 
Accountability Act (HIPAA) 
regulations as well as and 
applicable 
laws 
and 
regulations 
in 
Australia 
(Privacy Act 1988), China, 
South 
Korea, 
and 
New 
Zealand (Privacy Act 1993)” 
ICFs will comply with applicable laws 
and regulations in Australia (Privacy 
Act 1988), China, South Korea, and 
New Zealand (Privacy Act 1993). If new 
information becomes available during 
the course of the study
that can 
significantly affect a subject’s future 
health and medical care, Smith + 
Nephew will ensure that information 
shall be provided to the subject(s) 
affected in written form and if relevant, 
all affected subjects shall be asked to 
confirm their continuing consent in 
writing”. 
 
Section 
7.8.2 
“Withdrawal 
from Study” 
Original Text 
Added
“Withdrawn 
subjects 
will 
not 
be 
replaced” 
 

Clinical Protocol 
Study Number: CORI.2019.06
A Prospective, Multi-center, Randomized 
Controlled Study to Evaluate the Safety and 
Effectiveness of REAL INTELLIGENCE™ CORI™ in 
unicondylar knee arthroplasty (UKA) Procedure
Version: 4.0-Master, 07 Sep 
2022
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and is intended for use only by Smith+Nephew and its manufacturer. It shall not be reproduced or copied in whole or in 
part, nor shall the contents be disclosed by any means without prior written permission from Smith+Nephew, nor shall 
anyone make any use of it that is contrary to the expressed or implied wishes of Smith+Nephew. 
TMP-CD-05-01 Clinical Protocol - Device – Revision D; SOP-CD-05 Clinical Protocol
Section 8.1 
“Study 
Design” 
Original Text
“This study is a prospective, 
multi-center, 
randomized 
controlled, 
non-blinded 
follow-up study to evaluate 
the use of CORI in UKA 
procedure in achieving post-
operative leg alignment. Up 
to 8 sites will participate 
within Australia, China (Hong 
Kong), New Zealand, and 
China Mainland. 
Subjects will be enrolled and 
randomized into one of two 
(2) groups, as shown in Table 
8.1-8-1.  
All groups are treated with 
knee arthroplasty with a S+N 
Knee Implant System. (The 
implant 
system 
will 
be 
selected according to the 
registration status in each 
country)” 
 
 
Changed To
“This study is a prospective, multi-
center, randomized controlled, non-
blinded follow-up study to evaluate the 
use of CORI in UKA procedure in 
achieving 
post-operative 
leg 
alignment. Up to 8 sites will participate 
within Australia, Hong Kong, New 
Zealand, South Korea, and China 
Mainland. 
The pre-randomized stage of the study 
will comprise of at least 5 subjects 
enrolled and treated with CORI directly 
in order to fulfil the learning needs of 
the 
surgeons. 
Subjects 
who 
will 
comprise the randomized stage of the 
study will be enrolled and randomized 
into one of two (2) groups, as shown in 
Table 8.1-8-1. 
All groups are treated with knee 
arthroplasty with a S+N Knee Implant 
System. (The implant system will be 
selected according to the registration 
status in each country)” 
 

Clinical Protocol 
Study Number: CORI.2019.06
A Prospective, Multi-center, Randomized 
Controlled Study to Evaluate the Safety and 
Effectiveness of REAL INTELLIGENCE™ CORI™ in 
unicondylar knee arthroplasty (UKA) Procedure
Version: 4.0-Master, 07 Sep 
2022
Page: 140 of 167
CONFIDENTIAL AND PROPRIETARY
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. 
and is intended for use only by Smith+Nephew and its manufacturer. It shall not be reproduced or copied in whole or in 
part, nor shall the contents be disclosed by any means without prior written permission from Smith+Nephew, nor shall 
anyone make any use of it that is contrary to the expressed or implied wishes of Smith+Nephew.
TMP-CD-05-01 Clinical Protocol - Device – Revision D; SOP-CD-05 Clinical Protocol
Figure 8.1-
8-3 Study 
Recruitment 
Timeline
Section 10.2
“Analysis 
Population”
Dot point
“Randomize
d 
Population” 
and  “Safety 
Population
Original Text
“Randomized 
Population: 
This is defined as subjects 
randomized to either CORI or 
Conventional 
manual 
instrumentation groups.
“Safety 
Population 
(SAF): 
This is defined as all subjects 
who completed a TKA with 
the use of the CORI or 
conventional 
manual 
instrumentation”.
Changed To
“Randomized population” changed to 
“Enrolled Population”
“Enrolled Population: This is defined as 
subjects enrolled and/or randomized to 
either CORI or Conventional manual 
instrumentation groups. A total of 140 
patients will be competitively enrolled 
and or/randomized in the study across 
all the sites including the sites in 
China”. 
“Safety Population (SAF): This is 
defined as all subjects who completed 
a 
TKA 
(include 
non-randomized 
subjects in China as CORI is pre-
market product in China) with the use 
of the CORI or conventional manual 
instrumentation”
Section 11
“Sample 
Size 
Justification”
Original Text
Added 
“To account for up to a 10% attrition 
rate in knees enrolled, 70 knees in each 
Enrolment
Training & 
Pre-study 
Cases
USA Market
Access
Follow-u
August     March    April 
   March            Apr
2020     2022      2022
2024          2025

Clinical Protocol 
Study Number: CORI.2019.06
A Prospective, Multi-center, Randomized 
Controlled Study to Evaluate the Safety and 
Effectiveness of REAL INTELLIGENCE™ CORI™ in 
unicondylar knee arthroplasty (UKA) Procedure
Version: 4.0-Master, 07 Sep 
2022
Page: 141 of 167   
 
CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. 
and is intended for use only by Smith+Nephew and its manufacturer. It shall not be reproduced or copied in whole or in 
part, nor shall the contents be disclosed by any means without prior written permission from Smith+Nephew, nor shall 
anyone make any use of it that is contrary to the expressed or implied wishes of Smith+Nephew. 
TMP-CD-05-01 Clinical Protocol - Device – Revision D; SOP-CD-05 Clinical Protocol
group (140 knees combined) will be 
enrolled into the randomized stage of 
the study. A minimum of an additional 
5 subjects who will be treated with 
CORI directly to fulfil the learning 
needs of the surgeons will be enrolled 
at the pre-randomized study stage, 
thus leading to a minimum total study 
enrollment of 145 subjects”.  
 
Section 21.1 
” Publication 
of Study 
Data” 
Original Text 
Deleted Reference to  
“Health 
Insurance 
Portability 
and 
Accountability Act of 1996” 
Section 
23.1.1 
“General 
Purpose” 
Original Text 
Added 
“The Purpose of 3rd amendment is to 
expand 
the 
pre-operative 
data 
collection period, to increase 
the 
enrolment at all the sites and restrict 
the enrolment of patient who are either 
enrolled in the other study or were 
enrolled in the other study at least 1 
year prior to screening during the EC 
approval session. 
Section 
23.6.1 
 
Updated to ISO 14155:2020 guidelines.  

