Clinical, Radiographic and Patient-reported Outcomes Associated With the Use of the Navio™ Robotic-assisted Surgical System in Total Knee Arthroplasty
Conditions: Total Knee Arthroplasty, Arthroplasty of Knee
Sponsor: Smith & Nephew, Inc.

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Clinical, Radiographic and Patient-reported Outcomes Associated with the 
Use of the Navio™ Robotic-assisted Surgical System in Total Knee Arthroplasty 
Protocol Number: 
17-NPFS-04 
Protocol Date: 
19SEP2017 
Protocol Version: 
Version 2.0 
Study Product Name: 
Navio ™ Robotic-assisted Surgical System 
Sponsor:   
Smith & Nephew, Inc. 
1450 E. Brooks Road 
Memphis, TN 38116 
US    
Nondisclosure Statement 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith 
& Nephew, Inc. and is intended for use only by Smith & Nephew and its manufacturers.  It shall not be 
reproduced or copied in whole or in part, nor shall the contents be disclosed by any mean without prior 
written permission from Smith & Nephew, nor shall anyone make any use of it that is contrary to the 
expressed or implied wishes of Smith & Nephew. 

 
                                                
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Table of Contents 
 
ABBREVIATIONS & DEFINITIONS ................................................................................................................................................... 5 
Protocol Synopsis: ................................................................................................................................................................. 6 
1. 
BACKGROUND AND STUDY RATIONALE ................................................................................................................................. 8 
1.1. Background ................................................................................................................................................................... 8 
1.2. Study Rationale ............................................................................................................................................................. 8 
2. 
STUDY OBJECTIVES ............................................................................................................................................................ 8 
2.1. Primary Objective ......................................................................................................................................................... 8 
2.2. Secondary Objectives .................................................................................................................................................. 8 
3. 
STUDY ENDPOINTS ............................................................................................................................................................ 8 
3.1. Primary Endpoint .......................................................................................................................................................... 8 
3.2. Secondary Endpoints ................................................................................................................................................... 9 
3.3. Safety Endpoints ........................................................................................................................................................... 9 
5.1. Surgical Technique .......................................................................................................................................................11 
6. 
STUDY POPULATION ..........................................................................................................................................................11 
6.1. Subject Screening & Enrollment ..................................................................................................................................11 
6.2. Subject Inclusion Criteria .............................................................................................................................................11 
6.3. Subject Exclusion Criteria ........................................................................................................................................... 12 
7. 
STUDY PROCEDURES......................................................................................................................................................... 13 
7.1. Study Schematic .......................................................................................................................................................... 13 
7.2. Pre-Operative Visit ...................................................................................................................................................... 13 
7.3. Surgery ......................................................................................................................................................................... 13 
7.4. One Month Post-Operative Visit................................................................................................................................. 14 
8. 
SUBJECT COMPLETION AND DISPOSITION ............................................................................................................................ 14 
8.1. Screening ..................................................................................................................................................................... 14 
8.2. Enrolled Subject ........................................................................................................................................................... 14 
8.3. Conditions for Study Termination ............................................................................................................................... 14 
A. 
Screening Failure ......................................................................................................................................................... 14 
B. 
Voluntary Withdrawal .................................................................................................................................................. 14 
C. 
Lost to Follow-Up ......................................................................................................................................................... 15 
D. 
Study Termination by Investigator/Sponsor .............................................................................................................. 15 
E. 
Pregnancy .................................................................................................................................................................... 15 
F. 
Study Site Discontinuation .......................................................................................................................................... 15 
9. 
SAFETY REPORTING ........................................................................................................................................................... 15 

 
                                                
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9.1. Definitions for safety reporting ................................................................................................................................... 15 
A. 
Adverse Event (AE) ...................................................................................................................................................... 16 
B. 
Serious Adverse Event (SAE) ...................................................................................................................................... 16 
C. 
Adverse Device Effect (ADE) ....................................................................................................................................... 16 
D. 
Serious Adverse Device Effect (SADE) ....................................................................................................................... 16 
E. 
Unanticipated Serious Adverse Device Effect (USADE) ............................................................................................. 16 
F. 
Device Deficiency ........................................................................................................................................................ 16 
G. 
Revisions ...................................................................................................................................................................... 17 
9.2. Safety: Investigator’s Responsibilities ........................................................................................................................ 17 
9.3. Timelines for Submission of Safety Information: ....................................................................................................... 17 
9.4. Safety reporting: Sponsor’s Responsibilities ............................................................................................................. 18 
10. STATISTICAL PROCEDURES ................................................................................................................................................. 18 
10.1. Sample size calculation .............................................................................................................................................. 18 
10.2. General Statistical Considerations ............................................................................................................................. 18 
10.3. Missing Data ................................................................................................................................................................ 19 
10.4. Analysis Populations ................................................................................................................................................... 19 
10.5. Analysis of Primary Endpoint ...................................................................................................................................... 19 
10.6. Analysis of Secondary Endpoints: .............................................................................................................................. 19 
10.7. Analysis of Safety Endpoints: .................................................................................................................................... 20 
11. 
ETHICAL CONSIDERATIONS ............................................................................................................................................... 20 
11.1. Ethical Approval .......................................................................................................................................................... 20 
11.2. Protocol Amendments................................................................................................................................................ 20 
11.3. Informed Consent ....................................................................................................................................................... 20 
11.4. Risk – Benefit Analysis ............................................................................................................................................... 20 
A. 
Study Related Risks .................................................................................................................................................... 20 
B. 
Study Related Benefits ................................................................................................................................................ 21 
12. MONITORING PROCEDURES ............................................................................................................................................... 21 
12.1. Source Documentation ............................................................................................................................................... 21 
12.2. Direct Access ............................................................................................................................................................... 21 
12.3. Site Qualification Visit ................................................................................................................................................. 21 
12.4. Site Initiation Visit ........................................................................................................................................................ 21 
12.5. Interim Monitoring Visits ............................................................................................................................................ 22 
12.6. Closeout Visit .............................................................................................................................................................. 22 
12.7. Sponsor Audits and Regulatory Inspection .............................................................................................................. 22 
12.8. Data Handling and Record Keeping Requirements ................................................................................................. 22 

 
                                                
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12.9. Data Recording and Record Retention ...................................................................................................................... 22 
13. DEVIATIONS FROM PROTOCOL ........................................................................................................................................... 23 
13.1. Protocol Deviation Reporting Requirements ............................................................................................................. 23 
14. Publication policy ........................................................................................................................................................ 23 
BIBLIOGRAPHY ......................................................................................................................................................................... 24 
Appendix 1 
JOURNEY II BCS and CR Component Part Numbers…………………………………….…………………………………………………………………………………28 
 
