Comparison of Alignment Achieved Using the VELYS Robotic-Assisted Solution Versus Manual Instrumentation in Total Knee Arthroplasty: A Prospective, Non-Randomized Multi-Center Post-market Clinical Investigation
Phase: NA
Conditions: Osteo Arthritis Knee, Osteoarthritis
Sponsor: DePuy Orthopaedics

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DePuy Synthes 
CLINICAL RESEARCH 
PROTOCOL/CLINICAL INVESTIGATION PLAN (CIP) 
Comparison of Alignment achieved using the VELYSTM Robotic-Assisted 
Solution versus Manual Instrumentation in Total Knee Arthroplasty: A 
Prospective, Non-Randomized Multi-Center post-market Clinical 
Investigation 
This document is a confidential communication of DePuy Orthopaedics Inc. The recipient agrees that no unpublished 
information contained herein will be published or disclosed without prior written approval by DePuy Orthopaedics 
Inc. except that this document may be disclosed to appropriate oversight authorities or duly authorized 
representatives of the U.S. Food and Drug Administration or other responsible regulatory authorities under the 
condition that they are requested to keep it confidential. 
Clinical Investigation Plan (CIP) 
Number: 
DSJ_2019_08 
Country: 
USA 
CIP Prepared By: 
Ian Leslie, Ph.D, MEng 
Staff Clinical Research Scientist 
CIP Version & Date: 
Rev F   06-June-2022 
Clinical Investigation Sponsor: 
DePuy Orthopaedics, Inc. 
PO Box 988 
700 Orthopaedic Drive 
Warsaw, IN 46581-0988 
Tel: 1- (800)-473-3789 
NCT04730271

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PROTOCOL SIGNATURE PAGE 
DSJ_2019_08: Comparison of Alignment achieved using the VELYS Robotic-Assisted Solution versus Manual Instrumentation in Total 
Knee Arthroplasty: A Prospective, Non-Randomized Multi-Center post-market Clinical Investigation 
Version  
Version Date  
Description of changes  
C 
22 July 2020 
First version reviewed by Investigators  
D 
 04-Feb-21 
Updated to reflect regulatory clearance of the VELYS Robotic-Assisted 
Solution. Information on pre-clinical testing added, Exhibits C & D 
added with product codes.  
E 
11-Aug-21 
Updated Primary objective to assessment of accuracy of alignment to 
plan as opposed to neutral.  
F 
06-June-22 
Update to rules related to enrollment target reallocation. Removal of 
duplicate codes in Appendix D 
Principal Investigator: I have read this protocol and agree to conduct this clinical investigation in 
accordance with the design and specific provisions outlined herein. I understand the protocol, and 
I understand I am solely responsible to ensure the investigation is conducted accordance with Good 
Clinical Practices (GCP), applicable country regulations, the Declaration of Helsinki, applicable local 
regulations, the signed clinical study contract with Sponsor and with the protocol outlined herein.  
I will conduct this study as outlined therein and will make reasonable effort to complete the study within 
the time period designated by the Sponsor. 
I will provide copies of the protocol and all pertinent information to all individuals responsible to me 
who will assist in the conduct of this study. I will discuss this material with them to ensure they are fully 
informed regarding the device and the conduct of the study.  
I will fulfill the requirements of my Institutional Review Board (IRB)/ Ethics Committee (EC), or other 
oversight committee, to ensure complete and continual oversight of this clinical investigation.  
I will use an Informed Consent Document approved by the Sponsor and my reviewing IRB/EC (where 
required).  
I agree to report all information or data in accordance with the protocol and, in particular, I agree to 
report any serious adverse events, device related adverse events, or procedure related adverse events 
as defined in this protocol to the Sponsor and comply with all adverse events reporting requirements of 
my reviewing IRB/EC. 
I agree to permit the Sponsor, its authorized representatives, my reviewing IRB/EC, and any regulatory 
authority/body access to all records relating to the clinical investigation. The below signature confirms I 
have read and understood this protocol and its associated amendments or attachments and will accept 
respective revisions or amendments provided by the Sponsor. 
PRINTED OR TYPED NAME 
 
SIGNATURE 
 
DATE 
 
 
 
 
 
Principal Investigator 
 
 
 
 

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Table of Contents 
1 
SUMMARY ............................................................................................................................................ 6 
2 
INTRODUCTION .................................................................................................................................... 9 
2.1 Summary of Preclinical/Clinical Experience ...................................................................................... 9 
2.2 Summary of Published Literature .................................................................................................... 10 
3  
RATIONALE ......................................................................................................................................... 11 
3.1 Study Rationale ................................................................................................................................ 11 
3.2 Study Design Rationale .................................................................................................................... 11 
3.3 Rationale of Endpoints ..................................................................................................................... 11 
3.4 Rationale of Study Population ......................................................................................................... 12 
4 
SUBJECT DEFINITION .......................................................................................................................... 12 
4.1 Inclusion Criteria .............................................................................................................................. 12 
4.2 Exclusion Criteria .............................................................................................................................. 13 
4.3 Definition of Subject Enrollment ..................................................................................................... 13 
5 
OBJECTIVES ......................................................................................................................................... 13 
5.1 Primary Objective ............................................................................................................................. 13 
5.2 Secondary Objectives ....................................................................................................................... 14 
5.3 Tertiary Objectives ........................................................................................................................... 14 
6 
STUDY DESIGN .................................................................................................................................... 16 
7 
PROTOCOL .......................................................................................................................................... 17 
7.1 Subject Enrollment ........................................................................................................................... 17 
7.1.1 Subject Screening ....................................................................................................................... 17 
7.1.2 Subject Informed Consent ......................................................................................................... 17 
7.1.3 Subject Identification Numbering .............................................................................................. 20 
7.2 Study Procedures ............................................................................................................................. 20 
7.2.1 Detailed Instructions on Data Collection ................................................................................... 20 
7.2.2 Subject Evaluation Tools ............................................................................................................ 23 
7.2.3 Pre-operative Management ....................................................................................................... 24 
7.2.4 Operative Management ............................................................................................................. 24 
7.2.5 Post-operative Management ..................................................................................................... 25 
7.2.6 Radiographic Procedures ........................................................................................................... 26 
7.3 Discontinuation of Subject Participation ......................................................................................... 26 

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7.3.1 Enrollment Replacement Rules .................................................................................................. 26 
7.4 Post-operative Withdrawal of Enrolled Subjects ............................................................................ 27 
7.5 Revisions/Re-operations .................................................................................................................. 28 
7.6 Lost to Follow-up .............................................................................................................................. 28 
8   
STATISTICAL METHODOLOGY ............................................................................................................ 29 
8.1 Study Design ..................................................................................................................................... 29 
8.2 Treatment Assignment ..................................................................................................................... 29 
8.3 Randomization and Blinding Procedures ........................................................................................ 29 
8.4 Interval Windows ............................................................................................................................. 29 
8.5 Levels of Significance........................................................................................................................ 30 
8.6 Analysis Sets ..................................................................................................................................... 30 
8.6.1 ITT Analysis Set ........................................................................................................................... 30 
8.6.2 Safety Analysis Set ..................................................................................................................... 31 
8.6.3 PP Analysis Set ........................................................................................................................... 31 
8.7 Sample Size Justification .................................................................................................................. 31 
8.8 Analyses to be Conducted ................................................................................................................ 31 
8.8.1 General Conventions .................................................................................................................. 31 
8.8.2 Disposition of Study Subjects ..................................................................................................... 31 
8.8.3 Demographic and Baseline Characteristics ................................................................................ 32 
8.8.4 Primary and Secondary Endpoints and Associated Hypotheses ................................................ 33 
8.8.4.1 Primary Endpoint and associated hypotheses ........................................................................ 33 
8.8.4.2 Secondary Endpoints and associated hypotheses ................................................................... 33 
8.8.4.3 Additional Endpoints (Exploratory) ......................................................................................... 34 
8.8.5 Plans for Interim Analysis ........................................................................................................... 35 
8.8.6 Handling of Missing Data ........................................................................................................... 35 
9 RISK ANALYSIS ......................................................................................................................................... 35 
9.1 Anticipated Adverse Events / Non-Reportable Adverse Events ..................................................... 35 
9.2 Study Related Risks/Reportable Adverse Events ............................................................................ 35 
9.3 Benefit Analysis ................................................................................................................................ 36 
9.4 Adverse Event Reporting ................................................................................................................. 37 
9.4.1 Adverse Event Reporting Guidelines .......................................................................................... 38 
9.5 Minimization of Risks ....................................................................................................................... 40 

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10 DEVICE DESCRIPTION ............................................................................................................................ 41 
10.1 Surgical Instruments ...................................................................................................................... 41 
10.1.1 VELYS Robotic-Assisted Solution .............................................................................................. 41 
10.1.2 ATTUNE Intuition Instruments (Manual Instruments) ............................................................. 42 
10.2 Implants .......................................................................................................................................... 42 
11 INVESTIGATOR RESPONSIBILITIES AND GOOD CLINICAL PRACTICES .................................................. 43 
11.1 Institutional Review Board (IRB)/Ethics Committee (EC) Approval ............................................. 44 
11.2 Informed Consent ........................................................................................................................... 44 
11.3 Protected Health Information ....................................................................................................... 44 
11.4 Subject Discontinuation from the Clinical Investigation .............................................................. 45 
11.5 Source Documentation .................................................................................................................. 45 
11.6 Record of Device Inventory ............................................................................................................ 45 
11.7 Case Report Form Completion and Data Submission ................................................................... 45 
11.8 Protocol Adherence ........................................................................................................................ 46 
11.9 CIP Amendments ............................................................................................................................ 46 
11.10 Reports ......................................................................................................................................... 46 
11.11 Investigator Site File ..................................................................................................................... 47 
11.12 Investigator Study Termination ................................................................................................... 47 
12 SPONSOR OBLIGATIONS ........................................................................................................................ 48 
12.1 IRB/EC Approval ............................................................................................................................. 48 
12.2 Investigator Training, Study Initiation ........................................................................................... 48 
12.3 Study Monitoring ........................................................................................................................... 48 
12.4 Sponsor Study Termination ........................................................................................................... 48 
13 Investigational Plan EXHIBITS ............................................................................................................... 49 
EXHIBIT A: Non-Reportable Adverse Events ............................................................................................. 50 
EXHIBIT B: References ................................................................................................................................ 51 
EXHIBIT C: PRODUCT CODES OF THE VELYS ROBOTIC-ASSISTED SOLUTION ............................................ 53 
EXHIBIT D: PRODUCT CODES OF THE ATTUNE IMPLANTS ........................................................................ 58 
 

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1 
SUMMARY  
 
 
 
 
 
 
 
 
 
 
Title: 
Comparison of Alignment achieved using the VELYS Robotic-Assisted Solution versus Manual 
Instrumentation in Total Knee Arthroplasty: A Prospective, Non-Randomized Multi-Center 
post-market Clinical Investigation 
Short Title: 
Clinical Evaluation of the Accuracy of the VELYS Robotic-Assisted Solution 
Protocol 
Number: 
DSJ_2019_08 
Treatment 
Devices: 
The treatment device is the VELYS Robotic-Assisted Solution which is used for assessing the 
anatomy of a patient’s knee, assisting in the planning of the position of the femur and tibia 
implant components intra operatively and assisting the surgeon with the bone preparation 
during total knee arthroplasty. The system will be utilized to implant ATTUNE total knee 
replacements. Any of the commercially available configurations of the ATTUNE primary knee 
system are permitted for use according to the standard of care at the site. Those subjects 
treated using VELYS Robotic-Assisted Solution will be referred to as the Robotics cohort. 
Control Device: 
The control devices are the ATTUNE Intuition instruments which are manual instruments. 
This instrument system will be utilized to implant ATTUNE total knee replacements. Any of 
the commercially available configurations of the ATTUNE primary knee system are permitted 
for use according to the standard of care at the site. Those subjects treated using the 
Intuition Instruments will be referred to as the Manual cohort. 
Intended Use for 
the Device: 
The intended use of the VELYS Robotic-Assisted Solution is to assist the surgeon to perform 
primary total knee arthroplasty utilizing the ATTUNE knee system.  
Primary 
Objective: 
To determine whether the accuracy to plan of the  long leg alignment achieved with the 
VELYS Robotic-Assisted Solution is non-inferior to the accuracy to plan of the long leg 
alignment achieved with the manual ATTUNE Intuition instrumentation. This will be assessed 
on long-leg X-rays taken at 12 weeks.  
• 
Note: If non-inferiority is successfully demonstrated, then the study will be deemed 
to be successful, and a test for superiority of accuracy to plan of the long leg  
alignment achieved with VELYS Robotic-Assisted Solution will be conducted.  
Secondary 
Objectives: 
Evaluate the nature, severity, and frequency of local adverse events associated with the use 
of the VELYS Robotic-Assisted Solution in total knee arthroplasty during the procedure and 
within the subsequent 12 weeks, 90 days1 and 1 year.  
Conduct intra-operative clinical assessment of soft tissue damage in both Manual and 
Robotics cohorts. 
Summarize the alignment outliers (>3 degrees outside of plan) in both Manual and Robotics 
cohorts. 
Summarize surgical time for the Robotics and Manual cohorts.  
Summarize individual component alignment achieved with manual instruments and Robotics 
in the frontal and sagittal planes, specifically: distal femoral varus-valgus (FM), proximal tibial 
varus-valgus (TM), femoral component flexion and tibial slope. 
 
1 This is a specific analysis of data to determine number of AEs that occurred within 90 days of the procedure 
determined at 1year follow up – there is no 90 day visit.  

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Title: 
Comparison of Alignment achieved using the VELYS Robotic-Assisted Solution versus Manual 
Instrumentation in Total Knee Arthroplasty: A Prospective, Non-Randomized Multi-Center 
post-market Clinical Investigation 
Short Title: 
Clinical Evaluation of the Accuracy of the VELYS Robotic-Assisted Solution 
Protocol 
Number: 
DSJ_2019_08 
Tertiary 
Objectives: 
To evaluate impact of surgeon learning curve on the VELYS Robotic-Assisted Solution on 
accuracy of surgical procedure (assessed via accuracy of long leg alignment to plan), patient 
reported outcomes, safety, and surgical time. 
Comparison of patient reported outcomes (EQ-5D 5L, Knee Injury and Osteoarthritis 
Outcome Score (KOOS), Forgotten Joint Score (FJS), Pain and Satisfaction) for the Robotics 
cohort vs. the Manual cohort at 12 weeks and 1 year post-operatively.  
Comparison of length of hospitalization/stay for the Robotics cohort vs. the Manual cohort.  
For the Robotics cohort there will be additional exploratory objectives to measure the 
correlation between the various parameters that the system records in the case report and 
what is measured via other methods post operatively.   
Study Design: 
Prospective sequential controlled cohort study. Each site will enroll Subjects into the Manual 
cohort until their enrollment target has been reached, and then will enroll Subjects into the 
Robotics cohort.  
Level of evidence: Level II 
Number of Sites: 
Up to 8 sites in the USA. Cohort reallocation is permitted. 
Study Subject 
Population  
Patients aged 22-85 years who meet the indications of the ATTUNE Knee system in a primary 
case including patients with severely painful and/or severely disabled joint resulting from 
osteoarthritis, post-traumatic arthritis or rheumatoid arthritis. 
Sample Size 
N= 200 will be enrolled; 100 in the manual surgical technique arm, and 100 in the robotic 
arm.   
Study Duration: 
It is anticipated that recruitment for both arms will be completed in 6 months. Follow-up is 1 
year, therefore, the total planned study duration is approximately 18 months.   
Procedure 
Schedule 
Subjects included in the investigation will be evaluated pre-operatively, at 12 weeks and 1 year 
postoperatively. 
See Time & Events Table for details. 
Safety 
Type and frequency of Adverse Events will be collected. Site Ethics Committees/IRBs will 
provide oversight for study Subject safety. 
 
 
 

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Table 1-1: Time and Events Table 
  
Pre-op 
             
Operative 
12wks 
1yr 
Required 
-90 to 0d 
Day 0 
7d to 182d 
183d to 547d 
Preferred 
-90d to 0d 
28d to 112d 
335d to 395d 
Informed Consent 
S 
eCRF: Study Visit 
E 
E 
E 
eCRF: Demographics 
E 
 
 
eCRF: Medical History 
E 
 
 
eCRF: Height & Weight 
E 
 
 
eCRF: Range of Motion 
E 
E 
 
eCRF: KOOS 
P 
P 
P 
eCRF: FJS 
 
P 
P 
eCRF: EQ-5D-5L 
P 
P 
P 
 
eCRF: Subject Knee Outcome 
(Pain & Satisfaction) 
P 
P 
P 
 
eCRF: Pain Catastrophizing Scale 
P 
 
 
eCRF XR: Radiographs 
 
 
 
 Long leg AP (weight bearing) 
X2 
X 
 
 Lateral view 
X2 
X 
 
eCRF: Study Procedure 
 
E 
 
 
eCRF: Device Log 
 
E 
 
 
eCRF: Adverse Event 
 
E* 
E* 
E* 
eCRF: Device Deficiency 
 
E* 
 
 
eCRF: Discharge 
 
E 
 
 
System Case Report (Robotics 
cohort only)  
 
D 
 
 
eCRF: Subject 
Completion/Discontinuation 
E* 
E* 
E* 
eCRF: Protocol Deviation  
E* 
E* 
E* 
eCRF: Reoperation 
 
E* 
E* 
LEGEND: 
S = Remains on site as source document 
E = Source data transcribed onto electronic Case Report Form (eCRF) and submitted to sponsor 
E* = Source data transcribed onto eCRF and submitted to sponsor, as needed 
P = Patient Recorded Outcome, completed by Subject, data entered on eCRF & submitted to sponsor 
X = X-ray image to be submitted to core imaging lab for analysis 
D = case reports stored on the VELYS Robotic-Assisted Solution are the source document with copies of all reports related to 
Subjects sent to sponsor at the end of the study.  
 
2 Pre-operative assessment window is -90d to 0d, but pre-operative radiographs may be taken from -180d (or 
older, if they are still determined to be acceptable for surgical planning at the discretion of the PI) to day of surgery 
to avoid increased radiation exposure if the required views have already been taken as standard of care prior to -
90d.  
 

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2 
INTRODUCTION 
 
 
 
 
 
 
 
 
 
 
Primary total knee arthroplasty (TKA) is a common, elective surgical procedure performed frequently to 
alleviate pain most commonly due to osteoarthritis, with factors such as age (older being more frequently 
replaced) and gender (females being more frequent sufferers of knee OA) influencing the patient 
demographics. The clinical demand for TKA use is increasing, with demand for primary total knee 
replacement in the United States alone being forecast to rise by over 600% to 3.48M from 2005 to 2030[1].   
The surgical process is a key contributor to the success of TKA with orthopaedic surgeons striving to 
execute bone resections and make soft tissue adjustments to achieve optimal implant position; ensuring 
longevity and improved patient function and satisfaction. Therefore, over time there has been a continual 
evolution in the techniques and technologies employed to achieve this goal. Manual instrumentation 
including jigs, fixtures and cutting guides are used to guide the surgeons’ resections relative to anatomical 
landmarks such as the tibial axis, femoral canal and posterior condylar axis. This method was first 
developed in the 1980s and when combined with surgeon skill and experience generally results in good 
outcomes and remains the most commonly used methodology for implanting a total knee. However, up 
to 6% of patients who undergo a primary TKA may require a revision within 5 years of the procedure[2] 
and whilst the majority of revisions are attributed to infection it is widely accepted that implant 
positioning influences the rate of other leading causes of revision such as instability and  loosening [3].  
 
One of the key parameters in the outcome of the surgical procedure is the alignment of the knee implant 
components relative to the mechanical axis of the leg. The mechanical alignment philosophy was 
proposed by Insall and has become the standard procedure employed [4]. Mechanical axis alignment is 
defined as the line drawn from the center of the femoral head through the center of the knee and ankle. 
The knee is generally considered to be in proper alignment when these three points are collinear in the 
frontal plane [4-6]. Many authors have observed that the correct alignment of the lower limb is correlated 
with clinical success in total knee arthroplasty [6-8]. 
 
In a bid to increase consistency in the achievement of parameters such as alignment, Computer Assisted 
Surgery (CAS) was developed in the early 2000’s. Optical localization technology is used to collect intra-
operative data and track relative position of the bones and instruments during surgery. Intra-operative 
data is used to register the patient anatomy and enables the surgeon to define and adjust planning for 
the placement of the implant. Based on the plan, the system guides the surgeon to position cutting blocks 
which in turn controls alignment of the cutting plane for the required steps. More recently robotic systems 
have been introduced which build on the same technology developed for CAS whilst providing more 
control or assistance to the surgeon during execution of the resections to increase the probability of 
achieving the desired outputs. The VELYS Robotic-Assisted Solution is currently being developed by the 
sponsor and is the focus of this study.  
 
2.1 Summary of Preclinical/Clinical Experience 
Bench testing was performed on the subject device, VELYS Robotic-Assisted Solution, in accordance with 
the product risk analysis and product requirements. This included testing that addressed accuracy and 
repeatability, service life, mechanical integrity and usability of the system. All acceptance criteria were 
met, and no issues of Safety or Effectiveness were identified. 
 

