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
Phase: NA
Conditions: Arthroplasty, Replacement, Knee
Sponsor: Smith & Nephew, Inc.

 
Clinical Protocol  
Study Number: CORI.2019.07
A Prospective, Multi-center, Study to Evaluate the Safety and 
knee arthroplasty (UKA) and total knee arthroplasty (TKA) 
procedures  
Version: 6.0, 15/Jan/2024
Page: 1 of 122
 
 
 
Sponsor and funding source:
Smith & Nephew Inc, 1450 E. Brooks Road, Memphis, 
Tennessee 38116, USA  
Local Representative
Smith & Nephew Operations B.V, Bloemlaan 2, 2132 NP 
Hoofddorp, The Netherlands 
Investigational Product(s)
throughout this document) 
Single Identification Number of 
Clinical Investigation 
N/A
Protocol Author(s):
Judith Horner, Senior Clinical Study Manager
Babajide Olayinka, Senior Biostatistician 
Julie Lankiewicz, Director, Global Clinical Strategy Robotics
Michael Robinson, Senior Manager, Global Biostatistics & Data 
Sciences 
Summary of Revision History
V5.0, 08/Nov/2022
V4.0, 18/Jun/2020 
V3.0, 08/Jun/2020 
V2.0, 29/Apr/2020 
V1.0,  24/Feb/2020  

 
Clinical Protocol  
Study Number: CORI.2019.07
A Prospective, Multi-center, Study to Evaluate the Safety and 
knee arthroplasty (UKA) and total knee arthroplasty (TKA) 
procedures  
Version: 6.0, 15/Jan/2024
Page: 2 of 122
 
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.
A Prospective, Multi-center, Study to Evaluate the 
(UKA) and total knee arthroplasty (TKA) procedures
sion 6.0, dated 15/Jan/2024, and 
agree to abide by all provisions set forth herein. 
22.7 of the protocol, 
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.2019.07
A Prospective, Multi-center, Study to Evaluate the Safety and 
knee arthroplasty (UKA) and total knee arthroplasty (TKA) 
procedures
Version: 6.0, 15/Jan/2024
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1.2Coordinating Investigator Approval
I have read the attached protocol entitled A Prospective, Multi-center, Study to Evaluate the 
(UKA) and total knee arthroplasty (TKA) procedures , version 6.0, dated 15/Jan/2024, and 
agree to abide by all provisions set forth therein.
Name, Address, 
Professional Position
Signature and Date / DocuSign Stamp
Prof. Edward T Davis
The Royal Orthopaedic Hospital 
NHS Foundation Trust, Bristol Road 
South, Birmingham, West 
Midlands, UK, B31 2AP
Consultant Arthroplasty Surgeon 
and Clinical Service Lead for
Arthroplasty

Clinical Protocol 
Study Number: CORI.2019.07
A Prospective, Multi-center, Study to Evaluate the Safety and 
knee arthroplasty (UKA) and total knee arthroplasty (TKA) 
procedures
Version: 6.0, 15/Jan/2024
Page: 4 of 122
1.3Sponsor Approval
Name and Title
Signature and Date / DocuSign Stamp
Matt Christensen
SVP, GCMA
(Head of Global Clinical 
Operations)
Lori Fontaine
VP, GCS
(Global Clinical Strategy
Franchise Head)
Jay Jantz
Director, Global Biostatistics & 
Data Sciences (Head of Global 
Data Analytics)
Kolja Boese
Senior Director, Global Medical 
Affairs
(Medical Affairs Representative)
Sam Timson
Sr. Clinical Compliance & 
Training Specialist
(Clinical Compliance and 
Training/Clinical Quality 
Assurance)

Clinical Protocol 
Study Number: CORI.2019.07
A Prospective, Multi-center, Study to Evaluate the Safety and 
knee arthroplasty (UKA) and total knee arthroplasty (TKA) 
procedures
Version: 6.0, 15/Jan/2024
Page: 5 of 122
SYNOPSIS
Title of Study:
A Prospective, Multi-center, Study to Evaluate the Safety and 
arthroplasty (UKA) and total knee arthroplasty (TKA) procedures
Sponsor and Funding 
Source:
Smith & Nephew Inc, 1450 E. Brooks Road, Memphis, Tennessee 
38116, USA
Study Design:
Prospective
Multi-center
up to 8 sites
Cohort study 
2 arms
80 subjects (40 x UKA, 40 x TKA)
1 year follow-up
Study Type:
Post-market study 
Interventional, non-randomised, non-blinded
Study Product: 
-
assisted orthopedic surgical navigation and burring system. CORI 
Robotics 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 Robotics 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 Robotics software consists 
of a patient and user management module, a surgical planner, and 
an intra-operative cutting module.
Comparison Group(s)*:
(*if applicable)
N/A
Study Purpose:
This is a prospective study to demonstrate the safety and 
effectiveness of the CORI Robotics to meet the post-market clinical 
follow-up requirement in Europe and the US.
Primary Objective:
To evaluate the use of CORI Robotics in UKA and TKA procedures in 
achieving post-operative leg alignment.
Secondary Objective(s):
To assess the safety and performance of the CORI Robotics up to 12 
months after surgery.

 
Clinical Protocol  
Study Number: CORI.2019.07
A Prospective, Multi-center, Study to Evaluate the Safety and 
knee arthroplasty (UKA) and total knee arthroplasty (TKA) 
procedures  
Version: 6.0, 15/Jan/2024
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Other Objective(s):
To determine the Robotics System time and cutting time of the 
robotic drill of UKA and TKA procedures with the CORI Robotics.
Sample Size:
80 CORI Robotics procedures:
 
40 unicondylar knee arthroplasty (UKA) 
 
40 total knee arthroplasty (TKA) 
The statistical justification is provided separately for UKA and TKA 
N=40 subjects per arm, based on post-operative alignment (±3 
from a historical control. 
Number of Study Sites:
Up to 8 sites
Targeted Global 
Regions: 
Europe, UK, India, and the US 
Inclusion Criteria:
1) 
Knee Implant System is the best tre
UKA or TKA and the subject has agreed to the treatment.  
2) Subject requires a cemented UKA or TKA as a primary 
indication that meets either criterion A or B.  
A. Subject requires a cemented UKA as a primary 
indication due to any of the following conditions: 
1. Non-inflammatory degenerative joint disease, 
including osteoarthritis  
2. Avascular necrosis  
3. Requires correction of functional deformity 
4. Requires treatment of fractures that were 
unmanageable using other techniques  
B. Subject requires a cemented TKA as a primary indication 
due to any of the following condition:  
1. Degenerative joint disease, including osteoarthritis  
2. Rheumatoid arthritis  
3. Avascular necrosis  
4. Requires correction of functional deformity
5. Requires treatment of fractures that were 
unmanageable using other techniques  
3) Subject is of legal age to consent and considered skeletally 
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 Ethical Committee (EC) or 
Institutional Review Board (IRB) approved informed consent 
form. 
5) Subject plans to be available through one (1) year 
postoperative follow-up.  

 
Clinical Protocol  
Study Number: CORI.2019.07
A Prospective, Multi-center, Study to Evaluate the Safety and 
knee arthroplasty (UKA) and total knee arthroplasty (TKA) 
procedures  
Version: 6.0, 15/Jan/2024
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6) Routine radiographic assessment is possible. 
7) Subject able to follow instructions and deemed capable of 
completing all study questionnaires. 
Exclusion Criteria:
1) Subject receives a CORI Robotics UKA or TKA 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 
or TKA (e.g. stems, augments, or custom made devices). 
2) Subject has been diagnosed with post-traumatic arthritis
3) Subject receives bilateral UKA or TKA. 
4) Subject does not understand the language used in the 
Informed Consent Form. 
5) Subject does not meet the indication or is contraindicated for 
UKA or TKA according to specific Smith+Nephew knee 
 
6) Subject has active infection or sepsis (treated or untreated). 
7) Subject is morbidly obese with a body mass index (BMI) 
greater than 40. 
8) Subject is pregnant or breast feeding at the time of surgery.
9) 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. 
10) Subject has a condition(s) that may interfere with the TKA or 
vascular insufficiency, muscular atrophy, uncontrolled 
diabetes, moderate to severe renal insufficiency or 
neuromuscular disease, or an active, local infection). 
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. 
12) Subject, in the opinion of the Investigator, has a 
neuromuscular disorder that prohibited control of the index 
joint 
13) Subject is a prisoner or meets the definition of a Vulnerable 
Subject per ISO 14155 Section 3.55. 
Study Duration:
Estimated total study timeline: 36 months (Enrolment period: 24 
months, Follow-up period: 12 months)  
Primary endpoint:
The evaluation of the proportion of subjects achieving post-operative 
leg alignment at 6 weeks post-surgery. Achieved leg alignment is 
 
Secondary endpoint(s):
 
Component Alignment 6 weeks post-surgery
 
Radiographic assessment (Presence of radiolucent lines, 
osteolysis & implant migration) 12 months post-surgery

 
Clinical Protocol  
Study Number: CORI.2019.07
A Prospective, Multi-center, Study to Evaluate the Safety and 
knee arthroplasty (UKA) and total knee arthroplasty (TKA) 
procedures  
Version: 6.0, 15/Jan/2024
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2011 Knee Society Score (KSS) at baseline, 6 weeks, 6 and 12 
month post-surgery 
 
Oxford Knee Score (OKS) at baseline, 6 weeks, 6 and 12 
month post-surgery 
 
Forgotten Joint Score (FJS) at 6 weeks, 6 and 12 month post-
surgery 
 
Five-level EuroQol five-dimensional (EQ-5D-5L) VAS and index 
scores at baseline, 6 weeks, 6 and 12 month post-surgery
Other exploratory 
endpoint(s): 
 
Leg alignment pre- and post-cementation
 
Robotics Case Report generated by the CORI Robotics 
Software. 
 
CORI Robotics Case Report, generated by the CORI Robotics 
Software. 
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. 
(Including hardware and instrumentation), complications, and 
revisions.  
STUDY SCHEDULE  
Visit Type
Time point
Pre-Operative
-90 to 0 days
Operative Data & Discharge
Day 0 (+ up to 9 days)
6-Week Follow-Up
Day 42 ± 14

 
Clinical Protocol  
Study Number: CORI.2019.07
A Prospective, Multi-center, Study to Evaluate the Safety and 
knee arthroplasty (UKA) and total knee arthroplasty (TKA) 
procedures  
Version: 6.0, 15/Jan/2024
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6-Month Follow-Up*
Day 185 ± 14
12-Month Follow-Up
Day 365 ± 30
* The 6 month visit may be conducted remotely  
 

Clinical Protocol 
Study Number: CORI.2019.07
A Prospective, Multi-center, Study to Evaluate the Safety and 
knee arthroplasty (UKA) and total knee arthroplasty (TKA) 
procedures
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CONTENTS 
3.1Table of Contents
1 SIGNATURES ............................................................................................................... 2
1.1
Principal Investigator Signature Page.............................................................2
1.2
Coordinating Investigator Approval................................................................3
1.3
Sponsor Approval........................................................................................4
SYNOPSIS ................................................................................................................ 5
CONTENTS ..............................................................................................................10
3.1
Table of Contents...................................................................................... 10
3.2
List of Tables ............................................................................................ 12
3.3
List of Figures........................................................................................... 13
3.4
List of Abbreviations/Acronyms and Definitions ............................................. 14
INTRODUCTION .......................................................................................................16
4.1
Background .............................................................................................. 16
4.2
Literature Summary .................................................................................. 18
4.3
Study Purpose .......................................................................................... 21
4.4
Safety Considerations ................................................................................ 21
OBJECTIVE(S)..........................................................................................................24
5.1
Primary Objective...................................................................................... 24
5.2
Secondary Objective(s).............................................................................. 24
5.3
Other Objective(s)..................................................................................... 24
5.4
Claims ..................................................................................................... 24
INVESTIGATIONAL PRODUCT(S) ................................................................................24
6.1
Identification ............................................................................................ 24
6.2
Product Use.............................................................................................. 29
6.3
Packaging and Labelling............................................................................. 30
6.4
Product Accountability Procedures ............................................................... 30
6.5
Surgical Technique .................................................................................... 31
SUBJECT ENROLLMENT AND WITHDRAWAL .................................................................31
7.1
Subject Population .................................................................................... 31
7.2
Inclusion Criteria....................................................................................... 33
7.3
Exclusion Criteria ...................................................................................... 34
7.4
Screening................................................................................................. 34
7.5
Informed Consent ..................................................................................... 35

Clinical Protocol 
Study Number: CORI.2019.07
A Prospective, Multi-center, Study to Evaluate the Safety and 
knee arthroplasty (UKA) and total knee arthroplasty (TKA) 
procedures
Version: 6.0, 15/Jan/2024
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7.6
Enrollment ............................................................................................... 36
7.7
Lost to Follow-up ...................................................................................... 36
7.8
Withdrawal............................................................................................... 36
7.9
Subject Reimbursement and Incentives ....................................................... 37
STUDY DESIGN ........................................................................................................38
8.1
Study Design............................................................................................ 38
8.2
Data Management..................................................................................... 39
8.3
Study Endpoints........................................................................................ 40
8.4
Methods Used to Minimize Bias and Maximize Validity.................................... 42
STUDY PROCEDURES ................................................................................................42
9.1
Visits and Examinations ............................................................................. 42
9.2
Study Methods and Measurements .............................................................. 48
9.3
Health Economics/Quality of Life ................................................................. 54
STATISTICAL DESIGN ...............................................................................................54
10.1
General.................................................................................................... 54
10.2
Analysis Populations .................................................................................. 55
10.3
Baseline Data ........................................................................................... 55
10.4
Efficacy Analysis ....................................................................................... 56
10.5
Safety Analyses ........................................................................................ 59
10.6
Interim Analyses....................................................................................... 59
SAMPLE SIZE JUSTIFICATION ....................................................................................59
ADVERSE EVENTS AND DEVICE DEFICIENCIES ............................................................60
12.1
Definitions................................................................................................ 60
12.2
AE Coding Dictionary ................................................................................. 66
12.3
Reporting procedures ................................................................................ 66
12.4
Unblinding of Investigational Product ........................................................... 68
12.5
Follow-up of Subjects with Adverse Events ................................................... 68
INVESTIGATOR OBLIGATIONS ...................................................................................69
SPONSOR AND MONITOR RESPONSIBILITIES ..............................................................69
14.1
Site Qualification Visit................................................................................ 69
14.2
Site Initiation Visit..................................................................................... 70
14.3
Interim Monitoring Visit ............................................................................. 70
14.4
Close-Out Visit.......................................................................................... 70
14.5
Sponsor Audits and Regulatory Inspection.................................................... 70
PROTOCOL DEVIATIONS............................................................................................70

Clinical Protocol 
Study Number: CORI.2019.07
A Prospective, Multi-center, Study to Evaluate the Safety and 
knee arthroplasty (UKA) and total knee arthroplasty (TKA) 
procedures
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PROTOCOL AMENDMENTS .........................................................................................71
CONFIDENTIALITY OF THE STUDY ..............................................................................71
STATEMENTS OF COMPLIANCE...................................................................................71
END OF STUDY.........................................................................................................72
PUBLICATION POLICY ...............................................................................................73
20.1
Publication of Study Data ........................................................................... 73
20.2
Data Sharing ............................................................................................ 73
REFERENCES ...........................................................................................................73
APPENDICES............................................................................................................77
22.1
Protocol Amendment ................................................................................. 77
22.2
List of Instructions for Use & User Manuals................................................. 108
22.3
Equipment and Special Instructions ........................................................... 109
22.4
Health Economic Outcome Measures/Quality of Life measures ...................... 116
22.5
Clinical Study Sites.................................................................................. 116
22.6
Contract Research Organization ................................................................ 116
22.7
Principal Investigator Obligations (ISO 14155)............................................ 116
3.2List of Tables
TABLE 4-1 DEMOGRAPHIC INFORMATION FOR THE ROBOTIC KNEE SURGICAL SYSTEMS........19
TABLE 6-1 S+N IMPLANT SYSTEMS AVAILABLE WITH CORI ROBOTICS.................................25
TABLE 8-1 OVERVIEW OF STUDY GROUPS ........................................................................38
TABLE 9-1: STUDY PROCEDURES BY VISIT .......................................................................43
TABLE 9-2 KNEE SOCIETY SCORE 2011 ............................................................................52
TABLE 12.1-1: CATEGORIES OF ADVERSE EVENT ..............................................................60
TABLE 12.1-2 POTENTIAL ANTICIPATED SERIOUS ADVERSE DEVICE EFFECTS (ASADE) .........63
TABLE 22-1: CORI COMPONENTS...................................................................................109
TABLE 22-2: CORI ROBOTICS CART ...............................................................................109
TABLE 22-3: CORI ROBOTICS MONITOR .........................................................................109
TABLE 22-4: CORI ROBOTICS TRAY AND INSTRUMENTATION............................................109
TABLE 22-5: CORI ROBOTICS SHIPPING INSERTS ...........................................................110
TABLE 22-6: CORI ROBOTICS LIDS................................................................................110
TABLE 22-7: CORI ROBOTICS INSTRUMENT REDUCTION MODULES - KITS .........................111
TABLE 22-8: CORI ROBOTICS JOURNEY II UK INSERTS ....................................................111
TABLE 22-9: CORI ROBOTICS JOURNEY II INSTRUMENT REDUCTION INSERTS ...................112