 
 

 
                                                
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ABBREVIATIONS & DEFINITIONS 
AE 
Adverse Event 
ADE 
Adverse Device Effect 
AP  
Anteroposterior 
CAPA 
Corrective and Preventive Action  
CRO 
Contract Research Organization 
CRF 
Case Report Form 
EC 
Ethics Committee  
EQ-5D 
EuroQuol 5D 
FDA 
Food and Drug Administration  
FU 
Follow-Up 
GCP 
Good Clinical Practice 
ICF 
Informed Consent Form 
ICH 
International Conference on Harmonisation of Technical Requirements for Registration of 
Pharmaceuticals for Human Use 
IRB 
Institutional Review Board 
ITT 
Intention to Treat Population 
KSS 
Knee Society Score 
PI 
Principal Investigator 
PP 
Per-protocol Population  
QoL  
Quality of life 
SAE 
Serious Adverse Event 
SADE 
Serious Adverse Device Effect 
TKA 
Total Knee Arthroplasty 
USADE 
Unanticipated Serious Adverse Device Effect  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
                                                
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Protocol Synopsis:  
 
Title of Study: 
Clinical, Radiographic, and Patient-reported Outcomes associated with the use 
of the Navio ™ Robotic-assisted Surgical System in Total Knee Arthroplasty 
Study Type: 
 
Evidence Generation 
Study Device: 
Navio ™ Robotic-assisted Surgical System 
Study Purpose: 
To demonstrate superior accuracy with the Navio ™ Robotic-assisted Surgical 
System in achieving desired post-operative mechanical alignment, compared to 
TKA procedures using standard instruments, as well as to document clinical and 
patient-reported outcomes in subjects receiving TKA with the Navio ™ system. 
Study Design: 
Multicenter, prospective single-arm cohort study with historical control. 
Primary Endpoint: 
Post-operative Mechanical Alignment (percentage of subjects achieving target 
alignment, defined as +3o from target) at one month post-operative.  
Secondary 
Endpoints: 
• 
Implant survival rate from baseline to 2 year end of study visit. 
• 
Knee Society Score 2011 
• 
Quality of Life (EQ-5D) 5L 
• 
Forgotten Joint Score (FJS)  
• 
Hospital Length of Stay 
• 
Operative Time 
• 
Radiographic Assessments 
Safety Endpoints 
The number of occurrences and the frequency of subjects reporting: 
• 
adverse events (AE) 
• 
serious adverse events (SAE) 
• 
adverse device effects (ADE) 
• 
serious adverse device effects (SADE) 
• 
unanticipated serious adverse  
• 
device effects (USADE)  
• 
device deficiencies (DevD) 
Length of Study: 
Approximately 3 years 
• 
1 year for enrollment and 2 years for follow-up 
Number of Sites: 
Approximately 6 sites 
Sample Size: 
120 subjects 
Inclusion Criteria: 
1. Subject requires primary total knee arthroplasty with the Journey II BCS 
or Cruciate-Retraining (CR) Systems due to degenerative joint disease 

 
                                                
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(primary diagnosis of osteoarthritis, post-traumatic arthritis, avascular 
necrosis, or rheumatoid arthritis). 
2. Subject was considered skeletally mature at the time of implantation (at 
least 18 years or older). 
3. Subject agrees to consent to and to follow the study visit schedule (as 
defined in the study protocol and informed consent form) by signing the 
IRB/EC approved informed consent form. 
4. Subject plans to be available through two (2) years postoperative follow-
up. 
Exclusion Criteria: 
1. Subject has BMI ≥ 40. 
2. Subject has condition(s) that may interfere with the TKA survival or 
outcome (i.e., Paget’s or Charcot’s disease, vascular insufficiency, 
muscular atrophy, uncontrolled diabetes, moderate to severe renal 
insufficiency or neuromuscular disease, or an active, local infection). 
3. Subject is deemed by investigator to require a constrained or deep dish 
tibial insert. 
4. Subject has inadequate bone stock to support the device (severe 
osteopenia, history of severe osteoporosis, or severe osteopenia).  
5. Subject has mental or neurologic condition(s) that may pre-empt the 
ability or willingness to restrict activities. 
6. Subject is 80 years of age or older. 
7. Subject is a prisoner or impending incarceration. 
 
 

 
                                                
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1. 
BACKGROUND AND STUDY RATIONALE  
 
1.1. Background 
Total Knee Arthroplasty (TKA) has become an effective and reliable treatment for arthritis of the knee (1). 
TKA is associated with low morbidity and mortality, and its effectiveness in reducing joint pain and 
improving range of motion is well established. In 2014, over 750,000 knee replacements were performed 
in the US (2). 
 
A significant innovation in TKA has been the introduction of computer navigation and robotic-assisted 
surgery (3). One such technology is the Navio™ Robotic-assisted Surgical System.  This system is a semi-
autonomous image-free system. During the surgery, the surgeon maps the condylar landmarks and 
determines alignment indices to define the volume and orientation of bone to be removed. The tools to 
remove the bone and place the implants are controlled and manipulated by the surgeon with the 
guidance of a 3-dimensional digital map of the surgical surface.  
 
Originally the Navio™ system was launched for use in unicondylar knee replacement only.  To date, there 
have been over 1000 unicondylar knee replacement surgeries using the system.  In 2017, Smith & 
Nephew Inc. expanded the indications for the Navio™ system to include TKA.  The purpose of this 
multicenter, prospective study is to evaluate outcomes associated with this new indication. 
 
1.2. Study Rationale 
The purpose of this study is to demonstrate superior accuracy with the Navio ™ Robotic-assisted Surgical 
System in achieving desired post-operative mechanical alignment, compared to TKA procedures using 
standard instruments. An additional study purpose is to document clinical and patient-reported outcomes 
in subjects receiving TKA with the Navio ™ system. 
 
2. STUDY OBJECTIVES 
 
2.1. 
Primary Objective 
The primary objective of this study is to demonstrate the superiority of the use of the Navio™ Robotic-
assisted Surgical System in the implantation of the JOURNEY™ II BCS or CR Systems in achieving post-
operative mechanical alignment within +3° of target, as compared to TKA procedures using standard 
instruments. 
 
2.2. 
Secondary Objectives 
Secondary objectives of this study include the generation of safety, performance, and health economic 
evidence supporting the use of the Navio™ Robotic-assisted Surgical System in TKA procedures, per the 
endpoints listed below. 
 
3. STUDY ENDPOINTS 
 
3.1. Primary Endpoint  
Post-operative Mechanical Alignment (the proportion of subjects achieving post-operative mechanical 
alignment, defined as ±3o from target) at the 1 month study visit.  
 