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A cadaveric study compared the accuracy of the VELYS Robotic-Assisted Solution to manual 
instrumentation. Five surgeons each performed eight bilateral total knee replacement surgeries – with 
the VELYS Robotic-Assisted Solution one side and conventional instruments (ATTUNE Intuition) on the 
contralateral side (total sample size of 40). Bone resection depth levels were measured intra-operatively 
using digital calipers. Resected bones were CT and laser scanned, then bone preparation was completed, 
followed by implanting. Final implant position was measured using additional laser scanning.  
During each case, surgeons evaluated the integrity of defined knee soft tissue structures (medial collateral 
ligament [MCL], lateral collateral ligament [LCL], posterior cruciate ligament [PCL], Posterior Medial 
capsule, Posterior Lateral capsule, and the patellar ligament) after completing all bone resections. 
Additionally, surgeons were asked to evaluate resected bone quality, overall final long leg alignment, 
and soft-tissue balance during trialing.  
 The robotic-assisted surgical cohort had statistically smaller mean absolute errors for femoral varus-
valgus angle (p<0.000), tibial varus-valgus angle (p=0.001), and tibial proximal resection thickness 
(p<0.000) and were statistically equivalent to manual instrumentation for femoral flexion-extension angle, 
femoral internal external angle, femoral distal resection depth and tibial flexion-extension (posterior 
slope) angle. The robotic-assisted cohort was also found to have statistically smaller errors in final implant 
alignment for femoral varus-valgus angle, femoral flexion-extension and tibial varus-valgus angles.  
All inspected soft tissue was uncompromised following robotic-assisted bone resection. After each 
procedure, all surgeon participants responded ‘Yes’ when asked if the final long leg alignment was 
clinically acceptable. In addition, all surgeon participants responded ‘Yes’ when asked if the knee soft 
tissue was stable and balanced.  
 
2.2 Summary of Published Literature 
There are currently no published clinical results for the VELYS Robotic-Assisted Solution, however, the use 
of robotic systems in orthopaedics has been steadily increasing in popularity over the past 10 years.  
Literature suggests that the currently available systems can increase the accuracy vs. manual 
instrumentation in both unicondylar knee arthroplasty (UKA) [9-11] and TKA [12-15].  
A learning curve has been identified with the introduction of robotic systems for UKA and TKA which is 
associated with an increase in the operating time but importantly, based on the current literature this 
period is not associated with an increase in adverse events or a reduction in accuracy [16-21]. There is no 
consensus on the length of the learning curve with large variation in the number of cases found in these 
studies. It will clearly vary depending on the system, the amount of previous experience with 
CAS/Robotically assisted surgery, the training and support provided to the new user and how steady state 
is defined.   
Translation of the improvement in accuracy to improvements in other outcomes such as patient 
satisfaction, pain and function are less clear with some studies finding no difference [22, 23] and other 
studies finding subtle improvements [24-26]. This may be due to these clinical outcomes being highly 
dependent of factors beyond the accuracy of the placement of the implant.  

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3  
RATIONALE  
 
 
 
 
 
 
 
 
 
 
3.1 Study Rationale 
VELYS Robotic-Assisted Solution is a new system without pre-existing clinical data. Adoption of VELYS 
Robotic-Assisted Solution will be dependent on demonstrating that the system can effectively aid the 
surgeon to achieve the targeted alignment when compared to manual instrumentation. Furthermore, this 
study will provide opportunities for active post-market clinical follow-up including documentation and 
review of adverse effects in relation to use of the study device. 
 
3.2 Study Design Rationale 
The study is designed as a multi-center prospective sequential controlled cohort study. Each site will enroll 
Subjects into the manual cohort until their enrollment target has been reached, and then will enroll 
Subjects into the robotic cohort. The manual cohort will be used as benchmark data that the robotic 
cohort can be compared to. A sequential design was chosen to mitigate the risk of learnings from the 
study arm influencing the control arm. As the primary objective is accuracy which can be measured 
objectively randomizing was deemed to not add any benefit. Likewise blinding the Subjects would add 
significant complexity to the study without influencing the objective measures that are the focus of the 
study. A single knee system (ATTUNE) will be used to minimize variation.  
 
3.3 Rationale of Endpoints 
The primary endpoint of long leg alignment accuracy measured at 12 weeks was selected as accuracy of 
implant placement is the element of the procedure that the robotic system has greatest influence over. 
The mechanical alignment philosophy was proposed by Insall and has become the standard procedure 
employed [4]. The theory being that the knee replacement should be loaded evenly on the medial and 
lateral condyles to avoid subsidence or loosening at the side under greater load. This was subsequently 
supported by studies that showed improved survivorship of knees implanted in mechanical alignment Vs. 
those implanted with a varus or valgus alignment [6, 8]. More recently some authors have challenged the 
criticality of implanting the knee in perfect neutral alignment with some variation accepted with the goal 
of better replication of the patients’ specific knee alignment and improved management of the soft tissues 
of the knee [27-29]. Either way, achieving the planned long leg alignment is deemed important in the 
survivorship and function of the knee replacement and can be used as a surrogate measure of the 
procedure success and therefore the VELYS Robotic-Assisted Solution’s success in guiding the surgeon to 
this goal.    
The long leg alignment can be measured via X-ray at the first follow up (typically 6-12 weeks) when the 
Subjects are full weight bearing and the swelling has subsided sufficiently to allow the patient to reach 
full extension. Assuming good implant fixation, which has been demonstrated for the ATTUNE system via 
radiostereometric analysis [30] the alignment is unlikely to change significantly at later time points 
therefore the 12 week time point is considered an appropriate time to measure the primary endpoint. It 
is also the best opportunity to measure the direct output of the surgical process without the influence of 
anatomical adaptation/changes over time. The secondary and tertiary endpoints of this study pertain to 
other measurements of component alignment, safety outcomes, surgical time, patient outcomes, and 
health economics measures that are of interest to the Sponsor.  

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3.4 Rationale of Study Population 
Patients aged 22-85 years who meet the indications of the ATTUNE Knee system in a primary case 
including patients with severely painful and/or severely disabled joint resulting from osteoarthritis, post-
traumatic arthritis or rheumatoid arthritis are targeted for this study. The study is limited to primary TKA 
and excludes failed previous TKA as the VELYS Robotic-Assisted Solution is only cleared for use in primary 
TKA. In addition to contraindications specified by the TKA implant system used by the surgeon, 
contraindications for using the VELYS Robotic-Assisted Solution are as follows: 
• 
Patients for whom a hip center of rotation cannot be established using the VELYS™ Robotic-
Assisted registration protocols. 
• 
Patients in whom the necessary bony landmarks needed for registration are not present or 
accessible. 
These contraindications for the VELYS system are not included in the exclusion criteria for the study as 
they may be challenging to identify pre-operatively and may only become evident when the surgeon has 
made an intra-operative assessment. Information on the management of subjects in whom these 
contra-indications are detected intra-operatively is given in Table 7-3.  
4 
SUBJECT DEFINITION                                                                                           
 
 
 
 
 
 
 
Patients aged 22-85 years who meet the indications of the ATTUNE Knee system in a primary case 
including patients with severely painful and/or severely disabled joint resulting from osteoarthritis, post-
traumatic arthritis or rheumatoid arthritis may be considered for enrollment in this study.  
Subjects who do not meet all inclusion criteria or who meet any of the exclusion criteria are withdrawn 
from the study  
4.1 Inclusion Criteria  
Subjects meeting all of the following specific criteria will be considered for participation in the study: 
 
a) Subject is male or female and between the ages of 22 and 85 years at the time of consent, inclusive. 
b) Subject has a severely painful and/or severely disabled joint resulting from osteoarthritis, post-
traumatic arthritis or rheumatoid arthritis and in the opinion of the Investigator, is a suitable 
candidate for primary TKA using the devices described in this CIP with either resurfaced or non-
resurfaced patellae.  
c) Subject that is willing to give voluntary, written informed consent to participate in this clinical 
investigation and authorize the transfer of his/her information to the Sponsor  
d) Subject is currently not permanently bedridden, as determined by the Investigator  
e) Subject, in the opinion of the Investigator, is able to understand this clinical investigation and is 
willing and able to perform all study procedures and follow-up visits and co-operate with 
investigational procedures. 
f) Subject is able to read and comprehend the Informed Consent Document as well as complete the 
required PROs in English. 
g) Subject’s pre-operative alignment is such that (in the opinion of the Investigator) it is appropriate for 

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it to be adjusted to mechanical long leg alignment during surgery.   
 
4.2 Exclusion Criteria 
Subjects will be excluded from participation in the study if they meet any of the following criteria: 
a) The Subject is a woman who is pregnant or lactating. 
b) Contralateral knee has already been enrolled in this study. 
c) Subject had a contralateral amputation. 
d) Previous partial knee replacement (unicompartmental, bicompartamental or patellofemoral joint 
replacement), patellectomy, high tibial osteotomy or primary TKA in affected knee. 
e) Subject has an active local or systemic infection 
f) Subject has loss of bone or musculature, osteoporosis, neuromuscular compromise or vascular 
deficiency in the affected limb in sufficient degree to render the procedure unjustifiable in the 
opinion of the Investigator (e.g. absence of musculo-ligamentous supporting structures, joint 
neuropathy) 
g)  Subject has severe instability secondary to advanced loss of osteochondral structure or the absence 
of collateral ligament integrity.   
h) Subject has participated in a clinical investigation with an investigational product (drug or device) in 
the last three (3) months. 
i) 
Subject is currently involved in any personal injury litigation, medical-legal or worker’s 
compensation claims. 
 
4.3 Definition of Subject Enrollment 
A patient will be considered enrolled when they have provided written informed consent to participate in 
this Investigation, as well as Health Insurance Portability and Accountability Act of 1996 (HIPAA) 
authorization within the informed consent or a separate document as required per site policy. 
 
5 
OBJECTIVES  
 
 
 
 
 
 
 
 
 
 
 
5.1 Primary Objective  
 
The primary objective of this clinical investigation is to evaluate whether the accuracy to plan of the long 
leg alignment achieved with VELYS Robotic-Assisted Solution is non-inferior to the accuracy to plan of 
the long leg alignment achieved with the manual ATTUNE Intuition instrumentation. This will be 
assessed by measuring the Hip-Knee-Ankle angle (HKA) on long-leg X-rays taken at 12 weeks and 
comparing to the planned HKA.  

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 This will be followed by a subsequent superiority analysis to determine if the VELYS Robotic-Assisted 
Solution is more accurate in achieving this goal than the manual ATTUNE Intuition Instrumentation.  
 
5.2 Secondary Objectives 
• 
Evaluate the nature, severity, and frequency of local adverse events associated with the use of 
the Robotic system in total knee arthroplasty during the procedure and within the follow up 
period, assessed at 12 weeks, 90 days (specific cut of the data only, no visit) and 1 year.  
• 
Intra-operative clinical assessment of soft tissue damage in both Manual and Robotics cohorts. 
The condition and function of the key knee structures (medial collateral ligament (MCL), lateral 
collateral ligament (LCL), posterior cruciate ligament (PCL), patella tendon (PT), posterior lateral 
capsule (PLC) and posterior medial capsule (PMC) will be assessed intra-operatively. 
• 
Summarize the alignment outliers (long leg alignment >3 degrees outside of  plan ) in both 
Manual and Robotics cohorts. 
• 
Summarize surgical time for the Robotics and Manual cohorts; including skin-to-skin time, 
operating room utilization (wheels in-to-wheels out) and total operating room time (including 
set up and clean down).  
• 
Summarize individual component alignment achieved with manual instruments and Robotics in 
the frontal and sagittal planes, specifically: distal femoral varus-valgus (FM), proximal tibial 
varus-valgus (TM), femoral component flexion and tibial slope. 
 
5.3 Tertiary Objectives 
Additional tertiary objectives are: 
• 
To evaluate impact of surgeon learning curve on the Robotic system on accuracy of surgical 
procedure (assessed via accuracy to plan of long leg alignment), patient reported outcomes, 
safety, and surgical time.  
• 
Summarize the patient reported outcomes (EQ5-D, KOOS, FJS, Patient Knee Pain and Satisfaction) 
for the Robotics cohort vs. the Manual cohort.  
• 
Summarize the length of hospitalization/stay for the Robotics cohort vs. the Manual cohort.   
 
For the Robotics cohort there will be the following additional exploratory objectives:  
• 
Assessment of the correlation between the planned long leg alignment and the post-resection 
long leg alignment recorded on the VELYS Robotic-Assisted Solution case report.  
• 
Assessment of the correlation between the post-resection long leg alignment recorded on the 
VELYS Robotic-Assisted Solution case report and the long leg alignment measured via weight 
bearing X-ray at 12 weeks.  
• 
Assessment of the correlation between the planned medial and lateral gaps in extension and the 
post-resection medial and lateral gaps in extension recorded on the VELYS Robotic-Assisted 
Solution case report. 
• 
Assessment of the correlation between the planned medial and lateral gaps in flexion and the 
post-resection medial and lateral gaps in flexion recorded on the VELYS Robotic-Assisted Solution 
case report. 
• 
Assessment of the correlation between the post-resection medial and lateral gaps in flexion and 
extension and the thickness of the tibial insert implanted as recorded in the device log.  

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• 
Assessment of the reliability of the VELYS Robotic-Assisted Solution via review of information 
captured within device deficiency forms.   
 
The primary, secondary and tertiary clinical endpoints and the relevant statistical analyses are described 
in detail in Section 8.8. 
Table 5-1: Summary of Primary and Secondary Objectives with Respective Endpoints 
 
Outcome 
Endpoint Timing 
Primary 
Endpoint 
Accuracy to plan of Long leg alignment assessed by 
measuring the HKA on a long leg X-ray.  
12 weeks  
Secondary 
Endpoints 
Evaluate the nature, severity, and frequency of local 
adverse events associated with the use of the Robotic 
system in total knee arthroplasty during the procedure and 
within the subsequent 12 weeks, 90 days and 1 year.  
 
12 weeks, 90 days 
(Specific cut of data to 
determine number of 
AEs within 90 days 
determined at 1year 
follow up) 
1 year 
Intra-operative clinical assessment of soft tissue damage in 
both Manual and Robotics cohorts. 
 
Operative  
Summarize the alignment outliers (>3 degrees outside of 
plan) in both Manual and Robotics cohorts. 
 
12 weeks 
Summarize surgical time for the Robotics and Manual 
cohorts; including skin-to-skin time, operating room 
utilization (wheels in-to-wheels out) and total operating 
room time (including set up and clean down).  
 
 
Operative 
Summarize individual component alignment achieved with 
manual instruments and Robotics in the frontal and sagittal 
planes, specifically: distal femoral varus-valgus (FM), 
proximal tibial varus-valgus (TM), femoral component 
flexion and tibial slope 
12 weeks 
Tertiary 
Endpoints 
To evaluate impact of surgeon learning curve on the 
Robotic system on accuracy of surgical procedure (assessed 
via accuracy to plan of long leg alignment), patient reported 
outcomes, safety, and surgical time. 
Operative  
12 weeks 
1 year 
For both cohorts evaluate change from baseline for EQ-5D-
5L score  
12 weeks 
1 year 
For both cohorts evaluate change from baseline for KOOS 
12 weeks 
1 year 

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Outcome 
Endpoint Timing 
For both cohorts evaluate FJS 
12 weeks 
1 year 
For both cohorts evaluate change from baseline for 
Satisfaction  
12 weeks 
1 year 
For both cohorts evaluate change from baseline for Pain 
12 weeks 
1 year 
For both cohorts evaluate length of hospitalization stay 
post op  
Discharge 
For Robotic cohort assessment of correlation between the 
planned long leg alignment and the post-operative long leg 
alignment recorded on the VELYS Robotic-Assisted Solution 
case report 
Operative  
For Robotic cohort assessment of the correlation between 
the post-operative long leg alignment recorded on the 
VELYS Robotic-Assisted Solution case report and the long 
leg alignment measured via weight bearing X-ray at 12 
weeks. 
12 weeks  
For the Robotic cohort assessment of the correlation 
between the planned medial and lateral gaps in extension 
and the post-resection medial and lateral gaps in extension 
recorded on the VELYS Robotic-Assisted Solution case 
report. 
Operative 
For the Robotic cohort assessment of the correlation 
between the planned medial and lateral gaps in flexion and 
the post-resection medial and lateral gaps in flexion 
recorded on the VELYS Robotic-Assisted Solution case 
report. 
Operative 
For the Robotic cohort assessment of the correlation 
between the post-resection medial and lateral gaps in 
flexion and extension and the thickness of the tibial insert 
implanted as recorded in the device log.  
Operative 
For the Robotic cohort assessment of the reliability of 
VELYS Robotic-Assisted Solution based on the number and 
type of device deficiencies that occur  
Operative 
 
6 
STUDY DESIGN 
 
 
 
 
 
 
 
 
 
 
This study is designed as a prospective sequential controlled cohort study. Each site will enroll Subjects 
into the Manual cohort until their enrollment target has been reached, and then will enroll Subjects into 
the Robotic cohort. Level of Evidence is II.  
There will be a maximum of 8 sites that will recruit a total of 200 Subjects (100 manual control arm and 
100 in the Robotic study arm). Each site will use the implant configuration(s) that fit with their standard 

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of care. Both resurfaced patella and non-resurfaced patella are permitted in this investigation, consistent 
with the site’s standard of care. 
Each site is expected to implant approximately 10-20 knees in the control arm and 10-20 knees in the 
study arm. Details regarding sample size are presented in Section 8.7 Sample Size Justification. Single stage 
bilateral procedures are not permitted in the study, for staged bilateral procedures only one knee per 
patient can be enrolled in the study. 
The Sponsor will monitor overall project enrollment. The Sponsor can authorize a shift of a group of 
Subjects from one site to another to maintain project timelines. For example, the Sponsor can reduce the 
cohort of a slow-enrolling site to a faster-enrolling site and the faster-enrolling site will assume 
responsibility for the reallocated cohort. To prevent learnings from the Robotic procedures influencing 
the execution of the surgery in the manual control arm, once the study arm has been initiated at a site it 
will only be permissible to add additional enrolment in the study arm and not the control arm. 
 
7 
PROTOCOL  
 
 
 
 
 
 
 
 
 
 
 
7.1 Subject Enrollment 
No study-related procedure, eCRF or form associated with this study can be completed until written 
Informed Consent is obtained for that Subject (see Section 4.3. Definition of Subject Enrollment) except 
for information that was gathered previously as part of the standard of care at the site.   
 
7.1.1 Subject Screening 
All patients who are candidates for primary TKA, and who generally meet the study requirements, will be 
screened for general eligibility by reviewing the surgical schedule. Those patients who are approached for 
the study will be listed on the Consenting Log in order to document that the Subject selection was 
unbiased. The consenting log will document the date the patient was approached for the study and 
whether they consented.  
  After signing the Informed Consent, study Subjects are defined as “enrolled” and site will then complete 
the non-standard of care pre-operative data collection. 
It is expected that complete data collection will be obtained for all enrolled Subjects, with the only 
exception being a Subject who is subsequently withdrawn. See section 7.3 Discontinuation of Subject 
Participation for details. For Pre-operative Subject withdrawals the following are the minimum eCRFs to 
be completed: inclusion/ exclusion criteria, Demographics, Medical History (targeted) and surgical 
history. 
 
7.1.2 Subject Informed Consent 
The Principal Investigator is responsible for ensuring that no Subject is included in the study without 
adequate informed consent being provided.  Failure to obtain and properly document this process is in 
violation of 21 CFR Part 50, the Declaration of Helsinki, and this study protocol.   

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All Informed Consent Documents (ICD) must have favorable opinion of the responsible IRB/EC (Section 
12.1). Consent of a Subject needs to be from the subject themselves and documented on an ICD and the 
process documented within source documentation.   
Screening, consenting and enrollment are illustrated in Figure 7-1.  The Investigator or trained designee 
preliminarily screens to determine if a patient generally meets the eligibility criteria for the study.  If so, 
the Investigator or trained designee shall offer study participation to those patients. Having explained the 
study intent to the Subject, the Investigator or trained designee shall offer to answer any of the Subject’s 
questions.  If the Subject then agrees to participate, they must add their signature and write the date on 
the IRB/EC’s approved ICD and this document must then be countersigned and dated by the person taking 
consent. 
No names or dates should be prepopulated or completed by someone other than the person providing 
the signature.   
Upon successful completion of the consent process, the Patient is enrolled and is identified as a Study 
Subject.   
Acquiring Consent on Day of Surgery:  If the ICD signatures are acquired on the day of surgery, the time 
of the signature must be documented on the ICD signature page to support that consent was obtained 
from the study Subject prior to any treatment-related and/or mood-altering medications being 
administered. The documentation of time is not required where consent is obtained on a day prior to 
surgery.   
 