 
Clinical Protocol  
Study Number: CORI.2019.07
A Prospective, Multi-center, Study to Evaluate the Safety and 
knee arthroplasty (UKA) and total knee arthroplasty (TKA) 
procedures  
Version: 6.0, 15/Jan/2024
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TABLE 22-10: TOTAL KNEE INSTRUMENTS ......................................................................112 
TABLE 22-11: CORI ROBOTICS DISPOSABLES .................................................................113 
TABLE 22-12: CORI ROBOTICS COUNTRY BUNDLES .........................................................113 
TABLE 22-13: CORI ROBOTICS WELCOME BOX ................................................................114 
TABLE 22-14: CORI ROBOTICS PRODUCT DOCUMENTS / OTHER .......................................115 
TABLE 22-15: CORI ROBOTICS POWER CORDS ................................................................115 
 
 
 
3.3 List of Figures 
FIGURE 6-1 CORI ROBOTICS ...........................................................................................26 
FIGURE 6-2 CORI ROBOTIC SYSTEM REUSABLE INSTRUMENTS ...........................................27 
FIGURE 8-1 STUDY FLOWCHART ......................................................................................39 
FIGURE 9-1 LEG ALIGNMENT ...........................................................................................49 
FIGURE 9-2 A/P VIEW .....................................................................................................50 
FIGURE 12.3-12-1: EVALUATION AND REPORTING OF AE ...................................................67 
FIGURE 12-2: EVALUATION AND REPORTING OF DD ..........................................................68 
 
 
 

 
Clinical Protocol  
Study Number: CORI.2019.07
A Prospective, Multi-center, Study to Evaluate the Safety and 
knee arthroplasty (UKA) and total knee arthroplasty (TKA) 
procedures  
Version: 6.0, 15/Jan/2024
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3.4 List of Abbreviations/Acronyms and Definitions
Abbreviation/Acronym Definition
ADE
Adverse Device Effect(s)
AE
Adverse Event(s)
ACL
Anterior Cruciate Ligament
A/P
Antero-posterior
AVN
Avascular Necrosis
CAS
Computer-assisted navigation systems
CE
Conformité Européene 
CI
Confidence Interval
CORI Robotics
eCRF
Electronic Case Report Form(s)
CRO
Contract Research Organization
CTA
Clinical Trial Agreement
CV
Curriculum Vitae
DD
Device Deficiency(ies)
FAS
Full Analysis Set Population
FDA
Food and Drug Administration
FJS
Forgotten Joint Score
FU
Follow-Up
GCP
Good Clinical Practice
GDPR
EU Global Data Protection Regulation
HIPAA
Health Information Portability Accountability Act
HRQoL
Health Related Quality of Life
ICH
International Conference on Harmonisation 
IEC
Independent Ethics Committee
IFU
Instructions for Use
IP
Investigational Product 
IRB
Institutional Review Board
ISF
Investigator Site File
ITT
Intention to Treat population
KSS
Knee Society Score

 
Clinical Protocol  
Study Number: CORI.2019.07
A Prospective, Multi-center, Study to Evaluate the Safety and 
knee arthroplasty (UKA) and total knee arthroplasty (TKA) 
procedures  
Version: 6.0, 15/Jan/2024
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L
Lateral 
LCL
Lateral Collateral Ligament
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 
NMPA
National Medical Products Administration
OA
Osteoarthritis 
OKS
Oxford Knee Score
OR
Operating room
PCL
Posterior Cruciate Ligament
PI
Principal Investigator
PMA
Pre-Market Authorization
PP
Per-protocol Population
PSI
Patient specific instrumentation
RA
Rheumatoid Arthritis 
RCT
Randomized Controlled Trial
S+N
insert sponsor as per front page
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.2019.07
A Prospective, Multi-center, Study to Evaluate the Safety and 
knee arthroplasty (UKA) and total knee arthroplasty (TKA) 
procedures
Version: 6.0, 15/Jan/2024
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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, not walking on the 
affected leg. 
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 available 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].

 
Clinical Protocol  
Study Number: CORI.2019.07
A Prospective, Multi-center, Study to Evaluate the Safety and 
knee arthroplasty (UKA) and total knee arthroplasty (TKA) 
procedures  
Version: 6.0, 15/Jan/2024
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Unicondylar knee arthroplasty (UKA) is another conservative 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 the United States, it is estimated that 600,000 primary TKAs and 45,000 primary UKAs are 
performed each year, and the amount of procedures is expected to annually increase by 10% 
[18, 19]. The escalating prevalence of end-stage OA places an increased burden on healthcare 
providers, especially on less experienced surgeons and facilities that perform low numbers of 
arthroplasties [20, 21]. 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) [21, 22]. 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 [23]. 
Malalignment of components in any anatomical plane can cause major complications including 
aseptic loosening, instability, poor function, polyethylene wear, and pain [23-25]. Additionally, 
implant malposition and malalignment of the joint can result in failure of the prosthesis [26]. 
When not aligned wit
outcomes, decreased implant survivorship, increased wear, and early failure from component 
loosening may occur [27].  
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 [28].  
For partial knee procedures, approximately 30-60% of UKAs have been reported to be 
malaligned using conventional manual instruments [29]. The importance of alignment can be 
demonstrated by observing higher revision rates of UKA attributed to malposition or 
malalignment of partial knees [29, 30] while roughly 25% of TKAs have been revised for 
instability or malalignment [31]. 
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 [32]. Kinematic alignment restores the obliquity and level of the joint line 
anatomically so the femoral component is slightly more valgus (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 the CORI Robotics. 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 robotic systems to conventional instruments have demonstrated that robotic 
platforms produce fewer positioning errors in both UKA and TKA [33-35]. When used in medial 
or lateral UKA procedures, robotics reported short learning curves, increased accuracy in 

 
Clinical Protocol  
Study Number: CORI.2019.07
A Prospective, Multi-center, Study to Evaluate the Safety and 
knee arthroplasty (UKA) and total knee arthroplasty (TKA) 
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posterior tibial slope, and coronal tibial alignment in comparison to other alignment methods 
[36-38]. 
A summary of known and potential risks and benefits to humans of CORI Robotics can be found 
in the Instructions for Use (IFU). 
 
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 
Robotic Knee Surgical Systems.  
Use of the Robotic 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 1. Three (3) 
of the studies solely reported on outcomes of the Robotic Knee Surgical Systems, three (3) 
compared the Robotic Knee Surgical Systems to conventional instruments, and one (1) study 
compared the Robotic Knee Surgical Systems to conventional instruments, patient specific 
instrumentation (PSI), and computer-assisted navigation (CAS) systems. All of the studies were 
eported outcomes for UKA. The data provided in these 
publications is also applicable to the equivalent CORI Robotics. 
 
 

 
Clinical Protocol  
Study Number: CORI.2019.07
A Prospective, Multi-center, Study to Evaluate the Safety and 
knee arthroplasty (UKA) and total knee arthroplasty (TKA) 
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Table 4-1 Demographic Information for the Robotic Knee Surgical Systems 
Primary 
Author 
Year 
Robotic 
System 
Indication
Joints 
(n) 
Male 
(%) 
Age, 
mean±SD 
(range) 
Follow-up, 
mean±SD
Batailler 
[39] 
2019 
NAVIO1 
UKA 
80 
33.8 
69 ± 9.6 
(49-87) 
1.64 ± 
0.75 years
Battenberg 
[40] 
2019 
NAVIO1 
UKA 
128 
57.8 
64.7 ± 9.6 
(45-92) 
2.3 years 
Canetti [41] 
2018 
NAVIO1 
UKA 
11 
18.0 
66.5 ± 6.8 
(57-79) 
2.87 ± 
0.88 years
Gregori [42] 
2016 
NAVIO1 
UKA 
92 
- 
- 
Periop 
Herry [43] 
2017 
NAVIO1 
UKA 
40 
32.5 
69 ± 9.6 
(49-87) 
Periop 
Vega Parra 
[44] 
2017 
NAVIO1 
UKA 
47 
51.0 
67 
(45-77) 
1 years 
Sephton 
[45] 
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 
 
4.2.1 
Demographic Information 
A total of 414 joints were reported in the reviewed literature. Herry et al.[43] and Canetti et 
al.[41] likely shared the same patient population as Batailler et al.[39] 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 Robotic 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 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 Robotic Knee Surgical Systems 
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), University of 
California, Los Angeles (UCLA) activity scale, Knee injury and Osteoarthritis Outcome Score 
(KOOS) and Knee Society Function Score (KSFS) being reported. 

 
Clinical Protocol  
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A Prospective, Multi-center, Study to Evaluate the Safety and 
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KSS, KSFS, and satisfaction rates were the most commonly employed outcome measures, being 
reported by both Batailler et al.[39] and Canetti et al.[41].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.  
Surgical System 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.[41] observed a statistically significant increase in KSS and 
quick
observed in the larger cohort of Batailler et al.[39], the observed difference may be due to the 
smaller sample size. The percentage of patients returning to sports, UCLA, Lysholm scale, and 
FJS were not statistically significant between the two cohorts.  
Overall, patients undergoing knee procedures with the Robotic Knee Surgical Systems showed 
improved KSS, KSFS, KOOS, and UCLA scores compared to pre-operative values. 
4.2.3 
Mechanical alignment Accuracy 
The Robotic 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 Robotic 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 [39, 42, 43]. 
The reviewed publications indicate that the Robotic 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% [39]. 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 
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 
medial and lateral UKA, the tibial slope for medial UKA, and the coronal tibial angle. In addition, 
the joint line was significantly less distalized wh
 
Using the Robotic 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 distalized compared to when conventional 
instrumentation was utilized. 

 
Clinical Protocol  
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A Prospective, Multi-center, Study to Evaluate the Safety and 
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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 Robotic 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.[39] 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 Robotic 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 Robotic 
Knee Surgical Systems showed improved outcomes scores compared to pre-operative values. 
The clinical outcomes, alignment accuracy, and adverse events for the Robotic Knee Surgical 
Systems reported in the literature are similar to those reported for comparable devices.  
4.3 Study Purpose 
This is a prospective, multi-center study to demonstrate the safety and effectiveness of the 
CORI Robotics to meet the post-market clinical follow-up requirement in Europe, UK, India and 
the US. This is a post-market study in all countries involved.  In addition, the study may support 
regulatory approval by the National Medical Products Administration (NMPA) in China.
Study hypotheses are that the CORI surgical system will achieve post-operative leg alignment 
(± 3°), and an improvement in patient-reported outcome measures.  This primary endpoint is 
aligned to the primary study objective of evaluating the CORI surgical system for UKA and TKA 
procedures in achieving post-operative leg alignment.  Accuracy and alignment are two key 
variables in successful UKA and TKA procedures. These measures have been previously 
evaluated with the predicate NAVIO surgical system. The primary endpoint will support the 
continued evaluation of these variables for the CORI surgical system.  
4.4 Safety Considerations 
Representative language of the indications of use, contraindications and potential adverse 
effects of CORI Robotics can be found in the IFU. 
4.4.1 
Intended Use 
CORI Robotics is intended to assist the surgeon in providing software-defined spatial boundaries 
for orientation and reference information to anatomical structures during orthopedic procedures. 

 
Clinical Protocol  
Study Number: CORI.2019.07
A Prospective, Multi-center, Study to Evaluate the Safety and 
knee arthroplasty (UKA) and total knee arthroplasty (TKA) 
procedures  
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4.4.2 
Indications 
CORI Robotics 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 Robotics is indicated for use with cemented implants only. 
4.4.3 
Contraindications 
CORI Robotics 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 
Warnings and Precautions 
Knee Arthroplasty) states the following warnings and cautions: 
CORI Robotics is a surgical tool designed to provide assistance to the surgeon; it is not a 
planning and the conduct of the surgery during which CORI Robotics is being used. 
CORI Robotics 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 Smith & Nephew. 
Use of equipment not specifically designated in this manual as compatible with CORI 
Robotics 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 Robotics is not serviced properly. 
To avoid risk of electrical shock, only connect the CORI Robotics Cart to a supply main 
with protective earth. 
Modification of CORI Robotics 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 Robotics 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.2019.07
A Prospective, Multi-center, Study to Evaluate the Safety and 
knee arthroplasty (UKA) and total knee arthroplasty (TKA) 
procedures  
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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. 
 
4.4.5 
Environments of Use 
CORI Robotics is intended to be used by trained medical professionals in a hospital or clinical 
setting equivalent to an orthopedic surgery suite. The CORI Robotics Instruments will be used in 
a sterile environment and must be sterilized prior to use.  
4.4.6 
Anticipated Risks / 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.  
As this is a post-market study and the device is used according to the IFU, the use of CORI 
Robotics in this study introduces no additional potential risks to the study participant.
4.4.7 
Safety Data Collection 
All adverse device effects or device deficiencies will be categorised and reported as instructed in 
Section 12, Adverse Events and Device Deficiencies. During causality assessment activity 
(assessment of Related vs Unrelated) and expectancy assessment (assessment of Unanticipated 
vs Anticipated) clinical judgement shall be used and relevant documents, such as the IFU shall 
be consulted, as foreseeable serious adverse events and the potential risks are summarized 
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. 
 

Clinical Protocol 
Study Number: CORI.2019.07
A Prospective, Multi-center, Study to Evaluate the Safety and 
knee arthroplasty (UKA) and total knee arthroplasty (TKA) 
procedures
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OBJECTIVE(S)
To evaluate the safety and e
procedures.
5.1 Primary Objective
The primary objective of this study is to evaluate the use of CORI Robotics in UKA and TKA 
procedures in achieving post-operative leg alignment.
5.2 Secondary Objective(s)
The secondary objective of this study is to assess the safety and performance of the CORI 
Robotics up to 12 months after surgery.
5.3 Other Objective(s)
Other objectives are to determine the Robotics System time and cutting time of the robotic drill 
of UKA and TKA procedures with the CORI Robotics.
5.4 Claims
No claims to be confirmed by this investigation.
INVESTIGATIONAL PRODUCT(S)
6.1Identification
6.1.1
Investigational Product
The CORI Robotics 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.
For the purposes of this study, the CORI Robotics is currently available for the use of the 
following S+N implant Systems:

 
Clinical Protocol  
Study Number: CORI.2019.07
A Prospective, Multi-center, Study to Evaluate the Safety and 
knee arthroplasty (UKA) and total knee arthroplasty (TKA) 
procedures  
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Table 6-1 S+N Implant Systems available with CORI Robotics 
Implant System 
Manufacturer 
Region 
Journey II Unicompartmental Knee 
System 
Smith+Nephew
India, Germany, United Kingdom, 
USA 
Journey Uni 
Smith+Nephew
India, Germany, United Kingdom, 
USA 
STRIDE Unicondylar Knee System* 
Smith+Nephew
USA 
ZUK Select Knee System* 
Smith+Nephew
USA 
JOURNEY II Total Knee Systems 
Smith+Nephew
India, Germany, United Kingdom, 
USA 
LEGION Hinge Knee System 
Smith+Nephew
India, Germany, United Kingdom, 
USA 
GENESIS II Total Knee System 
Smith+Nephew
India, Germany, United Kingdom, 
USA 
ANTHEM Total Knee System 
Smith+Nephew
India, Germany, United Kingdom, 
USA 
*Only available in the USA.  
The CORI Robotics 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). The CORI Robotics 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. 
The CORI Robotics 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 
target surface of the bone. The CORI Robotics 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, the CORI Robotics 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. 

 
Clinical Protocol  
Study Number: CORI.2019.07
A Prospective, Multi-center, Study to Evaluate the Safety and 
knee arthroplasty (UKA) and total knee arthroplasty (TKA) 
procedures  
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The surgeon can disable both controls and operate the CORI robotic drill as a standard 
navigated surgical drill. 
Figure 6-1 CORI Robotics 
 
Instrument Tray 
 
 
Console: It houses the robotic drill tool control, power management, video and audio 
distribution, central processing unit, and irrigation pump/control. 
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 UKA and 
for 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. 
The CORI Robotics also includes specific reusable instruments as shown in Figure 6-2. 
 
Display Monitor 
Optical Tracking 
Camera  
Console
Foot Pedal 
Cart 
Tablet 

Clinical Protocol 
Study Number: CORI.2019.07
A Prospective, Multi-center, Study to Evaluate the Safety and 
knee arthroplasty (UKA) and total knee arthroplasty (TKA) 
procedures
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Figure 6-2 CORI Robotic System Reusable Instruments
  
Point Probe
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 5 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.
A full list of the components of the CORI Robotics can be found in Section 22.3 Equipment and 
Special Instructions. 
The CORI Robotics, as well as the single use components, are manufactured by Smith+Nephew, 
Blue Belt Technologies, 2905 Northwest Blvd. Suite 40, Plymouth, MN 55441, USA 
The indications of the compatible S+N Knee Implant Systems can be found below.
Journey Uni & Journey II Uni - Unicompartmental Knee Systems
Unicompartmental knee implants are indicated for restoring either compartment of a knee that 
has been affected by the following:
Noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, 
or avascular necrosis;
Correction of functional deformity;
Revision procedures where other treatments or devices have failed; and
Treatment of fractures that are unmanageable using other techniques.
Unicompartmental knee implants are single use only and are intended for implantation 
only with bone cement. HA coated unicompartmental knee implants are available outside 
the US for use without bone cement.

 
Clinical Protocol  
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A Prospective, Multi-center, Study to Evaluate the Safety and 
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procedures  
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ZUK Unicompartmental Knee 
The ZUK system is designed for the surface reconstruction of individual femoral/tibial condyles. 
Use of this device does not preclude subsequent reconstructive surgery with a stabilizing type 
device or a total knee replacement. 
Indications for Use of the ZUK Unicompartmental Knee are listed below: 
This device is indicated for patients with:  
Painful and/or disabling knee joints due to osteoarthritis or traumatic arthritis. 
Previous tibial condyle or plateau fractures with loss of anatomy or function 
Varus or valgus deformities.  
Revision of previous arthroplasty procedures.  
This device is indicated for cemented use only.  
The ZUK Unicompartmental Knee System is designed for use when load bearing ROM is 
expected to be less than or equal to 155 degrees. 
 