Clinical Protocol 
Study Number: CORI.2019.06
A Prospective, Multi-center, Randomized 
Controlled Study to Evaluate the Safety and 
Effectiveness of REAL INTELLIGENCE™ CORI™ in 
unicondylar knee arthroplasty (UKA) Procedure
Version: 4.0-Master, 07 Sep 
2022
Page: 142 of 167   
 
CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. 
and is intended for use only by Smith+Nephew and its manufacturer. It shall not be reproduced or copied in whole or in 
part, nor shall the contents be disclosed by any means without prior written permission from Smith+Nephew, nor shall 
anyone make any use of it that is contrary to the expressed or implied wishes of Smith+Nephew. 
TMP-CD-05-01 Clinical Protocol - Device – Revision D; SOP-CD-05 Clinical Protocol
“Principal 
Investigator 
Obligation 
according to 
ISO14155:2
020” 
 
 
 
22.1.5 Approval/Notification 
The version 2.0-master and 2.1-master of this protocol was not implemented as the 
study was still at design phase. The protocol v3.0-Master was implemented at all 
the sites following local EC approval. The protocol v4.0-Master will get implemented 
in each country following the local EC approval. China protocol v4.0-China, which 
incorporates the updates in the master, will be implemented at sites in China after 
local EC approval.  
22.2 SPONSOR DETAILS 
Smith & Nephew, Inc., 1450 E. Brooks Road, Memphis, TN 38116, United States   
22.3 INSTRUCTIONS FOR USE & USER MANUALS
 
CORI user’s manual (Document ID: 500230, REAL INTELLIGENCE™ CORI™ for 
Knee Arthroplasty) 
 
IFU REAL INTELLIGENCE™ CORI™ Burs (Document ID: 500172) 
 
IFU REAL INTELLIGENCE™ CORI™ Flat Markers (Document ID: 500198) 
 
IFU REAL INTELLIGENCE™ CORI™ Irrigation (Document ID: 500173) 
 
IFU REAL INTELLIGENCE™ CORI™ Instrumentation Tray (Document ID: 
500229) 
22.4 EQUIPMENT AND SPECIAL INSTRUCTIONS

Clinical Protocol 
Study Number: CORI.2019.06
A Prospective, Multi-center, Randomized 
Controlled Study to Evaluate the Safety and 
Effectiveness of REAL INTELLIGENCE™ CORI™ in 
unicondylar knee arthroplasty (UKA) Procedure
Version: 4.0-Master, 07 Sep 
2022
Page: 143 of 167   
 
CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. 
and is intended for use only by Smith+Nephew and its manufacturer. It shall not be reproduced or copied in whole or in 
part, nor shall the contents be disclosed by any means without prior written permission from Smith+Nephew, nor shall 
anyone make any use of it that is contrary to the expressed or implied wishes of Smith+Nephew. 
TMP-CD-05-01 Clinical Protocol - Device – Revision D; SOP-CD-05 Clinical Protocol
The following section provides a list of components of CORI (only UKA instruments 
will be used for this study): 
Table 22.4-22-1 CORI Components 
Article 
Description
ROB10000  
CORI Starter Kit 
ROB10024  
REAL INTELLIGENCE CORI  
ROB10025  
REAL INTELLIGENCE Tracking Camera  
ROB10026 
REAL INTELLIGENCE Foot Pedal 
ROB10027  
REAL INTELLIGENCE Tablet 
ROB10028  
REAL INTELLIGENCE Transportation Case 
Table 22.4-22-2 CORI Cart 
Article  
Description 
ROB10002  
REAL INTELLIGENCE Robotics Cart Column 
ROB100021 REAL INTELLIGENCE Robotics Cart Base 120  
ROB100022 REAL INTELLIGENCE Robotics Cart Base 220  
Table 22.4-22-3 CORI Monitor 
Article  
Description 
ROB10003 
REAL INTELLIGENCE 24 in.Touch Screen 
Table 22.4-22-4 CORI Tray and Instrumentation
Article  
Description 
ROB10001 REAL INTELLIGENCE Robotics Instruments 
ROB10010 REAL INTELLIGENCE Bone Pins 4 mm x 127 mm 
ROB10011 REAL INTELLIGENCE Bone Pins 4 mm x 152 mm 
ROB10012 REAL INTELLIGENCE Checkpoint Pins  
ROB10013 REAL INTELLIGENCE Robotic Drill 
ROB10014 REAL INTELLIGENCE Robotic Drill Tracker 
ROB10015 REAL INTELLIGENCE Robotic Drill Attachment 
ROB10016 REAL INTELLIGENCE Robotic Drill Guard  

Clinical Protocol 
Study Number: CORI.2019.06
A Prospective, Multi-center, Randomized 
Controlled Study to Evaluate the Safety and 
Effectiveness of REAL INTELLIGENCE™ CORI™ in 
unicondylar knee arthroplasty (UKA) Procedure
Version: 4.0-Master, 07 Sep 
2022
Page: 144 of 167   
 
CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. 
and is intended for use only by Smith+Nephew and its manufacturer. It shall not be reproduced or copied in whole or in 
part, nor shall the contents be disclosed by any means without prior written permission from Smith+Nephew, nor shall 
anyone make any use of it that is contrary to the expressed or implied wishes of Smith+Nephew. 
TMP-CD-05-01 Clinical Protocol - Device – Revision D; SOP-CD-05 Clinical Protocol
Article  
Description 
ROB10017 REAL INTELLIGENCE Point Probe 
ROB10018 REAL INTELLIGENCE Femur Tracker 
ROB10019 REAL INTELLIGENCE Tibia Tracker  
ROB10020 REAL INTELLIGENCE Tracker Clamp 
ROB10021 REAL INTELLIGENCE Drill Guide 
ROB10022 REAL INTELLIGENCE Checkpoint Tool  
ROB10050 REAL INTELLIGENCE Robotics Instruments Tray 
ROB10051 REAL INTELLIGENCE Robotics Pin Caddy 
ROB10052 REAL INTELLIGENCE Robotics Pin Caddy Lid  
71441351 
Rasp  
74013489 
Speed Pin Driver 
71935186 
SCOTT CEMENT CURETTE  
71935187 
CEMENT CURETTE 
ROB10086 REAL INTELLIGENCE Plane Visualizer
Table 22.4-22-5 CORI Shipping Inserts 
Article  
Description 
ROB10055 
REAL INTELLIGENCE Shipping Insert (A) 
ROB10056 
REAL INTELLIGENCE Shipping Insert (B) 
ROB10057 
REAL INTELLIGENCE Shipping Insert (C) 
ROB10058 
REAL INTELLIGENCE Shipping Insert (F)  
Table 22.4-22-6 CORI Lids 
Article  
Description 
ROB10087 
Universal Base Tray Lid  
ROB10088 
Universal Insert Lid (A) 
ROB10089 
Universal Insert Lid (B) 
ROB10090 
Universal Insert Lid (C) 
ROB10054 
Universal Insert Lid (F)  
ROB10091 
Universal Insert Lid (G) 
ROB10097 
Universal Insert Lid (H) 
ROB10098 
Universal Insert Lid (I)  
ROB10095 
Universal Insert Lid (J) 

Clinical Protocol 
Study Number: CORI.2019.06
A Prospective, Multi-center, Randomized 
Controlled Study to Evaluate the Safety and 
Effectiveness of REAL INTELLIGENCE™ CORI™ in 
unicondylar knee arthroplasty (UKA) Procedure
Version: 4.0-Master, 07 Sep 
2022
Page: 145 of 167   
 
CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. 
and is intended for use only by Smith+Nephew and its manufacturer. It shall not be reproduced or copied in whole or in 
part, nor shall the contents be disclosed by any means without prior written permission from Smith+Nephew, nor shall 
anyone make any use of it that is contrary to the expressed or implied wishes of Smith+Nephew. 
TMP-CD-05-01 Clinical Protocol - Device – Revision D; SOP-CD-05 Clinical Protocol
Table 22.4-22-7 CORI Instrument Reduction Modules - Kits 
Article  
Description 
ROB10004 
JOURNEY II Uni Medial 
ROB10085 
JOURNEY II Uni Lateral 
ROB10005 
JOURNEY II TKA Essentials 
ROB10006 
JOURNEY II Distal Burring 
ROB10007 
JOURNEY II CR Module 
ROB10008 
JOURNEY II BCS Module 
ROB10009 
JOURNEY II XR Module 
ROB10067 
JOURNEY II Options Module
Table 22.4-22-8 CORI JOURNEY II UKA Inserts 
Article  
Description 
ROB10053 
ROBOTICS FINISHING INSERT (F)  
74036185 
LEFT MEDIAL BASEPLATE TRIALS 
74036127 
MEDIAL INSERT TRIALS 
74036174 
RESECTION FEMORAL FINISHING TRIALS LM/RL 
74036187 
RIGHT MEDIAL BASEPLATE TRIALS 
74036190 
RESECTION FEMORAL FINISHING TRIALS RM/LL 
74036196 
LATERAL BASEPLATE TRIALS  
74036198 
LATERAL INSERT TRIALS 
74036190 
RESECTION FEMORAL FINISHING TRIALS RM/LL 
74036196 
LATERAL BASEPLATE TRIALS  
74036174 
RESECTION FEMORAL FINISHING TRIALS LM/RL
Table 22.4-22-9 CORI JOURNEY II Instrument Reduction Inserts 
Article  
Description 
ROB10060 
ROBOTICS FINISHING BASE 
ROB10066 
TIBIA FINISIHING INSERT (F) 
ROB10092 
LEFT TRIAL BASE 
ROB10062 
FEMUR TRIAL INSERT LEFT (FF) 
ROB10064 
TIBIA TRIAL INSERT LEFT (C)  

Clinical Protocol 
Study Number: CORI.2019.06
A Prospective, Multi-center, Randomized 
Controlled Study to Evaluate the Safety and 
Effectiveness of REAL INTELLIGENCE™ CORI™ in 
unicondylar knee arthroplasty (UKA) Procedure
Version: 4.0-Master, 07 Sep 
2022
Page: 146 of 167   
 
CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. 
and is intended for use only by Smith+Nephew and its manufacturer. It shall not be reproduced or copied in whole or in 
part, nor shall the contents be disclosed by any means without prior written permission from Smith+Nephew, nor shall 
anyone make any use of it that is contrary to the expressed or implied wishes of Smith+Nephew. 
TMP-CD-05-01 Clinical Protocol - Device – Revision D; SOP-CD-05 Clinical Protocol
Article  
Description 
ROB10093 
RIGHT TRIAL BASE  
ROB10063 
FEMUR TRIAL INSERT RIGHT (FF) 
ROB10065 
TIBIA TRIAL INSERT RIGHT (C) 
ROB10061 
DISTAL BURRING INSERT (GG) 
ROB10068 
CR POLY TRIAL INSERT LEFT (II) 
ROB10069 
CR POLY TRIAL INSERT RIGHT (II)  
ROB10070 
CAM TRIAL INSERT LEFT 
ROB10072 
JOURNEY II BCS Finishing Insert (A) 
ROB10071 
CAM TRIAL INSERT RIGHT 
ROB10079 
JOURNEY II Robotics XR Poly Trial Insert Left (CC) 
ROB10080 
JOURNEY II Robotics XR Poly Trial Insert Right (CC) 
ROB10094 
JOURNEY II XR Tibia Finishing Insert (J)  
ROB10096 
JOURNEY II XR TIBIA IMPACTOR INSERT (GG) 
ROB10073 
JOURNEY II BCS Poly Trial Insert Left (HH)  
ROB10074 
JOURNEY II BCS Poly Trial Insert Right (HH) 
ROB10075 
JOURNEY II BCS Constrained Insert Left (HH) 
ROB10076 
JOURNEY II BCS Constrained Insert Right (HH)  
ROB10077 
JOURNEY II CR Deep Dish Insert Left (HH)  
ROB10078 
JOURNEY II CR Deep Dish Insert Right (HH) 
ROB10081 
JOURNEY II XR Poly Upslope Trial Insert Left (HH)  
ROB10082 
JOURNEY II XR Poly Upslope Trial Insert Right (HH)  
ROB10083 
J2 Robotics Universal Spacer Trial Insert (CC)  
ROB10099 
REAL INTELLIGENCE Flex Base 
Table 22.4-22-10 Total Knee Instruments 
Article  
Description 
ROB00003 
TKA Femur Cut Adapter  
ROB00005 
TKA Femur Distal Cut Guide – Small  
ROB00006 
TKA Femur Distal Cut Guide – Med  
ROB00007 
TKA Femur Distal Cut Guide – Lg  
ROB00014 
TKA Femur Stabilizer – Small 
ROB00015 
TKA Femur Stabilizer – Med 
ROB00016 
TKA Femur Stabilizer – Lg 
ROB00018 
TKA Drill Guide – Journey II  

Clinical Protocol 
Study Number: CORI.2019.06
A Prospective, Multi-center, Randomized 
Controlled Study to Evaluate the Safety and 
Effectiveness of REAL INTELLIGENCE™ CORI™ in 
unicondylar knee arthroplasty (UKA) Procedure
Version: 4.0-Master, 07 Sep 
2022
Page: 147 of 167   
 
CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. 
and is intended for use only by Smith+Nephew and its manufacturer. It shall not be reproduced or copied in whole or in 
part, nor shall the contents be disclosed by any means without prior written permission from Smith+Nephew, nor shall 
anyone make any use of it that is contrary to the expressed or implied wishes of Smith+Nephew. 
TMP-CD-05-01 Clinical Protocol - Device – Revision D; SOP-CD-05 Clinical Protocol
Article  
Description 
ROB00024 
TKA Drill Guide – Genesis II/Legion 
ROB00025 
TKA Left Tibia Twin Peg Cut Guide 
ROB00026 
TKA Right Tibia Twin Peg Cut Guide 
ROB00060 
TKA Distal FMR Punches – 38mm 
ROB00061 
TKA Distal FMR Punches – 45mm
Table 22.4-22-11 CORI Disposables 
Article  
Description 
4951 
Tablet Drape  
ROB10031  
Tubing Set  
ROB10032 
PFSDV0016 
Flat Markers 
ROB10033  
6 mm Bullet Bur  
ROB10034  
6 mm Chip Breaker Bullet Bur 
ROB10035  
5 mm Cylindrical Bur 
ROB10036  
6 mm Cylindrical Bur 
74013401 
Speed Pins (110 mm)  
74013490 
Speed Pins (80 mm)
 
Table 22.4-22-12 CORI Country Bundles 
Article 
Description
ROB20000 
CORI Robotics USA 
ROB20001 
CORI Robotics EMEA Bundle 1 
ROB20002 
CORI Robotics EMEA Bundle 2 
ROB20003 
CORI Robotics EMEA Bundle 3 
ROB20004 
CORI Robotics EMEA Bundle 4 
ROB20005 
CORI Robotics EMEA Bundle 5 
ROB20006 
CORI Robotics EMEA Bundle 6 
ROB20007 
CORI Robotics APAC Bundle 1  
ROB20008 
CORI Robotics APAC Bundle 2  
ROB20009 
CORI Robotics APAC Bundle 3  
ROB20010 
CORI Robotics APAC Bundle 4  
ROB20011 
CORI Robotics APAC Bundle 5  
ROB20012 
CORI Robotics ROW Bundle 1 

Clinical Protocol 
Study Number: CORI.2019.06
A Prospective, Multi-center, Randomized 
Controlled Study to Evaluate the Safety and 
Effectiveness of REAL INTELLIGENCE™ CORI™ in 
unicondylar knee arthroplasty (UKA) Procedure
Version: 4.0-Master, 07 Sep 
2022
Page: 148 of 167   
 
CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. 
and is intended for use only by Smith+Nephew and its manufacturer. It shall not be reproduced or copied in whole or in 
part, nor shall the contents be disclosed by any means without prior written permission from Smith+Nephew, nor shall 
anyone make any use of it that is contrary to the expressed or implied wishes of Smith+Nephew. 
TMP-CD-05-01 Clinical Protocol - Device – Revision D; SOP-CD-05 Clinical Protocol
Article  
Description 
ROB20013 
CORI Robotics ROW Bundle 2 
ROB20014 
CORI Robotics ROW Bundle 3 
ROB20015 
CORI Robotics ROW Bundle 4 
ROB20016 
CORI Robotics ROW Bundle 5
Table 22.4-22-13 CORI Welcome Box 
Article 
Description
ROB10299 
Welcome Box USA  
ROB10300 
Welcome Box ROW 1 
ROB10301 
Welcome Box ROW 2 
ROB10302 
Welcome Box ROW 3 
ROB10303 
Welcome Box ROW 4 
ROB10304 
Welcome Box ROW 5 
ROB10305 
Welcome Box EMEA 1 
ROB10306 
Welcome Box EMEA 2 
ROB10307 
Welcome Box EMEA 3 
ROB10308 
Welcome Box EMEA 4 
ROB10309 
Welcome Box EMEA 5 
ROB10310 
Welcome Box APAC 1  
ROB10311 
Welcome Box APAC 2  
ROB10312 
Welcome Box APAC 3  
ROB10313 
Welcome Box APAC 4 
ROB10314 
Welcome Box APAC 5 
ROB10315 
Welcome Box APAC 6
Table 22.4-22-14 CORI Product Documents / Other  
Article  
Description 
ROB10400 
REAL INTELLIGENCE Implant Database v2.85 
ROB10401 
REAL INTELLIGENCE Archiving USB 
ROB10402 
REAL INTELLIGENCE Supporting Documents 
ROB10403 
REAL INTELLIGENCE CORI Quick Start Guide  
ROB10404 
REAL INTELLIGENCE CORI Tray Guide 
ROB10400 
REAL INTELLIGENCE Implant Database v2.85 

Clinical Protocol 
Study Number: CORI.2019.06
A Prospective, Multi-center, Randomized 
Controlled Study to Evaluate the Safety and 
Effectiveness of REAL INTELLIGENCE™ CORI™ in 
unicondylar knee arthroplasty (UKA) Procedure
Version: 4.0-Master, 07 Sep 
2022
Page: 149 of 167   
 
CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. 
and is intended for use only by Smith+Nephew and its manufacturer. It shall not be reproduced or copied in whole or in 
part, nor shall the contents be disclosed by any means without prior written permission from Smith+Nephew, nor shall 
anyone make any use of it that is contrary to the expressed or implied wishes of Smith+Nephew. 
TMP-CD-05-01 Clinical Protocol - Device – Revision D; SOP-CD-05 Clinical Protocol
 
Table 22.4-22-15 CORI Power Cords 
Article  
Description 
ROB10199 
Power Cord North America  
ROB10200 
Power Cord ROW 1 
ROB10201 
Power Cord ROW 2 
ROB10202 
Power Cord ROW 3 
ROB10203 
Power Cord ROW 4 
ROB10204 
Power Cord ROW 5 
ROB10205 
Power Cord EMEA 1  
ROB10206 
Power Cord EMEA 2 
ROB10207 
Power Cord EMEA 3  
ROB10208 
Power Cord EMEA 4  
ROB10209 
Power Cord EMEA 5  
ROB10210 
Power Cord EMEA 6  
ROB10211 
Power Cord APAC 1  
ROB10212 
Power Cord APAC 2  
ROB10213 
Power Cord APAC 3  
ROB10214 
Power Cord APAC 4  
ROB10215 
Power Cord APAC 5
22.5 HEALTH ECONOMIC OUTCOME MEASURES/ QUALITY OF LIFE MEASURES
Refer to Section 9.2 & 9.3 for Quality of Life measures. 
 
 
 
 
22.6 PRINCIPAL INVESTIGATOR OBLIGATIONS

Clinical Protocol 
Study Number: CORI.2019.06
A Prospective, Multi-center, Randomized 
Controlled Study to Evaluate the Safety and 
Effectiveness of REAL INTELLIGENCE™ CORI™ in 
unicondylar knee arthroplasty (UKA) Procedure
Version: 4.0-Master, 07 Sep 
2022
Page: 150 of 167   
 
CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. 
and is intended for use only by Smith+Nephew and its manufacturer. It shall not be reproduced or copied in whole or in 
part, nor shall the contents be disclosed by any means without prior written permission from Smith+Nephew, nor shall 
anyone make any use of it that is contrary to the expressed or implied wishes of Smith+Nephew. 
TMP-CD-05-01 Clinical Protocol - Device – Revision D; SOP-CD-05 Clinical Protocol
22.6.1 Principal Investigator Obligation according to ISO14155:2020
1. General:  
2. The role of the PI is to implement and manage the day-to-day conduct of the 
clinical investigation as well as ensure data integrity and the rights, safety, and 
well-being of the subjects involved in the clinical investigation.  
3. The PI is responsible for ensuring adequate training and qualification of the 
investigation site team and for maintaining oversight of their activities. The 
principal investigator may delegate tasks to qualified members of the 
investigation site team but retains responsibility for the clinical investigation (see 
also 7.6). This also applies when activities are outsourced to an external 
organization by the principal investigator in which case he/she shall implement 
procedures to ensure the integrity of all tasks performed and any data generated 
by this external organization. 
4. Qualification of the PI. The PI shall: 
5. be qualified by education, training, and experience to assume responsibility for 
the proper conduct of the clinical investigation in accordance with this 
International Standard; evidence of such qualifications of the PI and key 

Clinical Protocol 
Study Number: CORI.2019.06
A Prospective, Multi-center, Randomized 
Controlled Study to Evaluate the Safety and 
Effectiveness of REAL INTELLIGENCE™ CORI™ in 
unicondylar knee arthroplasty (UKA) Procedure
Version: 4.0-Master, 07 Sep 
2022
Page: 151 of 167   
 
CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. 
and is intended for use only by Smith+Nephew and its manufacturer. It shall not be reproduced or copied in whole or in 
part, nor shall the contents be disclosed by any means without prior written permission from Smith+Nephew, nor shall 
anyone make any use of it that is contrary to the expressed or implied wishes of Smith+Nephew. 
TMP-CD-05-01 Clinical Protocol - Device – Revision D; SOP-CD-05 Clinical Protocol
members of the investigation site team shall be provided to the Sponsor through 
up-to-date Curriculum Vitae (CV) or other relevant documentation, 
6. be experienced in the field of application and trained in the use of the 
investigational device under consideration, 
7. disclose potential conflicts of interest, including financial, that interfere with the 
conduct of the clinical investigation or interpretation of results, and 
8. be knowledgeable with the method of obtaining informed consent. 
9. Qualification of investigation site. The PI shall be able to demonstrate that the 
proposed investigation site: 
10.has the required number of eligible subjects needed within the agreed 
recruitment period, and; 
11.has an investigation site team that is: qualified by education, training, and 
experience to assume responsibility for the proper conduct of the clinical 
investigation in accordance with this document; evidence of such qualifications 
for members of the investigation site team shall be documented through up-to-
date CVs or other relevant documentation,. 
12.has adequate facilities. 
13.Communication with the IEC. The PI shall:  
14.provide the Sponsor with copies of any clinical-investigation-related 
communications between the PI and the IEC, 
15.comply with the requirements described in 4.5 of ISO 14155. 
16.Submit to the IEC the following information, any amendments and any additional 
documentation required by the IEC: The Protocol; IB or equivalent; informed 
consent form and any other written information provided to subjects; procedures 