 

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Figure 7-1: Screening and Enrollment Process
 
 
 

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7.1.3 Subject Identification Numbering  
The database assigns Subject ID numbers upon data entry into the database. 
Each site is identified uniquely, e.g., 01-, 02- followed by 001 for the first Subject at the site, 002 for the 
second Subject and so on. Together the Site number and the Subject number will then become the unique 
identifier of the Subject and will be recorded on each page of the eCRF, and on the Consenting log. 
In the instance of a Subject being enrolled, a number assigned and subsequently the Subject is deemed 
ineligible prior to undergoing the procedure, a Subject Completion/Discontinuation eCRF should be 
completed and the criteria not met should be documented on the inclusion/exclusion eCRF. In the case 
of pre-operative withdrawals, or subjects that are withdrawn intra-operatively due to the required 
equipment not being available a further Subject will be enrolled to replace the withdrawn Subject in order 
to ensure 200 Subjects have the procedure.  Once a Subject identification number is assigned, it may not 
be reused.  Refer to Section 7.3.1 Enrollment Replacement Rules. 
7.2 Study Procedures   
This section is applicable to enrolled study Subjects. This study does not limit the procedures involved in 
the treatment of the subject outside of the surgical process.  The pre-operative, anesthesia, post-op care, 
and follow up are not research procedures, and therefore are not restricted by the study. 
This section details the study requirements in terms of the pre-operative, operative, and post-operative 
management of Subjects. Visit evaluations include clinical and radiographic evaluations and Subject self-
assessments. eCRFs must be submitted to the sponsor as outlined in Section 11.7 Case Report Form 
Completion and Data Submission.                                  
The patient reported outcome instruments KOOS, EQ-5D-5L, FJS and Subject Knee Outcomes (Pain and 
Satisfaction scores) are compulsory at all sites.  
 
7.2.1 Detailed Instructions on Data Collection 
The following evaluation tools are to be used to collect and evaluate study subject outcomes pre-
operatively, intra-operatively and post-operatively as outlined in Table 7-1 and in accordance with the 
Time and Events Table (Table 1-1).  Patient reported outcomes (in italics) will be provided in hard copy 
printed sets for completion by the study subject during the in clinic visit- at Pre-op, 12 weeks and 1 year 
timepoints.   
While in clinic visits are the preferred method for the 1 Year visit, if unforeseen issues arise causing the 
inability to conduct an in clinic visit, the site may review adverse events with the study subject via 
telephone or other SOC virtual means.   These methods may only be used for the 1 year visit and may 
not be used to collect PRO data. 
The details associated with administration of PROs are described in Section 7-2-2. 
 
 
 

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Table 7-1: Data collection, with Subject Completed forms in italics 
Case Report Form 
Details of Evaluation 
Pre-Op/ 
Intra-
op/Post—
Op 
Study Visit 
Assists study site to verify that study visit occurred 
in the appropriate interval and by the appropriate 
means (at clinic or by phone) 
Pre-op & 
Post-op 
Demographics 
 
Authorized medical personnel will collect basic 
demographics. 
Pre-Op 
Only 
Targeted Medical History  
Authorized medical personnel will collect 
information about aspects of the patient’s medical 
history that is pertinent to the TKA procedure.  
Pre-Op 
Only  
Vital Signs (Height and 
Weight) 
Authorized medical personnel will collect patient’s 
height and weight. 
Pre-Op 
Only  
Range of Motion  
Authorized medical personnel will collect patient’s 
Range of Motion pre op and at the 12 week visit  
Pre-op & 
Post-op 
Knee injury and 
Osteoarthritis Outcomes 
Score (KOOS) 
A member of the research team will administer 
each of these PROs as detailed in Section 7-2-2, 
below. The total time for completion per study 
Subject is approximately 10-15 minutes. 
 
Pre-op & 
Post-op 
Forgotten Joint Score  
 Post-op 
Only 
Pain Catastrophizing Scale 
Pre-op 
Only 
 Subject Knee Outcomes 
(Pain & Satisfaction) 
Pre-op & 
Post-op 
EQ-5D-5L 
Pre-op & 
Post-op 

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Case Report Form 
Details of Evaluation 
Pre-Op/ 
Intra-
op/Post—
Op 
Radiographic Evaluation 
Weight bearing long leg AP and Lateral 
radiographs will be obtained pre-operatively and 
post-operatively. Note: Pre-operative radiographs 
can be taken up to -180 days prior to the surgical 
event. Pre-operative Radiographs provide 
background information only, and do not 
constitute either a primary or secondary endpoint. 
Radiographic guidelines will be provided to sites in 
an Image Acquisition Protocol. Image assessment 
will be done by an Independent Radiographic 
Reviewer. 
Pre-Op & 
Post-Op 
Operative Detail 
Description of Subject’s surgical procedure 
including such items as configuration used, 
surgery time, resection time, surgical technique 
details, planned femoral and tibial resection 
angles, soft tissue assessment. For the Robotic 
cohort the system case ID will be recorded.   
Intra-Op 
Discharge 
Information of when the patient is discharged and 
the location that the patient is discharged to.  
Discharge 
VELYS Robotic-Assisted 
Solution Case Report  
Report generated by system including the pre 
resection long leg alignment and medial and 
lateral gaps, planned resection angles and the 
post-resection alignment.  
Intra-Op 
(Robotic 
cohort 
only) 
Device Log 
Identification of devices implanted, including 
product codes, lot numbers and Universal ID 
code/device identifier. 
Intra-Op 
Adverse Event 
Includes diagnosis, date of onset, date of 
awareness, treatment and classification of the AE. 
As 
required 
(Intra-Op 
and/or 
Post-Op) 

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Case Report Form 
Details of Evaluation 
Pre-Op/ 
Intra-
op/Post—
Op 
Device Deficiency  
Any inadequacy in the identity, quality, durability, 
reliability, safety or performance of the VELYS 
Robotic-Assisted Solution, including malfunction, 
use errors or inadequacy in information supplied 
by the manufacturer will be recorded on the 
Device Deficiency form  
As 
required 
Intra-Op 
for 
Robotics 
Cohort 
only 
Subject Completion/ 
Discontinuation 
Reason for follow-up being concluded (e.g., 
completed study requirements, consent 
withdrawn) 
As 
required 
(Pre-op or 
Post-Op) 
Protocol Deviation  
Nature of deviation that has occurred and reason 
why  
As 
required 
(Pre-op or 
Post-Op) 
 
 
7.2.2 Subject Evaluation Tools  
The Patient Reported Outcomes included in this study are listed in Table 7-2 above, along with the other 
data to be captured. The PRO assessments should be administered before any diagnostic work-up, study 
procedure or clinical measurement is performed on the visit day in clinic.  If consent is the same day of 
surgery, consent should be taken and PROs completed before administering any mood altering 
medication.  
Each of the questionnaires should be completed by the Subject, and usually takes 2-3 minutes per 
questionnaire to complete.  
The PRO CRFs should be administered in the following order: EQ-5D-5L, KOOS, Subject Knee Outcomes 
then FJS.   The PROs may never be administered verbally, the Subject personally completes their portions 
of each document.   
Should a 1 year visit be conducted remotely as described in 7.2.1 the PROs may be mailed to the subject 
with a pre-paid return method included. The subject’s signature and date of completion should be 
provided so that this signature can be verified against the consent form to ensure the subject was the 
individual completing the questionnaire.  
 

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7.2.3 Pre-operative Management  
Prior to surgery, the data in Table 1-1 (the Time & Events Table) must be collected for each enrolled 
Subject. The interval for obtaining the Informed Consent and pre-op assessments is from -90 days through 
day 0 (day of surgery) as designated on the Time & Events Table (Table 1-1). The -90 day time frame is 
important to support PROs being collected closer to the time of surgery since it is anticipated that there 
may be deterioration in function as the patient awaits surgery. The interval for obtaining preoperative 
radiographs is extended to -180 days to day 0 (day of surgery) so that study subjects would not need to 
have repeat radiographs if any radiographs that had been taken as standard of care prior to the Subject 
being enrolled were the required views. This will be allowed to minimize the study subject’s unnecessary 
exposure to radiation. Note, it would be preferred if the radiographs were taken from -90 days through 
day 0, however if radiographs are available that exceed the 180 day maximum timepoint, they can still be 
used if they are thought to be acceptable for preoperative surgical planning (as per their standard of care) 
at the discretion of the PI.  
Once written informed consent is given, the below will be followed: 
• 
Pre-operative Radiograph assessment (unless acquired prior to enrollment), Subject History and 
all Patient Reported Outcome questionnaires will be completed.    
• 
The TKA surgical details and any procedure or device related intra-operative complications are 
captured on eCRFs for subsequent analysis. 
• 
Follow-up intervals include 12 week and 1 year post-operative clinic visits.  Post-operative 
radiographs will be taken at the 12 week follow-up. 
 
 
7.2.4 Operative Management 
The surgical process is to follow site standard of care for total knee arthroplasty. The approved surgical 
technique (specific to the configuration implanted and the instrumentation used) must be followed. Any 
deviation from the approved surgical technique must be reported as a protocol deviation. See Table 7-2 
for further detail.  

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Table 7-2: Protocol Requirements During Surgery 
Surgical Process detail 
Protocol instructions 
Instrumentation 
• 
The manual arm of the study will use the ATTUNE Intuition 
Instrumentation (Reusable or SOLO). Computer assisted 
surgery, TruMatch technology or any other type of Custom 
Patient Instruments is not permitted.  The surgeon will target 
placing the implant perpendicular to the mechanical axis of 
the leg but may vary by +/- 3 degrees if deemed 
advantageous to the soft tissue management of the knee. 
• 
The Robotic arm will use the VELYS Robotic-Assisted Solution 
supported by the ATTUNE Intuition instrumentation for the 
steps as indicated by the surgical technique. The surgeon will 
target placing the implant perpendicular to the mechanical 
axis of the leg but may vary by +/- 3 degrees if deemed 
advantageous to the soft tissue management of the knee. 
Implant system  
This investigation allows the Investigator to follow their current 
standard of care with respect to the choice of configuration of the 
ATTUNE system used including cemented CR FB, CR RP, PS FB, PS RP, 
or Cementless CR RP or PS RP (see section 10.2).  
Patellar Treatment 
This investigation allows the Investigator to follow their current 
standard of care with respect to patellar resurfacing.  Specifically, the 
Investigator can choose to: 
• 
resurface the patella  
• 
leave the patella unresurfaced. 
 
Data collected during the operative management of the Subject is listed in Table 7-1.  
 
7.2.5 Post-operative Management  
Immediate post-operative management including physical therapy protocol is at the discretion of the 
surgeon and support staff and should follow each Site’s standard of care. Rehabilitation programs are 
often individualized, however, efforts should be made by the principal investigator to ensure that these 
programs remain consistent throughout the execution of the study.  
The follow-up windows have been selected to achieve the primary objective of investigating the accuracy 
of the VELYS Robotic-Assisted Solution, as well as providing further data to characterize the patient 
recovery over the first post-operative year. Every effort should be made to schedule the post-operative 
follow-up within these windows to enhance follow-up compliance.  While required interval windows have 
been designed to be continuous (with the exception of the first week after surgery) to improve follow-up 
compliance and accommodate various standards of care across sites, this study includes preferred 

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windows as well to increase the consistency with respect to the timing of data collection, since function 
is changing with time, particularly in the early recovery phase. 
All follow-up visits will be conducted according to the Time and Events Table (Table 1-1), and applicable 
eCRFs must be submitted to the Sponsor.   
Data collected during the post-operative management of the Subject is listed in Table 7-1.  
 
7.2.6 Radiographic Procedures 
Radiographic guidelines regarding image collection and transmission to the independent radiographic 
reviewer will be provided to the Principal Investigator.  Weight bearing Long leg AP X-rays and lateral 
views are to be obtained pre-operatively and at the 12 week visit (baseline evaluation). Long leg AP X-rays 
are critical to be able to achieve the primary objective of assessing the alignment achieved. Skyline views 
will not be collected in this study.  
 
7.3 Discontinuation of Subject Participation 
Study participation may be discontinued through screen failure, not receiving the study treatment, 
revision of either the femoral component or metal tibial tray, withdrawal of consent, death or surgeon 
preference/ medical opinion (this should occur under very limited conditions, in order to avoid the 
investigator bias). Table 7-3 describes how data will be captured on Subjects that are discontinued prior 
to receiving the study treatment. In all cases, once a subject is enrolled (per Figure 7-1), if they discontinue 
study participation, a Subject Completion/Discontinuation eCRF must then be completed. 
 
 7.3.1 Enrollment Replacement Rules 
Since subjects are enrolled at the time of consent, any subject that is withdrawn preoperatively will be 
replaced with a subsequent subject.  Overall, the number of subjects who are enrolled and undergo a TKA 
procedure in the control group must meet the sample size of 100 subjects and the number of subjects 
who are enrolled and undergo a TKA procedure in the study group must meet the sample size of 100. For 
Intra-operative withdrawals the action will vary depending on the reason for the withdrawal or deviation 
per Table 7-3.  
Table 7-3: Enrollment Replacement examples  
Scenario 
Data 
submitted 
on eCRF? 
Example 
 
Action 
Pre-operative screen 
failure (discovered 
post-consent but 
pre-op) 
Yes 
Subject withdrew consent 
or the Subject no longer 
met inclusion/ exclusion 
criteria. 
• Complete at a minimum inclusion/ 
exclusion criteria, Demographics, 
Medical History and surgical history 
eCRFs. 
• Complete Subject Completion/ 
Discontinuation eCRF  
• Recruit an additional subject 

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Scenario 
Data 
submitted 
on eCRF? 
Example 
 
Action 
Inclusion/exclusion 
criteria violation 
discovered post-op 
Yes 
Too old 
• Keep as Subject – continue to follow as 
per protocol 
• Complete a Protocol deviation eCRF 
Intra-operative 
withdrawal  
Yes 
Did not use planned 
ATTUNE knee or planned  
process (manual or robotic) 
to implant the knee due to 
equipment not being 
available 
 
Or Investigator determined 
intra-operatively that the 
bone quality is insufficient 
to support planned 
procedure or they do not 
have sufficient access to the 
bony landmarks or the hip 
center of rotation cannot be 
established.  
• Complete Subject Completion/ 
Discontinuation eCRF 
• Recruit an additional subject 
Intra-operative 
deviation  
Yes 
Procedure started with 
robot (started executing 
bone cuts) then surgeon 
bails out to manual 
instruments midway 
through the procedure.   
• Consider submitting a Device Deficiency 
eCRF (depending on cause of change in 
surgical process) 
• Consider submitting AE eCRF (if event 
meets the definition of AE) 
• Complete a Protocol deviation eCRF 
• Keep as Subject – continue to follow as 
per protocol 
• Do not recruit another subject to 
replace 
 
 
7.4 Post-operative Withdrawal of Enrolled Subjects 
A post-operative withdrawal is a Subject who has signed the Informed Consent Document (ICD), has been 
implanted with a study device, and is later withdrawn from study participation (i.e., withdrawal of 
consent, revision of femoral or metal tibial components, death, etc.)  
 
Table 7-4 describes post-operative withdrawal scenarios and the eCRF to be completed.   
 
Further description of revision is provided in Section 7.6, Revisions/Reoperations.  No data after the date 
of withdrawal will be included in the clinical analysis.  
 

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Table 7-4: Post-operative Withdrawal Scenarios 
Example 
Action 
Follow Up 
Subject 
withdraws 
consent/lost 
to follow up  
• 
Study site documents Subject’s request for withdrawal from study. 
• 
Complete Subject Completion/ Discontinuation eCRF  
Do not 
continue  
Death 
• 
Complete Adverse Event eCRF  
• 
Complete Subject Completion/ Discontinuation eCRF 
Do not 
continue  
Revision  
See Section 7.5 and Table 7-5 Revision Examples 
 
7.5 Revisions/Re-operations 
A “revision” is defined as a surgical procedure of the affected knee where one or more of the TKA 
components (femoral component and/or metal tibial base, polyethylene insert, or patella polyethylene 
resurfacing component) are removed.  Should it be necessary for the Subject to undergo a revision of 
either the femoral or metal tibial base between the time of enrollment and completion of the study data 
acquisition, the Subject is to be withdrawn from study participation.  Thus, both an Adverse Event (AE) 
eCRF and a Subject Completion/Discontinuation eCRF must be completed.  Note that if a tibial 
polyethylene insert is exchanged and/or a resurfaced patella is revised but both femoral and tibial 
components remain intact, then an AE eCRF must be completed but the subject is not to be withdrawn.  
Examples of how to handle revisions are shown in table 7-5. 
Table 7-5: Revision Examples 
Example 
Actions 
Follow Up 
Removal / revision of metal tibial base and/or femoral 
component 
Complete Adverse Event eCRF 
Complete Subject 
Completion/ Discontinuation 
eCRF  
Do not continue 
Tibial polyethylene exchange 
Complete Adverse Event 
eCRF  
Continue 
Revision of a previously resurfaced patella  
Complete Adverse Event 
eCRF  
Continue 
Resurfacing of a previously unresurfaced patella 
Complete Adverse Event 
eCRF  
Continue 
 
A re-operation is defined as any surgical procedure of the affected knee in which no TKA components are 
removed. Examples include irrigation & debridement without tibial insert exchange or the resurfacing of 
a previously unresurfaced patella without tibial insert exchange.  These subjects are not to be withdrawn.  
An Adverse Event (AE) eCRF must be completed. 
 
7.6 Lost to Follow-up  
Although follow-up compliance is essential to study quality, some Subjects may not be able to return for 
follow-up evaluations.  Sites should make efforts to ensure complete follow-up including phone calls and 
written requests to a Subject as required.  If these approaches are not successful, then the site may 

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document a Subject as lost-to-follow-up on the Subject Completion/Discontinuation eCRF.  Contact 
attempts should be documented in the Subject’s medical notes.   
8   
STATISTICAL METHODOLOGY   
 
 
 
 
 
 
 
This section describes the statistical methods for the study design and planned analysis of study data. 
8.1 Study Design 
This study is designed as a prospective sequential controlled cohort study utilizing the ATTUNE knee. All 
procedures will be done either with traditional surgical instruments and cutting blocks (Manual Cohort) 
or with the VELYS Robotic-Assisted Solution (Robotic Cohort). Each site will enroll Subjects into the Manual 
Cohort until their enrollment target has been reached, and then will enroll Subjects into the Robotic 
Cohort.  
8.2 Treatment Assignment 
Each site is expected to implant approximately 10-20 ATTUNE knees in each of the control (Manual 
Cohort) arm and the study (Robotic Cohort) arm. There will be a maximum of 8 sites that will recruit a 
total of 200 Subjects (100 manual cohort and 100 in the Robotic cohort). Each site will use the implant 
configuration(s) that fit with their standard of care. Both resurfaced patella and non-resurfaced patella 
are permitted in this investigation, consistent with the site’s standard of care. 
Only one knee per subject will be included in the study. For bilateral subjects (staged) only the first knee 
implanted during study enrollment may be enrolled. 
8.3 Randomization and Blinding Procedures 
This is a non-randomized study. Surgeons will first perform their Manual Cohort cases followed by their 
Robotic Cohort cases. The purpose is to capture the current state of traditional, non-robotic procedures 
compared to robotic-assisted procedures. Following robotic-assisted procedures changes and 
improvements may be made to the standard of care with traditional, non-robotic instrumentation and 
would thus confound study comparisons. 
Subjects may be unblinded to the type of instruments used in their case. 
8.4 Interval Windows 
The pre-operative assessment is to be done 90 days prior to the procedure up to day 0 (defined as the 
day of the index procedure for this study); radiographs for this study may be from 180 days prior to day 0 
(or longer if the PI determines they are acceptable for surgical planning). The required window intervals 
for analysis purposes are defined as follows: 
 
 
 
 
 

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Table 8-1: Interval Windows 
Required* Follow-up Intervals (days) 
Pre-op** 
Day 0 
12 Weeks 
1 Year 
-90 to 0d 
0 (Defined as 
the Day of TKA) 7-182 
183-547 
* Although these are the windows for analysis purposes, 
narrower “preferred” interval windows have also been included 
in this protocol. 
** Pre-operative radiographs may be in the window -180 to 0 
days (or longer if the PI determines they are acceptable for 
surgical planning) 
 
Multiple visits within these defined windows for a single subject may occasionally occur. If this occurs then 
for both the pre-op and 12 week intervals the visit closest to the date of surgery will be considered the 
study visit. Individual pre-op data (i.e. radiographs, PROMs, etc.) may be collected at different pre-op visits 
and each type of data will be considered separately when considering multiple visits.  
8.5 Levels of Significance 
Where estimated, all confidence intervals will be 95% confidence intervals. For the primary endpoint 
hypothesis test an alpha = 0.05 will be used to determine statistical significance. No adjustments will be 
made for multiplicity as this is the only formal hypothesis in the study. Although there are no other formal 
hypotheses in this study, final results may be provided along with p-values to facilitate clinical judgement.  
8.6 Analysis Sets 
The following analysis sets are defined for the purpose of analysis: an Intent to Treat (ITT) analysis set, a 
Safety analysis set, and a Per Protocol (PP) analysis set.  The analyses of adverse events and the Kaplan-
Meier analysis of revisions will be carried out on the Safety analysis set. The primary endpoint analysis will 
be carried out on the ITT analysis set and all secondary endpoint analyses will be carried out on the Per 
Protocol analysis set.  The analysis of the tertiary endpoints will be carried out on the PP analysis set unless 
otherwise stated in the final clinical summary report.  
Enrolled subjects set who do not undergo surgery to implant the ATTUNE system with either manual 
instrumentation or with the VELYS Robotic-Assisted Solution will be withdrawn from the study without 
any further data collection, replaced per section 7.3.1 Enrollment Replacement Rules, and will not be 
included in any analysis set.   
8.6.1 ITT Analysis Set   
The ITT analysis set consists of all subjects who are consented, enrolled into the study, and undergo a TKA 
procedure with any cuts attempted with the intended device(s). The purpose of this analysis set is to 
perform the primary endpoint non-inferiority analysis. Analysis of the ITT set will be performed based on 
the intended instrumentation for the procedure. 