STRIDE Unicondylar Knee System  
The STRIDE Unicondylar Knee System is a unicompartmental prosthetic implant that resurfaces 
one femoral condyle and one side of the tibial plateau. The femoral component is made of cobalt 
chrome and the tibial component is composed of a titanium tibial tray with a ultra-high 
molecular weight polyethylene insert that snaps into place. The device is non-constrained; the 
articulating surface of the lntra-high molecular weight polyethylene insert is flat and joint 
stability is maintained by ligaments and other soft tissue surrounding the knee. 
The STRIDE Unicondylar Knee Systems are indicated for patients with: 
Painful and/or disabling knee joints due to osteoarthritis or traumatic arthritis. 
Previous tibial condyle or plateau fractures with loss of anatomy or function. 
Varus or valgus deformities. 
Revision of previous arthroplasty procedures. 
These devices are indicated for cemented use only. 
Smith+Nephew Total Knee Replacement Systems:  JOURNEY II Knee Systems, LEGION 
Hinge Knee System, and GENESIS II Total Knee System 
Smith & Nephew Knee Systems consist of femoral components, tibial components, patellar 
components, and accessories.  Femoral components are manufactured from cobalt chromium 
mponents are manufactured 
from ultra-high molecular weight polyethylene (UHMWPE) or cross-linked polyethylene (XLPE). 
Tibial bases are manufactured from titanium 6Al-4V alloy, or cobalt chromium (CoCr) alloy, or 
ultra-high molecular weight polyethylene (UHMWPE) (for all poly tibial bases). The component 
material for implantable devices is provided on the outside carton label. 
 

 
Clinical Protocol  
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A Prospective, Multi-center, Study to Evaluate the Safety and 
knee arthroplasty (UKA) and total knee arthroplasty (TKA) 
procedures  
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Smith+Nephew Total Knee Replacement Systems are indicated for patients with: 
Rheumatoid arthritis. 
Post-traumatic arthritis, osteoarthritis, or degenerative arthritis. 
Failed osteotomies, unicompartmental replacement, or total knee replacement.
Posterior stabilized knee systems are designed for use in patients in primary and revision 
surgery, where the anterior and posterior cruciate ligaments are incompetent and the 
collateral ligaments remain intact. 
Constrained knee systems are designed for use in patients in primary and revision 
surgery, where the posterior cruciate ligament and one or both of the collateral ligaments 
(i.e. medial collateral and/or lateral collateral ligament) are incompetent. 
Hinge knee systems are designed for use in patients in primary and revision surgery, 
where the posterior cruciate ligament and one or both of the collateral ligaments (i.e. 
medial collateral and/or lateral collateral ligament) are absent or incompetent.
ANTHEM Total Knee System 
The Smith & Nephew ANTHEM Total Knee System consists of femoral components and tibial 
components. Both the femoral and tibial components are to be used with bone cement. 
Anthem Total Knee System is indicated for patients with: 
Rheumatoid arthritis. 
Post-traumatic arthritis, osteoarthritis, or degenerative arthritis. 
Failed osteotomies, unicompartmental replacement, or total knee replacement.
Posterior stabilized knee systems are designed for use in patients in primary and revision 
surgery, where the anterior and posterior cruciate ligaments are incompetent and the 
collateral ligaments remain intact. 
For this study only the CORI Robotics is considered the IP and not the implant systems used.
All surgeons using CORI Robotics will have previously been fully trained on the use of the 
system by S+N staff.  
6.1.2 
Comparator Treatment
 
No comparator products are used. 
6.1.3 
Ancillary Product 
No ancillary products are to be provided for this study.  
6.2 Product Use 
Knee Arthroplasty). The purpose of this user manual is to serve as the master reference 

 
Clinical Protocol  
Study Number: CORI.2019.07
A Prospective, Multi-center, Study to Evaluate the Safety and 
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procedures  
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document for properly trained users in the function and operation of CORI Robotics 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: 
 
IFU REAL 
 
 
 
The list of reference documents can be found in Appendix 22.2 List of Instructions For Use & 
User Manuals. 
ites that are familiar with 
the use of CORI Robotics / Robotic-assisted surgery systems will be selected so no additional 
training is required. 
 
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 Robotics System as well as the Smith+Nephew Knee 
Implant Systems are commercial products in Europe, UK, India and the United States and are 
being used as approved. Labeling is done as per the standard commercial packaging. No 
additional labelling will take place. 
6.4 Product Accountability Procedures 
This study is a post-market study in Europe, UK, India, and the United States. However, the 
sponsor may provide the study sites with the CORI Robotics System (Console, Optical Tracking 
Camera, Foot Pedal, Tablet, Display Monitor, Cart, CORI Instrument Trays UKA & TKA) 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 Robotics supplied to study sites.  
In instances where CORI Robotics is supplied to site, the investigational site will maintain an 
inventory of the IP . 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. 

Clinical Protocol 
Study Number: CORI.2019.07
A Prospective, Multi-center, Study to Evaluate the Safety and 
knee arthroplasty (UKA) and total knee arthroplasty (TKA) 
procedures
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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.
No product accountability procedures will be applied for the S+N Knee Implant Systems as these 
are commercially available products. Nevertheless, the S+N Knee Implant System as well as the 
individual component reference and lot numbers (femoral component, tibial baseplate and 
insert) will be recorded in the eCRF.
Overall accountability for the use of the product is the responsibility of the Investigator or 
designated individual.
Following completion of enrolment all supplied CORI Robotics systems will be returned to S+N.
For details on the CORI Robotics System and reusable instrumentation please refer to Section 
6.1.1 Investigational Product.
6.5 Surgical Technique
All study related procedures with the CORI Robotics must be performed according to the user 
manual (Document ID: 500230 CORI Robotics for Knee Arthroplasty) and according to the 
according to the surgical technique and IFU of the specific Smith+Nephew Implant System.
IFU Smith+Nephew Knee Systems (Document ID: 81090287)
IFU ZUK (Document ID: 81093274)
IFU STRIDE (Document ID: 50030)
IFU ANTHEM Total Knee System (Document ID: 81105696)
Surgeons selected to participate in this study will be familiar with the CORI Robotics and have 
written evidence of training and expertise in the study procedure. If deemed necessary, pre-
study cases shall be performed until the surgeon feels comfortable with the system in order to 
prevent any learning curve during the study. The number of pre-study cases depends on the 
level of the individual experience of the surgeon. Anonymized CORI Robotics Case Reports will 
be collected for these pre-study cases as proof of experience. If no pre-study cases are 
completed the case log of the first study case will be collected and analysed as soon as possible 
following the surgery to ensure the additional data required for the study has been collected.
SUBJECT ENROLLMENT AND WITHDRAWAL
7.1Subject Population
A total of 80 subjects will be enrolled in the study in up to 8 sites in Europe, UK, India and the 
United States.
40 subjects will be enrolled for UKA with the use of the CORI Robotics 
40 subjects will be enrolled for primary TKA with the use of the CORI Robotics

 
Clinical Protocol  
Study Number: CORI.2019.07
A Prospective, Multi-center, Study to Evaluate the Safety and 
knee arthroplasty (UKA) and total knee arthroplasty (TKA) 
procedures  
Version: 6.0, 15/Jan/2024
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For those subjects, the clinician has decided that the best treatment for the subject is a UKA or 
TKA facilitated with robotic assisted surgery as a routine medical care. This decision will be 
made irrespectively of study participation.  
The subject will then consent to the study specific treatment with the CORI Robotics System. In 
case of non-participation, the patient can still receive a robotic assisted UKA or TKA with CORI 
Robotics or 
It is expected that all 
subjects will be enrolled within 24 months. 
Eligibility criteria are specified to ensure that the subject population of the study represents the 
target population of the IP. 
 
7.1.1 
Vulnerable subjects 
No vulnerable subjects will be included in the study. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
Clinical Protocol  
Study Number: CORI.2019.07
A Prospective, Multi-center, Study to Evaluate the Safety and 
knee arthroplasty (UKA) and total knee arthroplasty (TKA) 
procedures  
Version: 6.0, 15/Jan/2024
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7.2 Inclusion Criteria 
Subjects will be considered qualified for enrollment if they meet the following criteria:
1.
UKA or TKA and the subject has agreed to the treatment. 
2.
Subject requires a cemented UKA or TKA as a primary indication that meets either criterion 
A or B. 
A. Subject requires a cemented UKA as a primary indication due to any of the following 
conditions: 
1. Non-inflammatory degenerative joint disease, including osteoarthritis
2. Avascular necrosis 
3. Requires correction of functional deformity 
4. Requires treatment of fractures that were unmanageable using other 
techniques 
B. Subject requires a cemented TKA as a primary indication due to any of the following 
condition:  
1. Degenerative joint disease, including osteoarthritis  
2. Rheumatoid arthritis 
3. Avascular necrosis 
4. Requires correction of functional deformity 
5. Requires treatment of fractures that were unmanageable using other 
techniques 
3.
Subject is of legal 
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 Ethical 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.
Routine radiographic assessment is possible.
7.
Subject able to follow instructions and deemed capable of completing all study 
questionnaires. 

 
Clinical Protocol  
Study Number: CORI.2019.07
A Prospective, Multi-center, Study to Evaluate the Safety and 
knee arthroplasty (UKA) and total knee arthroplasty (TKA) 
procedures  
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7.3 Exclusion Criteria 
Any one (1) of the following criteria will disqualify a potential subject from participation in the 
study: 
1.
Subject receives a CORI Robotics UKA or TKA 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 or TKA (e.g. stems, augments, or custom made devices). 
2.
Subject has been diagnosed with post-traumatic arthritis.
3.
Subject receives bilateral UKA or TKA.
4.
Subject does not understand the language used in the Informed Consent Form.
5.
Subject does not meet the indication or is contraindicated for UKA or TKA according to 
 
6.
Subject has active infection or sepsis (treated or untreated).
7.
Subject is morbidly obese with a body mass index (BMI) greater than 40.
8.
Subject is pregnant or breast feeding at the time of surgery.
9.
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. 
10.
Subject has a condition(s) that may interfere with the TKA or UKA survival or outcome 
insufficiency, muscular atrophy, uncontrolled 
diabetes, moderate to severe renal insufficiency or neuromuscular disease, or an active, 
local infection). 
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. 
12.
Subject, in the opinion of the Investigator, has a neuromuscular disorder that prohibited 
control of the index joint. 
13.
Subject is a prisoner or meets the definition of a Vulnerable Subject per ISO 14155 
Section 3.551 
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 
                                       
1 ISO 14155 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 participated, or who could be manipulated or unduly influenced as a result of compromised position, 
expectation of benefits or fear of retaliatory response. 

 
Clinical Protocol  
Study Number: CORI.2019.07
A Prospective, Multi-center, Study to Evaluate the Safety and 
knee arthroplasty (UKA) and total knee arthroplasty (TKA) 
procedures  
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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. 
women of childbearing potential, study sites will determine whether the subject is pregnant 
using their standard clinical practice. 
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. Translations of informed consent 
documents will be available in the participating countries main language(s). 
The subject, or their legally authorized representative, 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 
original filed in the ISF. 
The subject will have sufficient time to consider study participation and ensure all questions 
have been answered this will usually be at least 24 hours unless approved or documented local 
site Informed Consent procedures allow for this to be shorter. There is no required interval 
between the time of consent and the first study procedure being carried out. 
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. 
Due to the nature of completing Patient Reported Outcome during the study the subject must be 
able to provide consent. A Legally Authorized Representative signature is not allowed in this 
study.  
ICFs will comply with the Health Information Portability Accountability Act (HIPAA) regulations 
as well as the EU Global Data Protection Regulation (GDPR) and applicable national regulations 
and laws. 
If new information becomes available during the course of the study that can significantly affect 
a 
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.  

 
Clinical Protocol  
Study Number: CORI.2019.07
A Prospective, Multi-center, Study to Evaluate the Safety and 
knee arthroplasty (UKA) and total knee arthroplasty (TKA) 
procedures  
Version: 6.0, 15/Jan/2024
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7.6 Enrollment 
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 does not return for a final visit, and study personnel is 
unable to contact the subject. 
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 
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 
Subjects withdrawn from having treatment will not be classed as being enrolled (section 7.6).
Subjects withdrawn from having treatment will be replaced and no further follow-up of the 
withdrawn subjects is required for the study. 
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 lost to follow-up (section 7.7) 

 
Clinical Protocol  
Study Number: CORI.2019.07
A Prospective, Multi-center, Study to Evaluate the Safety and 
knee arthroplasty (UKA) and total knee arthroplasty (TKA) 
procedures  
Version: 6.0, 15/Jan/2024
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The Investigator or the Sponsor stop 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 
electronic Case Report Form (eCRF), detailing circumstances leading to the withdrawal.  
Subjects who drop out or are withdrawn will not be re-entered into the study at a later date.  
If at any point during the study, the unicondylar or total knee prosthesis needs to be revised for 
any reason the following will apply: Subjects shall continue to have follow-up visits in order to 
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 
Study 
Study participation is voluntary, and subjects may withdraw at any point during the study 
without giving their reason for doing so. Where subjects withdraw consent, the Investigator 
privacy. The reason for withdrawal will be recorded in the CRF 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.  
7.9 Subject Reimbursement and Incentives  
Subjects will be reimbursed for the costs of taking part in the study in compliance with local 
regulations. These costs will only cover study-specific activities or visits including time, travel,
 
standard clinical care. Payments to the subject will be proportionate to the time and expense 
involved in study participation and not so large as to unduly encourage the subjects to 
participate 
arrangements for reimbursement payments to subjects will be approved by the IRB/IEC and/or 
local site authority as required. 
 

Clinical Protocol 
Study Number: CORI.2019.07
A Prospective, Multi-center, Study to Evaluate the Safety and 
knee arthroplasty (UKA) and total knee arthroplasty (TKA) 
procedures
Version: 6.0, 15/Jan/2024
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STUDY DESIGN
8.1 Study Design
This study is a prospective, multi-center, non-randomized, non-blinded follow-up study to 
evaluate the use of CORI Robotics in UKA and TKA procedures in achieving post-operative leg 
alignment. Up to 8 sites will participate within Europe, UK, India and the US.
Subjects will be enrolled in one of two (2) groups based on medical indication and general 
practice at the site, as shown in Table 8-1. All subjects are treated with knee arthroplasty with 
the use of the CORI Robotics and a Smith+Nephew Knee Implant System based local regulatory 
status and medical indication and general practice at the site (see Table 6-1 S+N Implant 
Systems available with CORI Robotics for this study).
Table 8-1 Overview of Study Groups
Group
Surgical 
Technique
Knee Implant system
Number of 
Subjects
Primary 
UKA
CORI Robotics
Smith+Nephew UKA Implant 
System
40
Primary 
TKA
CORI Robotics
Smith+Nephew TKA Implant 
System
40
The study is expected to enroll all subjects within a 24 month timeframe. Subjects will be 
followed-up for a time period of 12 months after surgery.
This study is being conducted in parallel to 2 randomized-controlled studies
Prospective, Multi-center, randomized-controlled Study to Evaluate the Safety and Effectiveness 
ID: CORI.2019.06) and A Prospective, Multi-center, Randomized Controlled Study to Evaluate 
(TKA) Procedure
(Protocol ID: CORI.2020.08). The study data may be combined for analysis to 
meet the requirements for regulatory approval of the CORI Robotics by the National Medical 
Products Administration (NMPA) in China. Further details are described in Section 10 Statistical 
Design and the Statistical Analysis Plan (SAP).
Figure 8-1 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).

Clinical Protocol 
Study Number: CORI.2019.07
A Prospective, Multi-center, Study to Evaluate the Safety and 
knee arthroplasty (UKA) and total knee arthroplasty (TKA) 
procedures
Version: 6.0, 15/Jan/2024
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Figure 8-1 Study Flowchart
The study design meets the needs of the aforementioned regulatory requirements and has been 
powered based on recent analyses from the NAVIO Surgical System.  This study is designed to 
demonstrate superiority in the proportion of TKAs post-operatively defined as mechanically 
aligned against the reference proportion of 73.4% (53).  The proportion of mechanically aligned 
sis was estimated to be 92.1%
(54). If this assumption holds for this study, then the enrollment of 36 knees for each of the two 
planned study groups (i.e. the CORI Robotics UKA and CORI Robotics TKA) for a total of 72
knees will individually provide approximately 80% power to show that the lower limit of the two-
sided 95% confidence interval for the proportion of mechanically aligned TKAs is greater than 
that obtained from literature. To account for up to a 10% attrition rate in knees enrolled, 40 
knees in each group (80 knees combined, 40 UKA and 40 TKA) will be enrolled in the study.
8.2 Data Management
This study utilizes a validated, 21 CFR Part 11 compliant, electronic data capture system. Access 
to the electronic data capture system is controlled through 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.
8.2.1
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. 

 
Clinical Protocol  
Study Number: CORI.2019.07
A Prospective, Multi-center, Study to Evaluate the Safety and 
knee arthroplasty (UKA) and total knee arthroplasty (TKA) 
procedures  
Version: 6.0, 15/Jan/2024
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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.  
 