 
 
 

 
                                                
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3.2. Secondary Endpoints  
The following assessments will be collected at each follow up visit, as described in Section 7.1, Table 1, 
Schedule of Events.  
• 
Implant survival rate from baseline to 2 year end of study visit. 
• 
Knee Society Score 2011 
• 
Quality of Life (EQ-5D) 5L 
• 
Forgotten Joint Score (FJS)  
• 
Hospital Length of Stay 
• 
Operative Time 
• 
Radiographic Assessments  
 
3.3. Safety Endpoints  
The number of occurrences and the frequency of subjects reporting: adverse events (AE), serious adverse 
events (SAE), adverse device effects (ADE), serious adverse device effects (SADE), unanticipated serious 
adverse device effects (USADE), and device deficiencies (DevD). 
 
4. STUDY DESIGN 
 
This is a multi-center, prospective cohort study with a comparison to historical control to collect 2-year 
safety and effectiveness data on 120 subjects, at approximately 6 sites in the United States, who have 
undergone Navio System-assisted TKA.  
 
Subject data will be evaluated at the pre-operative, operative, one month, six months, one year, and two 
year follow up visits.  
 
A final analysis will be conducted once all subjects have completed a two year visit. 
 
5. STUDY DEVICE 
 
The Smith & Nephew Navio Robotic-assisted Surgical System aids the surgeon in planning and 
executing a procedure involving bone preparation for prosthesis implantation. The system is comprised 
of computer-assisted surgical instrument control, a commercially available surgical drill, image-free 
navigation, and planning software with standard navigation technology.  
 
The Navio System uses data gathered during the beginning of the surgical procedure (planning phase) 
to generate a computer model of the knee surface to be remodeled in preparation for the implant. The 
software uses data collected during the planning phase along with pre-loaded data describing the 
implant geometry to guide the surgeon in shaping the knee for the selected implant. The Navio system 
software then allows the surgeon to evaluate the range of motion and fit of the implant prior to finalizing 
the procedure. 
 
The Navio system software consists of a patient and user management module, a surgical planner, and 
an intraoperative cutting module. The surgeon uses patient data collected at the surgical site to align the 
implant and shape the target surface of the bone to accept the intended implant. The Navio system also 
uses the tracked position of the surgical bur to control its cutting engagement to the bone that is to 
receive the implant. This cutting control is based on the bur’s proximity to the planned target surface of 
the bone. 

 
                                                
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The cutting control is achieved in two ways: 
• 
Exposure control adjusts the bur's exposure with respect to a guard. If the surgeon encroaches 
on a portion of bone that is not to be cut, the Navio system retracts the spinning bur behind the 
guard, disabling cutting. The Navio system software also adjusts the depth of the cut by adjusting 
the exposure of the bur outside of the bur guard. 
• 
Speed control regulates the signal transmitted to the drill motor. This limits the speed of the 
spinning bur or disables bur motion entirely if the target surface has been reached. Bur motion is 
also disabled if the bur is moved outside of expected cutting boundaries. 
 
The surgeon can alternate between these two cutting control modes. The surgeon can also disable both 
cutting control modes and operate the Navio system as a standard navigated drill. 
 
The Navio system incorporates a detailed user interface that provides procedure setup, tracking status, 
visual indicators, and real-time cutting progress during the procedure. 
 
The Navio System is shown below: 
 
The function of each component is as follows: 
• 
Tracking Camera and Stand - The mobile infrared tracking camera is used to determine the 
position of the point probe and the surgical bur tip and track their movement by scanning the 
position of reflective trackers relative to the position of trackers mounted on the patient’s femur 
and tibia. 
• 
Navio System Cart - The mobile cart contains the electronic control system, electrical system 
integration unit, computer, and uninterruptible power supply (UPS). Navio system carts are 

 
                                                
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available in 120 VAC and 220-240 VAC versions. The cart provides storage for the power cord, 
Anspach™ drill foot control, and the Navio system foot control. The touchscreen monitor is the 
primary user interface for the Navio system. 
• 
Anspach™ Drill Foot Control - The Anspach drill foot control is used to control the Anspach drill 
during surgery. The surgeon must press the foot control to activate the bur. The speed of the bur 
is controlled by the Navio system software in speed control mode. 
• 
Navio System Foot Control - The Navio system foot control is used as an alternative to the 
touchscreen monitor when data points are being collected to define landmarks, shape bone, and 
position the implant prior to surgery. 
• 
Navio System Handpiece - The Navio system handpiece controls the position of the Anspach Drill 
and bur relative to the position of the guard and the desired profile of the bone being cut. In 
exposure mode, as the bur nears the target surface of the bone intended to accept the implant, 
the Anspach drill and bur retracts into the guard to prevent further cutting of bone. 
 
The Navio system is intended to assist the surgeon in providing software-defined spatial boundaries for 
orientation and reference information to anatomical structures during orthopedic procedures. The 
system is indicated for use in surgical knee procedures, in which the use of stereotactic surgery may be 
appropriate, and where reference to rigid anatomical bony structures can be determined. These 
procedures include UKR and patellofemoral arthroplasty. The Navio System is indicated for use with 
cemented implants only (refer to User Manuals for more detail). 
 
5.1. Surgical Technique 
The Navio System is to be used per standard of care at the participating study sites. Each participating 
investigator will have performed a minimum of 8 Navio TKA procedures prior to enrolling subjects on 
this study. The Navio System is indicated for Smith & Nephew cemented Total Knee implants, but for the 
purposed of this study we are restricting the type of implant to the Journey II BCS or Cruciate-Retraining 
(CR) Systems and compatible S&N patellar implants.  The list of acceptable part numbers can be found 
in Appendix 1. The patella must be resurfaced during the primary TKA procedure.  
 
6. STUDY POPULATION  
 
6.1. Subject Screening & Enrollment 
To eliminate the potential for selection bias, Investigators should screen all subjects undergoing a Navio™ 
assisted TKA.  In order to do so, only the existing information obtained per standard routine medical 
procedures will be used.  No study-specific screening procedures, activities or questionnaires will be 
performed during pre-screening. 
 
Once a subject has completed the informed consent procedure and signed the Informed Consent Form, 
the Principle Investigator (PI), or delegated study research staff, can complete the screening process with 
the subject. All potential subjects who undergo the screening process will be documented on a Screening 
and Enrollment Log, on which reasons for exclusion from or denial to participate should be noted.  In the 
event that a subject has a bilateral Navio assisted TKA, only the first knee treated after informed consent 
will be enrolled in the study. 
 