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8.6.2 Safety Analysis Set   
The Safety analysis set consists of all ITT subjects who complete surgery to implant the ATTUNE primary 
TKA system with the intended instrumentation.  Analysis of the Safety set will be performed based on the 
actual instrumentation used for the procedure.  
 
All intraoperative events that occur before an intra-operative screen failure will be reported. 
8.6.3 PP Analysis Set 
The Per Protocol (PP) analysis set is a subset of the Safety analysis set that includes all subjects who meet 
the following criteria:  
• 
There are no clinically meaningful deviations from the protocol eligibility criteria, and 
• 
The subject receives an ATTUNE primary TKA system,  
• 
The subject is implanted with the intended surgical instrumentation, 
• 
The subject has at least one post-operative evaluation in the 6 week or later time window. 
Analysis of the PP set will be performed based on the instrumentation used to complete the procedure. 
8.7 Sample Size Justification 
The primary endpoint analysis is a non-inferiority comparison of the mean of the absolute values of 
deviation from planned Hip-Knee-Ankle angle (HKA)   with a non-inferiority margin of 1.5 degrees (as 
described in the Primary Endpoint section below). The study will be deemed to be successful if non-
inferiority is successfully demonstrated using a t-test with a 1-sided alpha of 5%. Based upon an 
anticipated standard deviation of approximately 2.4 degrees in deviation from plan measurements, it is 
estimated that there is greater than 99% power to demonstrate non-inferiority in this primary endpoint 
analysis.    
The sample size of N=100 has also been established to provide sufficient data for the evaluation of the 
nature, severity, and frequency of adverse events associated with the use of the Robotic system. 
Specifically, if a local serious adverse event is likely to occur in at least 5% of patients in the general 
population (as determined from review of previous ATTUNE total knee replacement studies using 
conventional instruments), then with a sample size of N=100 there is greater than a 99% chance of the 
observation of at least 1 such event in this study. There is greater than 80% change of observing at least 
one event for adverse events that occur with a rate of 1.6% or greater. 
8.8 Analyses to be Conducted 
8.8.1 General Conventions 
All analysis will be performed using SAS v9.4 or higher. Statistical summaries (tallies and percentages for 
categorical variables, and sample size, mean, standard deviation, minimum and maximum (and others as 
needed) for continuous variables) at each respective time point, or cumulatively for safety endpoints. 
8.8.2 Disposition of Study Subjects 
A detailed account of all enrolled subjects will be presented in a dataset flow diagram to display the 
analysis datasets, beginning with the set of ITT subjects and explicitly listing the subjects with 

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distinguishing reasons for exclusion from the other datasets. A template of this dataset flow diagram is 
given in Figure 8-1 below.  
 
Figure 8-1: Analysis Set Flow Diagram 
 
 
8.8.3 Demographic and Baseline Characteristics 
Demographic and baseline characteristics will be summarized overall and by configuration. The 
demographics characteristics will be presented along with p-values to facilitate clinical judgement on 
any differences.  
 
 
 
Enrolled Population 
N=(Total Sample Size) 
ITT Analysis Set 
N=(Total Sample Size) 
Safety Analysis Set 
N=(Total Sample Size) 
PP Analysis Set 
N=(Total Sample Size) 
Surgery Not Performed 
N=(pre- & intra-op screen failures causing end of study) 
Enrolled subjects that did not undergo surgery, list each 
subject number and reason 
minus 
No Data post-surgery 
N=(missing 6 week or later data) 
List subject numbers 
minus 
Protocol Non-compliances 
N=(Protocol Non-compliances) 
List subject numbers, and specific protocol 
non-compliances. 
minus 
Surgery Not Completed 
N=(intra-op failures not causing end of study) 
ITT subjects that did not complete surgery with the 
intended instrumentation, list each subject and reason. 
minus 

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8.8.4 Primary and Secondary Endpoints and Associated Hypotheses 
8.8.4.1 Primary Endpoint and associated hypotheses 
The primary endpoint to evaluate accuracy to plan is a non-inferiority comparison of mean absolute 
value for deviation from planned HKA.  
𝐻𝐻0:𝜇𝜇𝑉𝑉𝑉𝑉𝑉𝑉𝑉𝑉𝑉𝑉−𝜇𝜇𝑀𝑀𝑀𝑀𝑀𝑀𝑀𝑀𝑀𝑀𝑀𝑀≥1.5° 
 
𝐻𝐻𝐴𝐴: 𝜇𝜇𝑉𝑉𝑉𝑉𝑉𝑉𝑉𝑉𝑉𝑉−𝜇𝜇𝑀𝑀𝑀𝑀𝑀𝑀𝑀𝑀𝑀𝑀𝑀𝑀< 1.5° 
 
where 𝜇𝜇𝑉𝑉𝑉𝑉𝑉𝑉𝑉𝑉𝑉𝑉 is the mean absolute value of deviation from planned HKA for VELYS Robotic-Assisted 
Solution procedures, 𝜇𝜇𝑀𝑀𝑀𝑀𝑀𝑀𝑀𝑀𝑀𝑀𝑀𝑀 is the mean absolute value of deviation from planned HKA for procedures 
using manual instrumentation, and 1.5° represents the non-inferiority margin. Absolute value of the 
deviation from planned HKA angles will be calculated with the below calculation for both VELYS and 
Manual procedures: 
absolute value deviation from plan = |radiographic HKA – planned HKA| 
HKA measurements may be either positive or negative depending on varus/valgus alignment. The 
radiographic HKA is measured via the long leg, weight bearing X-ray at 12 weeks. The planned HKA for 
the Robotic procedures is the final planned HKA as determined via the robotic procedure workflow prior 
to making bone cuts. 
Non-inferiority will be tested using a two-sample t-test with a 1-sided alpha of 5%.  If non-inferiority is 
successfully demonstrated, then the study will be deemed to be successful, and a test for superiority of 
accuracy to plan achieved with VELYS Robotic-Assisted Solution (i.e. test margin of difference of 0°) will 
be conducted. 
8.8.4.2 Secondary Endpoints and associated hypotheses 
• 
Summarize the nature, severity, and frequency of local adverse events associated with the use 
of the Robotic system in total knee arthroplasty during the procedure and within the 
subsequent 12 weeks, 90 days3 and 1 year.  
• 
Summarize Intra-operative clinical assessment of soft tissue damage in both Manual and 
Robotics cohorts. The condition and function of the key knee structures (medial collateral 
ligament (MCL), lateral collateral ligament (LCL), posterior cruciate ligament (PCL), patella 
tendon (PT), posterior lateral capsule (PLC) and posterior medial capsule (PMC) will be assessed 
intra-operatively. The proportion of subjects that are uncompromised and fully functional for 
each structure will be presented along with a Fisher’s extract test p-value to facilitate clinical 
judgement on any differences. 
• 
If Per Protocol population differs from ITT population then perform the non-inferiority and 
superiority tests as specified above on the Per Protocol population. 
 
3 This is a specific analysis of data to determine number of AEs that occurred within 90 days of the procedure 
determined at 1year follow up – there is no 90 day visit. 

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• 
Summarize the alignment outliers (long leg alignment >3 degrees outside of plan) in both 
Manual and Robotics cohorts. Manual and Robotics cohorts will be presented along with a 
Fisher’s extract test p-value to facilitate clinical judgement on any differences.  
• 
Summarize surgical time for the Robotics and Manual cohorts; including skin-to-skin time and 
resection execution. Mean surgical time will be presented along with a two-sided sample t-test 
p-value to facilitate clinical judgement on any differences.  
• 
Summarize individual component alignment achieved with manual instruments and Robotics in 
the frontal and sagittal planes, specifically: distal femoral varus-valgus (FM), proximal tibial 
varus-valgus (TM), femoral component flexion and tibial slope. Mean alignment measures will 
be presented along with a two-sided two sample t-test p-value to facilitate clinical judgement on 
any differences.  
 
8.8.4.3 Additional Endpoints (Exploratory) 
• 
Summarize the patient reported outcomes (EQ-5D, KOOS, FJS, Patient Knee Pain and 
Satisfaction) for the Robotics cohort vs. the Manual cohort by visit.  
• 
Summarize the length of hospitalization/stay for the Robotics cohort vs. the Manual cohort.   
• 
Summarize the discharge location for the Robotics cohort vs. the Manual cohort.  
• 
Investigate impact of surgeon learning curve on the Robotic system on accuracy of surgical 
procedure (assessed via accuracy to plan of axis alignment measurements), patient reported 
outcomes, safety, and surgical time.  
o The mean of the first 10 procedures within a surgeon will comprise the learning curve 
cohort and will be compared to the later procedures.   
o Cut-off points other than the first 10 procedures (such as the first 3, or the first 5 
procedures) and statistical models may also be used to explore the size and effect of any 
potential learning curve. 
For the Robotics cohort there will be the following additional exploratory regression analyses. Each pair 
of variables below will be regressed on each other. The first variable (y) will be regressed on the second 
variable (x). The regression function, R-squared value, and the Pearson correlation will be estimated for 
each pair.  
• 
the post resection long leg alignment recorded on the VELYS Robotic-Assisted Solution case report 
and the planned long leg alignment.  
• 
the long leg alignment measured via weight bearing X-ray at 12 weeks and the post resection long 
leg alignment recorded on the VELYS Robotic-Assisted Solution case report.  
• 
the post resection medial gap in extension recorded on the VELYS Robotic-Assisted Solution case 
report and the planned medial gap in extension. 
• 
the post resection lateral gap in extension recorded on the VELYS Robotic-Assisted Solution case 
report and the planned lateral gap in extension. 
• 
the post resection medial gap in flexion recorded on the VELYS Robotic-Assisted Solution case 
report and the planned medial gap in flexion. 
• 
the post resection lateral gap in flexion recorded on the VELYS Robotic-Assisted Solution case 
report and the planned lateral gap in flexion. 

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• 
the thickness of the tibial insert implanted as recorded in the device log and the post resection 
medial gap in flexion.  
• 
the thickness of the tibial insert implanted as recorded in the device log and the post resection 
lateral gap in flexion. 
• 
the thickness of the tibial insert implanted as recorded in the device log and the post resection 
medial gap in extension.  
• 
the thickness of the tibial insert implanted as recorded in the device log and the post resection 
lateral gap in extension. 
For the Robotics cohort summarize the nature and frequency of device deficiencies associated with the 
use of the Robotic system in total knee arthroplasty during the procedure.  
 
8.8.5 Plans for Interim Analysis 
There are no plans for a formal interim analysis to evaluate early stopping of the trial. 
Summaries of the procedural data for manual instrumentation procedures may be produced after all 
subjects have been enrolled and surgeries completed.  
All secondary and tertiary endpoints associated with the surgery or a specific follow-up time point may be 
analyzed any time after all subjects have the visit window for that time point.  
Complications will be monitored continuously to assure that unexpected adverse event rates are 
identified as soon as they become evident.  
8.8.6 Handling of Missing Data 
Only actual data will be analyzed; there will be no imputation of missing data.   
 
9 RISK ANALYSIS                                                                                                                      
 
9.1 Anticipated Adverse Events / Non-Reportable Adverse Events  
There are particular immediate post-operative events that are changes from the baseline condition of the 
Subject but are expected events resulting from surgery. For the purposes of this protocol these are 
referred to as Expected/Anticipated Adverse Events and are listed in Exhibit A. If these events occur, they 
should be recorded in the Subject’s medical record, but these should NOT be reported as AEs in the eCRF 
or to the Sponsor unless in the opinion of the investigator the event is directly related to the use of the 
Robotic System. 
9.2 Study Related Risks/Reportable Adverse Events  
Any surgical procedure poses a potential risk and the procedures undertaken as part of this clinical 
investigation are no exception. There are known risks associated with the method of anesthesia (general, 
epidural, local). In addition, there are risks associated with implantation of a device. The risks associated 
with the use of the robotic system in the study arm and the manual instruments in the control arm are 

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similar to those associated with conventional TKA surgery. The following are generally the most frequently 
reported AEs and complications in total knee arthroplasty. The AEs identified below (Table 9-1) are to be 
reported as AEs. 
Table 9-1: Most Frequently Reported Adverse Events and Complications 
General  
 
• Early or late loosening, tibial subsidence, bending, cracking, fracture, deformation, 
or wear of one or more of the prosthetic components, often related to factors listed 
under WARNINGS AND PRECAUTIONS in the implant IFU. Loosening may also occur 
due to improper fixation or positioning.  
• Early or late infection which may require removal of the implant.  
• Pain, dislocation, subluxation, flexion contracture, decreased range of motion, or 
lengthening or shortening of the leg, caused by improper positioning, looseness or 
wear of components.  
• Excessive wear of the polyethylene components due to intraoperative damage to 
the femoral component, loose cement and/or bone fragments, and/or high patient 
activity levels or weight.  
• Fractures of the tibia or femur. lntraoperative fractures are usually associated with 
revision surgery, deformity and/or severe osteoporosis. Postoperative fractures are 
usually stress fractures. Fractures can be the result of defects in the cortex due to 
multiple pin holes, prior screw holes, misdirected reaming, and/or inadequate or 
maldistribution of bone cement.  
• Cardiovascular disorders and thromboembolic disease, including venous 
thrombosis, and pulmonary embolus, and heart attack.  
• Tissue reactions, osteolysis, and/or implant loosening caused by metallic corrosion, 
allergy or wear debris or loose cement particles.  
• Myositis ossificans, especially in males with hypertrophic arthritis, limited 
preoperative range of motion and/or previous myositis. The incidence of myositis 
ossificans is increased with a history of prior surgery and in cases of infection.  
Early Post-operative 
Study Related Adverse 
Events  
 
• Hematoma  
• Delayed wound healing or wound dehiscence 
• Varus-valgus deformity  
 
Late Post-operative Study 
Related Adverse Events  
 
• Inadequate range of motion due to improper selection or positioning of 
components, impingement and/or periarticular calcification.  
• Periarticular calcification or ossification, with or without impediment to joint 
mobility.  
• Patellar bone fracture as a result of excess tension or inadvertent intra-operative 
weakening.  
• Aggravated problems of the affected limb or contralateral extremity caused by leg 
length discrepancy.  
 
 
9.3 Benefit Analysis  
For subjects within the study arm, the study device (VELYS Robotic-Assisted Solution) aims to result in a 
more precise, repeatable surgery reducing the risk of poor implant placement and the associated poor 
outcomes but these benefits are not yet proven. For subjects within the control arm they will benefit from 

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receiving additional rigor on their follow up compared to standard of care potentially resulting in faster 
identification and reporting of adverse events allowing faster resolution/treatment.  
9.4 Adverse Event Reporting  
 
Table 9-2: Adverse Event definitions 
Term  
Details  
Adverse Event (AE)  
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 a medical device.  
Adverse Event is synonymous with complication or medical event.  
Serious Adverse Event (SAE)  
An Adverse Event that led to any of the following:  
• death,  
• serious deterioration in the health of the Subject that, resulted in any of the 
following:  
• life-threatening illness or injury,  
• permanent impairment of a body structure or a body function,  
• hospitalization or prolongation of existing hospitalization,  
• medical or surgical intervention to prevent life-threatening illness or 
injury or permanent impairment to body structure or a body function,  
• fetal distress, fetal death or a congenital abnormality or birth defect.  
 
Note: Planned hospitalization for a pre-existing condition, or a procedure 
required by the Clinical Investigational Plan, without serious deterioration in 
health, is not considered a serious adverse event.  
Expected/ Anticipated  
 The PI is responsible for determining whether an AE is anticipated or 
unanticipated.  This determination is based on whether the severity, type and 
frequency of the AE is consistent with the Instructions for Use (IFU), in the opinion 
of the PI.   
Awareness (Date of AE 
Awareness)  
The day, month and year that the study site becomes aware of information from 
any source that reasonably suggests that an Adverse Event has occurred.  
Note: This date may or may not correspond to the date of onset. The date of 
awareness is critical to reporting timelines (see Section 1.6).  
Device Deficiencies  
Are defined as inadequacy of a medical device with respect to its identity, quality, 
durability, reliability safety or performance. Device deficiencies include 
malfunctions, use errors and inadequate labeling. Upon identification of device 
deficiencies associated with the VELYS Robotic-Assisted Solution, the investigator 
should complete a device deficiency eCRF, institute appropriate therapeutic and 
follow-up measures in accordance with good medical practice and notify the IRB 
as applicable. The Investigator must document follow-up treatment of any 
resulting AE (if applicable) and the Sponsor will report the event through its 
applicable complaint reporting channels.  
 
 

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9.4.1 Adverse Event Reporting Guidelines 
This protocol requires each site to comply with all adverse event reporting requirements of their 
respective IRB/EC’s. For this protocol, not all AEs are required to be recorded in the eCRF and reported to 
the Sponsor. The below list are the reportable AEs that must be recorded on the eCRF and submitted to 
the Sponsor as soon as the site becomes aware:  
• All SAEs, regardless of relationship, and  
• All AEs related to the Device and/ or procedure, except for those listed in Exhibit A  
 
Table 9-3: Adverse Event Reporting 
Type of Adverse Event  
Reporting Timeline  
All SAEs  
As soon as site becomes aware but no later than 72 hours after 
awareness  
All Device Related AEs  
As soon as able but no later than 2 weeks from site awareness  
All Procedure Related AEs, except 
for those listed in Exhibit A  
As soon as able but no later than 2 weeks from site awareness  
 
The Investigator will record the nature, severity, seriousness, treatment and outcome of the AE, and will 
determine the association to the device and/or the study procedure.  
 
Determination of Relationship: The determination whether the AE is related to the device (ATTUNE or 
VELYS Robotic-Assisted Solution) and/or procedure will be conducted by the Investigator based upon 
whether a causal relationship between the device and/or procedure and the AE is a reasonable possibility, 
i.e. the relationship cannot be ruled out. A causal relationship cannot be ruled out if, in the medical 
judgment of the Investigator, the effect follows a reasonable temporal association with the use of the 
device and/or is confirmed by the improvement of the effect upon discontinuation of the clinical use of 
the device, and/or the effect is not reasonably explained by the Subject’s clinical state.  
 
Relationship to study device or procedure should be rated as follows:  
 
1) Not related (definitely not related): there is no relationship between study device and/or 
procedure and the event.  
2) Possibly related (remote possibility, possibly, or probably related): the relationship between 
study device and/or procedure could exist if there is no contradicting evidence that can 
reasonably explain the Subject’s condition.  
3) Causal relationship (definitely related): the relationship between study device and/or 
procedure and event does exist and is confirmed upon further investigation by the Investigator.  
 
The following categories of AE severity to be used are presented in Table 9-4 below: 
 
 

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Table 9-4: AE Severity definitions 
mild  
awareness of a sign, symptom or event that is easily tolerated and transient in nature 
with minimal or no impairment to normal activity.  
moderate  
moderate symptoms that are poorly tolerated, sustained, interfere with normal activity 
and require medical attention.  
severe  
symptom(s) require intervention, and the activities of daily living are significantly 
altered.  
 
Pre-existing medical conditions or symptoms reported prior to device implantation are not to be 
recorded as AEs. In the event there is an exacerbation of the pre-existing medical condition or symptoms, 
then an AE must be reported.  
 
As described above, all SAEs, all device related AEs and all procedure related AEs [with the exception of 
the Anticipated Adverse Events listed in Exhibit A] (refer to section 9.1) are required to be recorded on 
the AE eCRF beginning from the time of the initiation of the surgery until Subject participation has ended 
(study completed or withdrawal). AEs must be followed to resolution, or until the study completion or 
consent withdrawal. When an AE status changes (worsens, resolves), the AE eCRF should be updated to 
reflect the new information. When a Subject ends participation in the trial (either study completion or 
consent withdrawal) an AE must be designated either as “resolved” (end date must be provided), or as 
“ongoing.” 
Subjects should be encouraged to report AEs spontaneously and may volunteer AE information at any 
time. At each evaluation, the Investigator will determine whether an AE has occurred that meets the 
requirements for reporting in this study. If it is determined that an applicable AE has occurred, the 
Investigator should obtain all the information required to complete the appropriate AE form eCRF. If an 
event occurs at an outside institution, the Investigator should attempt to obtain, if possible, required 
AE information. 

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Figure 9-1: AE Reporting Flowchart 
The AE Reporting flowchart illustrates a series of questions a site must consider when determining 
whether a clinical observation must be reported and which AE’s do not need to be reported for this CIP. 
 