8.2.2 
Retention Period 
All eCRFs will be archived once the study is completed and will be 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. 
8.3 Study Endpoints 
8.3.1 
Primary Endpoint 
The primary endpoint of this study is defined as the evaluation of the proportion of subjects 
achieving post-operative leg alignment at 6 weeks post-surgery. Achieved leg alignment is 
 
This primary endpoint is aligned to the primary study objective of evaluating the CORI surgical 
system for UKA and TKA procedures in achieving post-operative leg alignment.  Accuracy and 
alignment are two key variables in successful UKA and TKA procedures. These measures have 
been previously evaluated with the predicate NAVIO surgical system. The primary endpoint will 
support the continued evaluation of these variables for the CORI surgical system. 
8.3.2 
Secondary Endpoints 
The following secondary endpoints have been defined for this study in order to evaluate the 
safety and performance of the CORI Robotics: 
Component Alignment 6 weeks post-surgery 
Radiographic assessment (Presence of radiolucent lines, osteolysis & implant migration) 
12 months post-surgery 
2011 Knee Society Score (KSS) at baseline, 6 weeks, 6 and 12 month post-surgery
Oxford Knee Score (OKS) at baseline, 6 weeks, 6 and 12 month post-surgery
Forgotten Joint Score (FJS) at 6 weeks, 6 and 12 month post-surgery 

 
Clinical Protocol  
Study Number: CORI.2019.07
A Prospective, Multi-center, Study to Evaluate the Safety and 
knee arthroplasty (UKA) and total knee arthroplasty (TKA) 
procedures  
Version: 6.0, 15/Jan/2024
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Five-level EuroQol five-dimensional (EQ-5D-5L) VAS & index scores at baseline, 6 weeks, 
6 and 12 month post-surgery 
Secondary endpoints are aligned to the secondary study objectives of generating safety and 
performance evidence related to the use of the CORI surgical system.  Assessing alignment, 
radiographic image assessment and patient-reported outcome measures (PROMS) are key 
variables in determining the success of UKA and TKA procedures. These endpoints have been 
previously evaluated with the predicate NAVIO surgical system and ongoing assessment of 
these secondary endpoints under this study will support safety and efficacy of these 
procedures performed with the CORI surgical system.  
 
8.3.3 
Other Endpoints 
The following additional endpoints collected during surgery have been defined for this study:
Leg alignment pre- and post-cementation 
generated by the CORI Robotics Software. 
Cutting time of the robotic drill 
generated by the CORI Robotics Software. 
8.3.4 
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 
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. (Including hardware and instrumentation), complications, and 
revisions. 
 

Clinical Protocol 
Study Number: CORI.2019.07
A Prospective, Multi-center, Study to Evaluate the Safety and 
knee arthroplasty (UKA) and total knee arthroplasty (TKA) 
procedures
Version: 6.0, 15/Jan/2024
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8.4 Methods Used to Minimize Bias and Maximize Validity
8.4.1
Multiple sites
Subjects will be enrolled at multiple sites, utilizing up to 8 sites in total for the study. This will 
reduce the effect of observer bias that might arise at any one investigational site as well as 
maximize the diversity of subjects treated.
8.4.2
Prospective Consecutive Enrolment
Consecutive enrollment will be utilized to enroll subjects who meet the inclusion/exclusion 
criteria. 
8.4.3
Subject Attrition 
The required sample size for the study includes adjustment for expected subject attrition.
8.4.4
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 the analysis 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.
STUDY PROCEDURES
9.1Visits and Examinations
9.1.1
Summary
For a summary of the required procedures by visit, refer to the Study Schematic Table 9-1:

 
Clinical Protocol  
Study Number: CORI.2019.07
A Prospective, Multi-center, Study to Evaluate the Safety and 
knee arthroplasty (UKA) and total knee arthroplasty (TKA) 
procedures  
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Table 9-1: Study Procedures by Visit 
Schedule of events 
Pre-
Operative 
Data 
-90 to 0 days 
Operative  
Data & 
Discharge 
Day 0 (+ up to 9 
days) 4 
6 weeks
42 ± 14 days 
6 months5
185 ± 14 days
12 
months
365 ± 30 days
Informed Consent 
X 
 
 
 
 
Inclusion/Exclusion  
X 
 
 
 
 
Demographics/ Medical 
History 
X 
 
 
 
 
Concomitant Medication 
Update 
 
X 
X 
X 
X
Operative Data Collection 
 
X 
 
 
 
Knee Implant Disposition 
 
X 
 
 
 
CORI Robotics Case Report 
(Robotic System time & 
cutting time) 
 
X 
 
 
 
Discharge Data Collection 
 
X 
 
 
 
Leg alignment Long leg X-
ray AP 
X 
(X)1 
X 
 
(X)2
Standard Lateral X-ray 
 
(X)1 
X 
 
X
Standard A/P X-ray 
 
 
 
 
X
KSS 
X 
 
X 
X 
X
OKS 
X 
 
X 
X 
X
FJS
 
 
X 
X 
X
EQ-5D-5L 
X 
 
X 
X 
X
Safety Assessment 
 
X 
X 
X 
X
End of Study/Exit   
 
 
(X)3 
(X)3 
(X)3
1 Post-operative standing weight bearing long leg X-rays (A/P & L) may be taken at discharge if standard of care. 
2 Only if standing weight bearing long leg A/P X-ray is taken as a standard of care at 12 months. 
3 Exit form to be completed at the point of withdrawal if the study is not completed. 
4 If any Pre-Operative data is collected on the day of surgery, it must be completed prior to the surgery occurring.
5 The 6 month visit may be conducted remotely 

 
Clinical Protocol 
Study Number: CORI.2019.07
A Prospective, Multi-center, Study to Evaluate the Safety and 
knee arthroplasty (UKA) and total knee arthroplasty (TKA) 
procedures  
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CONFIDENTIAL AND PROPRIETARY 
TMP-800052 Clinical Protocol - Device  Revision 3; PRO-201725 Clinical Protocols 
9.1.2 
Screening/Preoperative Visit (-90 to 0 days)  
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. 
----- Do not proceed until 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.
Assign the subject a study number and 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) (x-rays can be taken within 6 months of the surgery date) 
7.
Collect the KSS score objective measures (joint alignment, instability, motions & symptoms).
8.
Have the subject complete the 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.
Subjects will be instructed to return for the Operation Visit on a scheduled date.
9.1.3 
Operation Visit & Discharge (Day 0 up to Day 9) 
If any Pre-Operative data is collected on the day of surgery, it must be completed prior to the 
surgery occurring. 
 
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. 
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 as entered into the CORI Robotics.
4.
Perform surgery and collect intra-operative data on the appropriate eCRF. This includes but 
is not limited to the following information: 

 
Clinical Protocol 
Study Number: CORI.2019.07
A Prospective, Multi-center, Study to Evaluate the Safety and 
knee arthroplasty (UKA) and total knee arthroplasty (TKA) 
procedures  
Version: 6.0, 15/Jan/2024
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CONFIDENTIAL AND PROPRIETARY 
TMP-800052 Clinical Protocol - Device  Revision 3; PRO-201725 Clinical Protocols 
 
Knee Implant Disposition (recording of tibial baseplate, insert and femoral component 
name, reference & lot/batch number) 
 
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 Robotics. 
 
(Robotics System time, cutting time) 
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, including any contraindicated 
treatments/medication(s). 
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)  
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 the KSS score objective measures (joint alignment, instability, motions & 
symptoms). 
5.
Have the subject complete the 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 patient-reported outcome measure.
9.
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. 

 
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10.
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 or make arrangements 
for delivery of the 6 month PROMs by courier to the subject to be completed remotely. 
9.1.5 
6 months (185 ± 14 days) after surgery (phone call if 
remote) 
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 the KSS score objective measures (joint alignment, instability, motions & symptoms) 
(if it is an on-site visit) 
5.
Have the subject complete the 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 patient-reported outcome measure.
9.
If the visit was remote arrange for courier to return the completed PROMs to site.
10.
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. 

 
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4.
Collect standard A/P & 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 log leg X-ray is taken as a standard of care, please complete the 
respective leg alignment eCRF (optional). 
6.
Collect the KSS score objective measures (joint alignment, instability, motions & 
symptoms). 
7.
Have the subject complete the 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 patient-reported outcome measure.
11.
Complete Exit Visit eCRF.
9.1.7 
Unscheduled Visits 
Unscheduled examinations related to the study knee may be conducted at the discretion of the 
Investigator with all obtained information recorded in the source documents and on the appropriate 
eCRF. If any adverse events or device deficiencies are observed or reported, they must be recorded 
as instructed in Section 12. - Adverse Events and Device Deficiencies.  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 
r
 
Concomitant Medications 
9.1.8.1.1 Excluded Concomitant Medications 
There are no restrictions on concomitant medications for this study. 
9.1.8.1.2 Recording Concomitant Medications in CRF 
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 the eCRF. Reference the eCRF 
Completion Guidelines for how medications are recorded.   

 
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Concomitant Therapies 
9.1.8.1.3 Therapies Prohibited During the Study 
There are no restrictions on concomitant therapies for this study. 
9.1.8.1.4 Recording Concomitant Therapies in the CRF 
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 treatments/therapies, who are lost to follow-up, 
refer to Section 7.8 for further details. Where possible, a full Exit 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 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. 
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 
-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. 

 
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Mechanical Axis of the tibia: Axis from the center of the proximal to the center of the distal 
tibia. 
re 
9-1. The angular deviation from the neutral position shall be recorded in the eCRF. 
Figure 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. 
 
Pre-Operative Leg alignment 
The pre-operative leg alignment evaluated from a standing weight bearing long leg A/P shall be 
recorded. 
Target Leg alignment (Surgical Plan) 
The operative plan for leg alignment as entered in the CORI Robotics 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 
The pre-cementation leg alignment shall be recorded with the use of the CORI Robotics System 
(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 the CORI Robotics System (manual screenshot to be taken). 
 

 
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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. 
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). 
Total Valgus Angle: Is the sum of the femoral flexion 
angle and the tibial angle. 
Figure 9-2 A/P View
 
A: Femoral A/P Angle  
B: Tibial A/P Angle 
A+B: Total Valgus 
Angle 
 
 
 
 

 
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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 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 9-3). 
Figure 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 (L) 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 (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 [46, 47]. The KSS consists of 36 questions and provides 
sub-scores across 4 dimensions as shown in Table 9-2. 
 
 

 
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Table 9-2 Knee Society Score 2011 
# 
Sub-Score 
# Questions 
Range 
Completion by 
1 
Objective Knee Score 
7 
0-100 
Surgeon 
2 
Subject Satisfaction 
Score 
5 
0-40 
Subject 
3 
Subject Expectation 
3 
3-15 
Subject 
4 
Functional Knee Score 
19 
0-100 
Subject 
The Objective Knee Score is rated by the clinician and assesses a range of clinical outcomes: 
UKA/TKA 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, 
surgery. The post-operative questions differ from the pre-operative questions and ask if the 
-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 KSS will then be recorded in the eCRF. 
9.2.5 
Oxford Knee Score (OKS) 
The Oxford Knee Score (OKS) will be collected at the pre-operative visit and 6 weeks, 6- and 12-
months after surgery. 
The Oxford Knee Score (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 [48, 49]. Responses to each question ranges from 0-4 with a 
range of a 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. 

 
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9.2.6 
Forgotten Joint Score (FJS) 
The Forgotten Joint Score (FJS) will 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 comprises measures for the assessment of joint-specific patient reported outcomes. This 
questionnair
in everyday life. Joint awareness can be simply defined as any unintended perception of a joint 
[50]. Subjects are asked to rate their awareness of their knee arthroplasty in 12 questions with a 
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 will then be recorded in the eCRF. 
 
9.2.7 
Robotic System Time & Cutting Time 
The CORI Robotic System Time and the Cutting Time of the robotic drill shall be collected post-
operatively.  
The CORI Robotics Case Report, including case logs, will be extracted from the CORI system via 
USB and time data will be extracted for CORI Robotic System Time and the Cutting Time  
In the case logs, the following time stamps will be recorded in the log file of the CORI Robotics 
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 ]  
Robotics System Time  
Robotics System starts with the checkpoint definition until the bone is removed. This is calculated 
by the time difference between #3 and #1. 
 
 

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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 Robotics 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 Robotics Case Report.
9.3 Health Economics/Quality of Life
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).
The descriptive system is used 
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 [51]. 
-rated health on a vertical visual analogue scale. 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.
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
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 

 
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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 would 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: 
Safety Population (SAF): This is defined as all subjects who were treated for a UKA or TKA 
with the use of the CORI Robotics and a Smith+Nephew Knee Implant System. 
Full analysis set population (FAS): The FAS is a subset of the subjects of the SAF population 
who have at least one post-operative assessment on any of the effectiveness endpoints or 
health-related quality of life (HRQoL) endpoints.  
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 data. All 
demographic and pre-operative characteristics data will be summarized at baseline. All 
demographic and baseline characteristics will be summarized using the SAF, FAS and PP analysis 
populations. 
 
 

 
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10.4 
Efficacy Analysis 
10.4.1 Analysis of Primary Endpoint 
Leg alignment 
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 
 
The proportions as described above will be summarized along with their associated two-sided 95% 
confidence intervals (CIs), estimated using exact binomial methods. 
The hypothesis of superiority in leg alignment in both groups will incorporate the use of the 
Intersection Union Test (IUT) where superiority will be inferred if and only if the outcomes from the 
simultaneous comparisons relative to the literature-specified rate provided of 73.4% yield lower 
limits of their two-sided 95% CIs both greater than 73.4% (i.e. both lower limits of the 95% CIs 
from the two groups must be greater than 73.4%) [52]. No multiplicity adjustments are required 
through the use of the IUT. The leg alignment will additionally be summarized using summary 
 
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 Robotics UKA 
versus CORI Robotics TKA) as well as for the combined groups using summary statistics for 
continuous variables. Ninety-
-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. 
10.4.2 Analysis of Secondary Endpoint 
All analyses on the secondary endpoints will be carried out separately in the CORI Robotics UKA 
and CORI Robotics TKA groups. 
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. 
 

 
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Standard Radiographic Assessment 
Radiolucent lines (mm) by zone and visit will be summarized using descriptive statistics for 
continuous variables. 
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 KSS scores as the 
dependent variable. As a minimum, each model will contain a visit (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 
-
Model based means (adjusted means or Least Square Means, LSMeans) and corresponding 
standard errors associated with each KSS score at the pre-operative visit and postoperative visits 
will be presented. Model based changes (and corresponding standard errors) from the pre-
operative visit to each subsequent postoperative as well as their corresponding 95% CIs will 
additionally be summarized. If the p-value associated with the visit term in the model is significant 
(i.e. p < 0.05), then the 95% CIs corresponding to the model based change (LS Mean) from the 
pre-operative to each postoperative visit will indicate where significant differences (changes) from 
the pre-operative at postoperative are found.   
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. 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) 
The transformed FJS score (0-100) will be summarized at the postoperative visits using continuous 
summary characteristics. 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. 

 
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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. 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.  
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 carried out separately in the CORI Robotics UKA and CORI 
Robotics TKA groups. 
Leg alignment pre- and post-cementation 
Leg alignment pre- and post-cementation will be summarized using descriptive summary 
characteristics for continuous variables. 
Robotics System Time & Cutting Time 
Robotic System and cutting times will be summarized using summary statistics for continuous 
variables. Standard Robotics System and cutting times will be obtained from literature and included 
in the SAP. The average operating (µ11) and cutting times (µ21) and their commensurate 95% CIs 
will be summarized compared to the obtained literature-specified (i.e. µ10 and µ20 respectively) 
using the t-test.  
The following are the possible outcomes, where i=1 represents operating time and i=2 represents 
cutting time:  
If the lower limit (LL) of the 95% CI for µi1 is > µi0, then it is concluded that µi1 is significantly 
greater than µi0. 
If the upper limit (UL) of the 95% CI for µi1 is > µi0, then it is concluded that µi1 is significantly less 
than µi0. 
If (LL of 95% CI for µi1 
i0 
i1), then it is concluded that µi1 on-study is 
comparable to that specified in the literature (µi0).  
All other endpoints will be summarized using the FAS analysis population. 

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10.5
Safety Analyses
All safety analyses will be carried out separately for each of the groups (CORI Robotics UKA and 
CORI Robotics TKA groups) and overall as follows:
The number of adverse events will be reported both overall and by seriousness, relationship 
to study device and anticipation.
The number of subjects experiencing adverse events will be summarised both overall and 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
Not applicable.
SAMPLE SIZE JUSTIFICATION
Parratte et al.[53] 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 TKAs post-operatively 
defined as mechanically aligned against the reference proportion of 73.4% from above.

Clinical Protocol 
Study Number: CORI.2019.07
A Prospective, Multi-center, Study to Evaluate the Safety and 
knee arthroplasty (UKA) and total knee arthroplasty (TKA) 
procedures
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analysis was estimated to be 92.1% [54]. If this assumption holds for this study, then the 
enrollment of 36 knees for each of the two planned study groups (i.e. the CORI Robotics UKA and 
CORI Robotics TKA) for a total of 72 knees will individually provide approximately 80% power to 
show that the lower limit of the two-sided 95% confidence interval for the proportion of 
mechanically aligned TKAs is greater than that obtained from literature. To account for up to a 10% 
attrition rate in knees enrolled, 40 knees in each group (80 knees combined, 40 UKA, 40 TKA) will 
be enrolled in the study.
ADVERSE EVENTS AND DEVICE DEFICIENCIES
12.1
Definitions
The categories of adverse events are shown in table 12.1-1. The definitions for each of these 
categories are given in the subsequent sections.
Table 12.1-1: 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)
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. 

 
Clinical Protocol 
Study Number: CORI.2019.07
A Prospective, Multi-center, Study to Evaluate the Safety and 
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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 or comparators. 
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. 
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.
 
 

 
Clinical Protocol 
Study Number: CORI.2019.07
A Prospective, Multi-center, Study to Evaluate the Safety and 
knee arthroplasty (UKA) and total knee arthroplasty (TKA) 
procedures  
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12.1.3 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) a life-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) foetal distress, foetal 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 the CORI Robotics is provided in but not limited to Table 12.1-2. Please also refer to Section 
4.4.6 Anticipated Risks / Adverse Effects and the current IFUs (Appendix 22.2). 
 