 
6.2. Subject Inclusion Criteria 
Subjects must meet the following inclusion criteria to be included in the study: 

 
                                                
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1. Subject requires primary total knee arthroplasty with the Journey II BCS or Cruciate-Retraining (CR) 
Systems due to degenerative joint disease (primary diagnosis of osteoarthritis, post-traumatic 
arthritis, avascular necrosis, rheumatoid arthritis. 
2. Subject was considered skeletally mature at the time of cone implantation (at least 18 years or 
older.) 
3. Subject agrees to consent to and to follow the study visit schedule (as defined in the study 
protocol and informed consent form) by signing the IRB/EC approved informed consent form. 
4. Subject plans to be available through two (2) years postoperative follow-up. 
 
6.3. Subject Exclusion Criteria 
Subjects will be excluded from the study if they meet any of the following exclusion criteria: 
 
1. Subject has BMI ≥ 40. 
2. Subject has condition(s) that may interfere with the TKA survival or outcome (i.e., Paget’s or 
Charcot’s disease, vascular insufficiency, muscular atrophy, uncontrolled diabetes, moderate to 
severe renal insufficiency or neuromuscular disease, or an active, local infection). 
3. Subject is deemed by investigator to require a constrained or deep dish tibial insert. 
4. Subject has inadequate bone stock to support the device (severe osteopenia, history of severe 
osteoporosis or severe osteopenia).  
5. Subject has mental or neurologic condition(s) that may pre-empt the ability or willingness to 
restrict activities. 
6. Subject is 80 years of age or older. 
7. Subject is a prisoner or impending incarceration. 
 

 
                                                
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7. STUDY PROCEDURES 
 
7.1. Study Schematic 
 The intervals and schedule of events are provided in Table 1. 
* if applicable 
 
7.2. Pre-Operative Visit  
Procedures to be completed at the pre-operative visit:  
• 
Confirm informed consent   
• 
Assign a subject study number  
• 
Inclusion/Exclusion  
• 
Demographics and medical history  
• 
2011 Knee Society Score  
• 
Quality of Life (EQ-5D)  
• 
Forgotten Joint Score  
• 
Perform long leg X-rays to assess Mechanical Alignment  
 
7.3. Surgery 
Procedures to be completed at the time of surgery: 
• 
Update information in the Screening and Enrollment Log  
• 
Operative Data including target mechanical alignment 
• 
Discharge Data  
• 
Adverse Event Assessment 
Schedule of events (*as needed) 
 
Preop Op/DC 1 Month 6 Months 
1 Year 
2 Years 
Visit Window 
-28 
days 
0 
30+7 
days 
182+30 
days 
365+60 
days 
730+60 
days 
Informed Consent 
√ 
 
 
 
 
 
Inclusion/Exclusion 
√ 
 
 
 
 
 
Demographics/Medical History 
√ 
 
 
 
 
 
Operative Data Collection 
 
√ 
 
 
 
 
Discharge Data Collection 
 
√ 
 
 
 
 
Mechanical Alignment on Long Leg X-
rays 
√ 
 
 
√ 
 
 
 
Standard AP, Lateral, and Patellar 
(Skyline or Merchant) X-rays 
 
 
 
√ 
√ 
√ 
2011 Knee Society Score 
√ 
 
√ 
√ 
√ 
√ 
Quality of Life (EQ-5D-5L) 
√ 
 
√ 
√ 
√ 
√ 
Forgotten Joint Score (FJS) 
√ 
 
√ 
√ 
√ 
√ 
Adverse Event Assessment 
 
√ 
√ 
√ 
√ 
√ 
End of Study/Exit 
 
* 
* 
* 
* 
* 

 
                                                
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7.4.  One Month Post-Operative Visit  
• 
Perform long leg X-rays to assess Mechanical Alignment  
• 
2011 Knee Society Score  
• 
Quality of Life (EQ-5D)  
• 
Forgotten Joint Score  
• 
Obtain and record any AEs occurring from the time of study device implantation  
• 
Adverse Event Assessment  
 
7.5. 
Six Months, One Year, Two Years Post-Operative 
• 
Perform standard AP, lateral, and patellar X-rays 
• 
2011 Knee Society Score  
• 
Quality of Life (EQ-5D)  
• 
Forgotten Joint Score  
• 
Obtain and record any AEs occurring from the time of study device implantation  
• 
Adverse Event Assessment  
• 
Collect End of Study Information if applicable 
 
8. SUBJECT COMPLETION AND DISPOSITION 
 
8.1. Screening  
Subjects considered potential candidates for the study based on pre-screening will sign an IRB/EC 
approved Informed Consent Form (ICF) prior to any study activities. The PI, or delegated study research 
staff, may then complete the first study visit with the subject. 
 
8.2. Enrolled Subject 
Subject enrollment occurs at the time of surgery. Every subject that has signed consent, is assigned a 
Subject ID, and received a total knee implant from the Journey II family with surgical assist from the study 
device will be considered enrolled in the study.   
 
8.3. Conditions for Study Termination 
All reasonable efforts should be made to retain the subjects for the 2 year duration of this study. If the 
subject has a revision of any component, the subject will be terminated from the study. 
 
A. Screening Failure 
If a subject has provided consent, completed screening and for any reason is not operated on by the 
study device and does not receive a total knee implant from the Journey II BCS or Cruciate-Retraining (CR) 
Systems, the subject will not be considered enrolled in the study.  
For these subjects an Inclusion/Exclusion and Informed Consent CRF, Demographics CRF, Medical 
History CRF, and End of Study CRF need to be completed. However, the CRFs should not be 
submitted into the Sponsor’s database unless the subject signed consent and was assigned a 
Subject ID.  
 
B. Voluntary Withdrawal 
Study participation is voluntary and subjects may withdraw at any point during the study without giving 
their reason for doing so.  An End of Study CRF will be completed for all subjects who do not finish the 
study, and reason for withdrawal will be documented in the form.    

 
                                                
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C. Lost to Follow-Up 
Some actively enrolled subjects may not return for follow-up exams due to a variety of reasons.  Study 
personnel must make reasonable efforts to contact the subject and document the following contact 
attempts prior to declaring a subject to be lost to follow-up: the subject has been contacted according to 
the site’s policies, but no less than 2 documented phone contacts and 1 certified letter without response. 
Copies of all attempts to reach the subjects per regular mail or email and/or the attempts to contact the 
subject via other means should be documented and that documentation should be kept with the subjects 
CRF at the site.  A subject will be considered lost to follow-up if he/she does not appear for the scheduled 
study visit for 2 consecutive visits and study personnel are unable to contact the subject.  
 