 
9.5 Minimization of Risks 
The Sponsor will further minimize the identified and/or emergent risks throughout the study, by reviewing 
the reported complications and adverse effects. The Medical Monitor may contact the PI should questions 

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exist related to the determination of the event. All AEs reported to the Sponsor will be reviewed by the 
Sponsor and reported if applicable to the appropriate regulatory body.  
Should an IRB/EC decide to suspend or withdraw its approval for an Investigator to conduct the study at 
that institution, based on unacceptable risks to the study Subjects, the study Sponsor will notify all 
reviewing IRB/ECs and Investigators of this action. To further minimize risks, any new information 
obtained during the study relating to unanticipated adverse findings (that is those not mentioned in any 
of the IFU, this CIP or Exhibit B) will be provided to all Subjects, Investigators, and IRB/ECs.  
The study has been designed to minimize the number of Subjects yet provide sufficient numbers of 
Subjects for valid scientific analysis of the compiled study data. The study design, the procedures for 
monitoring and the documentation, reporting and evaluation of the results from its surgical use will 
further control risks. In addition, only trained orthopaedic surgeons with expertise in treating this 
condition will conduct surgeries. 
10 DEVICE DESCRIPTION  
 
The intended purpose, indications, contraindications and population are described in the Instructions for 
Use (IFU), which is contained in the packaging and the associated surgical technique. The instrumentation 
is the primary focus of this study but the associated implants are included and their performance will also 
be assessed by default.  
10.1 Surgical Instruments  
Surgical instruments aid the surgeon in the execution of bone preparation to allow the implantation of 
the TKA implant components. The study design consists of two arms; the study arm will utilize the VELYS 
Robotic-Assisted Solution in combination with the manual ATTUNE Intuition instruments to support the 
implantation of the ATTUNE Knee whilst the control arm will only use the manual ATTUNE Intuition 
instruments to support the implantation of the ATTUNE Knee.  
10.1.1 VELYS Robotic-Assisted Solution  
The VELYS Robotic-Assisted Solution assists the surgeon in the execution of the bone resections required 
during TKA. The system uses a stereotaxic methodology whereby marker arrays reference and track the 
position of the femur, tibia and instrumentation to generate a surgical plan on the graphical user interface 
based on the surgeon’s instructions/preferences. The robotic-assisted device then moves the saw into 
position and controls the plane of the resection (according to the plan) whilst the surgeon executes the 
resections, once the resection is complete the robotic-assisted device then moves onto the next resection. 
It is intended that this system/method will result in greater precision and accuracy in the execution of 
these resections. Once the resections (distal femoral, proximal tibia and femoral anterior, posterior and 
chamfer) are executed by the system the ATTUNE Intuition manual instruments are used to complete the 
remainder of the procedure including preparation of the tibia, femoral finishing, patella prep (if 
resurfacing) and trialing. The VELYS Robotic-Assisted Solution is only indicated for use with the ATTUNE 
Total Knee system. The products codes associated with the system are listed in EXHIBIT C. 

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10.1.2 ATTUNE Intuition Instruments (Manual Instruments)  
The ATTUNE Intuition Instruments were developed to aid the implantation of the ATTUNE TKA implants. 
The system includes jigs/fixtures that reference anatomical landmarks and help the surgeons to position 
a series of cutting blocks which are pinned to the bone and guide the surgeon to execute the resections 
with a sawblade/saw console. Once the resections are executed, other instruments are used to complete 
the final bone preparation to prepare for the implants before finally trial components are used whereby 
the surgeon can check he has used appropriately sized components and achieved ‘balanced’ soft tissues.  
 
10.2 Implants  
The implants to be used in this study are the ATTUNE total knee system. There are many different 
configurations of the ATTUNE Knee system (see Table 10-1). Depending on the standard of care, each site 
may use different configurations of the system but are required to remain consistent in the selection 
criteria between the two study arms. e.g. if the investigator at a site uses the ATTUNE cemented CR FB 
knees by default for every case, they should use this same construct for both the control and study arm. 
The product codes of the implants are listed in EXHIBIT D.   
Table 10-1: Detailed Device Information for ATTUNE Implants  
Device 
Component  
Component offerings  
Details  
Femoral 
Components  
Cruciate 
Retaining 
(CR)  
Cemented  
ATTUNE femoral components are available in cruciate retaining (CR) and 
posterior stabilized (PS) configurations. The femoral components are 
manufactured from cast Co-Cr-Mo alloy conforming to ASTM standard F-75. 
They are available in lefts and rights. Fourteen sizes are available including 
standard sizes 1-10 and narrow sizes: 3N, 4N, 5N, 6N. Femoral components are 
sterilized using gamma irradiation.  
The PS femoral components have a cam mechanism that articulates with a 
corresponding spine on the PS tibial insert. Both the CR and PS configurations 
are available in cemented and Cementless designs with the Cementless designs 
including a porocoat coating to facilitate cementless fixation.   
Cementless 
Posterior 
Stabilized 
(PS) 
Cemented 
Cementless 
Tibial Bases  
Fixed 
Bearing 
(FB)  
Cemented  
The FB cemented tibial bases are manufactured from Co-Cr-Mo alloy 
conforming to ASTM standard F-75. The proximal surface has a universal 
locking feature that is used for securing the FB tibial insert and permits up-
sizing and downsizing. Ten sizes are available including 1-10. The cemented 
components have a blasted finish to provide for enhanced cement fixation. FB 
Tibial Bases are sterilized using gamma irradiation.  

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Device 
Component  
Component offerings  
Details  
Rotating 
Platform 
(RP) 
Cemented 
The RP tibial bases are manufactured from Co-Cr-Mo alloy conforming to ASTM 
standard F-75. The metal bases have a hollow, conical intramedullary stem. 
The flat superior surface of the base has a central hole continuous with the 
hollow conical medullary stem which receives the conical spike of the RP tibial 
insert components. The RP tibial insert component is not secured to the metal 
base but rotates axially to maintain congruent contact with the femoral 
prosthesis. Ten sizes are available including 1-10. The cemented RP base is 
offered only in a keeled version. The RP base articulates with the RP CR and RP 
PS tibial inserts. The cemented components have a blasted finish to provide for 
enhanced cement fixation. RP Tibial Bases are sterilized using gamma 
irradiation. The Cementless design includes a porocoat coating on the distal 
surface to facilitate cementless fixation and features a central cone and four 
pegs.   
Cementless 
Tibial Inserts 
Fixed 
Bearing 
(FB) 
Cruciate 
Retaining 
(CR) 
The CR and PS tibial inserts are manufactured from UHMWPE and are available 
in sizes 1-10 and thicknesses from 5, 6, 7, 8, 10, 12, 14, 16, 18mm. Additional 
thicknesses 20 & 22mm are available for the PS inserts. The distal surface has 
features that secure the insert to the FB tibial base. Tibial inserts are sterilized 
using gas plasma sterilization. The PS insert has a spine which articulates with 
the cam on the corresponding PS femoral component.  
Posterior 
Stabilized 
(PS) 
Rotating 
Platform 
(RP) 
Cruciate 
Retaining 
(CR) 
CR and PS inserts are manufactured from UHMWPE and are available in sizes 
1-10 and thicknesses from 5, 6, 7, 8, 10, 12, 14, 16, 18mm. Additional 
thicknesses 20 & 22mm are available for the PS inserts. RP inserts should be 
the same size as the selected femoral component. The RP inserts articulate 
with the RP primary bases and should be within 2 sizes of the RP tibial base. 
Tibial inserts are sterilized using gas plasma sterilization. The CR RP insert can 
be used with or without an intact PCL. The PS insert has a spine which 
articulates with the cam on the corresponding PS femoral component.  
Posterior 
Stabilized 
(PS) 
Patellae  
Medial 
Offset 
Cemented 
only  
Patellar components are manufactured from UHMWPE. They are available in 
two styles, medialized dome and medialized anatomic. They are available in 5 
sizes with proportionally increasing thicknesses from 8.5 to 10.5 mm.  
Anatomic  
11 INVESTIGATOR RESPONSIBILITIES AND GOOD CLINICAL PRACTICES  
 
In conducting this medical device clinical investigation the Investigator is responsible for:  
• 
Ensuring that a clinical investigation is conducted according to the Declaration of Helsinki, 
applicable local regulations, the signed statement of Investigator, and the Clinical 
Investigation Plan;  
• 
Protecting the rights, safety, and welfare of Subjects under the Investigator’s care;  
• 
Ensuring the integrity of the data; and 
• 
Ensuring that they have participated on the appropriate training for the devices used in this 
study.   
 
Prior to the initiation of this clinical investigation at each site, the responsible Principal Investigator will 
acknowledge their understanding of this Clinical Investigation Plan (CIP) by signing the signature page.  

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11.1 Institutional Review Board (IRB)/Ethics Committee (EC) Approval  
All Principal Investigators must submit to their institution’s IRB/EC for initial review a copy of the clinical 
investigational plan (CIP) and a sample Informed Consent Document (ICD) provided by the Sponsor. Many 
institutions request modification of the ICD to satisfy specific institutional requirements. The use of a 
modified or unique Informed Consent Document is permitted provided that the document is reviewed 
and approved by the Sponsor.  
All Principal Investigators must submit the Clinical Investigation for continuing review and any other 
additional required submissions to their IRB/EC according to their IRB/EC’s policies and procedures.  
Initial approval/favorable opinion and all continuing review approvals must be documented; originals of 
correspondence and approvals are to be filed by the Investigator and copies forwarded to the Sponsor. 
 
11.2 Informed Consent  
The Principal Investigator is responsible for maintaining source documents evidencing informed consent 
was obtained from study Subjects prior to participation in the study and the process followed to obtain 
consent.  
The Principal Investigator is responsible for taking the necessary steps to collect, process, and maintain 
confidentiality of the study Subject’s personal data in accordance with data protection legislation 
including the Health Insurance Portability and Accountability Act of 1996 (HIPAA). Subjects will be asked 
to sign an Authorization for Release of Protected Health Information (PHI) for the purpose of this in 
investigation. This authorization may be combined with the ICD depending on local IRB preference. 
 
If an Investigator performs any study-specific data collection without obtaining written informed consent, 
the Investigator will promptly report such use to the Sponsor after becoming aware of such a non-
compliance and the reviewing IRB/EC per their procedures.  
For further details and a description of the Informed Consent process, please refer to Section 7.1.2, 
Subject Informed Consent. 
 
11.3 Protected Health Information  
The Principal Investigator is responsible to inform study Subjects their personal data will be collected, 
processed, and confidentially maintained in accordance with local data privacy regulation and law. Data 
protection consent will be obtained from the Subjects as part of the informed consent process.  
Results from the Clinical Investigation may be published. However, Subject confidentiality will always be 
maintained, and it will not be possible to identify individual Subjects from any data presented. 
 

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11.4 Subject Discontinuation from the Clinical Investigation  
Any Subject is entitled to discontinue/withdraw from this clinical investigation for any reason without 
obligation and/or prejudice to further treatment. In addition, the Investigator may decide, for reasons of 
medical prudence, to withdraw a Subject.  
The Investigator will clearly document the date and reason(s) for the Subject’s discontinuation from this 
clinical investigation in the eCRF and submit to the Sponsor.  
Please refer to Section 7.3 Discontinuation of Subject Participation for further details. 
11.5 Source Documentation  
The Investigator will maintain a complete, current and accurate case history (Source Documentation 
records) on each study Subject according to the usual procedure at the investigational site. Case histories 
typically include medical records, including progress notes, hospital charts, nurses’ notes etc. Additional 
documents to be retained include:  
• Signed original Informed Consent Document  
• Executed Authorization for Release of Personal Health Information (may be combined with 
Informed Consent Document based on local IRB/EC requirements)  
• Completed Source worksheets (if used)  
• Results of relevant diagnostic and laboratory tests  
• Intraoperative and post-operative complications and treatment, and  
• Any other relevant information or documentation pertaining to the condition of the Subject.  
The Investigator should retain copies of all documents pertaining to this clinical investigation (for at least 
3 years in the United States after this clinical investigation is completed, or according to institutional policy 
if longer. In addition, if the Investigator moves/retires, etc., s/he should provide the Sponsor with the 
name and address of the person who will be responsible for the Subjects’ clinical investigation related 
records. 
Monitors may verify data reported in the electronic data capture (EDC) system with site source 
documents. The Investigator agrees that the Sponsor’s employees or designees will have the right to audit 
and review pertinent medical records relating to this clinical investigation and the Subject will grant 
approval for such access to his/her medical records via the Informed Consent process. 
11.6 Record of Device Inventory  
As this is a Post-Market Study, there is no regulatory requirement to record device inventory, 
however, product that is supplied to the sites by the Sponsor specifically for the purposes of 
conducting the study will be tracked in an accountability log at each site. 
11.7 Case Report Form Completion and Data Submission 
   Electronic Case Report Forms (eCRFs) entered into an electronic data capture (EDC) system will be used 
to collect all Subject data once a Subject is enrolled in the study. Study sites will be asked to enter Subject 
data into the eCRFs via the EDC web-based database portal promptly after each subject is enrolled. 
Detailed description of the eCRF components and eCRF completion guidelines are included in the User 

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Instructions available in the MediData Rave System and eCRF Completion Guidelines (eCCGs), which will 
be provided to the Investigators and applicable site staff to aid in data entry in the EDC system. The 
respective eCRFs should be fully completed for each Subject and signed electronically by the Investigator. 
 
   Data collected during the study for each Subject will be maintained as accurately and completely as 
possible with entries into an EDC system provided by the Sponsor. The personal data recorded on all 
documents and within the EDC system will be regarded as confidential. The Investigator will be 
responsible for the timing, completeness and accuracy of the details entered within the EDC system. All 
data entered in the database must have source documents in the Subject’s medical records.  
 
11.8 Protocol Adherence  
The Investigator(s) agrees to conduct the study in accordance with this protocol. Prior to beginning the 
study, the Investigator(s) must sign the protocol signature page.  
An Investigator must not make any changes in a study without first receiving approval from the Sponsor 
and IRB/EC, except when necessary to eliminate apparent immediate hazards to a Subject. 
Except for emergency situations, no deviations to this CIP will be permitted. In the event of an emergency 
situation, the Investigator must notify the Sponsor immediately. The Site will be responsible for 
completing a Protocol Deviation form within the EDC system, which will serve as Sponsor notification. The 
appropriate IRB/EC will be notified as applicable in accordance with their respective requirements. 
Protocol deviations cover all departures from the protocol including but not limited to: missed study visits, 
missing radiographic views, late reporting of adverse events, informed consent documentation issues, 
improper informed consent. 
11.9 CIP Amendments  
If it becomes necessary to amend the Clinical Investigation Plan then the nature of the amendment will 
be agreed between the Sponsor and the Principal Investigator(s) and this will be recorded with a 
justification for the amendment. The appropriate IRB/EC, will be informed of any amendments. 
11.10 Reports  
In fulfillment of study related requirements, the Investigator is responsible for preparing and submitting 
complete, accurate, and timely reports as described below. 
Table 11-2: Investigator Reporting Responsibilities 
Report  
Description  
Action  
Withdrawal of 
IRB/EC approval  
The Investigator will promptly notify the sponsor of 
a withdrawal of approval by the reviewing IRB/EC or 
of the investigator’s part in an investigation within 2 
weeks.  
Preferably within 2 
weeks  
Progress Report  
If required by his/her IRB/EC, the investigator is 
responsible for submitting progress reports on the 
investigation to the reviewing IRB/EC.  
As required per IRB/EC 
requirements 

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Report  
Description  
Action  
Reports of 
deviations from the 
investigational plan  
The Investigator will notify the Sponsor of any 
deviation from the Investigational Plan as soon as 
able.  
 
The Investigator will notify the IRB/EC of any 
deviation from the Investigational Plan per the 
IRB/EC requirements.  
As required per IRB/EC 
requirements  
Other  
The Investigator will, upon request of a reviewing 
IRB/EC or Sponsor, provide accurate, complete, and 
current information about any aspect of the 
investigation.  
As requested 
 
The Principal Investigator may delegate a qualified associate(s) to complete one or more of the above 
functions. However, the Principal Investigator retains the overall responsibility for Subject safety, proper 
conduct of the study including obtaining Subject Informed Consent, compliance with this study plan, and 
the collection of all required data. 
 
11.11 Investigator Site File  
Each Investigator and all personnel from the investigational site must maintain accurate, complete, and 
current information about all aspects of this Clinical Investigation. This includes documentation relating 
to the Investigator’s participation, Subject information and correspondence: electronic, written, and 
verbal, relating to any aspect of the clinical investigation. 
The Investigator Site Files (ISFs) may be kept in paper or electronic format, however at any one time only 
one format should be used for the ISF at any particular site. The records are maintained in the Investigator 
Site File consisting of, but not limited to, correspondence with other participating Investigators, the 
reviewing IRB/EC, and the Sponsor. 
Upon receipt of copies of changes or revision updates to the Clinical Investigation Plan (otherwise known 
as the Study Protocol) from the Sponsor, the Investigator will add the updated document and Revision 
Log to the Investigator Site File. The outdated version will be filed. 
11.12 Investigator Study Termination  
The Investigator may prematurely terminate the clinical investigation at any time. Should this be 
necessary, the procedures will be arranged on an individual clinical investigation basis after review and 
consultation by both parties. In terminating the clinical investigation, the Sponsor and the Investigator 
will assure that adequate consideration is given to the protection of the Subject’s interests, all 
documentation is archived and the appropriate bodies such as the IRB/EC are informed as appropriate. 
 

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12 SPONSOR OBLIGATIONS  
 
12.1 IRB/EC Approval  
The Sponsor requires this Clinical Investigation Plan to be submitted to the IRB/EC for initial review and 
approval before implementation at each site. Additionally, all protocol amendments must be submitted 
to the IRB/EC for review and approval before implementation. 
Each site is required to submit a copy of the IRB/EC initial approval, and any subsequent renewals to the 
Sponsor for filing in the study’s Trial Master File. The site is to maintain the original documentation of the 
initial approval and renewals in the site’s Investigator Site File. 
12.2 Investigator Training, Study Initiation  
Prior to enrolling Subjects in this study, the Investigator and/or appropriate site personnel will be 
trained on the study protocol to include: 
• the general aspects of study administration, 
• all procedures in the protocol, and 
• the procedure for e-data acquisition and transmission. 
The Sponsor will be offering hands on training to supplement professional education of the surgeon on 
the implant and surgical instruments, as needed. 
12.3 Study Monitoring  
Sponsor oversight will be maintained per Sponsor policies and procedures.  
 
Monitoring procedures and frequency will be conducted throughout the course of the study according 
to the Clinical Monitoring Plan. Qualified site study personnel are expected to meet with the clinical 
monitor to resolve queries and review action items at any onsite monitoring visit. 
 
During the visit, the Sponsor and authorized Sponsor representatives shall be given access to all study 
records, to include study Subject medical records. 
If under certain circumstances (i.e. limited access for sponsor study personnel to hospitals due to Covid-
19 pandemic) on site monitoring is not possible, Sponsor may plan for remote monitoring and source data 
review or verification, where applicable. Details will be described in the study specific documents, such as 
monitoring plan, or other applicable documents. 
 
12.4 Sponsor Study Termination  
The Sponsor may prematurely terminate or suspend the clinical study as a whole or at an individual 
investigational site for significant and documented reasons. Reasons for premature termination or 

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suspension include, but are not limited to safety, inadequate recruitment, Principal Investigator issues, 
device-related problems, alignment with business strategy or administrative issues. 
In the event of the study being terminated, any enrolled Subjects that have not yet had the surgical 
procedure would be treated as per their surgeon's standard practice using implants and instruments of 
the surgeon's choice. Each enrolled Subject would continue to be cared for by his/her surgeon according 
to his/her standard of care. No further study-related procedures or data collection would occur. 
 
13 Investigational Plan EXHIBITS  
 
Exhibit  Description of Exhibit  
A  
Listing of Anticipated Adverse Events  
B  
References 
C 
Product codes of the VELYS Robotic-Assisted 
Solution  
D 
Product codes of the ATTUNE Implants 
 
 

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EXHIBIT A: Non-Reportable Adverse Events   
In addition to the information provided in the Instructions for Use included with the packaging for all 
implants, the following adverse events are anticipated. Assuming the following events are consistent 
with the normal postoperative course, then they do NOT have to be reported as Adverse Events. 
Up to 24 Hours Postoperative 
Genitourinary  
• Urinary retention  
Cardiovascular  
• Hypotension, not requiring treatment  
• Hypertension, not requiring treatment  
• Dysrhythmia (resolving within 36 hrs post-op)  
Central Nervous 
System  
• Incisional pain  
• Post-op consequences of narcotics use  
• Fatigue  
Integumentary  
• Surgical site ecchymosis  
• Sanguinous / sero-sanguinous drainage from incision  
• Venous congestion without thrombosis (foot swelling alleviated when 
lower limb is raised)  
Constitutional  
• Elevated temperature (no greater than 38.3oC / 101oF)  
Prior to Discharge 
Haematological  
• Changes in lab values not resulting in clinical symptomatology 
(Electrolytes, CBC, BS, PT/ PTT)  
• Anemia, not requiring treatment  
Gastrointestinal  
• Transitory:  
o Nausea  
o Vomiting  
o Constipation  
o Diarrhea  
Central Nervous 
System  
• Headache  
• Disorientation  
• Confusion  
• Dizziness  
• Incisional /operative site pain  
Respiratory  
• Atelectasis not requiring treatment  
Integumentary  
• Foot Swelling not requiring intervention  
• Surgical site ecchymosis  
• Sanguinous / sero-sanguinous drainage from incision  
• Skin blisters secondary to tape  
• Suture granuloma not involving cellulitis or deeper infection (“spitting 
suture”, abscess suture)  
Constitutional  
• Elevated temperature (no greater than 38.3oC / 101oF)  
If you have any questions about potential adverse events or adverse event reporting, then please 
contact the Sponsor.  
 