 
 
 
 

 
Clinical Protocol 
Study Number: CORI.2019.07
A Prospective, Multi-center, Study to Evaluate the Safety and 
knee arthroplasty (UKA) and total knee arthroplasty (TKA) 
procedures  
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Table 12.1-2 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.2019.07
A Prospective, Multi-center, Study to Evaluate the Safety and 
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# 
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.  

 
Clinical Protocol 
Study Number: CORI.2019.07
A Prospective, Multi-center, Study to Evaluate the Safety and 
knee arthroplasty (UKA) and total knee arthroplasty (TKA) 
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# 
Potential Harm 
Description 
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 flow. If blood flow to the leg is not restored, the 
patient's leg may need to be amputated. 
12.1.5 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 
activities. 
Severe -  
inability to work or engage in their usual activities. 
12.1.6 Device Deficiency 
A Device Deficiency (DD) is an inadequacy of a medical device with respect to its identity, quality, 
durability, reliability, safety, or performance.  
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 if 
a) suitable action had not been taken,  
b) intervention had not been made, or  
c) circumstances had been less fortunate,  

 
Clinical Protocol 
Study Number: CORI.2019.07
A Prospective, Multi-center, Study to Evaluate the Safety and 
knee arthroplasty (UKA) and total knee arthroplasty (TKA) 
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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 2020 v2.1  Clinical signs, symptoms, and conditions. 
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: 
 have led to SADE will be reported to IEC/IRB and 
regulatory authorities within 10 working days. 

 
Clinical Protocol 
Study Number: CORI.2019.07
A Prospective, Multi-center, Study to Evaluate the Safety and 
knee arthroplasty (UKA) and total knee arthroplasty (TKA) 
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All other events will be reported on a periodic/annual basis. 
Depending on the nature of the adverse event, S+N 
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. 
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
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.2019.07
A Prospective, Multi-center, Study to Evaluate the Safety and 
knee arthroplasty (UKA) and total knee arthroplasty (TKA) 
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Figure 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 
Without Unreasonable Delay
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 CRF/Clinical Study Report. 
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 
 

Clinical Protocol 
Study Number: CORI.2019.07
A Prospective, Multi-center, Study to Evaluate the Safety and 
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Adverse events which are not related to a study procedure or S+N IP and are ongoing at the end 
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.
INVESTIGATOR OBLIGATIONS
The Principal Investigator will comply with the commitments outlined in the Statement of 
Investigator, provided by the Sponsor, and with Good Clinical Practice (GCP), and all applicable 
regulatory requirements as outlined in Appendix 22.7 Principal Investigator Obligations (ISO
14155) of this protocol. Sub-Investigators, who are individual member of the investigation site 
team designated and supervised by the Principal Investigator at an investigation site to perform 
clinical investigation-related procedures or to make important clinical investigation-related and 
medical treatment decisions, may have responsibilities delegated to them by the Principal 
Investigator. However, the Principal Investigator retains overall responsibility for the clinical 
investigation at the site.
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 as any changes that affect their financial 
disclosure status occur during the course of the study and up to one year after study completion.
The Coordinating Investigator appointed by the Sponsor will assist in coordinating the work in the 
multicentre clinical investigation.
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 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
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.

Clinical Protocol 
Study Number: CORI.2019.07
A Prospective, Multi-center, Study to Evaluate the Safety and 
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14.2
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 and documented IRB/IEC
approval. 
14.3
Interim Monitoring Visit
Regular interim monitoring visits will be performed by the Sponsor or qualified person designated 
by the Sponsor.
14.4
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/IEC reporting requirements.  When no subjects have been 
included, a remove close-out visit may be conducted. 
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 any and all study reports and 
source documentation, regardless of location and format.  
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 (FRM-402046 Protocol/GCP Deviation Log). Significant and/or recurrent protocol/GCP 
deviations will be documented on a protocol deviation form (FRM-400347 Protocol/GCP Deviation) 
including identified root cause and, as necessary, appropriate corrective and preventive actions will 
be put in place and signed off by the study personnel. If it is deemed necessary full clinical 
Corrective and Preventive Action (CAPA) will be initiated. 
It is not allowed to use waivers to allow planned deviation of the study protocol. 

Clinical Protocol 
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An investigator may be early terminated from the study upon identification of serious protocol 
deviations whereby there are concerns for patient safety or data quality (especially those not 
reported to the sponsor by the site). Early termination may also occur if there are repeated 
protocol deviations which have previously been addressed via corrective and preventative actions 
thereby suggesting an issue with site compliance.
Protocol deviations requiring reporting to the IRB/IEC should be done so in the timeframe 
stipulated by the IRB/IEC.
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/IEC. 
Protocol amendments need to be approved by the IRB/IEC, according to the applicable 
requirements prior to implementation at the site.
CONFIDENTIALITY OF THE STUDY
The confidentiality of this study and associated documents is governed by the terms of the Clinical 
Trial Agreement (CTA).
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 clinical study is financed by the sponsor. All financial arrangements between the sponsor and 
investigation sites/investigators are documented separate clinical trial agreements.

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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.
ard of care as prescribed by the individual sites if 
further follow-up is needed. The study is expected to last 36 months (enrolment period: 24
months, Follow-up period: 12 months).
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.
An End of Study CRF needs to be completed for all subjects including any subject that does not 
complete the study, to document the reason for termination.
This study may be temporarily suspended or prematurely terminated if there is sufficient 
reasonable cause. Written notification, documenting the reason for study suspension or 
termination, will be provided by the suspending or terminating party to other parties (Investigator, 
IRB/IEC, Sponsor and regulatory authorities). If the study is prematurely terminated or suspended, 
the Investigator will promptly inform the IRB/IEC and the study sites and will provide the reason(s) 
for the termination or suspension. Circumstances that may warrant termination or suspension 
include, but are not limited to: 
Determination of unexpected, significant or unacceptable risk to participants 
Demonstration of efficacy that would warrant stopping 
Insufficient compliance with study protocol requirements 
Data that are not sufficiently complete and/or evaluable 
Determination of futility 
Study may resume once concerns about safety, study protocol compliance, data quality are 
addressed and satisfy the Sponsor and IRB/IEC.
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

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PUBLICATION POLICY
20.1
Publication of Study Data
The study will be registered in a publicly accessible database (ClinicalTrials.gov and Clinical Trials 
Registry - India (CTRI)) and the results will be made available within that database. 
It is intended that the results of this study will be submitted for publication within a manuscript.
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, including, but not limited to the Health Insurance Portability 
and Accountability Act of 1996.
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. 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 directed to datasharing.gcs@smith-
nephew.com. To gain access, data requestors will need to sign a data access agreement.
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Cutolo, M., et al., Commentary on recent therapeutic guidelines for osteoarthritis. Semin 
Arthritis Rheum, 2015. 44(6): p. 611-7.
3.
Arora, S., A. Rafiq, and M. Jolly, Management of rheumatoid arthritis: Review of current 
guidelines. Journal of Arthroscopy and Joint Surgery, 2016. 3(2): p. 45-50.
4.
Saxby, D.J. and D.G. Lloyd, Osteoarthritis year in review 2016: mechanics. Osteoarthritis 
Cartilage, 2017. 25(2): p. 190-198.
5.
Xie, K., et al., The effect of varus knee deformities on the ankle alignment in patients with 
knee osteoarthritis. J Orthop Surg Res, 2019. 14(1): p. 134.

 
Clinical Protocol 
Study Number: CORI.2019.07
A Prospective, Multi-center, Study to Evaluate the Safety and 
knee arthroplasty (UKA) and total knee arthroplasty (TKA) 
procedures  
Version: 6.0, 15/Jan/2024
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TMP-800052 Clinical Protocol - Device  Revision 3; PRO-201725 Clinical Protocols 
6.
Cross, M., et al., The global burden of hip and knee osteoarthritis: estimates from the global 
burden of disease 2010 study. Ann Rheum Dis, 2014. 73(7): p. 1323-30. 
7.
Karim, A.R., et al., Osteonecrosis of the knee. Annals of translational medicine, 2015. 3(1). 
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Pape, D., et al., Prevalence of spontaneous osteonecrosis of the medial femoral condyle in 
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Parratte, S., et al., Primary total knee arthroplasty in the management of epiphyseal fracture 
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10. 
Tang, X.B., et al., A Meta-Analysis of Patellar Replacement in Total Knee Arthroplasty for 
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11. 
Winter, A.R., J.E. Collins, and J.N. Katz, The likelihood of total knee arthroplasty following 
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12. 
Hofstede, S.N., et al., Mobile bearing vs fixed bearing prostheses for posterior cruciate 
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Evans, J.T., et al., How long does a knee replacement last? A systematic review and meta-
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Yoon, C., et al., Does unicompartmental knee arthroplasty have worse outcomes in 
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Yue, J., L. Zhang, and C. Yang, The impact of patellofemoral arthritis on unicompartmental 
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Registry, N.J., Types of primary knee replacements undertaken. 2018: England, Wales, 
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Beal, M.D., D. Delagramaticas, and D. Fitz, Improving outcomes in total knee arthroplasty-
do navigation or customized implants have a role? J Orthop Surg Res, 2016. 11(1): p. 60. 
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Urish, K.L., et al., Robotic Total Knee Arthroplasty: Surgical Assistant for a Customized 
Normal Kinematic Knee. Orthopedics, 2016. 39(5): p. e822-7. 
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Camarda, L., et al., Patient-specific instrumentation for total knee arthroplasty: a literature 
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Burnett, R.S. and R.L. Barrack, Computer-assisted total knee arthroplasty is currently of no 
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van der List, J.P., et al., Current state of computer navigation and robotics in 
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24. 
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. 

 
Clinical Protocol 
Study Number: CORI.2019.07
A Prospective, Multi-center, Study to Evaluate the Safety and 
knee arthroplasty (UKA) and total knee arthroplasty (TKA) 
procedures  
Version: 6.0, 15/Jan/2024
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TMP-800052 Clinical Protocol - Device  Revision 3; PRO-201725 Clinical Protocols 
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Mayman, D., Handheld navigation in total knee arthroplasty. Orthop Clin North Am, 2014. 
45(2): p. 185-90. 
26. 
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. 
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Clayton, A.W., et al., Does the use of navigation in total knee arthroplasty affect outcomes? J 
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28. 
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. 
29. 
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. 
30. 
Banerjee, S., et al., Robotic-assisted knee arthroplasty. Expert Review of Medical Devices, 
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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. 
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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. 
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33. 
Lonner, J.H. and V.M. Moretti, The Evolution of Image-Free Robotic Assistance in 
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34. 
Khlopas, A., et al., Robotic Arm-Assisted Total Knee Arthroplasty. J Arthroplasty, 2018. 
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35. 
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-
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36. 
Jacofsky, D.J. and M. Allen, Robotics in Arthroplasty: A Comprehensive Review. J 
Arthroplasty, 2016. 31(10): p. 2353-63. 
37. 
Thein, R., et al., Lateral Robotic Unicompartmental Knee Arthroplasty. Sports Medicine and 
Arthroscopy Review, 2014. 22(4): p. 223-228. 
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Roche, M., Robotic-assisted unicompartmental knee arthroplasty: the MAKO experience. 
Orthop Clin North Am, 2015. 46(1): p. 125-31. 
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Batailler, C., et al., Improved implant position and lower revision rate with robotic-assisted 
unicompartmental knee arthroplasty. Knee surgery, sports traumatology, arthroscopy : official 
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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, 
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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. 
42. 
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. 
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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. 

 
Clinical Protocol 
Study Number: CORI.2019.07
A Prospective, Multi-center, Study to Evaluate the Safety and 
knee arthroplasty (UKA) and total knee arthroplasty (TKA) 
procedures  
Version: 6.0, 15/Jan/2024
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Chilena de Ortopedia y Traumatologia, 2017. 58(1): p. 7-12. 
45. 
Sephton, B.M., et al., Predictors of extended length of stay after unicompartmental knee 
arthroplasty. Journal of Clinical Orthopaedics and Trauma, 2019. 
46. 
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. 
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Insall, J.N., et al., Rationale of the Knee Society clinical rating system. Clin Orthop Relat Res, 
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Dawson, J., et al., Questionnaire on the perceptions of patients about total knee 
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Murray, D.W., et al., The use of the Oxford hip and knee scores. J Bone Joint Surg Br, 2007. 
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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. 
51.  
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. 
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Berger R. L., H., Jason C. , Bioequivalence trials, intersection-union tests and equivalence 
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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. 
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Nephew, S., Clinical Study Report 6-month Follow-up: "Clinical, Radiographic and Patient-
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Total Knee Arthroplasty". 2019. 
55. 
2011 Knee Society Knee Scoring System Licensed User Manual -
https://www.kneesociety.org/assets/2011KSS%20Support%20Materials.pdf 
 
 

Clinical Protocol 
Study Number: CORI.2019.07
A Prospective, Multi-center, Study to Evaluate the Safety and 
knee arthroplasty (UKA) and total knee arthroplasty (TKA) 
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TMP-800052 Clinical Protocol - Device 
Revision 3; PRO-201725 Clinical Protocols
APPENDICES
22.1
Protocol Amendment
22.1.1 Protocol Amendment 1
22.1.1.1 General Purpose
This amendment has been completed to:
1) increase the pre-operative visit window from 28 days to 90 days and to allow pre-operative 
activities to occur on the day of surgery as long as they occur prior to the surgery itself.
2) allow the 6-month visit to be conducted remotely.
22.1.1.2 Rationale
1) Following the COVID pandemic and the cancellations of elective surgery the waiting lists for 
surgery have increased globally. Extending the visit window will aid sites in being able to 
include subjects whose surgery is longer than 28 days from their initial pre-operative visit
without having to schedule an additional pre-operative visit.
2) No x-rays are taken at the 6-month visit so the subject does not need to come in to site. The 
PROMs collected at the visit can be sent to the subject who can complete them whilst on the 
phone to a member of the study team. The PROMs will then be securely sent back to site and 
entered into the EDC. The KSS would not have the
-generated) 
component of the questionnaire completed if the visit is remote. However, per the 2011 
Knee Society Knee Scoring System Licensed User Manual [55] outcomes are only scored 
using the patient report
-
generated) component of the questionnaire is collected for background information and to 
facilitate comparison of patient outcome with the old KSCR.
22.1.1.3 Effect on Study Status
1) The amendment will ensure more potential subjects can be included in the study and reflect 
the consequences of the COVID pandemic on the current routine clinical schedules. There is 
no impact on any subjects that are enrolled prior the amendment being effective as the 
amendment is lengthening rather than reducing the pre-operative visit window.
2) There will be no impact on any subjects reaching the 6-month visit prior to the amendment 
being effective because they will have the 6-month visit on site.
The database will be updated according to the new protocol once approved.

 
Clinical Protocol 
Study Number: CORI.2019.07
A Prospective, Multi-center, Study to Evaluate the Safety and 
knee arthroplasty (UKA) and total knee arthroplasty (TKA) 
procedures  
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22.1.1.4 Details 
At the time of the amendment the protocol template was also updated throughout to ensure it is 
compliant with the current effective protocol template (TMP-800052/TMP-CD-05 Rev 3). The major 
changes are included in the table below. 

 
Clinical Protocol - Device
Study Number: CORI.2019.07
A Prospective, Multi-center, Study to Evaluate the Safety and 
knee arthroplasty (UKA) and total knee arthroplasty (TKA) 
Procedures 
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TMP-800052  Clinical Protocol-Device  Revision E; PRO-201725 Clinical Protocols 
Section
Current Text 18/Jun/2020
Version 4.0 
Revised Text 08/Nov/2022
Version 5.0 
Front Page
Sponsor
Sponsor and funding source:
Front Page 
N/A
Single Identification Number of 
Clinical Investigation: N/A 
Front Page 
N/A
Summary of Revision History
V4.0, 18/Jun/2020  
V3.0, 08/Jun/2020 
V2.0, 29/Apr/2020 
V1.0,  24/Feb/2020  
2. Synopsis
N/A
Sponsor and Funding Source: Smith & 
Nephew Inc, 1450 E. Brooks Road, 
Memphis, Tennessee 38116, USA 
2. Synopsis
Study Design 
Prospective, multi-center, cohort 
study, 2 arms 
Prospective
 Multi-center  up to 8 sites,  
 Cohort study,  
 2 arms 
 140 subjects (70 x UKA, 70 x TKA) 
 1 year follow-up 
2. Synopsis 
Study Type 
Post-market study
Post-market study 
Interventional, non-randomised, non-
blinded 
2. Synopsis 
Comparison 
Group(s)*: 
(*if applicable) 
N/A
Comparison Group(s)*: N/A
(*if applicable) 
2. Synopsis
Primary Objective: 
To evaluate the use of CORI 
Robotics in unicondylar knee 
arthroplasty (UKA) and total knee 
arthroplasty (TKA) procedures in 
achieving post-operative leg 
alignment. 
To evaluate the use of CORI Robotics 
in UKA and TKA procedures in 
achieving post-operative leg 
alignment. 
2. Synopsis 
Secondary 
Objective(s): 
To generate safety and 
performance evidence supporting 
the use of CORI Robotics 
procedures. 
To assess the safety and performance 
of the CORI Robotics up to 12 months 
after surgery. 
2. Synopsis Other 
Objective(s): 
To collect Robotics System time 
and cutting time of the robotic drill 
To determine the Robotics System 
time and cutting time of the robotic 

 
Clinical Protocol - Device
Study Number: CORI.2019.07
A Prospective, Multi-center, Study to Evaluate the Safety and 
knee arthroplasty (UKA) and total knee arthroplasty (TKA) 
Procedures 
Version: 6.0, 15/Jan/2024
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TMP-800052  Clinical Protocol-Device  Revision E; PRO-201725 Clinical Protocols 
Section
Current Text 18/Jun/2020
Version 4.0 
Revised Text 08/Nov/2022
Version 5.0 
from the CORI Robotics Case 
Report. 
drill of UKA and TKA procedures with 
the CORI Robotics. 
2. Synopsis 
Safety Data 
complications occurring from the 
time of subject enrollment until 
study termination or study 
completion including intra-
operative adverse events and 
complications. 
 