D. Study Termination by Investigator/Sponsor 
The Investigator may withdraw subjects from the study for many reasons, including but not limited to the 
following: 
• 
subject noncompliance to study schematic 
• 
subject lost to follow-up 
 
The Investigator should withdraw subjects from the study: 
• 
in case any component of the original Journey II hardware is revised/exchanged 
• 
if the Investigator or the Sponsor stops the study for any reason 
 
For each case, information will be obtained on the End of Study CRF, detailing circumstances leading to 
the withdrawal.   
 
E. Pregnancy 
If during the course of the study a subject becomes pregnant, study procedures that are contraindicated 
during pregnancy and/or lactation (e.g. X-Rays) will not be obtained; however, the subject will continue to 
be followed for study visits and information will be collected regarding the outcome of the birth. 
 
F. Study Site Discontinuation 
A specific study site in this multicenter study may also warrant termination under the following conditions: 
 
• 
non-compliance to Good Clinical Practice (GCP) or protocol 
• 
failure to enroll subjects 
• 
major protocol deviations 
• 
inaccurate or incomplete data 
• 
unsafe or unethical practices 
• 
safety or performance considerations 
• 
investigator involuntarily discontinues participation in study 
 
9. SAFETY REPORTING  
Adverse events and device deficiencies, noted by study staff and reported by the subject, and occurring 
from the time of study device implantation through study completion should be recorded on the 
appropriate CRFs and reported as below.  
 
9.1. Definitions for safety reporting 
 

 
                                                
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A. Adverse Event (AE) 
An AE is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs 
(including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the 
investigational medical device [1]. 
This definition includes: 
• 
events related to the investigational medical device or the comparator 
• 
events related to the procedures involved 
 
B. Serious Adverse Event (SAE) 
A SAE is an adverse event that [1]: 
• 
led to death, 
• 
led to serious deterioration in the health of the subject, that either resulted in: 
1) a life-threatening illness or injury, or 
2) a permanent impairment of a body structure or a body function, or 
3) in-patient or prolonged hospitalization, or 
4) medical or surgical intervention to prevent life-threatening illness or injury or permanent 
impairment to a body structure or a body function 
• 
led to fetal distress, fetal death or a congenital abnormality or birth defect 
 
Planned hospitalization for a pre-existing condition, or a procedure required by the protocol, without 
serious deterioration in health, is not considered a serious adverse event. 
 
C. Adverse Device Effect (ADE) 
An ADE is an adverse event related to the use of an investigational medical device [1]. 
 
This definition includes: 
• 
adverse events resulting from insufficient or inadequate instructions for use, deployment, 
implantation, installation, or operation, or any malfunction of the investigational medical device. 
• 
any event resulting from use error or from intentional misuse of the investigational medical device. 
 
D. Serious Adverse Device Effect (SADE) 
An SADE is an adverse device effect that has resulted in any of the consequences characteristic of a 
serious adverse event [1]. 
 
E. Unanticipated Serious Adverse Device Effect (USADE) 
A serious adverse device effect which by its nature, incidence, severity or outcome has not been 
identified in the current version of the risk analysis report or the clinical investigation plan [1,2]. 
 
F. Device Deficiency 
A device deficiency is an inadequacy of a medical device with respect to its identity, quality, durability, 
reliability, safety or performance. Device deficiencies include malfunctions, use errors, and inadequate 
labelling.  
For the purpose of this study, device deficiencies should be reported when they concern any component 
of the study device or any components of the Journey II implants, as well as its packaging and tools that 
need to be used during implantation according to the Instructions for Use. 
 
 

 
                                                
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G. Revisions 
A specially designed Revision Case Report Form will be used in addition to the Adverse Event Form, to 
document in detail revisions of any of the components of the study device.  
 
9.2. Safety: Investigator’s Responsibilities 
Investigators shall record adverse events and observed device deficiencies, together with an assessment 
of seriousness, severity, and relatedness, in the subject’s source data. Following, Investigators are 
responsible for documenting AEs and device deficiencies on the appropriate CRF and submitting them to 
the Sponsor according to the timelines described here below.  
At each contact with the subject, the Investigator must seek information on AEs by specific questioning 
and, as appropriate, by assessment of the subject. AEs must be recorded in Standard English medical 
terminology.  
Unresolved AEs should be followed by the Investigator until the events are resolved, the subject is lost to 
follow-up or through to the end of the study, whichever timing occurs first. Unresolved AEs at the end of 
the subject’s participation will be monitored by the Investigator as part of the site’s normal standard of 
care. 
 
The Investigator will categorize AEs as mild, moderate or severe based on the following definitions: 
• 
Mild: the subject is aware of the sign or symptom, but finds it easily tolerated.  The event is of 
little concern to the subject and/or little clinical significance.  The event is not expected to have 
any effect on the subject’s overall health or wellbeing. 
• 
Moderate: the subject has discomfort enough to cause interference with or change in usual 
activities.  The event is of some concern to the subject’s health or wellbeing and may require 
medical intervention and/or close follow-up. 
• 
Severe:  the adverse event interferes considerably with the subject’s usual activities.  The event 
is of definite concern to the subject and/or poses substantial risk to the subject’s health or 
wellbeing.  The event is likely to require medical intervention and/or close follow-up and may be 
incapacitating or life threatening.  Hospitalization and treatment may be required.   
 
The Investigator is responsible for describing the relationship of the AE to Navio (the study device), the 
implant and the procedure based on the following definitions: 
• 
Unrelated: the event is clearly not related to the study device or procedure 
• 
Possible: the event may or may not be related to the study device or procedure.  A relationship 
cannot be ruled out. 
• 
Definite: the event is clearly related to the study device or procedure. 
 
9.3. Timelines for Submission of Safety Information: 
The timelines begin when the Investigator becomes aware of the event. 
 
The Investigator will report to the Sponsor: 
• 
As soon as possible, but no greater than  24 hours  upon becoming aware of the event, 
SAEs*, SADEs, U(S)ADEs and device deficiencies that could have led to a SADE: 
o if suitable action had not been taken 
o if intervention had not been made, or 
o if circumstances had been less fortunate 