Clinical Protocol 
Study Number: CORI.2019.06
A Prospective, Multi-center, Randomized 
Controlled Study to Evaluate the Safety and 
Effectiveness of REAL INTELLIGENCE™ CORI™ in 
unicondylar knee arthroplasty (UKA) Procedure
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CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. 
and is intended for use only by Smith+Nephew and its manufacturer. It shall not be reproduced or copied in whole or in 
part, nor shall the contents be disclosed by any means without prior written permission from Smith+Nephew, nor shall 
anyone make any use of it that is contrary to the expressed or implied wishes of Smith+Nephew. 
TMP-CD-05-01 Clinical Protocol - Device – Revision D; SOP-CD-05 Clinical Protocol
for recruiting subjects and advertising materials, if any; a copy of the CV of the 
PI(s) for with the IEC has oversight. 
17.Provide documentation of the IECs approval/favorable opinion, identifying the 
documents and amendments on which the opinion was based, to the Sponsor, 
prior to commencing the clinical investigation.  
18.Submit the following to the IEC if required by national regulations, the protocol 
or IEC, whichever is more stringent: 
19.SAEs 
20.Requests for deviations, and reports of deviations, if the deviation affects 
subject’s rights, safety, and well-being, or the scientific integrity of the clinical 
investigation. Document and report to the Sponsor and IEC a report of 

Clinical Protocol 
Study Number: CORI.2019.06
A Prospective, Multi-center, Randomized 
Controlled Study to Evaluate the Safety and 
Effectiveness of REAL INTELLIGENCE™ CORI™ in 
unicondylar knee arthroplasty (UKA) Procedure
Version: 4.0-Master, 07 Sep 
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CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. 
and is intended for use only by Smith+Nephew and its manufacturer. It shall not be reproduced or copied in whole or in 
part, nor shall the contents be disclosed by any means without prior written permission from Smith+Nephew, nor shall 
anyone make any use of it that is contrary to the expressed or implied wishes of Smith+Nephew. 
TMP-CD-05-01 Clinical Protocol - Device – Revision D; SOP-CD-05 Clinical Protocol
deviations made to protect the rights, safety, and well-being of human subjects 
under emergency circumstances.  
21.Progress reports, including safety summary and deviations 
22.Amendments to any documents already approved by the IEC.  
23.If applicable, notifications of suspension or premature termination 
24.If applicable, justification and request for resuming the clinical investigation after 
suspension.  
25.Clinical investigation report or summary. 
26.As a minimum, during the clinical investigation, the following information shall 
be obtained in writing from the IEC prior to implementation: 
27.Approval/favorable opinion of amendments 
28.Approval of the request for deviations that can affect the subject’s rights, safety, 
and well-being or scientific integrity of the clinical investigation 
29.Approval for resumption of a suspended clinical investigation if applicable.  
30.obtain the written and dated approval/favorable opinion of the IEC for the clinical 
investigation before recruiting subjects and implementing all subsequent 
amendments, if required, 
31.promptly report any deviations from the protocol that affect the rights, safety or 
well-being of the subject or the scientific integrity of the clinical investigation, 
including those which occur under emergency circumstances, if required by the 
IEC, protocol or national regulations. In particular circumstances, the 
communication with the IEC can be performed by the Sponsor, partly or in full, 
in which case the Sponsor shall keep the Principal Investigator informed. 
32.Informed consent process. The PI shall: 
33.General: 
34.Informed consent shall be obtained in writing from the subject and the process 
shall be documented before any procedure specific to the clinical investigation is 

Clinical Protocol 
Study Number: CORI.2019.06
A Prospective, Multi-center, Randomized 
Controlled Study to Evaluate the Safety and 
Effectiveness of REAL INTELLIGENCE™ CORI™ in 
unicondylar knee arthroplasty (UKA) Procedure
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CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. 
and is intended for use only by Smith+Nephew and its manufacturer. It shall not be reproduced or copied in whole or in 
part, nor shall the contents be disclosed by any means without prior written permission from Smith+Nephew, nor shall 
anyone make any use of it that is contrary to the expressed or implied wishes of Smith+Nephew. 
TMP-CD-05-01 Clinical Protocol - Device – Revision D; SOP-CD-05 Clinical Protocol
applied to the subject; except when special circumstances for emergency 
treatments apply (see below) 
35.Process of obtaining informed consent. The general process for obtaining 
informed consent shall be documented in the protocol and shall comply with the 
following. These requirements also apply with respect to informed consent 
obtained from a subject’s legally authorized representative:  
36.Ensure that the PI or his/her authorized designee conducts the informed consent 
process 
37.Include all aspects of the clinical investigation that are relevant to the subject’s 
decision to participate throughout the clinical investigation 
38.Avoid any coercion or undue improper influence on, or inducement of, the 
subject to participate 
39.Not waive or appear to waive the subject’s legal rights 
40.Use native non-technical language that is understandable to the subject 
41.Provide ample time for the subject to read and understand the informed consent 
form and to consider participation in the clinical investigation 
42.Include personally dated signatures and the PI or an authorized designee 
responsible for conducting the informed consent process 
43.Show how informed consent will be obtained in special circumstances (see 
below) where the subject is unable to provide him or herself, and  
44.Ensure important new information is provided to new and existing subjects 
throughout the clinical investigation.  
45.Special circumstances for informed consent (the following provisions are subject 
to national regulations): 
46.Subject needing legally authorized representatives:  informed consent may be 
given by the legally authorized representative only if a subject is unable to make 
the decision to participate in a clinical investigation (e.g., infant, child, or 

Clinical Protocol 
Study Number: CORI.2019.06
A Prospective, Multi-center, Randomized 
Controlled Study to Evaluate the Safety and 
Effectiveness of REAL INTELLIGENCE™ CORI™ in 
unicondylar knee arthroplasty (UKA) Procedure
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This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. 
and is intended for use only by Smith+Nephew and its manufacturer. It shall not be reproduced or copied in whole or in 
part, nor shall the contents be disclosed by any means without prior written permission from Smith+Nephew, nor shall 
anyone make any use of it that is contrary to the expressed or implied wishes of Smith+Nephew. 
TMP-CD-05-01 Clinical Protocol - Device – Revision D; SOP-CD-05 Clinical Protocol
juvenile, seriously ill or unconscious subject, mentally ill person, mentally 
handicapped person). In such cases, the subject shall also be informed about the 
clinical investigation within his/her ability to understand.  
47.Subject unable to read or write: informed consent shall be obtained through a 
supervised oral process if a subject or legally authorized representative is unable 
to read or write. An independent witness shall be present throughout the 
process. The written informed consent form and any other information shall be 
read aloud and explained to the prospective subject or his/her legally authorized 
representative and, whenever possible, either shall sign and personally date the 
informed consent form. The witness also signs and personally dates the informed 
consent for attesting that the information was accurately explained and that the 
informed consent was freely given.  
48.Emergency treatments:  
49.For clinical investigations involving emergency treatments, when prior informed 
consent of the subject is not possible because of the subject’s medical condition, 
the informed consent of the subject’s legally authorized representative, if 
present, shall be requested.  
50.When it is not possible to obtain prior informed consent from the subject, and 
the subject’s legally authorized representative, is not available, the subject may 
still be enrolled if a specific process has been described in the protocol.  
51.Arrangements shall be made to inform the subject or legally authorized 
representative, as soon as possible, about the subject’s inclusion in the clinical 
investigation and about all aspects of the clinical investigation.  
52.The subject shall be asked to provide informed consent for continued 
participation as soon as his/her medical condition allows.  
53.The Principal Investigator may not enroll a subject without obtaining informed 
consent of the subject or his/her legally authorized representative only when the 
following conditions are fulfilled: the prospective subject fulfils the emergency 

Clinical Protocol 
Study Number: CORI.2019.06
A Prospective, Multi-center, Randomized 
Controlled Study to Evaluate the Safety and 
Effectiveness of REAL INTELLIGENCE™ CORI™ in 
unicondylar knee arthroplasty (UKA) Procedure
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CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. 
and is intended for use only by Smith+Nephew and its manufacturer. It shall not be reproduced or copied in whole or in 
part, nor shall the contents be disclosed by any means without prior written permission from Smith+Nephew, nor shall 
anyone make any use of it that is contrary to the expressed or implied wishes of Smith+Nephew. 
TMP-CD-05-01 Clinical Protocol - Device – Revision D; SOP-CD-05 Clinical Protocol
conditions and is obviously in a life-threatening situation; no sufficient clinical 
benefits are anticipated from the currently available treatment; there is a fair 
possibility that the life-threatening risk to the prospective subject can be avoided 
if the investigational device is used; anticipated risks are outweighed by the 
potential benefits of applying the investigational device ; the legally authorized 
representative cannot be promptly reached and informed.  
54.Information provided to the subject. All information pertinent to the clinical 
investigation, including at least the following, shall be provided in writing and in 