 
All AEs will be categorized in 
terms of seriousness and 
relatedness to the study device or 
to the surgical procedure. All 
Serious Adverse Device Effects will 
be further categorized as 
Anticipated or Unanticipated. The 
definitions for each of these 
categories are based on ISO 
14155:2011. 
Deleted section as repeated lower in 
Synopsis 
2. Synopsis
Targeted Global 
Regions: 
Europe, India, and the US
Europe, UK, India, and the US
2. Synopsis 
Inclusion Criteria 
1. 
has decided that REAL 
compatible Smith+Nephew Knee 
Implant System is the best 
unicondylar knee arthroplasty 
(UKA) or total knee arthroplasty 
(TKA) and the subject has agreed 
to the treatment.  
 
1. 
Smith+Nephew Knee Implant System 
UKA or TKA and the subject has 
agreed to the treatment. 
 
7. Subject able to follow instructions 
and deemed capable of completing all 
study questionnaires. 
2. Synopsis 
Study Duration 
Estimated Timelines 
 Study period: 25 months (12 
months enrolment)  
 Start enrolment: July 2020  
Estimated total study timeline: 36 
months (Enrolment period: 24 
months, Follow-up period: 12 
months) 

 
Clinical Protocol - Device
Study Number: CORI.2019.07
A Prospective, Multi-center, Study to Evaluate the Safety and 
knee arthroplasty (UKA) and total knee arthroplasty (TKA) 
Procedures 
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Section
Current Text 18/Jun/2020
Version 4.0 
Revised Text 08/Nov/2022
Version 5.0 
 Last subject first visit: June 
2021  
 Last subject last visit: July 2022 
 
2. Synopsis 
Primary Endpoint 
Post-operative leg alignment via 
radiographic assessment (the 
proportion of subjects achieving 
post-operative leg alignment 6 
weeks after surgery, defined as ± 
3° from target)  
 
The evaluation of the proportion of 
subjects achieving post-operative leg 
alignment at 6 weeks post-surgery. 
Achieved leg alignment is defined as 
target. 
2. Synopsis
Secondary 
endpoint(s): 
(Presence of radiolucent lines, 
osteolysis & implant migration) 
 
Score (OKS) 
 
-level EuroQol five-
dimensional (EQ-5D-5L) VAS and 
index scores 
 
Component Alignment 6 weeks 
post-surgery 
 
Radiographic assessment 
(Presence of radiolucent lines, 
osteolysis & implant migration) 
12 months post-surgery 
 
2011 Knee Society Score (KSS)
at baseline, 6 weeks, 6 and 12 
month post-surgery 
 
Oxford Knee Score (OKS) at 
baseline, 6 weeks, 6 and 12 
month post-surgery 
 
Forgotten Joint Score (FJS) at 6 
weeks, 6 and 12 month post-
surgery 
Five-level EuroQol five-dimensional 
(EQ-5D-5L) VAS and index scores at 
baseline, 6 weeks, 6 and 12 month 
post-surgery 
2. Synopsis 
Other exploratory 
endpoint(s): 
Robotics Case Report will be 
collected to document the robotic 
system time and cutting time of 
the robotic drill  
 
 
Leg alignment pre- and post-
cementation 
 
Robotics System time as 
CORI Robotics Case Report 
generated by the CORI Robotics 
Software. 
 
Cutting time of the robotic drill 

 
Clinical Protocol - Device
Study Number: CORI.2019.07
A Prospective, Multi-center, Study to Evaluate the Safety and 
knee arthroplasty (UKA) and total knee arthroplasty (TKA) 
Procedures 
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Current Text 18/Jun/2020
Version 4.0 
Revised Text 08/Nov/2022
Version 5.0 
CORI Robotics Case Report, 
generated by the CORI Robotics 
Software. 
2. Synopsis
Safety Data 
N/A
Additional text: 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. 
(Including hardware and 
instrumentation), complications, and 
revisions. 
2. Synopsis 
Study Schedule 
Pre-Operative: -28 to 0 days
 
Operative Data & Discharge: Day 
1 (+ up to 9 days) 
 
6-Month Follow-Up: Day 185 ± 14 
Pre-Operative: -90 to 0 days
 
Operative Data & Discharge: Day 0 (+ 
up to 9 days) 
 
6-Month Follow-Up*: Day 185 ± 14 
* The 6 month visit may be conducted 
remotely. 
4.1 Background
N/A
Additional text: A summary of known 
and potential risks and benefits to 
humans of CORI Robotics can be 
found in the Instructions for Use 
(IFU). 
4.3 Study Purpose
This is a prospective, multi-center 
study to demonstrate the safety 
and effectiveness of the CORI 
Robotics to meet the post-market 
clinical follow-up requirement in 
Europe, India and the US. In 
addition, the study may support 
regulatory approval by the 
This is a prospective, multi-center 
study to demonstrate the safety and 
effectiveness of the CORI Robotics to 
meet the post-market clinical follow-
up requirement in Europe, UK, India 
and the US. This is a post-market 
study in all countries involved.  In 
addition, the study may support 

 
Clinical Protocol - Device
Study Number: CORI.2019.07
A Prospective, Multi-center, Study to Evaluate the Safety and 
knee arthroplasty (UKA) and total knee arthroplasty (TKA) 
Procedures 
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Revised Text 08/Nov/2022
Version 5.0 
National Medical Products 
Administration (NMPA) in China. 
 
regulatory approval by the National 
Medical Products Administration 
(NMPA) in China. 
Study hypotheses are that the CORI 
surgical system will achieve post-
operative leg alignment (± 3°), and 
an improvement in patient-reported 
outcome measures.  This primary 
endpoint is aligned to the primary 
study objective of evaluating the 
CORI surgical system for UKA and 
TKA procedures in achieving post-
operative leg alignment.  Accuracy 
and alignment are two key variables 
in successful UKA and TKA 
procedures. These measures have 
been previously evaluated with the 
predicate NAVIO surgical system. The 
primary endpoint will support the 
continued evaluation of these 
variables for the CORI surgical 
system.  
4.4 Safety 
Considerations 
N/A
Representative language of the 
indications of use, contraindications 
and potential adverse effects of CORI 
Robotics can be found in the IFU. 
4.4.6 Anticipated 
Risks / Adverse 
Effects 
4.4.6 Potential Adverse Effects
4.4.6 Anticipated Risks / Adverse 
Effects 
Additional text: As this is a post-
market study and the device is used 
according to the IFU, the use of CORI 
Robotics in this study introduces no 
additional potential risks to the study 
participant. 
4.4.7 Safety Data 
Collection 
N/A
All adverse device effects or device 
deficiencies will be categorised and 
reported as instructed in Section 12, 
Adverse Events and Device 

 
Clinical Protocol - Device
Study Number: CORI.2019.07
A Prospective, Multi-center, Study to Evaluate the Safety and 
knee arthroplasty (UKA) and total knee arthroplasty (TKA) 
Procedures 
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Revised Text 08/Nov/2022
Version 5.0 
Deficiencies. During causality 
assessment activity (assessment of 
Related vs Unrelated) and expectancy 
assessment (assessment of 
Unanticipated vs Anticipated) clinical 
judgement shall be used and relevant 
documents, such as the IFU shall be 
consulted, as foreseeable serious 
adverse events and the potential risks 
are summarized 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. 
5. Objectives
N/A
To evaluate the safety and 
effectiveness of REAL 
TKA procedures. 
5.1 Primary Objective The primary objective of this study 
is to evaluate the use of CORI 
Robotics in UKA (phase 1) and 
TKA procedures in achieving post-
operative leg alignment. 
The primary objective of this study is 
to evaluate the use of CORI Robotics 
in UKA and TKA procedures in 
achieving post-operative leg 
alignment. 
6.1.1 Investigational 
Product 
The CORI Robotics is currently 
avaible for the use of the following 
S+N implant Systems: 
 
For the purposes of this study, the 
CORI Robotics is currently available 
for the use of the following S+N 
implant Systems: 
 
Additional text: For this study only the 
CORI Robotics is considered the IP 
and not the implant systems used. 
All surgeons using CORI Robotics will 
have previously been fully trained on 
the use of the system by S+N staff.  
6.1.2 Comparator 
Treatment
 
N/A
No comparator products are used.

 
Clinical Protocol - Device
Study Number: CORI.2019.07
A Prospective, Multi-center, Study to Evaluate the Safety and 
knee arthroplasty (UKA) and total knee arthroplasty (TKA) 
Procedures 
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Section
Current Text 18/Jun/2020
Version 4.0 
Revised Text 08/Nov/2022
Version 5.0 
6.1.3 Ancillary 
Product 
N/A
No ancillary products are to be 
provided for this study. 
6.2 Product Use
N/A
Additional text: 
responsibility to ensure adherence to 
the IFU. Sites that are familiar with 
the use of CORI Robotics / Robotic-
assisted surgery systems will be 
selected so no additional training is 
required. 
6.3.1 Labelling of 
Investigational 
Product 
N/A
Additional text: No additional labelling 
will take place. 
6.4 Product 
Accountability 
Procedures 
N/A
Clarification added: In instances 
where CORI Robotics is supplied to 
site, 
 
Additional text for when CORIs are 
supplied to site: 
Overall accountability for the use of 
the product is the responsibility of the 
Investigator or designated individual. 
Following completion of enrolment all 
supplied CORI Robotics systems will 
be returned to S+N. 
6.5 Surgical 
Technique 
Pre-study cases shall be 
performed until the surgeon feels 
comfortable with the system in 
order to prevent any learning 
curve during the study. The 
number of pre-study cases 
depends on the level of the 
individual experience of the 
surgeon. Anonymized CORI 
Robotics Case Reports will be 
collected for these pre-study cases 
as proof of experience. 
If deemed necessary, pre-study cases 
shall be performed until the surgeon 
feels comfortable with the system in 
order to prevent any learning curve 
during the study. The number of pre-
study cases depends on the level of 
the individual experience of the 
surgeon. Anonymized CORI Robotics 
Case Reports will be collected for 
these pre-study cases as proof of 
experience. If no pre-study cases are 
completed the case log of the first 
study case will be collected and 
analysed as soon as possible following 
the surgery to ensure the additional 

 
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data required for the study has been 
collected. 
7.1 Subject 
Population 
N/A
Additional text: It is expected that all 
subjects will be enrolled within 24 
months. 
Eligibility criteria are specified to 
ensure that the subject population of 
the study represents the target 
population of the IP. 
7.1.1 Vulnerable 
Subjects 
N/A
No vulnerable subjects will be 
included in the study. 
7.2 Inclusion Criteria
1. 
has decided that REAL 
compatible Smith+Nephew Knee 
Implant System is the best 
unicondylar knee arthroplasty 
(UKA) or total knee arthroplasty 
(TKA) and the subject has agreed 
to the treatment.  
 
1. 
Smith+Nephew Knee Implant System 
UKA or TKA and the subject has 
agreed to the treatment. 
 
7. Subject able to follow instructions 
and deemed capable of completing all 
study questionnaires. 
7.4 Screening
N/A
Additional text: Part of the screening 
process will include documentation of 
women of childbearing potential, 
study sites will determine whether the 
subject is pregnant using their 
standard clinical practice. 
7.5 Informed 
Consent 
N/A
Additional text:
 
Translations of informed consent 
documents will be available in the 
participating countries main 
language(s). 
 

 
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The subject will have sufficient time to 
consider study participation and 
ensure all questions have been 
answered this will usually be at least 
24 hours unless approved or 
documented local site Informed 
Consent procedures allow for this to 
be shorter. There is no required 
interval between the time of consent 
and the first study procedure being 
carried out. 
Due to the nature of completing 
Patient Reported Outcome during the 
study the subject must be able to 
provide consent. A Legally Authorized 
Representative signature is not 
allowed in this study. 
7.8.1 Withdrawal 
from Treatment 
N/A
Additional text:
Subjects withdrawn from having 
treatment will not be classed as being 
enrolled (section 7.6).  
Subjects withdrawn from having 
treatment will be replaced and no 
further follow-up of the withdrawn 
subjects is required for the study. 
8.1 Study Design
This study is being conducted in 
parallel to a  randomized-
Prospective, Multi-center, 
randomized-controlled Study to 
Evaluate the Safety and 
Effectiveness of REAL 
unicondylar knee arthroplasty 
(UKA) and total knee arthroplasty 
This study is being conducted in 
parallel to 2 randomized-controlled 
studies 
Multi-center, randomized-controlled 
Study to Evaluate the Safety and 
Effectiveness of REAL 
unicondylar knee arthroplasty (UKA) 
CORI.2019.06) 
A Prospective, 
Multi-center, Randomized Controlled 

 
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CORI.2019.06). The study data 
will be combined for analysis to 
meet the requirements for 
regulatory approval of the CORI 
Robotics by the National Medical 
Products Administration (NMPA) in 
China. Further details are 
described in Section 10 Statistical 
Design and the Statistical Analysis 
Plan (SAP). 
 
Study to Evaluate the Safety and 
Effectiveness of the REAL 
arthroplasty (TKA) Procedure
(Protocol ID: CORI.2020.08). The 
study data will be combined for 
analysis to meet the requirements for 
regulatory approval of the CORI 
Robotics by the National Medical 
Products Administration (NMPA) in 
China. Further details are described in 
Section 10 Statistical Design and the 
Statistical Analysis Plan (SAP). 
Additional text: 
The study design meets the needs of 
the aforementioned regulatory 
requirements and has been powered 
based on recent analyses from the 
NAVIO Surgical System.  This study is 
designed to demonstrate superiority 
in the proportion of TKAs post-
operatively defined as mechanically 
aligned against the reference 
proportion of 73.4% (53).  The 
proportion of mechanically aligned 
System from a recent analysis was 
estimated to be 92.1% (54). If this 
assumption holds for this study, then 
the enrollment of 63 knees for each of 
the two planned study groups (i.e. the 
CORI Robotics UKA and CORI Robotics 
TKA) for a total of 126 knees will 
individually provide 80% power to 
show that the lower limit of the two-
sided 95% confidence interval for the 
proportion of mechanically aligned 
TKAs 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 

 
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combined, 70 UKA and 70 TKA) will 
be enrolled in the study. 
8.2 Data 
Management 
N/A
This study utilizes a validated, 21 CFR 
Part 11 compliant, electronic data 
capture system. Access to the 
electronic data capture system is 
controlled through 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. 
8.2.1 Data Review 
and Quality 
Assurance 
N/A
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.  

 
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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.  
8.2.2 Retention 
Period 
N/A
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. 
8.3.1 Primary 
Endpoint 
The primary endpoint of this study 
is defined as the evaluation of the 
proportion of subjects achieving 
post-operative leg alignment. 
Achieved leg alignment is defined 
target. 
The primary endpoint of this study is 
defined as the evaluation of the 
proportion of subjects achieving post-
operative leg alignment at 6 weeks 
post-surgery. Achieved leg alignment 
specific target.   
This primary endpoint is aligned to 
the primary study objective of 
evaluating the CORI surgical system 
for UKA and TKA procedures in 
achieving post-operative leg 
alignment.  Accuracy and alignment 
are two key variables in successful 
UKA and TKA procedures. These 
measures have been previously 
evaluated with the predicate NAVIO 
surgical system. The primary endpoint 
will support the continued evaluation 
of these variables for the CORI 
surgical system.  

 
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8.3.2 Secondary 
Endpoints 
The following secondary endpoints 
have been defined for this study in 
order to evaluate the safety and 
performance of the CORI 
Robotics: 
 
(Presence of radiolucent lines, 
osteolysis & implant migration) 
 
 
 
-level EuroQol five-
dimensional (EQ-5D-5L) VAS & 
index scores 
The following secondary endpoints 
have been defined for this study in 
order to evaluate the safety and 
performance of the CORI Robotics: 
 
Component Alignment 6 weeks 
post-surgery 
 
Radiographic assessment 
(Presence of radiolucent lines, 
osteolysis & implant migration) 
12 months post-surgery 
 
2011 Knee Society Score (KSS) 
at baseline, 6 weeks, 6 and 12 
month post-surgery 
 
Oxford Knee Score (OKS) at 
baseline, 6 weeks, 6 and 12 
month post-surgery 
 
Forgotten Joint Score (FJS) at 6 
weeks, 6 and 12 month post-
surgery 
 
Five-level EuroQol five-
dimensional (EQ-5D-5L) VAS & 
index scores at baseline, 6 
weeks, 6 and 12 month post-
surgery 
Secondary endpoints are aligned 
to the secondary study objectives 
of generating safety and 
performance evidence related to 
the use of the CORI surgical 
system.  Assessing alignment, 
radiographic image assessment 
and patient-reported outcome 
measures (PROMS) are key 
variables in determining the 
success of UKA and TKA 
procedures. These endpoints have 
been previously evaluated with the 
predicate NAVIO surgical system 
and ongoing assessment of these 

 
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secondary endpoints under this 
study will support safety and 
efficacy of these procedures 
performed with the CORI surgical 
system.  
8.3.4 Safety 
Endpoints 
N/A
Additional text:
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. (Including 
hardware and instrumentation), 
complications, and revisions. 
Table 9 1: Study 
Procedures by Visit 
Pre-Operative Data
-28 to 0 days 
 
Operative  Data & Discharge 
Day 1 (+ up to 9 days) 
 
1. Post-operative standing weight 
bearing long leg X-rays (A/P & L) 
may be taken at discharge already
 
 
Pre-Operative Data
-90 to 0 days 
 
Operative  Data & Discharge 
Day 0 (+ up to 9 days) 4 
 
1. Post-operative standing weight 
bearing long leg X-rays (A/P & L) may 
be taken at discharge if standard of 
care 
 
Addition of: 
4. If any Pre-Operative data is 
collected on the day of surgery, it 
must be completed prior to the 
surgery occurring. 
5. The 6 month visit may be conducted 
remotely. 