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•
Revisions, within 24 hours upon becoming aware of the event. Sponsor will provide an
explant retrieval kit on becoming aware of a revision and ask the Investigator to return any revised
components for retrieval analysis.
Investigators may also be asked to supply the Sponsor, upon Sponsor’s request, with any additional 
information related to the safety reporting of a particular event. 
The Principal Investigator will be responsible for reporting to the IRB/EC of the study site and to the 
regulatory authorities, SAEs, SADEs and device deficiencies that could have led to a SADE, as required by 
the national regulations.  
9.4. Safety reporting: Sponsor’s Responsibilities 
Sponsor will provide progress reports on safety events to the Investigator to report to the IRB/EC as 
required.   
In the case of multicenter studies, Sponsor will inform all Investigators in writing of all SAEs that were 
reported by all sites throughout the clinical investigation and based on perceived risk. 
The Sponsor will also, in case of SADEs and device deficiencies that could have led to SADEs, determine 
whether the risk analysis needs to be updated and assess whether corrective or preventive action is 
required. 
10. STATISTICAL PROCEDURES
10.1. Sample size calculation 
Parratte et al.7 looked at the effects of postoperative mechanical axis alignment on the survival of TKAs. 
They found that of the 398 TKAs reviewed in the paper there were 292 (73.4%) which post-operatively 
were defined as mechanically aligned (with a mechanical axis of 0™ ± 3™). 
This study aims to show superiority in the proportion of TKAs post-operatively defined as mechanically 
aligned against the reference proportion of 73.4% from above. 
It is estimated that the proportion of mechanically aligned TKAs using the Navio system will be around 
88%. If this assumption holds then the recruitment of 115 subjects would be sufficient to provide 80% 
power to show that the lower limit of the two-sided 95% confidence interval for the proportion of 
mechanically aligned TKAs is greater than 73.4%, hence proving superiority to the reference literature. 
It is expected that approximately 5% of subjects will be lost to follow up at the 1 month visit and therefore 
120 subjects will be recruited for this study. 
10.2. General Statistical Considerations 
Smith & Nephew’s Global Biostatistics group will conduct the statistical analysis for this study and they 
will prepare Statistical Analysis Plan (SAP). Unless otherwise stated, all significance tests and hypothesis 
testing will be two-sided, performed at the 5% significance level. Resulting p-values will be quoted and 
95% two-sided confidence intervals will be generated where appropriate. All p-values will be rounded to 
three decimal places, p-values less than 0.001 will be presented as ‘<0.001’ in all tables. 
Where data summaries are specified, categorical and ordinal variables will be summarized with 
frequencies and percentages. Continuous variables will be summarized with the following summary 
statistics: number of observations, mean, median, standard deviation, minimum and maximum values. All 
analyses will be performed in SAS 9.4 (or later). 

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10.3.  Missing Data  
A complete disposition report, along with the explanation for lost-to-follow-up, death, revision, and 
withdrawn subjects is to be provided in the Clinical Study Report (CSR). The methods used to handle 
missing or incomplete data for the efficacy and safety measures will be detailed in the Statistical Analysis 
Plan (SAP). 
10.4. Analysis Populations  
All subjects that are operated on by the study device are considered study participants. The following 
study populations and analysis sets will be defined: 
•
Safety Population: This population will include all subjects that received the study device and will
be used for analysis of demographics, disposition data and safety.
•
Modified Intention to Treat Population (mITT): Following the intention to treat principle, this
population Full Analysis Set (FAS): This will include all subjects that received the study device and
attended at least one post-baseline assessment. This population will be used for the primary
analysis of all efficacy endpoints.
•
Per Protocol Population (PP): This population will include all subjects that received the study
device, meet the inclusion/exclusion criteria, attend all follow-up assessments within the
specified window, and have no significant protocol deviations. Subjects that are required to be
withdrawn from the study under the protocol (e.g. due to revision) will be included regardless of
attendance of follow-up visits unless they are deemed to have significant protocol deviations or
failed to meet the inclusion/exclusion criteria.  This population will be used as secondary analysis
of all efficacy endpoints.
10.5. Analysis of Primary Endpoint  
The primary endpoint of the study is the proportion of subjects achieving post-operative mechanical 
alignment, defined as ±3o from target, assessed at the 1 month study visit, and after undergoing a Navio 
assisted TKA. 
The proportion defined above will be presented along with the associated two-sided 95% confidence 
interval, to be calculated using exact binomial methods. 
Superiority of the proportion of subjects achieving post-operative mechanical alignment, after undergoing 
a Navio assisted TKA against those in the reference literature (Parratte et al.)7 will be achieved if the lower 
limit of the two-sided 95% confidence interval is greater than 73.4%. 
Mechanical alignment will also be summarized using summary statistics. 
10.6. Analysis of Secondary Endpoints:  
Implant survival rate will be assessed for a final analysis using the number and proportion of subjects who 
had no implant revisions by the 2-year time point, the associated 95% confidence intervals will be 
calculated using exact binomial methods. Time to occurrence of revisions will also be analyzed using 
Kaplan-Meier survival analysis. 
KSS, EQ-5D-5L, and FJS scores will be analyzed separately at the end of study using Repeated Measures 
ANOVA models, prognostic and baseline factors will be adjusted for. 

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Length of hospital stay, operative time (both skin to skin time and anesthetic time), and radiographic 
assessments will be assessed using summary statistics. Trends in operative time measures for individual 
investigators over the course of the study will be assessed. 
10.7. Analysis of Safety Endpoints:  
The safety endpoints for this study are the number of occurrences and the frequency of subjects 
reporting: adverse events (AE), serious adverse events (SAE), adverse device effects (ADE), serious 
adverse device effects (SADE), unanticipated serious adverse device effects (USADE) and device 
deficiencies (DevD). 
In addition, for each event, the following will be summarised: seriousness, the relationship to the 
investigational device (Navio), relationship to implant, relationship to study procedure, outcome and either 
the duration of the resolved events or the duration of the events at study completion. 
11. ETHICAL CONSIDERATIONS
11.1. Ethical Approval 
In accordance with the Declaration of Helsinki and local regulations of the participating countries, sites 
must gain written IRB/EC approval prior to enrolling research participants in the study.  
11.2. Protocol Amendments 
Neither the Investigator nor the Sponsor will modify this protocol without mutual agreement. After 
agreement to initiate the modification - in the form of a protocol amendment - the Investigator agrees not 
to implement this modification until instructed to do so by the Sponsor.  It will be necessary to obtain 
IRB/EC approval prior to implementation of any change in the protocol that may affect the scientific 
soundness or the rights, safety, or welfare of the subjects involved. Notification shall be submitted to the 
IRB/EC of the study site by the Investigator.  
11.3. Informed Consent 
All study subjects must sign an IRB/EC approved ICF according to 2011:ISO14155 guidelines, GCP 
guidelines and all applicable national regulations. Potential subjects must be informed as to the purpose 
of the study and the potential risks and benefits known or that can be reasonably predicted or expected 
as described in the written consent form. The subject shall have sufficient opportunity to consider 
participation in the study; a subject cannot be led to believe that he/she is waiving his/her rights as a 
subject or the liability of the Sponsor or Investigator. Subjects are then invited to sign and date the 
consent form, indicating their consent for enrollment. The Investigator will retain the original copy of the 
signed consent form in the study files. A duplicate copy shall be provided to the subject. 
11.4. Risk – Benefit Analysis 
A. Study Related Risks 
Possible risks that may occur as a result of study procedures are: 
•
Subjects will be asked to complete questionnaires; however these are not interventional procedures
and are not expected to add significant time to any appointments.
•
This study involves the use of x-ray evaluation.  X-ray exposure is cumulative over a lifetime and total
exposure should be kept to a minimum.  However, if the x-ray exposure when participating in the