Clinical Protocol 
Study Number: CORI.2019.06
A Prospective, Multi-center, Randomized 
Controlled Study to Evaluate the Safety and 
Effectiveness of REAL INTELLIGENCE™ CORI™ in 
unicondylar knee arthroplasty (UKA) Procedure
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CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. 
and is intended for use only by Smith+Nephew and its manufacturer. It shall not be reproduced or copied in whole or in 
part, nor shall the contents be disclosed by any means without prior written permission from Smith+Nephew, nor shall 
anyone make any use of it that is contrary to the expressed or implied wishes of Smith+Nephew. 
TMP-CD-05-01 Clinical Protocol - Device – Revision D; SOP-CD-05 Clinical Protocol
native, non-technical language that is understandable to the subject (or the 
subject’s legally authorized representative): 
55.Description and purpose 
56.Potential benefits 
57.Risks and inconveniences or the subject and, when applicable, for any embryo, 
fetus or nursing infant 
58.Alternative procedures 
59.Confidentiality 
60.Compensation 
61.Anticipated expenses, if any, to be borne by the subject for participating in the 
clinical investigation 
62.Information on the role of Sponsor’s representative in the clinical investigation 
63.Contact persons 
64.Statement declaring that new findings or the reasons for any amendment to the 
protocol that affect the subject’s continued participation shall be made available 
to the subject  
65.Statement indicating that, upon the subject’s approval, the subject’s personal 
physician will be informed of the subject’s participation in the clinical 
investigation 
66.Statement indicating that a description of the clinical investigation has or shall 
be registered in a publicly accessible database 
67.Termination procedures 
68.Informed consent signature shall contain the following:  
69.The voluntary agreement to participate in the clinical investigation and follow the 
investigator’s instructions 
70.A statement declaring that refusal of participation incurs no penalty for the 
subject and no loss of benefits to which the subject is otherwise entitled; 

Clinical Protocol 
Study Number: CORI.2019.06
A Prospective, Multi-center, Randomized 
Controlled Study to Evaluate the Safety and 
Effectiveness of REAL INTELLIGENCE™ CORI™ in 
unicondylar knee arthroplasty (UKA) Procedure
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CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. 
and is intended for use only by Smith+Nephew and its manufacturer. It shall not be reproduced or copied in whole or in 
part, nor shall the contents be disclosed by any means without prior written permission from Smith+Nephew, nor shall 
anyone make any use of it that is contrary to the expressed or implied wishes of Smith+Nephew. 
TMP-CD-05-01 Clinical Protocol - Device – Revision D; SOP-CD-05 Clinical Protocol
71.A statement declaring that discontinuation/withdrawal and thereby revoking the 
informed consent at any time incurs no penalty for the subject; 
72.A statement with regard to the possible consequences of withdrawal 
73.An acknowledgment of the information provided and confirmation that all the 
subject’s questions were answered that the subject acknowledges the 
information provided during the informed consent process and that (s)he had 
ample time to consider participation 
74.A statement confirming that the subject or his/her legally authorized 
representative agrees to the use of the subject’s relevant personal data for the 
purpose of the clinical investigation 
75.A statement confirming that the subject or his/her legally authorized 
representative agrees that Sponsor’s representatives, regulatory authorities and 
IEC representatives will be granted direct access to the subject’s medical 
records.  
76.New information: if new information becomes available that can significantly 
affect a subject’s future health and medical care, that information shall be 
provided to the subject(s) affected in written form. If relevant, all affected 
subjects shall be asked to confirm their continuing consent in writing.  
77.ensure compliance with the applicable regulatory requirements and ethical 
principles for the process of obtaining informed consent, and ensure and 

Clinical Protocol 
Study Number: CORI.2019.06
A Prospective, Multi-center, Randomized 
Controlled Study to Evaluate the Safety and 
Effectiveness of REAL INTELLIGENCE™ CORI™ in 
unicondylar knee arthroplasty (UKA) Procedure
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CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. 
and is intended for use only by Smith+Nephew and its manufacturer. It shall not be reproduced or copied in whole or in 
part, nor shall the contents be disclosed by any means without prior written permission from Smith+Nephew, nor shall 
anyone make any use of it that is contrary to the expressed or implied wishes of Smith+Nephew. 
TMP-CD-05-01 Clinical Protocol - Device – Revision D; SOP-CD-05 Clinical Protocol
document appropriate training if an authorized designee is appointed to conduct 
the informed consent process. 
78.Compliance with the protocol. The Principal Investigator shall: 
79.indicate his/her acceptance of the protocol in writing, 
80.conduct the clinical investigation in compliance with the protocol, 
81.create and maintain source documents throughout the clinical investigation and 
make them available as requested during monitoring visits or audits as well as 
maintain documentation of the type and location of these source documents,, 
82.ensure that the investigational device is used solely by authorized users as 
specified in 7.2, and in accordance with the protocol and instructions for use, 
83.propose to the Sponsor any appropriate modification(s) of the protocol or 
investigational device or of the use of the investigational device, 
84.refrain from implementing any modifications to the protocol without agreement 
from the Sponsor, IEC and regulatory authorities, if required, 
85.document and explain any deviation from the approved protocol that occurred 
during the course of the clinical investigation, 
86.ensure that an adequate investigation site team and facilities exist and are 
maintained and documented during the clinical investigation, 
87.ensure that maintenance and calibration of the equipment relevant for the 
assessment of the clinical investigation is appropriately performed and 
documented, where applicable, 
88.ensure the accuracy, completeness, legibility, and timeliness of the data reported 
to the Sponsor in the CRF and in all required reports, 
89.maintain the device accountability records, 
90.Comply with the procedure for the safe return of investigational devices including 
potentially hazardous devices and, in the case of reported device deficiencies, 
collaborate with the sponsor to provide the necessary information allowing an 

Clinical Protocol 
Study Number: CORI.2019.06
A Prospective, Multi-center, Randomized 
Controlled Study to Evaluate the Safety and 
Effectiveness of REAL INTELLIGENCE™ CORI™ in 
unicondylar knee arthroplasty (UKA) Procedure
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CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. 
and is intended for use only by Smith+Nephew and its manufacturer. It shall not be reproduced or copied in whole or in 
part, nor shall the contents be disclosed by any means without prior written permission from Smith+Nephew, nor shall 
anyone make any use of it that is contrary to the expressed or implied wishes of Smith+Nephew. 
TMP-CD-05-01 Clinical Protocol - Device – Revision D; SOP-CD-05 Clinical Protocol
accurate analysis where appropriate. requirements and provide any information 
need to analyze device deficiencies, if applicable. 
91.allow and support the Sponsor to perform monitoring and auditing activities, 
92.be accessible to the monitor and respond to questions during monitoring visits, 
93.determine the cause and implement appropriate corrective and preventative 
actions to address significant noncompliance, 
94.allow and support regulatory authorities and the IEC when performing auditing 
activities, 
95.ensure that all clinical-investigation-related records are retained as required 
taking measures to prevent accidental or premature destruction, and 
96.review and sign the clinical investigation report, as applicable. 
97.Medical care of subjects. The Principal Investigator shall 
98.provide adequate medical care to a subject during and after a subject's 
participation in a clinical investigation in the case of adverse events,  
99.inform the subject of the nature and possible cause of any adverse events 
experienced, 
100. provide the subject with the necessary instructions on proper use, handling, 
storage, and return of the investigational device, when it is used or operated by 
the subject, 
101. inform the subject of any new significant findings occurring during the clinical 
investigation, including the need for additional medical care that may be 
required, 
102. provide the subject with well-defined procedures for possible emergency 
situations related to the clinical investigation, and make the necessary 