 
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9.1.2 Screening /
Preoperative Visit 
9.1.2 Screening / Preoperative 
Visit 
 
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). 
9.1.2 Screening / Preoperative Visit (-
90 to 0 days) 
 
5. Assign the subject a study number 
and 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) (x-rays can be 
taken within 6 months of the surgery 
date) 
9.1.3 Operation Visit 
& Discharge 
Operation Visit & Discharge (Day 
0) 
9.1.3 Operation Visit & Discharge 
(Day 0 up to Day 9) 
 
If any Pre-Operative data is collected 
on the day of surgery, it must be 
completed prior to the surgery 
occurring. 
9.1.4 Follow-up visits 
at 6 weeks (42 ± 14 
days) 
10. 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. 
10. 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 or make arrangements 
for delivery of the 6 month PROMs by 
courier to the subject to be completed 
remotely. 
9.1.5 6 months (185 
± 14 days) after 
surgery 
9.1.5 6 months (185 ± 14 days) 
after surgery 
 
 
4. Collect the KSS score objective 
measures (joint alignment, 
instability, motions & symptoms). 
9.1.5 9.1.5
6 months (185 ± 14 
days) after surgery (phone call if 
remote) 
 
4. Collect the KSS score objective 
measures (joint alignment, instability, 
motions & symptoms) (if it is an on-
site visit) 
 
Addition: 

 
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9. If the visit was remote arrange for 
courier to return the completed 
PROMs to site. 
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. 
Unscheduled examinations related to 
the study knee may be conducted at 
the discretion of the Investigator with 
all obtained information recorded in 
the source documents and on the 
appropriate eCRF. If any adverse 
events or device deficiencies are 
observed or reported, they must be 
recorded as instructed in Section 12. -
Adverse Events and Device 
Deficiencies. The subject should be 
scheduled to return for the next 
scheduled study visit within the 
acceptable time window. 
10.6 Interim Analysis A first interim analysis is planned 
for H2 2020. More specific details 
on the interim analyses will be 
included in the SAP. 
Not applicable.
12.1.1 Adverse Event An Adverse Event (AE) is any 
untoward medical occurrence, 
unintended disease of untoward 
clinical sign (including abnormal 
laboratory findings) in subjects, 
users or other persons, whether or 
not causally related to the 
IP/Ancillary Product. 
Note 1: This definition includes 
events related to the IP, 
comparator or ancillary products. 
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 
IP 
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 

 
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related to the use of investigational 
medical devices or comparators. 
 
12.1.2 Adverse 
Device Effect 
An Adverse Device Effect (ADE) is 
an adverse event that, in the 
opinion of the investigator, is 
related to the use of the IP. 
An Adverse Device Effect (ADE) is an 
adverse event related to the use of an 
investigational medical device. 
 
 
Addition: 
Note 3: This includes "comparator" if 
the comparator is a medical device. 
12.1.3 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, in the view of either the 
Investigator or the Sponsor, it led 
to any of the following: 
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: 
 
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 
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]. 
Deleted
12.1.6 Device 
Deficiency 
A Device Deficiency (DD) is an 
inadequacy of a medical device 
with respect to its identity, 
quality, durability, reliability, 
A Device Deficiency (DD) is an 
inadequacy of a medical device with 
respect to its identity, quality, 
durability, reliability, safety, or 

 
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safety, or performance. DD 
includes malfunctions, use errors 
and inadequate labeling. 
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. 
12.3 Reporting 
procedures 
AE of any kind and DD will be 
recorded in the applicable eCRF 
and source notes. The Investigator 
will evaluate all AE for a 
relationship to the device and 
procedure, if applicable, 
seriousness, and severity. The 
following timescales should be 
followed for the AE/DD 
information to be entered into the 
eCRF and reported to the Sponsor 
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, if applicable, 
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 

 
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or designee (see Figure 12-1 & 
Figure 12-2): 
 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) 
 
For ADE and DD, 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 
eCRF 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 
the criteria for expedited reporting 
to the regulatory authorities. 
 
The investigator will inform the 
IRB/IEC of adverse events 
according to the IRB/IEC 
requirements. 
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 

 
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adverse events according to as per 
the requirements listed below: 
could have led to SADE will be 
reported to IEC/IRB and regulatory 
authorities within 10 working days. 
All other events will be reported on a 
periodic/annual basis. 
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 
 
Deleted 14.1 Contract Research 
Organization 
14.3 Interim 
Monitoring Visit  
N/A
Regular interim monitoring visits will 
be performed by the Sponsor or 
qualified person designated by the 
Sponsor. 
14.4 Close-Out Visit
N/A
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/IEC reporting requirements.  
When no subjects have been included, 
a remove close-out visit may be 
conducted. 
15 Protocol 
Deviations 
N/A
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 

 
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discovered during monitoring visits 
will be compiled in a Protocol / GCP 
Deviation Log (FRM-402046 
Protocol/GCP Deviation Log). 
Significant and/or recurrent 
protocol/GCP deviations will be 
documented on a protocol deviation 
form (FRM-400347 Protocol/GCP 
Deviation) including identified root 
cause and, as necessary, appropriate 
corrective and preventive actions will 
be put in place and signed off by the 
study personnel. If it is deemed 
necessary full clinical Corrective and 
Preventive Action (CAPA) will be 
initiated.  
It is not allowed to use waivers to 
allow planned deviation of the study 
protocol.  
 
An investigator may be early 
terminated from the study upon 
identification of serious protocol 
deviations whereby there are 
concerns for patient safety or data 
quality (especially those not reported 
to the sponsor by the site). Early 
termination may also occur if there 
are repeated protocol deviations 
which have previously been addressed 
via corrective and preventative 
actions thereby suggesting an issue 
with site compliance.  
 
Protocol deviations requiring reporting 
to the IRB/IEC should be done so in 
the timeframe stipulated by the 
IRB/IEC. 
18. Statements of 
Compliance 
N/A
The clinical study is financed by the 
sponsor. All financial arrangements 
between the sponsor and 

 
Clinical Protocol - Device
Study Number: CORI.2019.07
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investigation sites/investigators are 
documented separate clinical trial 
agreements. 
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 sponsor may decide to 
discontinue a specific study site 
under the following conditions: 
-compliance to GCP or study 
protocol 
in subjects 
 
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. 
return to standard of care as 
prescribed by the individual sites if 
further follow-up is needed. The study 
is expected to last 36 months 
(enrolment period: 24 months, 
Follow-up period: 12 months). 
 
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. 
 
An End of Study CRF needs to be 
completed for all subjects including 
any subject that does not complete 
the study, to document the reason for 
termination. 
 
This study may be temporarily 
suspended or prematurely terminated 
if there is sufficient reasonable cause. 
Written notification, documenting the 
reason for study suspension or 

 
Clinical Protocol - Device
Study Number: CORI.2019.07
A Prospective, Multi-center, Study to Evaluate the Safety and 
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termination, will be provided by the 
suspending or terminating party to 
other parties (Investigator, IRB/IEC, 
Sponsor and regulatory authorities). 
If the study is prematurely terminated 
or suspended, the Investigator will 
promptly inform the IRB/IEC and the 
study sites and will provide the 
reason(s) for the termination or 
suspension. Circumstances that may 
warrant termination or suspension 
include, but are not limited to:  
 Determination of unexpected, 
significant or unacceptable risk to 
participants  
 Demonstration of efficacy that 
would warrant stopping  
 Insufficient compliance with study 
protocol requirements  
 Data that are not sufficiently 
complete and/or evaluable  
 Determination of futility  
 
Study may resume once concerns 
about safety, study protocol 
compliance, data quality are 
addressed and satisfy the Sponsor 
and IRB/IEC. 
 
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 
20.1 Publication of 
Study Data 
N/A
The study will be registered in a 
publicly accessible database 
(ClinicalTrials.gov and Clinical Trials 
Registry - India (CTRI)) and the 

 
Clinical Protocol - Device
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results will be made available within 
that database.  
It is intended that the results of this 
study will be submitted for publication 
within a manuscript. 
21 References
N/A
55.
2011 Knee Society Knee 
Scoring System Licensed User Manual 
-
https://www.kneesociety.org/assets/2
011KSS%20Support%20Materials.pdf 
22.1 Protocol 
Amendment 1  
N/A
22.1.1 General Purpose
This amendment has been completed 
to: 
1) increase the pre-operative visit 
window from 28 days to 90 days and 
to allow pre-operative activities to 
occur on the day of surgery as long as 
they occur prior to the surgery itself. 
2) allow the 6-month visit to be 
conducted remotely. 
 
22.1.2 Rationale 
1) Following the COVID pandemic and 
the cancellations of elective surgery 
the waiting lists for surgery have 
increased globally. Extending the visit 
window will aid sites in being able to 
include subjects whose surgery is 
longer than 28 days from their initial 
pre-operative visit without having to 
schedule an additional pre-operative 
visit. 
2) No x-rays are taken at the 6-
month visit so the subject does not 
need to come in to site. The PROMs 
collected at the visit can be sent to 
the subject who can complete them 
whilst on the phone to a member of 
the study team. The PROMs will then 
be securely sent back to site and 
entered into the EDC. The KSS would 

 
Clinical Protocol - Device
Study Number: CORI.2019.07
A Prospective, Multi-center, Study to Evaluate the Safety and 
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-
generated) component of the 
questionnaire completed if the visit is 
remote. However, per the 2011 Knee 
Society Knee Scoring System Licensed 
User Manual [55] outcomes are only 
scored using the patient reported 
responses. Data derived from items 
cian-
generated) component of the 
questionnaire is collected for 
background information and to 
facilitate comparison of patient 
outcome with the old KSCR. 
 
22.1.3 Effect on Study Status 
1) The amendment will ensure more 
potential subjects can be included in 
the study and reflect the 
consequences of the COVID pandemic 
on the current routine clinical 
schedules. There is no impact on any 
subjects that are enrolled prior the 
amendment being effective as the 
amendment is lengthening rather 
than reducing the pre-operative visit 
window. 
2) There will be no impact on any 
subjects reaching the 6-month visit 
prior to the amendment being 
effective because they will have the 
6-month visit on site.  
The database will be updated 
according to the new protocol once 
approved. 
 
22.1.4 Details 
At the time of the amendment the 
protocol template was also updated 
throughout to ensure it is compliant 
with the current effective protocol 
template (TMP-800052/TMP-CD-05 

 
Clinical Protocol - Device
Study Number: CORI.2019.07
A Prospective, Multi-center, Study to Evaluate the Safety and 
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Revised Text 08/Nov/2022
Version 5.0 
Rev 3). The major changes are 
included in the table below. 
 
Addition of this table 
 
22.1.5 Approval/Notification 
These updates will be submitted for 
EC/IRB approval. The changes will 
only be implemented after EC/IRB 
approval confirmation. 
22.5 Clinical Study 
Sites 
N/A
Smith + Nephew will maintain a list of 
the name and address of involved 
sites in the Trial Master File. This list 
is available upon request. 
22.6 Contract 
Research 
Organization 
N/A
S+N will use the following external 
organisations in the conduct of this 
study: 
 providing Clinical Research 
Associates 
 providing 
data management services 
22.7 Principal 
Investigator 
Obligations (ISO 
14155) 
21.4
Principal Investigator 
Obligations (ISO14155:2011) 
Wording updated to ensure ISO 
14155:2020 compliance 
Section numbering / 
protocol version and 
date updated 
throughout 
22.1.1.5 Approval/Notification 
These updates will be submitted for EC/IRB approval. The changes will only be implemented after 
EC/IRB approval confirmation. 

 
Clinical Protocol - Device
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A Prospective, Multi-center, Study to Evaluate the Safety and 
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22.1.2 Protocol Amendment 2 
22.1.2.1 Protocol Version Details 
Protocol Type 
Version and Date of 
protocol being amended
Amendment 
Number 
Version and Date of 
amended protocol 
Master
5.0; 08Nov2023
4
6.0; 15Jan2024
 
22.1.2.2 General Purpose and Rationale 
The purpose of the amendment and the rationale for the changes are as follows: 
1. Adjustment to the sample size calculation used in the CORI.2019.07 study. On a review of 
the sample size it was found that an error had led to too many patients being planned under 
the assumptions provided. A calculation was re-run under the same assumptions as the 
original sample size which found that the reduction of sample size allowed the study to still 
be appropriately powered and avoided recruiting further patients unnecessarily. 
2. Update to the Insurance provision paragraph to reflect the fact this is a global study protocol 
and remove reference to a UK only guideline. 
3. Protocol template update. At the time of the amendment the protocol template was also 
updated throughout to ensure it is compliant with the current effective protocol template 
(TMP-800052/TMP-CD-05 Rev 4). 
22.1.2.3 Summary of Changes 
22.1.2.3.1 Sample Size Changes 
Synopsis, Section 11, Throughout (Where the Total Number of 
Subjects is Stated) 
Old Text - Synopsis: 
140 CORI Robotics procedures: 
70 unicondylar knee arthroplasty (UKA) 
70 total knee arthroplasty (TKA) 
The statistical justification is provided separately for UKA and TKA and is based on data collected 
-operative alignment (±3 
 a historical control. 

 
Clinical Protocol - Device
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New Text - Synopsis 
80 CORI Robotics procedures: 
40 unicondylar knee arthroplasty (UKA) 
40 total knee arthroplasty (TKA) 
The statistical justification is provided separately for UKA and TKA and is based on data collected 
from the NAV
40 subjects per arm, based on post-operative alignment (±3 
 
 
Old Text  Section 11: 
Parratte et al.[53] 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 TKAs post-operatively 
defined as mechanically aligned against the reference proportion of 73.4% from above. 
analysis was estimated to be 92.1% [54]. If this assumption holds for this study, then the 
enrollment of 63 knees for each of the two planned study groups (i.e. the CORI Robotics UKA and 
CORI Robotics TKA) for a total of 126 knees will individually provide 80% power to show that the 
lower limit of the two-sided 95% confidence interval for the proportion of mechanically aligned 
TKAs 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, 70 UKA, 70 TKA) will be enrolled in 
the study.  
New Text  Section 11: 
Parratte et al.[53] 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 TKAs post-operatively 
defined as mechanically aligned against the reference proportion of 73.4% from above. 
The proportion of mechan
analysis was estimated to be 92.1% [54]. If this assumption holds for this study, then the 
enrollment of 36 knees for each of the two planned study groups (i.e. the CORI Robotics UKA and 
CORI Robotics TKA) for a total of 72 knees will individually provide approximately 80% power to 
show that the lower limit of the two-sided 95% confidence interval for the proportion of 

 
Clinical Protocol - Device
Study Number: CORI.2019.07
A Prospective, Multi-center, Study to Evaluate the Safety and 
knee arthroplasty (UKA) and total knee arthroplasty (TKA) 
Procedures 
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mechanically aligned TKAs is greater than that obtained from literature. To account for up to a 10% 
attrition rate in knees enrolled, 40 knees in each group (80 knees combined, 40 UKA, 40 TKA) will 
be enrolled in the study.  
22.1.2.3.2 Insurance 
Section 18 
Old Text: 
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.  
 
New Text:  
Public/Products Liability Insurance has been purchased by Smith & Nephew plc. Worldwide and 
incorporates coverage for personal injury in respect of clinical studies. 
 
22.1.2.3.3 Protocol Template Update 
Section 7 
Addition of a new section: 
7.9 Subject Reimbursement and Incentives  
Subjects will be reimbursed for the costs of taking part in the study in compliance with local 
regulations. These costs will only cover study-specific activities or visits including time, travel, 
standard clinical care. Payments to the subject will be proportionate to the time and expense 
involved in study participation and not so large as to unduly encourage the subjects to participate 
reimbursement payments to subjects will be approved by the IRB/IEC and/or local site authority as 
required. 
Section 13 
13. Investigator Obligations 
Old Text: 
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 22.7 Principal Investigator Obligations (ISO 
14155) of this protocol.  

 
Clinical Protocol - Device
Study Number: CORI.2019.07
A Prospective, Multi-center, Study to Evaluate the Safety and 
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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 as any changes that affect their financial 
disclosure status occur during the course of the study and up to one year after study completion. 
 
New Text: 
The Principal Investigator will comply with the commitments outlined in the Statement of 
Investigator, provided by the Sponsor, and with Good Clinical Practice (GCP), and all applicable 
regulatory requirements as outlined in Appendix 22.7 Principal Investigator Obligations (ISO 
14155) of this protocol. Sub-Investigators, who are individual member of the investigation site 
team designated and supervised by the Principal Investigator at an investigation site to perform 
clinical investigation-related procedures or to make important clinical investigation-related and 
medical treatment decisions, may have responsibilities delegated to them by the Principal 
Investigator. However, the Principal Investigator retains overall responsibility for the clinical 
investigation at the site. 
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 as any changes that affect their financial 
disclosure status occur during the course of the study and up to one year after study completion. 
The Coordinating Investigator appointed by the Sponsor will assist in coordinating the work in the 
multicentre clinical investigation. 
 
22.1.2.3.4 Corrections 
Various typographical, grammatical and formatting errors were corrected within the document.  In 
addition, use of abbreviations was standardized, and terms were added to/removed from the 
abbreviations list as necessary.  
 