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EXHIBIT B: References 
  
1. 
Kurtz, S., et al., Projections of primary and revision hip and knee arthroplasty in the United States 
from 2005 to 2030. J. Bone Joint Surg. Am, 2007. 89(4): p. 780-785. 
2. 
Labek, G., et al., Revision rates after total joint replacement: cumulative results from worldwide 
joint register datasets. J Bone Joint Surg Br, 2011. 93(3): p. 293-7. 
3. 
Sharkey, P.F., et al., Why are total knee arthroplasties failing today--has anything changed after 
10 years? J. Arthroplasty, 2014. 29(9): p. 1774-1778. 
4. 
Insall, J.N., et al., Total knee arthroplasty. Clin Orthop Relat Res, 1985(192): p. 13-22. 
5. 
Krackow, K.A., et al., A new technique for determining proper mechanical axis alignment during 
total knee arthroplasty: progress toward computer-assisted TKA. Orthopedics, 1999. 22(7): p. 
698-702. 
6. 
Jeffery, R.S., R.W. Morris, and R.A. Denham, Coronal alignment after total knee replacement, in 
The Journal of bone and joint surgery. British volume J Bone Joint Surg Br. 1991. p. 709-714. 
7. 
Hungerford, D.S. and K.A. Krackow, Total joint arthroplasty of the knee. Clin Orthop Relat Res, 
1985. 192: p. 23-33. 
8. 
Fang, D.M., M.A. Ritter, and K.E. Davis, Coronal alignment in total knee arthroplasty: just how 
important is it? J Arthroplasty, 2009. 24(6 Suppl): p. 39-43. 
9. 
Lonner, J.H., T.K. John, and M.A. Conditt, Robotic arm-assisted UKA improves tibial component 
alignment: a pilot study. Clin Orthop Relat Res, 2010. 468(1): p. 141-6. 
10. 
Cobb, J., et al., Hands-on robotic unicompartmental knee replacement: a prospective, 
randomised controlled study of the acrobot system. J Bone Joint Surg Br, 2006. 88(2): p. 188-97. 
11. 
Bell, S.W., et al., Improved Accuracy of Component Positioning with Robotic-Assisted 
Unicompartmental Knee Arthroplasty: Data from a Prospective, Randomized Controlled Study. J 
Bone Joint Surg Am, 2016. 98(8): p. 627-35. 
12. 
Song, E.K., et al., Robotic-assisted TKA reduces postoperative alignment outliers and improves 
gap balance compared to conventional TKA. Clin Orthop Relat Res, 2013. 471(1): p. 118-26. 
13. 
Liow, M.H., et al., Robot-assisted total knee arthroplasty accurately restores the joint line and 
mechanical axis. A prospective randomised study. J Arthroplasty, 2014. 29(12): p. 2373-7. 
14. 
Hampp, E.L., et al., Robotic-Arm Assisted Total Knee Arthroplasty Demonstrated Greater 
Accuracy and Precision to Plan Compared with Manual Techniques. J Knee Surg, 2019. 32(3): p. 
239-250. 
15. 
Sultan, A.A., et al., Robotic-Arm Assisted Total Knee Arthroplasty More Accurately Restored the 
Posterior Condylar Offset Ratio and the Insall-Salvati Index Compared to the Manual Technique; 
A Cohort-Matched Study. Surg Technol Int, 2019. 34. 
16. 
Kayani, B., et al., Robotic-arm assisted total knee arthroplasty has a learning curve of seven 
cases for integration into the surgical workflow but no learning curve effect for accuracy of 
implant positioning. Knee Surg Sports Traumatol Arthrosc, 2019. 27(4): p. 1132-1141. 
17. 
Kayani, B., et al., The learning curve associated with robotic-arm assisted unicompartmental 
knee arthroplasty: a prospective cohort study. Bone Joint J, 2018. 100-b(8): p. 1033-1042. 
18. 
Sodhi, N., et al., The Learning Curve Associated with Robotic Total Knee Arthroplasty. J Knee 
Surg, 2018. 31(1): p. 17-21. 
19. 
Koenig;J.A.;;Suero;E.M.;;Plaskos;C., SURGICAL ACCURACY AND EFFICIENCY OF COMPUTER-
NAVIGATED TKA WITH A ROBOTIC CUTTING GUIDE – REPORT ON THE FIRST 100 CASES. 
Orthopaedic Proceedings, 2012. 94-B(SUPP_XLIV): p. 103-103. 

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20. 
Siebert, W., et al., Technique and first clinical results of robot-assisted total knee replacement. 
Knee, 2002. 9(3): p. 173-80. 
21. 
Jinnah, R., et al., The learning curve of robotic-assisted UKA. 2011: International Journal of 
Medical Robotics and Computer Assisted Surgery. 2011 Nov; Conference: 6th International 
MIRA Congress. Athens Greece. Conference Publication: (var.pagings). 7 (SUPPL. 2) :54. 
22. 
Cho, K.J., et al., Robotic versus conventional primary total knee arthroplasty: clinical and 
radiological long-term results with a minimum follow-up of ten years. Int Orthop, 2018. 
23. 
Song, E.K., et al., Simultaneous bilateral total knee arthroplasty with robotic and conventional 
techniques: a prospective, randomized study. Knee Surg Sports Traumatol Arthrosc, 2011. 19(7): 
p. 1069-76. 
24. 
Khlopas, A., et al., Patient-Reported Functional and Satisfaction Outcomes after Robotic-Arm-
Assisted Total Knee Arthroplasty: Early Results of a Prospective Multicenter Investigation. J Knee 
Surg, 2019. 
25. 
Marchand, R.C., et al., One-Year Patient Outcomes for Robotic-Arm-Assisted versus Manual Total 
Knee Arthroplasty. J Knee Surg, 2019. 
26. 
Kayani, B., et al., Robotic-arm assisted total knee arthroplasty is associated with improved early 
functional recovery and reduced time to hospital discharge compared with conventional jig-
based total knee arthroplasty. Bone Joint J, 2018. 100-b(7): p. 930-937. 
27. 
Winnock de Grave, P., et al., Higher satisfaction after total knee arthroplasty using restricted 
inverse kinematic alignment compared to adjusted mechanical alignment. Knee Surg Sports 
Traumatol Arthrosc, 2020. 
28. 
MacDessi, S.J., et al., Coronal Plane Alignment of the Knee (CPAK) classification. Bone Joint J, 
2021. 103-B(2): p. 329-337. 
29. 
Bellemans, J., et al., The Chitranjan Ranawat award: is neutral mechanical alignment normal for 
all patients? The concept of constitutional varus, in Clinical orthopaedics and related research 
Clin Orthop Relat Res. 2012. p. 45-53. 
30. 
Turgeon, T.R., et al., The assessment of the stability of the tibial component of a novel knee 
arthroplasty system using radiostereometric analysis. Bone Joint J, 2018. 100-b(12): p. 1579-
1584. 
 
 
 
 
 
 
 
 
 

DSJ_2019_08 Rev F 
 
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06-June-2022                                                                                                                                 Page 53 of 76 
 
EXHIBIT C: PRODUCT CODES OF THE VELYS ROBOTIC-ASSISTED SOLUTION  
 
Hardware  
Product Code 
Description 
Picture 
Sub Assemblies  
451570100 
Base Station 
Footswitch 
Power Cable 
Camera 
Touchscreen 
Main Console 
Robotic-assisted Device Console 
Saw Console 
Cart 
451570101 
Satellite Station 
 
Satellite Station Touchscreen 
Satellite Station Console 
Satellite Station Transfer 
Satellite Station Cart 
Satellite Station Cable 
Robotic Assisted 
Device 
Actuation Unit 
Planar 
Articulation 
Holding Arm US 
Standard 
Holding Arm 
Horizontal 
Adjustment 
Holding Arm 
Vertical 
Adjustment 
 
 
 
 
 
 
 

DSJ_2019_08 Rev F 
 
DePuy Orthopaedics Inc.  
06-June-2022                                                                                                                                 Page 54 of 76 
 
Accessories – Reusable Instruments 
 
Product Code 
Description 
Picture 
451570102 
Saw Handpiece 
 
451570105 
Saw Interface Left 
 
451570106 
Saw Interface Right 
 
451570107 
 
Array Clamp 
 
 
451570108 
  Array Drill Pin Inserter 
 
 
 
 
 
 
 
 

DSJ_2019_08 Rev F 
 
DePuy Orthopaedics Inc.  
06-June-2022                                                                                                                                 Page 55 of 76 
 
Accessories – Single Use Instruments 
Product Code 
Description 
Picture 
451570000 
Oscillating Saw Blade 
451570001 
Array Set -Knee 
Femur Array 
 
Tibia Array 
 
Saw Array 
Device Unit Array 
Plane Checker 
 
Pointer 
 
451570203 
 
 
 
 
 
 
 
 
 
 
 
Array full set Knee 
 
 
 
 
 
 
 
 
 
 
 
Femur Array (PIM) 
 
Tibial Array (PIM)_ 
 
Saw Array  
 
Device Array (PIM)  
 
Pointer 
 

DSJ_2019_08 Rev F 
 
DePuy Orthopaedics Inc.  
06-June-2022                                                                                                                                 Page 56 of 76 
 
Product Code 
Description 
Picture 
451570011 
Array Set Knee 
 
Femur Array (PIM) 
 
Tibial Array (PIM)_ 
Saw Array (PIM)  
Device Array (PIM)  
 
Pointer (PIM) 
451570012 
Metal Plane Tool  
 
451570004 
Array Drill Pin 100 
mm x 4 mm 
 
451570005 
Array Drill Pin 125 
mm x 4 mm 
 
451570006 
Array Drill Pin 175 
mm x 4 mm 
 
451570008  
Actuation Unit Sterile 
Drape (20 pack) 
 
451570009  
Satellite Station 
Sterile Drape (20 
pack) 
 

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DePuy Orthopaedics Inc.  
06-June-2022                                                                                                                                 Page 57 of 76 
 
Additional Accessories 
Product Code  
Description 
869188 
Patellar Caliper 
129901054 
CAS Ligament Tensor Handle 
129901055 
CAS Tensor Spacer 5 mm 
129901056 
CAS Tensor Spacer 10 mm 
129901080 
CAS Ligament Tensor Size: 2 
129901081 
CAS Ligament Tensor Size: 4 
254500049 
Patella Femoral Lug Drill 
480000100 
DePuy Synthes Instrument Case Base 
480010000 
DePuy Synthes Instrument Case Lid 
200420933 
ATTUNE Trumatch Half Lid 
254501700 
ATTUNE DePuy Synthes Lid 
451570232 
VELYS Instrument Case 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

DSJ_2019_08 Rev F 
 
DePuy Orthopaedics Inc.  
06-June-2022                                                                                                                                 Page 58 of 76 
 
EXHIBIT D: PRODUCT CODES OF THE ATTUNE IMPLANTS   
 
Product Code 
Description 
1504-00-101 
ATTUNE CR Cemented Femoral Size 1 Left 
1504-00-102 
ATTUNE CR Cemented Femoral Size 2 Left 
1504-00-103 
ATTUNE CR Cemented Femoral Size 3 Left 
1504-00-123 
ATTUNE CR Cemented Femoral Size 3 Narrow Left 
1504-00-104 
ATTUNE CR Cemented Femoral Size 4 Left 
1504-00-124 
ATTUNE CR Cemented Femoral Size 4 Narrow Left 
1504-00-105 
ATTUNE CR Cemented Femoral Size 5 Left 
1504-00-125 
ATTUNE CR Cemented Femoral Size 5 Narrow Left 
1504-00-106 
ATTUNE CR Cemented Femoral Size 6 Left 
1504-00-126 
ATTUNE CR Cemented Femoral Size 6 Narrow Left 
1504-00-107 
ATTUNE CR Cemented Femoral Size 7 Left 
1504-00-108 
ATTUNE CR Cemented Femoral Size 8 Left 
1504-00-109 
ATTUNE CR Cemented Femoral Size 9 Left 
1504-00-110 
ATTUNE CR Cemented Femoral Size 10 Left 
1504-00-201 
ATTUNE CR Cemented Femoral Size 1 Right 
1504-00-202 
ATTUNE CR Cemented Femoral Size 2 Right 
1504-00-203 
ATTUNE CR Cemented Femoral Size 3 Right 
1504-00-223 
ATTUNE CR Cemented Femoral Size 3 Narrow Right 
1504-00-204 
ATTUNE CR Cemented Femoral Size 4 Right 
1504-00-224 
ATTUNE CR Cemented Femoral Size 4 Narrow Right 
1504-00-205 
ATTUNE CR Cemented Femoral Size 5 Right 
1504-00-225 
ATTUNE CR Cemented Femoral Size 5 Narrow Right 
1504-00-206 
ATTUNE CR Cemented Femoral Size 6 Right 
1504-00-226 
ATTUNE CR Cemented Femoral Size 6 Narrow Right 
1504-00-207 
ATTUNE CR Cemented Femoral Size 7 Right 
1504-00-208 
ATTUNE CR Cemented Femoral Size 8 Right 
1504-00-209 
ATTUNE CR Cemented Femoral Size 9 Right 
1504-00-210 
ATTUNE CR Cemented Femoral Size 10 Right 
1504-10-101 
ATTUNE PS Cemented Femoral Size 1 Left 
1504-10-102 
ATTUNE PS Cemented Femoral Size 2 Left 
1504-10-103 
ATTUNE PS Cemented Femoral Size 3 Left 
1504-10-123 
ATTUNE PS Cemented Femoral Size 3 Narrow Left 
1504-10-104 
ATTUNE PS Cemented Femoral Size 4 Left 
1504-10-124 
ATTUNE PS Cemented Femoral Size 4 Narrow Left 
1504-10-105 
ATTUNE PS Cemented Femoral Size 5 Left 
1504-10-125 
ATTUNE PS Cemented Femoral Size 5 Narrow Left 
1504-10-106 
ATTUNE PS Cemented Femoral Size 6 Left 
1504-10-126 
ATTUNE PS Cemented Femoral Size 6 Narrow Left 
1504-10-107 
ATTUNE PS Cemented Femoral Size 7 Left 

DSJ_2019_08 Rev F 
 
DePuy Orthopaedics Inc.  
06-June-2022                                                                                                                                 Page 59 of 76 
 
Product Code 
Description 
1504-10-108 
ATTUNE PS Cemented Femoral Size 8 Left 
1504-10-109 
ATTUNE PS Cemented Femoral Size 9 Left 
1504-10-110 
ATTUNE PS Cemented Femoral Size 10 Left 
1504-10-201 
ATTUNE PS Cemented Femoral Size 1 Right 
1504-10-202 
ATTUNE PS Cemented Femoral Size 2 Right 
1504-10-203 
ATTUNE PS Cemented Femoral Size 3 Right 
1504-10-223 
ATTUNE PS Cemented Femoral Size 3 Narrow Right 
1504-10-204 
ATTUNE PS Cemented Femoral Size 4 Right 
1504-10-224 
ATTUNE PS Cemented Femoral Size 4 Narrow Right 
1504-10-205 
ATTUNE PS Cemented Femoral Size 5 Right 
1504-10-225 
ATTUNE PS Cemented Femoral Size 5 Narrow Right 
1504-10-206 
ATTUNE PS Cemented Femoral Size 6 Right 
1504-10-226 
ATTUNE PS Cemented Femoral Size 6 Narrow Right 
1504-10-207 
ATTUNE PS Cemented Femoral Size 7 Right 
1504-10-208 
ATTUNE PS Cemented Femoral Size 8 Right 
1504-10-209 
ATTUNE PS Cemented Femoral Size 9 Right 
1504-10-210 
ATTUNE PS Cemented Femoral Size 10 Right 
1504-01-101 
ATTUNE CR  Femoral Left Size 1 Porous 
1504-01-102 
ATTUNE CR  Femoral Left Size 2 Porous 
1504-01-103 
ATTUNE CR  Femoral Left Size 3 Porous 
1504-01-123 
ATTUNE CR  Femoral Left Size 3 Narrow Porous 
1504-01-104 
ATTUNE CR  Femoral Left Size 4 Porous 
1504-01-124 
ATTUNE CR  Femoral Left Size 4 Narrow Porous 
1504-01-105 
ATTUNE CR  Femoral Left Size 5 Porous 
1504-01-125 
ATTUNE CR  Femoral Left Size 5 Narrow Porous 
1504-01-106 
ATTUNE CR  Femoral Left Size 6 Porous 
1504-01-126 
ATTUNE CR  Femoral Left Size 6 Narrow Porous 
1504-01-107 
ATTUNE CR  Femoral Left Size 7 Porous 
1504-01-108 
ATTUNE CR  Femoral Left Size 8 Porous 
1504-01-109 
ATTUNE CR  Femoral Left Size 9 Porous 
1504-01-110 
ATTUNE CR  Femoral Left Size 10 Porous 
1504-01-201 
ATTUNE CR  Femoral Right Size 1 Porous 
1504-01-202 
ATTUNE CR  Femoral Right Size 2 Porous 
1504-01-203 
ATTUNE CR  Femoral Right Size 3 Porous 
1504-01-223 
ATTUNE CR  Femoral Right Size 3 Narrow Porous 
1504-01-204 
ATTUNE CR  Femoral Right Size 4 Porous 
1504-01-224 
ATTUNE CR  Femoral Right Size 4 Narrow Porous 
1504-01-205 
ATTUNE CR  Femoral Right Size 5 Porous 
1504-01-225 
ATTUNE CR  Femoral Right Size 5 Narrow Porous 
1504-01-206 
ATTUNE CR  Femoral Right Size 6 Porous 
1504-01-226 
ATTUNE CR  Femoral Right Size 6 Narrow Porous 
1504-01-207 
ATTUNE CR  Femoral Right Size 7 Porous 

DSJ_2019_08 Rev F 
 
DePuy Orthopaedics Inc.  
06-June-2022                                                                                                                                 Page 60 of 76 
 
Product Code 
Description 
1504-01-208 
ATTUNE CR  Femoral Right Size 8 Porous 
1504-01-209 
ATTUNE CR  Femoral Right Size 9 Porous 
1504-01-210 
ATTUNE CR  Femoral Right Size 10 Porous 
1504-11-101 
ATTUNE PS  Femoral Left Size 1 Porous 
1504-11-102 
ATTUNE PS  Femoral Left Size 2 Porous 
1504-11-103 
ATTUNE PS  Femoral Left Size 3 Porous 
1504-11-123 
ATTUNE PS  Femoral Left Size 3 Narrow Porous 
1504-11-104 
ATTUNE PS  Femoral Left Size 4 Porous 
1504-11-124 
ATTUNE PS  Femoral Left Size 4 Narrow Porous 
1504-11-105 
ATTUNE PS  Femoral Left Size 5 Porous 
1504-11-125 
ATTUNE PS  Femoral Left Size 5 Narrow Porous 
1504-11-106 
ATTUNE PS  Femoral Left Size 6 Porous 
1504-11-126 
ATTUNE PS  Femoral Left Size 6 Narrow Porous 
1504-11-107 
ATTUNE PS  Femoral Left Size 7 Porous 
1504-11-108 
ATTUNE PS  Femoral Left Size 8 Porous 
1504-11-109 
ATTUNE PS  Femoral Left Size 9 Porous 
1504-11-110 
ATTUNE PS  Femoral Left Size 10 Porous 
1504-11-201 
ATTUNE PS  Femoral Right Size 1 Porous 
1504-11-202 
ATTUNE PS  Femoral Right Size 2 Porous 
1504-11-203 
ATTUNE PS  Femoral Right Size 3 Porous 
1504-11-223 
ATTUNE PS  Femoral Right Size 3 Narrow Porous 
1504-11-204 
ATTUNE PS  Femoral Right Size 4 Porous 
1504-11-224 
ATTUNE PS  Femoral Right Size 4 Narrow Porous 
1504-11-205 
ATTUNE PS  Femoral Right Size 5 Porous 
1504-11-225 
ATTUNE PS  Femoral Right Size 5 Narrow Porous 
1504-11-206 
ATTUNE PS  Femoral Right Size 6 Porous 
1504-11-226 
ATTUNE PS  Femoral Right Size 6 Narrow Porous 
1504-11-207 
ATTUNE PS  Femoral Right Size 7 Porous 
1504-11-208 
ATTUNE PS  Femoral Right Size 8 Porous 
1504-11-209 
ATTUNE PS  Femoral Right Size 9 Porous 
1504-11-210 
ATTUNE PS  Femoral Right Size 10 Porous 
1516-20-105 
ATTUNE CR FB Insert Size 1 5 mm 
1516-20-106 
ATTUNE CR FB Insert Size 1 6 mm 
1516-20-107 
ATTUNE CR FB Insert Size 1 7 mm 
1516-20-108 
ATTUNE CR FB Insert Size 1 8 mm 
1516-20-110 
ATTUNE CR FB Insert Size 1 10 mm 
1516-20-112 
ATTUNE CR FB Insert Size 1 12 mm 
1516-20-114 
ATTUNE CR FB Insert Size 1 14 mm 
1516-20-116 
ATTUNE CR FB Insert Size 1 16 mm 
1516-20-205 
ATTUNE CR FB Insert Size 2 5 mm 
1516-20-206 
ATTUNE CR FB Insert Size 2 6 mm 
1516-20-207 
ATTUNE CR FB Insert Size 2 7 mm 