Clinical Protocol 
Study Number: CORI.2019.06
A Prospective, Multi-center, Randomized 
Controlled Study to Evaluate the Safety and 
Effectiveness of REAL INTELLIGENCE™ CORI™ in 
unicondylar knee arthroplasty (UKA) Procedure
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CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. 
and is intended for use only by Smith+Nephew and its manufacturer. It shall not be reproduced or copied in whole or in 
part, nor shall the contents be disclosed by any means without prior written permission from Smith+Nephew, nor shall 
anyone make any use of it that is contrary to the expressed or implied wishes of Smith+Nephew. 
TMP-CD-05-01 Clinical Protocol - Device – Revision D; SOP-CD-05 Clinical Protocol
arrangements for emergency treatment, including decoding procedures for 
blinded/masked clinical investigations, as needed, 
103. ensure that clinical records are clearly marked to indicate that the subject is 
enrolled in a particular clinical investigation, 
104. if appropriate, subjects enrolled in the clinical investigation shall be provided 
with some means of showing their participation in the clinical investigation, 
together with identification and compliance information for concomitant 
treatment measures (contact address and telephone numbers shall be provided), 
105. inform, with the subject's approval or when required by national regulations, 
the subject's personal physician about the subject's participation in the clinical 
investigation, and  
106. make all reasonable efforts to ascertain the reason(s) for a subject's 
premature withdrawal from the clinical investigation while fully respecting the 
subject's rights. 
107. Safety reporting. The Principal Investigator shall: 
108. record every adverse event and observed device deficiency, together with an 
assessment, 
109. report to the Sponsor, without unjustified delay, all serious adverse events and 
device deficiencies that could have led to a serious adverse device effect; this 

Clinical Protocol 
Study Number: CORI.2019.06
A Prospective, Multi-center, Randomized 
Controlled Study to Evaluate the Safety and 
Effectiveness of REAL INTELLIGENCE™ CORI™ in 
unicondylar knee arthroplasty (UKA) Procedure
Version: 4.0-Master, 07 Sep 
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CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. 
and is intended for use only by Smith+Nephew and its manufacturer. It shall not be reproduced or copied in whole or in 
part, nor shall the contents be disclosed by any means without prior written permission from Smith+Nephew, nor shall 
anyone make any use of it that is contrary to the expressed or implied wishes of Smith+Nephew. 
TMP-CD-05-01 Clinical Protocol - Device – Revision D; SOP-CD-05 Clinical Protocol
information shall be promptly followed by detailed written reports, as specified in 
the protocol, 
110. report to the IEC serious adverse events and device deficiencies that could 
have led to a serious adverse device effect, if required by the national 
regulations or protocol or by the IEC,  
111. report to regulatory authorities, serious adverse events and device deficiencies 
that could have led to a serious adverse device effect, as required by the 
national regulations, and 
112. supply the Sponsor, upon Sponsor's request, with any additional information 
related to the safety reporting of a particular event. 
113. Note, for studies conducted under 21 CFR Part 812 Investigational Device 
Exemption Regulations, an investigator shall prepare and submit the following 
complete, accurate, and timely reports: 
114. Unanticipated Adverse Device Effects An investigator shall submit to the 
sponsor and to the reviewing IRB a report of any unanticipated adverse device 
effect occurring during an investigation as soon as possible, but in no event later 
than 10 working days after the investigator first learns of the effect. 
115. Withdrawal of IRB approval. An investigator shall report to the sponsor, within 
5 working days, a withdrawal of approval by the reviewing IRB of the 
investigator's part of an investigation. 
116. Progress. An investigator shall submit progress reports on the investigation to 
the sponsor, the monitor, and the reviewing IRB at regular intervals, but in no 
event less often than yearly. 
117. Deviations from the investigational plan. An investigator shall notify the 
sponsor and the reviewing IRB of any deviation from the investigational plan to 
protect the life or physical well-being of a subject in an emergency. Such notice 
shall be given as soon as possible, but in no event later than 5 working days 
after the emergency occurred. Except in such an emergency, prior approval by 

Clinical Protocol 
Study Number: CORI.2019.06
A Prospective, Multi-center, Randomized 
Controlled Study to Evaluate the Safety and 
Effectiveness of REAL INTELLIGENCE™ CORI™ in 
unicondylar knee arthroplasty (UKA) Procedure
Version: 4.0-Master, 07 Sep 
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CONFIDENTIAL AND PROPRIETARY 
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and is intended for use only by Smith+Nephew and its manufacturer. It shall not be reproduced or copied in whole or in 
part, nor shall the contents be disclosed by any means without prior written permission from Smith+Nephew, nor shall 
anyone make any use of it that is contrary to the expressed or implied wishes of Smith+Nephew. 
TMP-CD-05-01 Clinical Protocol - Device – Revision D; SOP-CD-05 Clinical Protocol
the sponsor is required for changes in or deviations from a plan, and if these 
changes or deviations may affect the scientific soundness of the plan or the 
rights, safety, or welfare of human subjects, FDA and IRB also is required. 
118. Informed consent. If an investigator uses a device without obtaining informed 
consent, the investigator shall report such use to the sponsor and the reviewing 
IRB within 5 working days after the use occurs. 
119. Investigational device including clinical procedure risks and their disclosure.  
The PI shall: 
120. Evaluate risks according to ISO 14971 before starting a trial, 
121. Summarize benefit-risk analysis in trial documents, 
122. Add residual risk and their nature, occurrence, severity, and outcome to the 
IB, 
123. Include in CIP all anticipated adverse device effects and a rationale for the 
related benefit-risk ratio, 
124. Include any anticipated adverse device effect in the consent form. 
22.6.2 Principal Investigator Obligations according to GCP NMPA 
2016 
 
Article 59 Before accepting clinical trial, clinical trial institutions shall evaluate 
relevant resources in accordance with the characteristics of investigational 
medical devices to decide whether to accept this clinical trial.  
 
Article 60 Clinical trial institutions shall properly keep clinical trial records and 
basic documents according to the agreement with the sponsor.  
 
Article 61 Investigators who are in charge of the clinical trial shall:  
 Have professional title and qualification above associate level, such as 
associate chief physician, associate professor and associate researcher in 
the clinical trial institutions;  

Clinical Protocol 
Study Number: CORI.2019.06
A Prospective, Multi-center, Randomized 
Controlled Study to Evaluate the Safety and 
Effectiveness of REAL INTELLIGENCE™ CORI™ in 
unicondylar knee arthroplasty (UKA) Procedure
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CONFIDENTIAL AND PROPRIETARY 
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and is intended for use only by Smith+Nephew and its manufacturer. It shall not be reproduced or copied in whole or in 
part, nor shall the contents be disclosed by any means without prior written permission from Smith+Nephew, nor shall 
anyone make any use of it that is contrary to the expressed or implied wishes of Smith+Nephew. 
TMP-CD-05-01 Clinical Protocol - Device – Revision D; SOP-CD-05 Clinical Protocol
 Have professional knowledge and experience required for investigational 
medical devices and pass relevant trainings if necessary;  
 Be familiar with clinical trial requirements provided by sponsor, and the 
data and literatures related to clinical trial;  
 Be able to coordinate, allocate and assign personnel and devices of this 
trial, and to handle the adverse events and other correlating events 
related to investigational medical devices;  
 Be familiar with relevant national laws, regulations and this Provision.  
 