22.2 
List of Instructions for Use & User Manuals 
Knee Arthroplasty)  
 
 
 
 
IFU Smith+Nephew Knee Implant Systems (Document ID: 81090287) 
IFU ZUK (Document ID: 81093274) 
IFU STRIDE (Document ID: 50030) 

 
Clinical Protocol - Device
Study Number: CORI.2019.07
A Prospective, Multi-center, Study to Evaluate the Safety and 
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IFU ANTHEM Total Knee System (Document ID: 81105696) 
22.3 
Equipment and Special Instructions 
The following section provides a list of components of the CORI Robotics: 
Table 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 22-2: CORI Robotics Cart 
Article  
Description 
ROB10002 
REAL INTELLIGENCE Robotics Cart Column 
ROB100021 REAL INTELLIGENCE Robotics Cart Base 120 
ROB100022 REAL INTELLIGENCE Robotics Cart Base 220 
 
Table 22-3: CORI Robotics Monitor 
Article  
Description 
ROB10003 REAL INTELLIGENCE 24 in.Touch Screen 
 
Table 22-4: CORI Robotics 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 

 
Clinical Protocol - Device
Study Number: CORI.2019.07
A Prospective, Multi-center, Study to Evaluate the Safety and 
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Description 
ROB10013 REAL INTELLIGENCE Robotic Drill 
ROB10014 REAL INTELLIGENCE Robotic Drill Tracker 
ROB10015 REAL INTELLIGENCE Robotic Drill Attachment 
ROB10016 REAL INTELLIGENCE Robotic Drill Guard 
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 22-5: CORI Robotics 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 22-6: CORI Robotics Lids 
Article  
Description 
ROB10087 Universal Base Tray Lid 
ROB10088 Universal Insert Lid (A) 
ROB10089 Universal Insert Lid (B) 

 
Clinical Protocol - Device
Study Number: CORI.2019.07
A Prospective, Multi-center, Study to Evaluate the Safety and 
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Description 
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) 
 
Table 22-7: CORI Robotics 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 22-8: CORI Robotics JOURNEY II UK 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

 
Clinical Protocol - Device
Study Number: CORI.2019.07
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Table 22-9: CORI Robotics 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) 
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 22-10: Total Knee Instruments 
Article  
Description 
ROB00003 TKA Femur Cut Adapter 
ROB00005 TKA Femur Distal Cut Guide 
Small 

 
Clinical Protocol - Device
Study Number: CORI.2019.07
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Description 
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 
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 22-11: CORI Robotics 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 22-12: CORI Robotics 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 

 
Clinical Protocol - Device
Study Number: CORI.2019.07
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knee arthroplasty (UKA) and total knee arthroplasty (TKA) 
Procedures 
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Description 
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 
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 22-13: CORI Robotics 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
 
 

 
Clinical Protocol - Device
Study Number: CORI.2019.07
A Prospective, Multi-center, Study to Evaluate the Safety and 
knee arthroplasty (UKA) and total knee arthroplasty (TKA) 
Procedures 
Version: 6.0, 15/Jan/2024
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Table 22-14: CORI Robotics 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 
 
Table 22-15: CORI Robotics 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
 

 
Clinical Protocol - Device
Study Number: CORI.2019.07
A Prospective, Multi-center, Study to Evaluate the Safety and 
knee arthroplasty (UKA) and total knee arthroplasty (TKA) 
Procedures 
Version: 6.0, 15/Jan/2024
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TMP-800052  Clinical Protocol-Device  Revision E; PRO-201725 Clinical Protocols 
22.4 
Health Economic Outcome Measures/Quality of 
Life measures 
Not applicable 
22.5 
Clinical Study Sites 
Smith + Nephew will maintain a list of the name and address of involved sites in the Trial Master 
File. This list is available upon request. 
22.6 
Contract Research Organization  
S+N will use the following external organisations in the conduct of this study: 
IQVIA  providing Clinical Research Associates 
Veranex (Quartesian)  providing data management services 
22.7 
Principal Investigator Obligations (ISO 14155) 
1. General:  
a.
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.  
b. 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. 
2. Qualification of the PI. The PI shall: 
a.
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 members of the investigation site team 
shall be provided to the Sponsor through up-to-date Curriculum Vitae (CV) or other 
relevant documentation, 
b. be experienced in the field of application and trained in the use of the investigational device 
under consideration, 
c.
disclose potential conflicts of interest, including financial, that interfere with the conduct of 
the clinical investigation or interpretation of results, and 
d. be knowledgeable with the method of obtaining informed consent. 

 
Clinical Protocol - Device
Study Number: CORI.2019.07
A Prospective, Multi-center, Study to Evaluate the Safety and 
knee arthroplasty (UKA) and total knee arthroplasty (TKA) 
Procedures 
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3. Qualification of investigation site. The PI shall be able to demonstrate that the proposed 
investigation site: 
a.
has the required number of eligible subjects needed within the agreed recruitment period, 
and; 
b. 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,. 
c.
has adequate facilities. 
4. Communication with the IEC. The PI shall:  
a.
provide the Sponsor with copies of any clinical-investigation-related communications 
between the PI and the IEC, 
b. comply with the requirements described in 4.5 of ISO 14155. 
i. 
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 for recruiting 
subjects and advertising materials, if any; a copy of the CV of the PI(s) for with the 
IEC has oversight. 
ii. 
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.  
iii. 
Submit the following to the IEC if required by national regulations, the protocol or IEC, 
whichever is more stringent: 
1. SAEs 
2. 
rights, safety, and well-being, or the scientific integrity of the clinical investigation. 
Document and report to the Sponsor and IEC a report of deviations made to 
protect the rights, safety, and well-being of human subjects under emergency 
circumstances.  
3. Progress reports, including safety summary and deviations 
4. Amendments to any documents already approved by the IEC.  
5. If applicable, notifications of suspension or premature termination 
6. If applicable, justification and request for resuming the clinical investigation after 
suspension.  
7. Clinical investigation report or summary. 
iv. 
As a minimum, during the clinical investigation, the following information shall be 
obtained in writing from the IEC prior to implementation: 
1. Approval/favorable opinion of amendments 
2. 
and well-being or scientific integrity of the clinical investigation 
3. Approval for resumption of a suspended clinical investigation if applicable.  
c.
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, 

 
Clinical Protocol - Device
Study Number: CORI.2019.07
A Prospective, Multi-center, Study to Evaluate the Safety and 
knee arthroplasty (UKA) and total knee arthroplasty (TKA) 
Procedures 
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d. 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. 
5. Informed consent process. The PI shall: 
a.
General: 
i. 
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 applied to 
the subject; except when special circumstances for emergency treatments apply (see 
below) 
b. 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 
egally 
authorized representative:  
i. 
Ensure that the PI or their authorized designee conducts the informed consent process 
ii. 
decision to participate throughout the clinical investigation 
iii. 
Avoid any coercion or undue improper influence on, or inducement of, the subject to 
participate 
iv. 
 
v. 
Use native non-technical language that is understandable to the subject 
vi. 
Provide ample time for the subject to read and understand the informed consent form 
and to consider participation in the clinical investigation 
vii. 
Include personally dated signatures and the PI or an authorized designee responsible 
for conducting the informed consent process 
viii. 
Show how informed consent will be obtained in special circumstances (see below) 
where the subject is unable to provide him or herself, and  
ix. 
Ensure important new information is provided to new and existing subjects throughout 
the clinical investigation.  
c.
Special circumstances for informed consent (the following provisions are subject to national 
regulations): 
i. 
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 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 
their ability to understand.  
ii. 
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 their legally authorized representative and, 
whenever possible, either shall sign and personally date the informed consent form. 

 
Clinical Protocol - Device
Study Number: CORI.2019.07
A Prospective, Multi-center, Study to Evaluate the Safety and 
knee arthroplasty (UKA) and total knee arthroplasty (TKA) 
Procedures 
Version: 6.0, 15/Jan/2024
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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.  
iii. 
Emergency treatments:  
1. For clinical investigations involving emergency treatments, when prior informed 
consent of the subject is not possible because 
shall be requested.  
2. When it is not possible to obtain prior informed consent from the subject, and the 
epresentative, is not available, the subject may still be 
enrolled if a specific process has been described in the protocol.  
3. Arrangements shall be made to inform the subject or legally authorized 
representative
clusion in the clinical 
investigation and about all aspects of the clinical investigation.  
4. The subject shall be asked to provide informed consent for continued participation 
as soon as their medical condition allows.  
d. The Principal Investigator may not enroll a subject without obtaining informed consent of 
the subject or their legally authorized representative only when the following conditions are 
fulfilled: the prospective subject fulfils the emergency 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.  
e.
Information provided to the subject. All information pertinent to the clinical investigation, 
including at least the following, shall be provided in writing and in native, non-technical 
authorized 
representative): 
i. 
Description and purpose 
ii. 
Potential benefits 
iii. 
Risks and inconveniences or the subject and, when applicable, for any embryo, fetus 
or nursing infant 
iv. 
Alternative procedures 
v. 
Confidentiality 
vi. 
Compensation 
vii. 
Anticipated expenses, if any, to be borne by the subject for participating in the clinical 
investigation 
viii. 
Information on the 
 
ix. 
Contact persons 
x. 
Statement declaring that new findings or the reasons for any amendment to the 
subject  
xi. 
 
xii. 
Statement indicating that a description of the clinical investigation has or shall be 
registered in a publicly accessible database 

 
Clinical Protocol - Device
Study Number: CORI.2019.07
A Prospective, Multi-center, Study to Evaluate the Safety and 
knee arthroplasty (UKA) and total knee arthroplasty (TKA) 
Procedures 
Version: 6.0, 15/Jan/2024
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CONFIDENTIAL AND PROPRIETARY 
TMP-800052  Clinical Protocol-Device  Revision E; PRO-201725 Clinical Protocols 
xiii. 
Termination procedures 
f. 
Informed consent signature shall contain the following:  
i. 
The voluntary agreement to participate in the clinical investigation and follow the 
 
ii. 
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; 
iii. 
A statement declaring that discontinuation/withdrawal and thereby revoking the 
informed consent at any time incurs no penalty for the subject; 
iv. 
A statement with regard to the possible consequences of withdrawal 
v. 
An acknowledgment of the information provided and confirmation that all the subje
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 
vi. 
A statement confirming that the subject or their legally authorized representative 
investigation 
vii. 
A statement confirming that the subject or their legally authorized representative 
IEC representatives 
 
g. New information: if new information becomes available that can significantly affect a 
subject(s) affected in written form. If relevant, all affected subjects shall be asked to 
confirm their continuing consent in writing.  
h. ensure compliance with the applicable regulatory requirements and ethical principles for the 
process of obtaining informed consent, and 
i. 
ensure and document appropriate training if an authorized designee is appointed to conduct 
the informed consent process. 
6. Compliance with the protocol. The Principal Investigator shall: 
a.
indicate their acceptance of the protocol in writing, 
b. conduct the clinical investigation in compliance with the protocol, 
c.
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,, 
d. ensure that the investigational device is used solely by authorized users as specified in 6.2, 
and in accordance with the protocol and instructions for use, 
e.
propose to the Sponsor any appropriate modification(s) of the protocol or investigational 
device or of the use of the investigational device, 
f. 
refrain from implementing any modifications to the protocol without agreement from the 
Sponsor, IEC and regulatory authorities, if required, 
g. document and explain any deviation from the approved protocol that occurred during the 
course of the clinical investigation, 
h. ensure that an adequate investigation site team and facilities exist and are maintained and 
documented during the clinical investigation, 
i. 
ensure that maintenance and calibration of the equipment relevant for the assessment of 
the clinical investigation is appropriately performed and documented, where applicable, 

 
Clinical Protocol - Device
Study Number: CORI.2019.07
A Prospective, Multi-center, Study to Evaluate the Safety and 
knee arthroplasty (UKA) and total knee arthroplasty (TKA) 
Procedures 
Version: 6.0, 15/Jan/2024
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CONFIDENTIAL AND PROPRIETARY 
TMP-800052  Clinical Protocol-Device  Revision E; PRO-201725 Clinical Protocols 
j. 
ensure the accuracy, completeness, legibility, and timeliness of the data reported to the 
Sponsor in the CRF and in all required reports, 
k.
maintain the device accountability records, 
l. 
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 accurate analysis where 
appropriate. requirements and provide any information need to analyze device deficiencies, 
if applicable. 
m. allow and support the Sponsor to perform monitoring and auditing activities, 
n. be accessible to the monitor and respond to questions during monitoring visits, 
o.
determine the cause and implement appropriate corrective and preventative actions to 
address significant noncompliance, 
p. allow and support regulatory authorities and the IEC when performing auditing activities, 
q. ensure that all clinical-investigation-related records are retained as required taking 
measures to prevent accidental or premature destruction, and 
r. 
review and sign the clinical investigation report, as applicable. 
7. Medical care of subjects. The Principal Investigator shall 
a.
provide adequate medical care to a subject during and after a subject's participation in a 
clinical investigation in the case of adverse events,  
b. inform the subject of the nature and possible cause of any adverse events experienced, 
c.
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, 
d. inform the subject of any new significant findings occurring during the clinical investigation, 
including the need for additional medical care that may be required, 
e.
provide the subject with well-defined procedures for possible emergency situations related 
to the clinical investigation, and make the necessary arrangements for emergency 
treatment, including decoding procedures for blinded/masked clinical investigations, as 
needed, 
f. 
ensure that clinical records are clearly marked to indicate that the subject is enrolled in a 
particular clinical investigation, 
g. 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), 
h. 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  
i. 
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. 
8. Safety reporting. The Principal Investigator shall: 
a.
record every adverse event and observed device deficiency, together with an assessment, 
b. 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 information shall be 
promptly followed by detailed written reports, as specified in the protocol, 

 
Clinical Protocol - Device
Study Number: CORI.2019.07
A Prospective, Multi-center, Study to Evaluate the Safety and 
knee arthroplasty (UKA) and total knee arthroplasty (TKA) 
Procedures 
Version: 6.0, 15/Jan/2024
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CONFIDENTIAL AND PROPRIETARY 
TMP-800052  Clinical Protocol-Device  Revision E; PRO-201725 Clinical Protocols 
c.
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,  
d. 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 
e.
supply the Sponsor, upon Sponsor's request, with any additional information related to the 
safety reporting of a particular event. 
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: 
1. 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. 
2. 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. 
3. 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. 
4. 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 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. 
5. 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. 
 
Investigational device including clinical procedure risks and their disclosure.  The PI shall: 
a. Evaluate risks according to ISO 14971 before starting a trial, 
b. Summarize benefit-risk analysis in trial documents, 
c. Add residual risk and their nature, occurrence, severity, and outcome to the IB, 
d. Include in CIP all anticipated adverse device effects and a rationale for the related 
benefit-risk ratio, 
e. Include any anticipated adverse device effect in the consent form. 

Certificate Of Completion
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inadvertently not receiving any notice or disclosure, we prefer to provide all of the required 
notices and disclosures to you by the same method and to the same address that you have given 
us. Thus, you can receive all the disclosures and notices electronically or in paper format through 
the paper mail delivery system. If you do not agree with this process, please let us know as 
described below. Please also see the paragraph immediately above that describes the 
consequences of your electing not to receive delivery of the notices and disclosures 
electronically from us. 
 
How to contact Smith Nephew - Sub:  
You may contact us to let us know of your changes as to how we may contact you electronically, 
to request paper copies of certain information from us, and to withdraw your prior consent to 
receive notices and disclosures electronically as follows: 
To contact us by email send messages to: joshua.cohen@smith-nephew.com 
 
To advise Smith Nephew - Sub of your new email address  
To let us know of a change in your email address where we should send notices and disclosures 
electronically to you, you must send an email message to us at joshua.cohen@smith-nephew.com 
and in the body of such request you must state: your previous email address, your new email 
address.  We do not require any other information from you to change your email address.  
If you created a DocuSign account, you may update it with your new email address through your 
account preferences.  
 
To request paper copies from Smith Nephew - Sub  
To request delivery from us of paper copies of the notices and disclosures previously provided 
by us to you electronically, you must send us an email to joshua.cohen@smith-nephew.com and 
in the body of such request you must state your email address, full name, mailing address, and 
telephone number. We will bill you for any fees at that time, if any. 
 
To withdraw your consent with Smith Nephew - Sub  
To inform us that you no longer wish to receive future notices and disclosures in electronic 
format you may: 

i. decline to sign a document from within your signing session, and on the subsequent page, 
select the check-box indicating you wish to withdraw your consent, or you may; 
ii. send us an email to joshua.cohen@smith-nephew.com and in the body of such request you 
must state your email, full name, mailing address, and telephone number. We do not need any 
other information from you to withdraw consent..  The consequences of your withdrawing 
consent for online documents will be that transactions may take a longer time to process.. 
 
Required hardware and software  
The minimum system requirements for using the DocuSign system may change over time. The 
current system requirements are found here: https://support.docusign.com/guides/signer-guide-
signing-system-requirements.  
 
Acknowledging your access and consent to receive and sign documents electronically  
To confirm to us that you can access this information electronically, which will be similar to 
other electronic notices and disclosures that we will provide to you, please confirm that you have 
read this ERSD, and (i) that you are able to print on paper or electronically save this ERSD for 
your future reference and access; or (ii) that you are able to email this ERSD to an email address 
where you will be able to print on paper or save it for your future reference and access. Further, 
if you consent to receiving notices and disclosures exclusively in electronic format as described 
herein, then select the check-
 
By selecting the check-
that: 
 
You can access and read this Electronic Record and Signature Disclosure; and 
 
You can print on paper this Electronic Record and Signature Disclosure, or save or send 
this Electronic Record and Disclosure to a location where you can print it, for future 
reference and access; and 
 
Until or unless you notify Smith Nephew - Sub as described above, you consent to 
receive exclusively through electronic means all notices, disclosures, authorizations, 
acknowledgements, and other documents that are required to be provided or made 
available to you by Smith Nephew - Sub during the course of your relationship with 
Smith Nephew - Sub.