DSJ_2019_08 Rev F 
 
DePuy Orthopaedics Inc.  
06-June-2022                                                                                                                                 Page 61 of 76 
 
Product Code 
Description 
1516-20-208 
ATTUNE CR FB Insert Size 2 8 mm 
1516-20-210 
ATTUNE CR FB Insert Size 2 10 mm 
1516-20-212 
ATTUNE CR FB Insert Size 2 12 mm 
1516-20-214 
ATTUNE CR FB Insert Size 2 14 mm 
1516-20-216 
ATTUNE CR FB Insert Size 2 16 mm 
1516-20-305 
ATTUNE CR FB Insert Size 3 5 mm 
1516-20-306 
ATTUNE CR FB Insert Size 3 6 mm 
1516-20-307 
ATTUNE CR FB Insert Size 3 7 mm 
1516-20-308 
ATTUNE CR FB Insert Size 3 8 mm 
1516-20-310 
ATTUNE CR FB Insert Size 3 10 mm 
1516-20-312 
ATTUNE CR FB Insert Size 3 12 mm 
1516-20-314 
ATTUNE CR FB Insert Size 3 14 mm 
1516-20-316 
ATTUNE CR FB Insert Size 3 16 mm 
1516-20-405 
ATTUNE CR FB Insert Size 4 5 mm 
1516-20-406 
ATTUNE CR FB Insert Size 4 6 mm 
1516-20-407 
ATTUNE CR FB Insert Size 4 7 mm 
1516-20-408 
ATTUNE CR FB Insert Size 4 8 mm 
1516-20-410 
ATTUNE CR FB Insert Size 4 10 mm 
1516-20-412 
ATTUNE CR FB Insert Size 4 12 mm 
1516-20-414 
ATTUNE CR FB Insert Size 4 14 mm 
1516-20-416 
ATTUNE CR FB Insert Size 4 16 mm 
1516-20-505 
ATTUNE CR FB Insert Size 5 5 mm 
1516-20-506 
ATTUNE CR FB Insert Size 5 6 mm 
1516-20-507 
ATTUNE CR FB Insert Size 5 7 mm 
1516-20-508 
ATTUNE CR FB Insert Size 5 8 mm 
1516-20-510 
ATTUNE CR FB Insert Size 5 10 mm 
1516-20-512 
ATTUNE CR FB Insert Size 5 12 mm 
1516-20-514 
ATTUNE CR FB Insert Size 5 14 mm 
1516-20-516 
ATTUNE CR FB Insert Size 5 16 mm 
1516-20-605 
ATTUNE CR FB Insert Size 6 5 mm 
1516-20-606 
ATTUNE CR FB Insert Size 6 6 mm 
1516-20-607 
ATTUNE CR FB Insert Size 6 7 mm 
1516-20-608 
ATTUNE CR FB Insert Size 6 8 mm 
1516-20-610 
ATTUNE CR FB Insert Size 6 10 mm 
1516-20-612 
ATTUNE CR FB Insert Size 6 12 mm 
1516-20-614 
ATTUNE CR FB Insert Size 6 14 mm 
1516-20-616 
ATTUNE CR FB Insert Size 6 16 mm 
1516-20-705 
ATTUNE CR FB Insert Size 7 5 mm 
1516-20-706 
ATTUNE CR FB Insert Size 7 6 mm 
1516-20-707 
ATTUNE CR FB Insert Size 7 7 mm 
1516-20-708 
ATTUNE CR FB Insert Size 7 8 mm 
1516-20-710 
ATTUNE CR FB Insert Size 7 10 mm 

DSJ_2019_08 Rev F 
 
DePuy Orthopaedics Inc.  
06-June-2022                                                                                                                                 Page 62 of 76 
 
Product Code 
Description 
1516-20-712 
ATTUNE CR FB Insert Size 7 12 mm 
1516-20-714 
ATTUNE CR FB Insert Size 7 14 mm 
1516-20-716 
ATTUNE CR FB Insert Size 7 16 mm 
1516-20-805 
ATTUNE CR FB Insert Size 8 5 mm 
1516-20-806 
ATTUNE CR FB Insert Size 8 6 mm 
1516-20-807 
ATTUNE CR FB Insert Size 8 7 mm 
1516-20-808 
ATTUNE CR FB Insert Size 8 8 mm 
1516-20-810 
ATTUNE CR FB Insert Size 8 10 mm 
1516-20-812 
ATTUNE CR FB Insert Size 8 12 mm 
1516-20-814 
ATTUNE CR FB Insert Size 8 14 mm 
1516-20-816 
ATTUNE CR FB Insert Size 8 16 mm 
1516-20-905 
ATTUNE CR FB Insert Size 9 5 mm 
1516-20-906 
ATTUNE CR FB Insert Size 9 6 mm 
1516-20-907 
ATTUNE CR FB Insert Size 9 7 mm 
1516-20-908 
ATTUNE CR FB Insert Size 9 8 mm 
1516-20-910 
ATTUNE CR FB Insert Size 9 10 mm 
1516-20-912 
ATTUNE CR FB Insert Size 9 12 mm 
1516-20-914 
ATTUNE CR FB Insert Size 9 14 mm 
1516-20-916 
ATTUNE CR FB Insert Size 9 16 mm 
1516-21-005 
ATTUNE CR FB Insert Size 10 5 mm 
1516-21-006 
ATTUNE CR FB Insert Size 10 6 mm 
1516-21-007 
ATTUNE CR FB Insert Size 10 7 mm 
1516-21-008 
ATTUNE CR FB Insert Size 10 8 mm 
1516-21-010 
ATTUNE CR FB Insert Size 10 10 mm 
1516-21-012 
ATTUNE CR FB Insert Size 10 12 mm 
1516-21-014 
ATTUNE CR FB Insert Size 10 14 mm 
1516-21-016 
ATTUNE CR FB Insert Size 10 16 mm 
1516-40-105 
ATTUNE PS FB Insert Size 1 5 mm 
1516-40-106 
ATTUNE PS FB Insert Size 1 6 mm 
1516-40-107 
ATTUNE PS FB Insert Size 1 7 mm 
1516-40-108 
ATTUNE PS FB Insert Size 1 8 mm 
1516-40-110 
ATTUNE PS FB Insert Size 1 10 mm 
1516-40-112 
ATTUNE PS FB Insert Size 1 12 mm 
1516-40-114 
ATTUNE PS FB Insert Size 1 14 mm 
1516-40-116 
ATTUNE PS FB Insert Size 1 16 mm 
1516-40-118 
ATTUNE PS FB Insert Size 1 18 mm 
1516-40-205 
ATTUNE PS FB Insert Size 2 5 mm 
1516-40-206 
ATTUNE PS FB Insert Size 2 6 mm 
1516-40-207 
ATTUNE PS FB Insert Size 2 7 mm 
1516-40-208 
ATTUNE PS FB Insert Size 2 8 mm 
1516-40-210 
ATTUNE PS FB Insert Size 2 10 mm 
1516-40-212 
ATTUNE PS FB Insert Size 2 12 mm 

DSJ_2019_08 Rev F 
 
DePuy Orthopaedics Inc.  
06-June-2022                                                                                                                                 Page 63 of 76 
 
Product Code 
Description 
1516-40-214 
ATTUNE PS FB Insert Size 2 14 mm 
1516-40-216 
ATTUNE PS FB Insert Size 2 16 mm 
1516-40-218 
ATTUNE PS FB Insert Size 2 18 mm 
1516-40-305 
ATTUNE PS FB Insert Size 3 5 mm 
1516-40-306 
ATTUNE PS FB Insert Size 3 6 mm 
1516-40-307 
ATTUNE PS FB Insert Size 3 7 mm 
1516-40-308 
ATTUNE PS FB Insert Size 3 8 mm 
1516-40-310 
ATTUNE PS FB Insert Size 3 10 mm 
1516-40-312 
ATTUNE PS FB Insert Size 3 12 mm 
1516-40-314 
ATTUNE PS FB Insert Size 3 14 mm 
1516-40-316 
ATTUNE PS FB Insert Size 3 16 mm 
1516-40-318 
ATTUNE PS FB Insert Size 3 18 mm 
1516-40-320 
ATTUNE PS FB Insert Size 3 20 mm 
1516-40-405 
ATTUNE PS FB Insert Size 4 5 mm 
1516-40-406 
ATTUNE PS FB Insert Size 4 6 mm 
1516-40-407 
ATTUNE PS FB Insert Size 4 7 mm 
1516-40-408 
ATTUNE PS FB Insert Size 4 8 mm 
1516-40-410 
ATTUNE PS FB Insert Size 4 10 mm 
1516-40-412 
ATTUNE PS FB Insert Size 4 12 mm 
1516-40-414 
ATTUNE PS FB Insert Size 4 14 mm 
1516-40-416 
ATTUNE PS FB Insert Size 4 16 mm 
1516-40-418 
ATTUNE PS FB Insert Size 4 18 mm 
1516-40-420 
ATTUNE PS FB Insert Size 4 20 mm 
1516-40-505 
ATTUNE PS FB Insert Size 5 5 mm 
1516-40-506 
ATTUNE PS FB Insert Size 5 6 mm 
1516-40-507 
ATTUNE PS FB Insert Size 5 7 mm 
1516-40-508 
ATTUNE PS FB Insert Size 5 8 mm 
1516-40-510 
ATTUNE PS FB Insert Size 5 10 mm 
1516-40-512 
ATTUNE PS FB Insert Size 5 12 mm 
1516-40-514 
ATTUNE PS FB Insert Size 5 14 mm 
1516-40-516 
ATTUNE PS FB Insert Size 5 16 mm 
1516-40-518 
ATTUNE PS FB Insert Size 5 18 mm 
1516-40-520 
ATTUNE PS FB Insert Size 5 20 mm 
1516-40-605 
ATTUNE PS FB Insert Size 6 5 mm 
1516-40-606 
ATTUNE PS FB Insert Size 6 6 mm 
1516-40-607 
ATTUNE PS FB Insert Size 6 7 mm 
1516-40-608 
ATTUNE PS FB Insert Size 6 8 mm 
1516-40-610 
ATTUNE PS FB Insert Size 6 10 mm 
1516-40-612 
ATTUNE PS FB Insert Size 6 12 mm 
1516-40-614 
ATTUNE PS FB Insert Size 6 14 mm 
1516-40-616 
ATTUNE PS FB Insert Size 6 16 mm 
1516-40-618 
ATTUNE PS FB Insert Size 6 18 mm 

DSJ_2019_08 Rev F 
 
DePuy Orthopaedics Inc.  
06-June-2022                                                                                                                                 Page 64 of 76 
 
Product Code 
Description 
1516-40-620 
ATTUNE PS FB Insert Size 6 20 mm 
1516-40-705 
ATTUNE PS FB Insert Size 7 5 mm 
1516-40-706 
ATTUNE PS FB Insert Size 7 6 mm 
1516-40-707 
ATTUNE PS FB Insert Size 7 7 mm 
1516-40-708 
ATTUNE PS FB Insert Size 7 8 mm 
1516-40-710 
ATTUNE PS FB Insert Size 7 10 mm 
1516-40-712 
ATTUNE PS FB Insert Size 7 12 mm 
1516-40-714 
ATTUNE PS FB Insert Size 7 14 mm 
1516-40-716 
ATTUNE PS FB Insert Size 7 16 mm 
1516-40-718 
ATTUNE PS FB Insert Size 7 18 mm 
1516-40-720 
ATTUNE PS FB Insert Size 7 20 mm 
1516-40-805 
ATTUNE PS FB Insert Size 8 5 mm 
1516-40-806 
ATTUNE PS FB Insert Size 8 6 mm 
1516-40-807 
ATTUNE PS FB Insert Size 8 7 mm 
1516-40-808 
ATTUNE PS FB Insert Size 8 8 mm 
1516-40-810 
ATTUNE PS FB Insert Size 8 10 mm 
1516-40-812 
ATTUNE PS FB Insert Size 8 12 mm 
1516-40-814 
ATTUNE PS FB Insert Size 8 14 mm 
1516-40-816 
ATTUNE PS FB Insert Size 8 16 mm 
1516-40-818 
ATTUNE PS FB Insert Size 8 18 mm 
1516-40-820 
ATTUNE PS FB Insert Size 8 20 mm 
1516-40-905 
ATTUNE PS FB Insert Size 9 5 mm 
1516-40-906 
ATTUNE PS FB Insert Size 9 6 mm 
1516-40-907 
ATTUNE PS FB Insert Size 9 7 mm 
1516-40-908 
ATTUNE PS FB Insert Size 9 8 mm 
1516-40-910 
ATTUNE PS FB Insert Size 9 10 mm 
1516-40-912 
ATTUNE PS FB Insert Size 9 12 mm 
1516-40-914 
ATTUNE PS FB Insert Size 9 14 mm 
1516-40-916 
ATTUNE PS FB Insert Size 9 16 mm 
1516-40-918 
ATTUNE PS FB Insert Size 9 18 mm 
1516-40-920 
ATTUNE PS FB Insert Size 9 20 mm 
1516-41-005 
ATTUNE PS FB Insert Size 10 5 mm 
1516-41-006 
ATTUNE PS FB Insert Size 10 6 mm 
1516-41-007 
ATTUNE PS FB Insert Size 10 7 mm 
1516-41-008 
ATTUNE PS FB Insert Size 10 8 mm 
1516-41-010 
ATTUNE PS FB Insert Size 10 10 mm 
1516-41-012 
ATTUNE PS FB Insert Size 10 12 mm 
1516-41-014 
ATTUNE PS FB Insert Size 10 14 mm 
1516-41-016 
ATTUNE PS FB Insert Size 10 16 mm 
1516-41-018 
ATTUNE PS FB Insert Size 10 18 mm 
1516-41-020 
ATTUNE PS FB Insert Size 10 20 mm 
1506-00-001 
ATTUNE FB Cemented Tibial Base Size 1 

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06-June-2022                                                                                                                                 Page 65 of 76 
 
Product Code 
Description 
1506-00-002 
ATTUNE FB Cemented Tibial Base Size 2 
1506-00-003 
ATTUNE FB Cemented Tibial Base Size 3 
1506-00-004 
ATTUNE FB Cemented Tibial Base Size 4 
1506-00-005 
ATTUNE FB Cemented Tibial Base Size 5 
1506-00-006 
ATTUNE FB Cemented Tibial Base Size 6 
1506-00-007 
ATTUNE FB Cemented Tibial Base Size 7 
1506-00-008 
ATTUNE FB Cemented Tibial Base Size 8 
1506-00-009 
ATTUNE FB Cemented Tibial Base Size 9 
1506-00-010 
ATTUNE FB Cemented Tibial Base Size 10 
1506-70-001 
ATTUNE FB Cemented Tibial Base Size 1 
1506-70-002 
ATTUNE FB Cemented Tibial Base Size 2 
1506-70-003 
ATTUNE FB Cemented Tibial Base Size 3 
1506-70-004 
ATTUNE FB Cemented Tibial Base Size 4 
1506-70-005 
ATTUNE FB Cemented Tibial Base Size 5 
1506-70-006 
ATTUNE FB Cemented Tibial Base Size 6 
1506-70-007 
ATTUNE FB Cemented Tibial Base Size 7 
1506-70-008 
ATTUNE FB Cemented Tibial Base Size 8 
1506-70-009 
ATTUNE FB Cemented Tibial Base Size 9 
1506-70-010 
ATTUNE FB Cemented Tibial Base Size 10 
1518-20-029 
ATTUNE Medialized Dome Patella Size 29 
1518-20-032 
ATTUNE Medialized Dome Patella Size 32 
1518-20-035 
ATTUNE Medialized Dome Patella Size 35 
1518-20-038 
ATTUNE Medialized Dome Patella Size 38 
1518-20-041 
ATTUNE Medialized Dome Patella Size 41 
1518-10-029 
ATTUNE Medialized Anatomic Patella Size 29 
1518-10-032 
ATTUNE Medialized Anatomic Patella Size 32 
1518-10-035 
ATTUNE Medialized Anatomic Patella Size 35 
1518-10-038 
ATTUNE Medialized Anatomic Patella Size 38 
1518-10-041 
ATTUNE Medialized Anatomic Patella Size 41 
150611001 
ATTUNE RP TIB BASE SZ 1 POR 
150611002 
ATTUNE RP TIB BASE SZ 2 POR 
150611003 
ATTUNE RP TIB BASE SZ 3 POR 
150611004 
ATTUNE RP TIB BASE SZ 4 POR 
150611005 
ATTUNE RP TIB BASE SZ 5 POR 
150611006 
ATTUNE RP TIB BASE SZ 6 POR 
150611007 
ATTUNE RP TIB BASE SZ 7 POR 
150611008 
ATTUNE RP TIB BASE SZ 8 POR 
150611009 
ATTUNE RP TIB BASE SZ 9 POR 
150611010 
ATTUNE RP TIB BASE SZ 10 POR 
150680001 
S+ ATTUNE Cemented Tibial Base, RP Sz1 
150680002 
S+ ATTUNE Cemented Tibial Base, RP Sz2 
150680003 
S+ ATTUNE Cemented Tibial Base, RP Sz3 

DSJ_2019_08 Rev F 
 
DePuy Orthopaedics Inc.  
06-June-2022                                                                                                                                 Page 66 of 76 
 
Product Code 
Description 
150680004 
S+ ATTUNE Cemented Tibial Base, RP Sz4 
150680005 
S+ ATTUNE Cemented Tibial Base, RP Sz5 
150680006 
S+ ATTUNE Cemented Tibial Base, RP Sz6 
150680007 
S+ ATTUNE Cemented Tibial Base, RP Sz7 
150680008 
S+ ATTUNE Cemented Tibial Base, RP Sz8 
150680009 
S+ ATTUNE Cemented Tibial Base, RP Sz9 
150680010 
S+ ATTUNE Cemented Tibial Base, RP Sz10 
150610001 
ATTUNE TIBIAL BASE RP SZ1 CEMENTED 
150610002 
ATTUNE TIBIAL BASE RP SZ2 CEMENTED 
150610003 
ATTUNE TIBIAL BASE RP SZ3 CEMENTED 
150610004 
ATTUNE TIBIAL BASE RP SZ4 CEMENTED 
150610005 
ATTUNE TIBIAL BASE RP SZ5 CEMENTED 
150610006 
ATTUNE TIBIAL BASE RP SZ6 CEMENTED 
150610007 
ATTUNE TIBIAL BASE RP SZ7 CEMENTED 
150610008 
ATTUNE TIBIAL BASE RP SZ8 CEMENTED 
150610009 
ATTUNE TIBIAL BASE RP SZ9 CEMENTED 
150610010 
ATTUNE TIBIAL BASE RP SZ10 CEMENTED 
151630105 
ATTUNE TIBIAL INSERT RP CR INSERT SZ1 5MM AOX 
151630106 
ATTUNE TIBIAL INSERT RP CR INSERT SZ1 6MM AOX 
151630107 
ATTUNE TIBIAL INSERT RP CR INSERT SZ1 7MM AOX 
151630108 
ATTUNE TIBIAL INSERT RP CR INSERT SZ1 8MM AOX 
151630110 
ATTUNE TIBIAL INSERT RP CR INSERT SZ1 10MM AOX 
151630112 
ATTUNE TIBIAL INSERT RP CR INSERT SZ1 12MM AOX 
151630114 
ATTUNE TIBIAL INSERT RP CR INSERT SZ1 14MM AOX 
151630116 
ATTUNE TIBIAL INSERT RP CR INSERT SZ1 16MM AOX 
151630118 
ATTUNE TIBIAL INSERT RP CR INSERT SZ1 18MM AOX 
151630205 
ATTUNE TIBIAL INSERT RP CR INSERT SZ2 5MM AOX 
151630206 
ATTUNE TIBIAL INSERT RP CR INSERT SZ2 6MM AOX 
151630207 
ATTUNE TIBIAL INSERT RP CR INSERT SZ2 7MM AOX 
151630208 
ATTUNE TIBIAL INSERT RP CR INSERT SZ2 8MM AOX 
151630210 
ATTUNE TIBIAL INSERT RP CR INSERT SZ2 10MM AOX 
151630212 
ATTUNE TIBIAL INSERT RP CR INSERT SZ2 12MM AOX 
151630214 
ATTUNE TIBIAL INSERT RP CR INSERT SZ2 14MM AOX 
151630216 
ATTUNE TIBIAL INSERT RP CR INSERT SZ2 16MM AOX 
151630218 
ATTUNE TIBIAL INSERT RP CR INSERT SZ2 18MM AOX 
151630305 
ATTUNE TIBIAL INSERT RP CR INSERT SZ3 5MM AOX 
151630306 
ATTUNE TIBIAL INSERT RP CR INSERT SZ3 6MM AOX 
151630307 
ATTUNE TIBIAL INSERT RP CR INSERT SZ3 7MM AOX 
151630308 
ATTUNE TIBIAL INSERT RP CR INSERT SZ3 8MM AOX 
151630310 
ATTUNE TIBIAL INSERT RP CR INSERT SZ3 10MM AOX 
151630312 
ATTUNE TIBIAL INSERT RP CR INSERT SZ3 12MM AOX 
151630314 
ATTUNE TIBIAL INSERT RP CR INSERT SZ3 14MM AOX 