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study is equivalent to the exposure the subject would receive if they chose not to participate in the 
study, there is no additional risk associated with this study. 
•
As a result of participating in the study there could be a risk of loss of protected subject information
confidentiality.  All applicable confidentiality standards and data protection and privacy laws will be
followed by the Sponsor to ensure that data collected is handled in confidence.  Data will be coded
and handled only by appropriately qualified and authorized personnel.
Risks related to the general surgical procedures are not considered here because these could be present 
regardless of participation into the study. 
B. Study Related Benefits 
Because the surgery and all the follow-up visits are the same as if the subject would not participate in this 
study, there are no additional medical benefits associated with participating in this study. The information 
gained from this study may help improve the treatment of people that need to undergo TKA. 
12. MONITORING PROCEDURES
12.1. Source Documentation 
Investigators are responsible for obtaining and maintaining complete subject health information in the 
medical record for each subject (source documents).  Examples of source documents follows: hospital 
records, clinic and office charts, memoranda, dispensing records, subject questionnaires, clinic 
evaluation transcriptions, operative notes, x-rays, radiology reports, blood collection reports and shipment 
records, and research subject files.   
Original CRFs may be used as source documents only in the case of 2011 Knee Society Score, Quality of 
Life (EQ-5D) and the Forgotten Joint Score.  
The Principal Investigator shall ensure that clinical records are clearly marked to indicate that the subject 
is enrolled in a particular clinical study and if he/she completed per protocol or discontinued early and the 
reason. 
12.2. Direct Access 
This study may be monitored by the Sponsor or a qualified person designated by the Sponsor. This 
qualified person could be an employee of the Sponsor or of a contract research organization (Sponsor’s 
agent).  
The investigator will provide Sponsor, Sponsor’s agents, IRB/EC and regulatory agencies with direct 
access to all source data/documents to permit study-related monitoring, audits, IRB/EC review, and 
regulatory inspections. 
12.3. Site Qualification Visit 
A site qualification visit may be performed by the Sponsor prior to the execution of a clinical agreement to 
ensure that all Investigators have the appropriate training, staff, facilities and resources to adequately 
conduct the study. 
12.4. Site Initiation Visit 

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A site initiation visit to provide training on the specifics of the study, site obligations and expectations of 
study conduct will be performed by the Sponsor. No screening or other study procedures may be 
performed prior to the execution of the Clinical Study Agreement and documented IRB/EC approval.   
12.5. Interim Monitoring Visits 
The Sponsor or its designee will conduct the appropriate site visits at the appropriate intervals. The 
clinical investigation will be monitored to ensure that: the rights and wellbeing of the subjects are 
protected; the reported data are accurate, complete, and verifiable from the source documents; and the 
study is conducted in compliance with currently approved protocol, with GCP regulations, and with 
applicable regulatory requirements. Detailed monitoring requirements will be documented within the 
Clinical Monitoring Plan for this study.  
12.6. Closeout Visit 
A study close out visit will be performed by the Sponsor or designee to retrieve and account for all 
remaining clinical data and to resolve outstanding queries.  During study close-out, the monitor will review 
investigator files to ensure required documents and records are on file, confirm the disposition of any 
other ancillary items used for the study, and review regulatory requirements regarding records retention 
and IRB/EC reporting requirements. 
12.7. Sponsor Audits and Regulatory Inspection 
The Sponsor, Sponsor’s agents, IRB/EC and regulatory agencies may audit study data.  The site must 
accommodate audit requests, notify the Sponsor of any requests as soon as they are received, and 
provide direct access to study records during the audit.   
12.8. 
Data Handling and Record Keeping Requirements 
Case report forms (CRFs) will be supplied by the Sponsor. Subjects will be identified by a study number 
and subject identification code. Only the Investigator site will have the key to identify individual subjects. 
The Investigator is responsible for the timely and accurate completion of CRFs. All documents related to 
the study must be securely archived at the study site or in a central archive.  
Data required according to this protocol are to be recorded on the case report forms (CRFs) at the time of 
the scheduled visits. Once a subject is enrolled, completed CRFs should be sent to the Sponsor, either by 
fax or by e-mail, as soon as possible, and is generally expected within 10 working days upon completion 
of the CRFs. 
12.9. Data Recording and Record Retention 
Clinical research records shall be stored in a manner that ensures privacy, confidentiality, security and 
accessibility of the records both during and after the conduct of the study.  The Investigator/Institution will 
take measures to prevent accidental or premature destruction of those documents.  The investigator must 
retain essential study documents for at least 2 years after the latest of the following: the date the study is 
terminated or completed or the date the documents are no longer needed to support a premarket 
approval application. If the Investigator needs to dispose of the documents, the Sponsor should be 
contacted for approval prior to disposal or destruction. For discontinued product, the essential documents 
will be retained until at least 2 years have elapsed since the formal discontinuation (via notification of the 
FDA or other regulatory agency) of clinical development of the investigational product. The investigator will 
retain these documents for a longer period if required by the applicable local laws. 

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If the responsible investigator retires, relocates, or withdraws from responsibility of keeping the study 
records, custody must be transferred to a person who will accept the responsibility.  The Sponsor must be 
notified in writing of the name and address of the new custodian.  Under no circumstance shall the 
Investigator relocate or dispose of any study documents before having obtained written approval from the 
Sponsor. 
13. DEVIATIONS FROM PROTOCOL
A protocol deviation is an instance of failure, intentionally or unintentionally, to follow the requirements of 
the protocol. Protocol deviations include but are not limited to deviations from inclusion/exclusion criteria, 
endpoint variable criteria, study visits outside the window, and GCP guidelines. 
13.1. Protocol Deviation Reporting Requirements 
Deviations must be reported to the Sponsor through the specially designed Protocol Deviation Log as 
soon as reasonably possible.  
When protocol deviations affect the scientific soundness of the study, or the rights, safety or welfare of the 
study subjects, the Investigator must also report protocol deviations to the IRB/EC of the study site.  It is 
the responsibility of the PI to inform the IRB/EC of the study site of the incident, per local requirements. 
The local IRB/EC should be consulted on protocol deviation reporting requirements.   
Investigators and all study staff (staff at site and at Sponsor) are responsible for ensuring adherence to 
study protocol. During the monitoring visits, the Sponsor representative will review all deviations with the 
Investigator. If a deviation is discovered outside of a monitoring visit, it should be evaluated via phone, 
email or letter.  Appropriate measures to address the occurrence, additional monitoring visits, or audit of 
the study should be taken, which may include defining and implementing a Corrective and Preventive 
Action (CAPA).  
14. Publication policy
The preparation and submission for publication of manuscripts containing the study results shall be in 
accordance with a process determined by the Clinical Trial Agreements between the study Sponsor and 
participating institutions. The publication or presentation of any study results shall comply with all 
applicable privacy laws, including, but not limited to the Health Insurance Portability and Accountability 
Act of 1996. 