Article 62 Prior to a clinical trial, the medical device clinical trial administrative 
department of clinical trial institutions shall coordinate sponsor to file 
applications to the ethics committee and submit relevant documents in 
accordance with relevant provisions. 
 
Article 63 Investigators shall ensure that the staff member participating in the 
trial are familiar with the principles, indications, product performance, 
operating methods, installation requirements and technical specifications of 
investigational medical devices, understand preclinical research data and 
safety data of investigational medical devices, and master precautions and 
emergency treatment for possible risks in clinical trial.  
 
Article 64 Investigators shall ensure all participants of clinical trial fully 
understand the clinical trial protocol, relevant provisions, characteristics of 
investigational medical devices and relevant responsibilities of clinical trial, 
make sure that enough subjects meeting inclusion criteria in clinical trial 
protocol can be enrolled into clinical trial, ensure enough time in the agreed 
trial period, to implement and complete clinical trial safely according relevant 
regulations.  
 
Article 65 The investigator shall ensure that the investigational medical devices 
are only used for subjects of the clinical trial, and used for free. 
 
Article 66 Investigators shall strictly comply with clinical trial protocol. Without 
consent of sponsor and ethics committee or approval of China Food and Drug 

Clinical Protocol 
Study Number: CORI.2019.06
A Prospective, Multi-center, Randomized 
Controlled Study to Evaluate the Safety and 
Effectiveness of REAL INTELLIGENCE™ CORI™ in 
unicondylar knee arthroplasty (UKA) Procedure
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CONFIDENTIAL AND PROPRIETARY 
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and is intended for use only by Smith+Nephew and its manufacturer. It shall not be reproduced or copied in whole or in 
part, nor shall the contents be disclosed by any means without prior written permission from Smith+Nephew, nor shall 
anyone make any use of it that is contrary to the expressed or implied wishes of Smith+Nephew. 
TMP-CD-05-01 Clinical Protocol - Device – Revision D; SOP-CD-05 Clinical Protocol
Administration in accordance with regulations, investigators shall not deviate 
the protocol or substantially change the protocol. However, in case of an 
emergency that subjects face direct danger that needs to be eliminated 
immediately, it can be reported in writing afterwards.  
 
Article 67 Investigators shall be responsible for recruiting subjects and talking 
with subjects or their guardians. Investigators are responsible to specify the 
details relating to investigational medical devices and clinical trial for subjects, 
inform subjects of possible benefits and known and foreseeable risks, and 
obtain the signed and dated informed consent form from subjects and their 
guardians.  
 
Article 68 Investigators and other personnel participated in the trial shall not 
force or induce subjects in improper way to take part in the trial.  
 
Article 69 In case of finding unanticipated adverse events of investigational 
medical devices during clinical trial, investigators shall revise relevant content 
of informed consent form together with the sponsor. After being reviewed and 
approved by ethics committee in accordance with relevant working procedure, 
the affected subjects and their guardians shall resign the revised informed 
consent form for confirmation. 
 
Article 70 Investigators shall be responsible for making decisions relating to 
clinical trial. In case of adverse events relating to clinical trial, clinical trial 
institutions and investigators shall provide sufficient and timely treatment and 
management to subjects. In case subjects have complications and need 
treatment and management, investigators shall timely notify subjects.  
 
Article 71 In case of serious adverse events during clinical trial, investigators 
shall take proper treatment measures for subjects immediately, then report to 
medical device clinical trial administrative departments of clinical trial 
institutions where they belong to, and notify sponsor in writing through them. 
Clinical trial administrative departments of medical devices shall report to 
corresponding ethics committee and Food and Drug Administration of province, 

Clinical Protocol 
Study Number: CORI.2019.06
A Prospective, Multi-center, Randomized 
Controlled Study to Evaluate the Safety and 
Effectiveness of REAL INTELLIGENCE™ CORI™ in 
unicondylar knee arthroplasty (UKA) Procedure
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2022
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CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. 
and is intended for use only by Smith+Nephew and its manufacturer. It shall not be reproduced or copied in whole or in 
part, nor shall the contents be disclosed by any means without prior written permission from Smith+Nephew, nor shall 
anyone make any use of it that is contrary to the expressed or implied wishes of Smith+Nephew. 
TMP-CD-05-01 Clinical Protocol - Device – Revision D; SOP-CD-05 Clinical Protocol
autonomous region or municipality and the Health and Family Planning 
Commission where the clinical trial institution is located in written form within 
24 hours. For lethal events, clinical trial institutions and investigators shall 
provide all necessary data to ethics committee and sponsor.  
 
Article 72 Investigators shall record all adverse events and device deficiency 
that occur during the process of clinical trial, analyze event cases together with 
sponsor, draft written analysis report, put forward opinions of continuing, 
suspending or terminating the trial, and report to ethics committee for review 
through medical device clinical trial administrative departments of clinical trial 
institutions.  
 
Article 73 Investigators shall ensure that clinical trial data are filled in case 
report forms accurately, completely, clearly and timely. Case report forms shall 
be signed by investigators. Any change of data shall be signed and dated by 
investigator, original records should be kept, clear and recognizable.  
 
Article 74 Clinical trial institutions and investigators shall ensure authenticity, 
accuracy, clarity and safety of data and documents generated in clinical trial. 
 
Article 75 Clinical trial institutions and investigators shall accept the monitoring 
and audit of sponsor as well as supervision of ethics committee, and provide 
all required records relating to the trial. In case Food and Drug Administration 
and Health and Family Planning Commission send inspectors to implement 
inspection, clinical trial institutions and investigators shall cooperate with them. 
 
Article 76 In case clinical trial institutions and investigators identify risks 
overweighting possible benefits, or have obtained the results that is sufficient 
to judge the safety and effectiveness of investigational medical devices, thus 
need to suspend or terminate clinical trial, it is required to notify subjects and 
ensure subjects to obtain proper treatment and follow-up, report in accordance 
with regulations and provide detailed written explanation at the same time. If 
necessary, report to the Food and Drug Administration of province, 
autonomous region or municipality where it locates.  

Clinical Protocol 
Study Number: CORI.2019.06
A Prospective, Multi-center, Randomized 
Controlled Study to Evaluate the Safety and 
Effectiveness of REAL INTELLIGENCE™ CORI™ in 
unicondylar knee arthroplasty (UKA) Procedure
Version: 4.0-Master, 07 Sep 
2022
Page: 167 of 167   
 
CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. 
and is intended for use only by Smith+Nephew and its manufacturer. It shall not be reproduced or copied in whole or in 
part, nor shall the contents be disclosed by any means without prior written permission from Smith+Nephew, nor shall 
anyone make any use of it that is contrary to the expressed or implied wishes of Smith+Nephew. 
TMP-CD-05-01 Clinical Protocol - Device – Revision D; SOP-CD-05 Clinical Protocol
 
In case of receiving the notification of sponsor or ethics committee on the need 
of suspending or terminating clinical trial, investigators shall timely notify 
subjects and ensure subjects to obtain proper treatment and follow-up.  
 
Article 77 In case the sponsor violates relevant regulations or request to change 
the trial data and conclusion, clinical trial institutions and investigators shall 
report to Food and Drug Administration of province, autonomous region or 
municipality where the sponsor is located or report to the China Food and Drug 
Administration.  
 
Article 78 At the end of a clinical trial, the investigator shall ensure the 
completion of all records and reports. Meanwhile, the investigator shall ensure 
the quantity of received investigational medical devices is consistent with the 
used, discarded or returned devices, and ensure that the rest investigational 
medical devices are disposed properly and recorded for filing.  
 
Article 79 Investigators can authorize corresponding personnel to recruit 
subjects, continuously communicate with subjects, record the clinical trial data, 
and manage investigational medical devices in accordance with the needs of 
clinical trial. Investigators shall implement relevant training for the authorized 
personnel and document accordingly.