DSJ_2019_08 Rev F 
 
DePuy Orthopaedics Inc.  
06-June-2022                                                                                                                                 Page 67 of 76 
 
Product Code 
Description 
151630316 
ATTUNE TIBIAL INSERT RP CR INSERT SZ3 16MM AOX 
151630318 
ATTUNE TIBIAL INSERT RP CR INSERT SZ3 18MM AOX 
151630405 
ATTUNE TIBIAL INSERT RP CR INSERT SZ4 5MM AOX 
151630406 
ATTUNE TIBIAL INSERT RP CR INSERT SZ4 6MM AOX 
151630407 
ATTUNE TIBIAL INSERT RP CR INSERT SZ4 7MM AOX 
151630408 
ATTUNE TIBIAL INSERT RP CR INSERT SZ4 8MM AOX 
151630410 
ATTUNE TIBIAL INSERT RP CR INSERT SZ4 10MM AOX 
151630412 
ATTUNE TIBIAL INSERT RP CR INSERT SZ4 12MM AOX 
151630414 
ATTUNE TIBIAL INSERT RP CR INSERT SZ4 14MM AOX 
151630416 
ATTUNE TIBIAL INSERT RP CR INSERT SZ4 16MM AOX 
151630418 
ATTUNE TIBIAL INSERT RP CR INSERT SZ4 18MM AOX 
151630505 
ATTUNE TIBIAL INSERT RP CR INSERT SZ5 5MM AOX 
151630506 
ATTUNE TIBIAL INSERT RP CR INSERT SZ5 6MM AOX 
151630507 
ATTUNE TIBIAL INSERT RP CR INSERT SZ5 7MM AOX 
151630508 
ATTUNE TIBIAL INSERT RP CR INSERT SZ5 8MM AOX 
151630510 
ATTUNE TIBIAL INSERT RP CR INSERT SZ5 10MM AOX 
151630512 
ATTUNE TIBIAL INSERT RP CR INSERT SZ5 12MM AOX 
151630514 
ATTUNE TIBIAL INSERT RP CR INSERT SZ5 14MM AOX 
151630516 
ATTUNE TIBIAL INSERT RP CR INSERT SZ5 16MM AOX 
151630518 
ATTUNE TIBIAL INSERT RP CR INSERT SZ5 18MM AOX 
151630605 
ATTUNE TIBIAL INSERT RP CR INSERT SZ6 5MM AOX 
151630606 
ATTUNE TIBIAL INSERT RP CR INSERT SZ6 6MM AOX 
151630607 
ATTUNE TIBIAL INSERT RP CR INSERT SZ6 7MM AOX 
151630608 
ATTUNE TIBIAL INSERT RP CR INSERT SZ6 8MM AOX 
151630610 
ATTUNE TIBIAL INSERT RP CR INSERT SZ6 10MM AOX 
151630612 
ATTUNE TIBIAL INSERT RP CR INSERT SZ6 12MM AOX 
151630614 
ATTUNE TIBIAL INSERT RP CR INSERT SZ6 14MM AOX 
151630616 
ATTUNE TIBIAL INSERT RP CR INSERT SZ6 16MM AOX 
151630618 
ATTUNE TIBIAL INSERT RP CR INSERT SZ6 18MM AOX 
151630705 
ATTUNE TIBIAL INSERT RP CR INSERT SZ7 5MM AOX 
151630706 
ATTUNE TIBIAL INSERT RP CR INSERT SZ7 6MM AOX 
151630707 
ATTUNE TIBIAL INSERT RP CR INSERT SZ7 7MM AOX 
151630708 
ATTUNE TIBIAL INSERT RP CR INSERT SZ7 8MM AOX 
151630710 
ATTUNE TIBIAL INSERT RP CR INSERT SZ7 10MM AOX 
151630712 
ATTUNE TIBIAL INSERT RP CR INSERT SZ7 12MM AOX 
151630714 
ATTUNE TIBIAL INSERT RP CR INSERT SZ7 14MM AOX 
151630716 
ATTUNE TIBIAL INSERT RP CR INSERT SZ7 16MM AOX 
151630718 
ATTUNE TIBIAL INSERT RP CR INSERT SZ7 18MM AOX 
151630805 
ATTUNE TIBIAL INSERT RP CR INSERT SZ8 5MM AOX 
151630806 
ATTUNE TIBIAL INSERT RP CR INSERT SZ8 6MM AOX 
151630807 
ATTUNE TIBIAL INSERT RP CR INSERT SZ8 7MM AOX 
151630808 
ATTUNE TIBIAL INSERT RP CR INSERT SZ8 8MM AOX 

DSJ_2019_08 Rev F 
 
DePuy Orthopaedics Inc.  
06-June-2022                                                                                                                                 Page 68 of 76 
 
Product Code 
Description 
151630810 
ATTUNE TIBIAL INSERT RP CR INSERT SZ8 10MM AOX 
151630812 
ATTUNE TIBIAL INSERT RP CR INSERT SZ8 12MM AOX 
151630814 
ATTUNE TIBIAL INSERT RP CR INSERT SZ8 14MM AOX 
151630816 
ATTUNE TIBIAL INSERT RP CR INSERT SZ8 16MM AOX 
151630818 
ATTUNE TIBIAL INSERT RP CR INSERT SZ8 18MM AOX 
151630905 
ATTUNE TIBIAL INSERT RP CR INSERT SZ9 5MM AOX 
151630906 
ATTUNE TIBIAL INSERT RP CR INSERT SZ9 6MM AOX 
151630907 
ATTUNE TIBIAL INSERT RP CR INSERT SZ9 7MM AOX 
151630908 
ATTUNE TIBIAL INSERT RP CR INSERT SZ9 8MM AOX 
151630910 
ATTUNE TIBIAL INSERT RP CR INSERT SZ9 10MM AOX 
151630912 
ATTUNE TIBIAL INSERT RP CR INSERT SZ9 12MM AOX 
151630914 
ATTUNE TIBIAL INSERT RP CR INSERT SZ9 14MM AOX 
151630916 
ATTUNE TIBIAL INSERT RP CR INSERT SZ9 16MM AOX 
151630918 
ATTUNE TIBIAL INSERT RP CR INSERT SZ9 18MM AOX 
151631005 
ATTUNE TIBIAL INSERT RP CR INSERT SZ10 5MM AOX 
151631006 
ATTUNE TIBIAL INSERT RP CR INSERT SZ10 6MM AOX 
151631007 
ATTUNE TIBIAL INSERT RP CR INSERT SZ10 7MM AOX 
151631008 
ATTUNE TIBIAL INSERT RP CR INSERT SZ10 8MM AOX 
151631010 
ATTUNE TIBIAL INSERT RP CR INSERT SZ10 10MM AOX 
151631012 
ATTUNE TIBIAL INSERT RP CR INSERT SZ10 12MM AOX 
151631014 
ATTUNE TIBIAL INSERT RP CR INSERT SZ10 14MM AOX 
151631016 
ATTUNE TIBIAL INSERT RP CR INSERT SZ10 16MM AOX 
151631018 
ATTUNE TIBIAL INSERT RP CR INSERT SZ10 18MM AOX 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

DSJ_2019_08 Rev F 
 
DePuy Orthopaedics Inc.  
06-June-2022                                                                                                                                 Page 69 of 76 
 
Product Code 
Description 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

DSJ_2019_08 Rev F 
 
DePuy Orthopaedics Inc.  
06-June-2022                                                                                                                                 Page 70 of 76 
 
Product Code 
Description 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
151650105 
ATTUNE TIBIAL INSERT RP PS INSERT SZ1 5MM AOX 
151650106 
ATTUNE TIBIAL INSERT RP PS INSERT SZ1 6MM AOX 
151650107 
ATTUNE TIBIAL INSERT RP PS INSERT SZ1 7MM AOX 
151650108 
ATTUNE TIBIAL INSERT RP PS INSERT SZ1 8MM AOX 
151650109 
ATTUNE TIBIAL INSERT RP PS INSERT SZ1 9MM AOX 
151650110 
ATTUNE TIBIAL INSERT RP PS INSERT SZ1 10MM AOX 
151650112 
ATTUNE TIBIAL INSERT RP PS INSERT SZ1 12MM AOX 
151650114 
ATTUNE TIBIAL INSERT RP PS INSERT SZ1 14MM AOX 
151650116 
ATTUNE TIBIAL INSERT RP PS INSERT SZ1 16MM AOX 
151650118 
ATTUNE TIBIAL INSERT RP PS INSERT SZ1 18MM AOX 
151650120 
ATTUNE TIBIAL INSERT RP PS INSERT SZ1 20MM AOX 
151650122 
ATTUNE TIBIAL INSERT RP PS INSERT SZ1 22MM AOX 
151650205 
ATTUNE TIBIAL INSERT RP PS INSERT SZ2 5MM AOX 

DSJ_2019_08 Rev F 
 
DePuy Orthopaedics Inc.  
06-June-2022                                                                                                                                 Page 71 of 76 
 
Product Code 
Description 
151650206 
ATTUNE TIBIAL INSERT RP PS INSERT SZ2 6MM AOX 
151650207 
ATTUNE TIBIAL INSERT RP PS INSERT SZ2 7MM AOX 
151650208 
ATTUNE TIBIAL INSERT RP PS INSERT SZ2 8MM AOX 
151650209 
ATTUNE TIBIAL INSERT RP PS INSERT SZ2 9MM AOX 
151650210 
ATTUNE TIBIAL INSERT RP PS INSERT SZ2 10MM AOX 
151650212 
ATTUNE TIBIAL INSERT RP PS INSERT SZ2 12MM AOX 
151650214 
ATTUNE TIBIAL INSERT RP PS INSERT SZ2 14MM AOX 
151650216 
ATTUNE TIBIAL INSERT RP PS INSERT SZ2 16MM AOX 
151650218 
ATTUNE TIBIAL INSERT RP PS INSERT SZ2 18MM AOX 
151650220 
ATTUNE TIBIAL INSERT RP PS INSERT SZ2 20MM AOX 
151650222 
ATTUNE TIBIAL INSERT RP PS INSERT SZ2 22MM AOX 
151650305 
ATTUNE TIBIAL INSERT RP PS INSERT SZ3 5MM AOX 
151650306 
ATTUNE TIBIAL INSERT RP PS INSERT SZ3 6MM AOX 
151650307 
ATTUNE TIBIAL INSERT RP PS INSERT SZ3 7MM AOX 
151650308 
ATTUNE TIBIAL INSERT RP PS INSERT SZ3 8MM AOX 
151650309 
ATTUNE TIBIAL INSERT RP PS INSERT SZ3 9MM AOX 
151650310 
ATTUNE TIBIAL INSERT RP PS INSERT SZ3 10MM AOX 
151650312 
ATTUNE TIBIAL INSERT RP PS INSERT SZ3 12MM AOX 
151650314 
ATTUNE TIBIAL INSERT RP PS INSERT SZ3 14MM AOX 
151650316 
ATTUNE TIBIAL INSERT RP PS INSERT SZ3 16MM AOX 
151650318 
ATTUNE TIBIAL INSERT RP PS INSERT SZ3 18MM AOX 
151650320 
ATTUNE TIBIAL INSERT RP PS INSERT SZ3 20MM AOX 
151650322 
ATTUNE TIBIAL INSERT RP PS INSERT SZ3 22MM AOX 
151650405 
ATTUNE TIBIAL INSERT RP PS INSERT SZ4 5MM AOX 
151650406 
ATTUNE TIBIAL INSERT RP PS INSERT SZ4 6MM AOX 
151650407 
ATTUNE TIBIAL INSERT RP PS INSERT SZ4 7MM AOX 
151650408 
ATTUNE TIBIAL INSERT RP PS INSERT SZ4 8MM AOX 
151650409 
ATTUNE TIBIAL INSERT RP PS INSERT SZ4 9MM AOX 
151650410 
ATTUNE TIBIAL INSERT RP PS INSERT SZ4 10MM AOX 
151650412 
ATTUNE TIBIAL INSERT RP PS INSERT SZ4 12MM AOX 
151650414 
ATTUNE TIBIAL INSERT RP PS INSERT SZ4 14MM AOX 
151650416 
ATTUNE TIBIAL INSERT RP PS INSERT SZ4 16MM AOX 
151650418 
ATTUNE TIBIAL INSERT RP PS INSERT SZ4 18MM AOX 
151650420 
ATTUNE TIBIAL INSERT RP PS INSERT SZ4 20MM AOX 
151650422 
ATTUNE TIBIAL INSERT RP PS INSERT SZ4 22MM AOX 
151650505 
ATTUNE TIBIAL INSERT RP PS INSERT SZ5 5MM AOX 
151650506 
ATTUNE TIBIAL INSERT RP PS INSERT SZ5 6MM AOX 
151650507 
ATTUNE TIBIAL INSERT RP PS INSERT SZ5 7MM AOX 
151650508 
ATTUNE TIBIAL INSERT RP PS INSERT SZ5 8MM AOX 
151650509 
ATTUNE TIBIAL INSERT RP PS INSERT SZ5 9MM AOX 
151650510 
ATTUNE TIBIAL INSERT RP PS INSERT SZ5 10MM AOX 
151650512 
ATTUNE TIBIAL INSERT RP PS INSERT SZ5 12MM AOX 

DSJ_2019_08 Rev F 
 
DePuy Orthopaedics Inc.  
06-June-2022                                                                                                                                 Page 72 of 76 
 
Product Code 
Description 
151650514 
ATTUNE TIBIAL INSERT RP PS INSERT SZ5 14MM AOX 
151650516 
ATTUNE TIBIAL INSERT RP PS INSERT SZ5 16MM AOX 
151650518 
ATTUNE TIBIAL INSERT RP PS INSERT SZ5 18MM AOX 
151650520 
ATTUNE TIBIAL INSERT RP PS INSERT SZ5 20MM AOX 
151650522 
ATTUNE TIBIAL INSERT RP PS INSERT SZ5 22MM AOX 
151650605 
ATTUNE TIBIAL INSERT RP PS INSERT SZ6 5MM AOX 
151650606 
ATTUNE TIBIAL INSERT RP PS INSERT SZ6 6MM AOX 
151650607 
ATTUNE TIBIAL INSERT RP PS INSERT SZ6 7MM AOX 
151650608 
ATTUNE TIBIAL INSERT RP PS INSERT SZ6 8MM AOX 
151650609 
ATTUNE TIBIAL INSERT RP PS INSERT SZ6 9MM AOX 
151650610 
ATTUNE TIBIAL INSERT RP PS INSERT SZ6 10MM AOX 
151650612 
ATTUNE TIBIAL INSERT RP PS INSERT SZ6 12MM AOX 
151650614 
ATTUNE TIBIAL INSERT RP PS INSERT SZ6 14MM AOX 
151650616 
ATTUNE TIBIAL INSERT RP PS INSERT SZ6 16MM AOX 
151650618 
ATTUNE TIBIAL INSERT RP PS INSERT SZ6 18MM AOX 
151650620 
ATTUNE TIBIAL INSERT RP PS INSERT SZ6 20MM AOX 
151650622 
ATTUNE TIBIAL INSERT RP PS INSERT SZ6 22MM AOX 
151650705 
ATTUNE TIBIAL INSERT RP PS INSERT SZ7 5MM AOX 
151650706 
ATTUNE TIBIAL INSERT RP PS INSERT SZ7 6MM AOX 
151650707 
ATTUNE TIBIAL INSERT RP PS INSERT SZ7 7MM AOX 
151650708 
ATTUNE TIBIAL INSERT RP PS INSERT SZ7 8MM AOX 
151650709 
ATTUNE TIBIAL INSERT RP PS INSERT SZ7 9MM AOX 
151650710 
ATTUNE TIBIAL INSERT RP PS INSERT SZ7 10MM AOX 
151650712 
ATTUNE TIBIAL INSERT RP PS INSERT SZ7 12MM AOX 
151650714 
ATTUNE TIBIAL INSERT RP PS INSERT SZ7 14MM AOX 
151650716 
ATTUNE TIBIAL INSERT RP PS INSERT SZ7 16MM AOX 
151650718 
ATTUNE TIBIAL INSERT RP PS INSERT SZ7 18MM AOX 
151650720 
ATTUNE TIBIAL INSERT RP PS INSERT SZ7 20MM AOX 
151650722 
ATTUNE TIBIAL INSERT RP PS INSERT SZ7 22MM AOX 
151650805 
ATTUNE TIBIAL INSERT RP PS INSERT SZ8 5MM AOX 
151650806 
ATTUNE TIBIAL INSERT RP PS INSERT SZ8 6MM AOX 
151650807 
ATTUNE TIBIAL INSERT RP PS INSERT SZ8 7MM AOX 
151650808 
ATTUNE TIBIAL INSERT RP PS INSERT SZ8 8MM AOX 
151650809 
ATTUNE TIBIAL INSERT RP PS INSERT SZ8 9MM AOX 
151650810 
ATTUNE TIBIAL INSERT RP PS INSERT SZ8 10MM AOX 
151650812 
ATTUNE TIBIAL INSERT RP PS INSERT SZ8 12MM AOX 
151650814 
ATTUNE TIBIAL INSERT RP PS INSERT SZ8 14MM AOX 
151650816 
ATTUNE TIBIAL INSERT RP PS INSERT SZ8 16MM AOX 
151650818 
ATTUNE TIBIAL INSERT RP PS INSERT SZ8 18MM AOX 
151650820 
ATTUNE TIBIAL INSERT RP PS INSERT SZ8 20MM AOX 
151650822 
ATTUNE TIBIAL INSERT RP PS INSERT SZ8 22MM AOX 
151650905 
ATTUNE TIBIAL INSERT RP PS INSERT SZ9 5MM AOX 

DSJ_2019_08 Rev F 
 
DePuy Orthopaedics Inc.  
06-June-2022                                                                                                                                 Page 73 of 76 
 
Product Code 
Description 
151650906 
ATTUNE TIBIAL INSERT RP PS INSERT SZ9 6MM AOX 
151650907 
ATTUNE TIBIAL INSERT RP PS INSERT SZ9 7MM AOX 
151650908 
ATTUNE TIBIAL INSERT RP PS INSERT SZ9 8MM AOX 
151650909 
ATTUNE TIBIAL INSERT RP PS INSERT SZ9 9MM AOX 
151650910 
ATTUNE TIBIAL INSERT RP PS INSERT SZ9 10MM AOX 
151650912 
ATTUNE TIBIAL INSERT RP PS INSERT SZ9 12MM AOX 
151650914 
ATTUNE TIBIAL INSERT RP PS INSERT SZ9 14MM AOX 
151650916 
ATTUNE TIBIAL INSERT RP PS INSERT SZ9 16MM AOX 
151650918 
ATTUNE TIBIAL INSERT RP PS INSERT SZ9 18MM AOX 
151650920 
ATTUNE TIBIAL INSERT RP PS INSERT SZ9 20MM AOX 
151650922 
ATTUNE TIBIAL INSERT RP PS INSERT SZ9 22MM AOX 
151651005 
ATTUNE TIBIAL INSERT RP PS INSERT SZ10 5MM AOX 
151651006 
ATTUNE TIBIAL INSERT RP PS INSERT SZ10 6MM AOX 
151651007 
ATTUNE TIBIAL INSERT RP PS INSERT SZ10 7MM AOX 
151651008 
ATTUNE TIBIAL INSERT RP PS INSERT SZ10 8MM AOX 
151651009 
ATTUNE TIBIAL INSERT RP PS INSERT SZ10 9MM AOX 
151651010 
ATTUNE TIBIAL INSERT RP PS INSERT SZ10 10MM AOX 
151651012 
ATTUNE TIBIAL INSERT RP PS INSERT SZ10 12MM AOX 
151651014 
ATTUNE TIBIAL INSERT RP PS INSERT SZ10 14MM AOX 
151651016 
ATTUNE TIBIAL INSERT RP PS INSERT SZ10 16MM AOX 
151651018 
ATTUNE TIBIAL INSERT RP PS INSERT SZ10 18MM AOX 
151651020 
ATTUNE TIBIAL INSERT RP PS INSERT SZ10 20MM AOX 
151651022 
ATTUNE TIBIAL INSERT RP PS INSERT SZ10 22MM AOX 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

DSJ_2019_08 Rev F 
 
DePuy Orthopaedics Inc.  
06-June-2022                                                                                                                                 Page 74 of 76 
 
Product Code 
Description 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

DSJ_2019_08 Rev F 
 
DePuy Orthopaedics Inc.  
06-June-2022                                                                                                                                 Page 75 of 76 
 
Product Code 
Description 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

DSJ_2019_08 Rev F 
 
DePuy Orthopaedics Inc.  
06-June-2022                                                                                                                                 Page 76 of 76 
 
Product Code 
Description