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BIBLIOGRAPHY 
List all relevant references here. 
1.
ISO 14155:2011
2.
21 CFR 812
3.
ICH Guideline for Clinical Safety Data Management: Definitions and Standards for Expedited Reporting
4.
Rand, et al, J Arthroplasty (1991) Sep; 6(3);279-84
5.
2015 Hip and Knee Implant Review, www.OrthopedicNetworkNews.com
6.
Dalton, et al, J. Arthroplasty (2016) 31, 1366-1372
7.
Parratte S, Pagnano MW, Trousdale RT, Berry DJ. Effect of Postoperative Mechanical Axis Alignment
on the Fifteen-Year Survival of Modern, Cemented Total Knee replacements. JBJS 2010:92:2143-9

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Appendix 1 
JOURNEY II BCS and CR Component Part Numbers 
JOURNEY II FEMORALS 
Catalog Item Number 
Description 
7402-2111 
JOURNEY II BCS FEMORAL OXINIUM RIGHT SIZE 1 
7402-2112 
JOURNEY II BCS FEMORAL OXINIUM RIGHT SIZE 2 
7402-2113 
JOURNEY II BCS FEMORAL OXINIUM RIGHT SIZE 3 
7402-2114 
JOURNEY II BCS FEMORAL OXINIUM RIGHT SIZE 4 
7402-2115 
JOURNEY II BCS FEMORAL OXINIUM RIGHT SIZE 5 
7402-2116 
JOURNEY II BCS FEMORAL OXINIUM RIGHT SIZE 6 
7402-2117 
JOURNEY II BCS FEMORAL OXINIUM RIGHT SIZE 7 
7402-2118 
JOURNEY II BCS FEMORAL OXINIUM RIGHT SIZE 8 
7402-2119 
JOURNEY II BCS FEMORAL OXINIUM RIGHT SIZE 9 
7402-2110 
JOURNEY II BCS FEMORAL OXINIUM RIGHT SIZE 10 
7402-2121 
JOURNEY II BCS FEMORAL OXINIUM LEFT SIZE 1 
7402-2122 
JOURNEY II BCS FEMORAL OXINIUM LEFT SIZE 2 
7402-2123 
JOURNEY II BCS FEMORAL OXINIUM LEFT SIZE 3 
7402-2124 
JOURNEY II BCS FEMORAL OXINIUM LEFT SIZE 4 
7402-2125 
JOURNEY II BCS FEMORAL OXINIUM LEFT SIZE 5 
7402-2126 
JOURNEY II BCS FEMORAL OXINIUM LEFT SIZE 6 
7402-2127 
JOURNEY II BCS FEMORAL OXINIUM LEFT SIZE 7 
7402-2128 
JOURNEY II BCS FEMORAL OXINIUM LEFT SIZE 8 
7402-2129 
JOURNEY II BCS FEMORAL OXINIUM LEFT SIZE 9 
7402-2120 
JOURNEY II BCS FEMORAL OXINIUM LEFT SIZE 10 
7402-4211 
JOURNEY II BCS FEMORAL COCR RIGHT SIZE 1 
7402-4212 
JOURNEY II BCS FEMORAL COCR RIGHT SIZE 2 
7402-4213 
JOURNEY II BCS FEMORAL COCR RIGHT SIZE 3 
7402-4214 
JOURNEY II BCS FEMORAL COCR RIGHT SIZE 4 
7402-4215 
JOURNEY II BCS FEMORAL COCR RIGHT SIZE 5 
7402-4216 
JOURNEY II BCS FEMORAL COCR RIGHT SIZE 6 
7402-4217 
JOURNEY II BCS FEMORAL COCR RIGHT SIZE 7 
7402-4218 
JOURNEY II BCS FEMORAL COCR RIGHT SIZE 8 
7402-4219 
JOURNEY II BCS FEMORAL COCR RIGHT SIZE 9 
7402-4921 
JOURNEY II BCS FEMORAL COCR LEFT SIZE 1 
7402-4922 
JOURNEY II BCS FEMORAL COCR LEFT SIZE 2 
7402-4923 
JOURNEY II BCS FEMORAL COCR LEFT SIZE 3 
7402-4924 
JOURNEY II BCS FEMORAL COCR LEFT SIZE 4 
7402-4925 
JOURNEY II BCS FEMORAL COCR LEFT SIZE 5 
7402-4926 
JOURNEY II BCS FEMORAL COCR LEFT SIZE 6 
7402-4927 
JOURNEY II BCS FEMORAL COCR LEFT SIZE 7 

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JOURNEY II FEMORALS 
7402-4928 
JOURNEY II BCS FEMORAL COCR LEFT SIZE 8 
7402-4929 
JOURNEY II BCS FEMORAL COCR LEFT SIZE 9 
7402-1151 
JOURNEY II CR  FEMORAL OXINIUM RT SZ1 
7402-1152 
JOURNEY II CR  FEMORAL OXINIUM RT SZ2 
7402-1153 
JOURNEY II CR  FEMORAL OXINIUM RT SZ3 
7402-1154 
JOURNEY II CR  FEMORAL OXINIUM RT SZ4 
7402-1155 
JOURNEY II CR  FEMORAL OXINIUM RT SZ5 
7402-1156 
JOURNEY II CR  FEMORAL OXINIUM RT SZ6 
7402-1157 
JOURNEY II CR  FEMORAL OXINIUM RT SZ7 
7402-1158 
JOURNEY II CR  FEMORAL OXINIUM RT SZ8 
7402-1159 
JOURNEY II CR  FEMORAL OXINIUM RT SZ9 
7402-1150 
JOURNEY II CR  FEMORAL OXINIUM RT SZ10 
7402-1161 
JOURNEY II CR  FEMORAL OXINIUM LT SZ1 
7402-1162 
JOURNEY II CR  FEMORAL OXINIUM LT SZ2 
7402-1163 
JOURNEY II CR  FEMORAL OXINIUM LT SZ3 
7402-1164 
JOURNEY II CR  FEMORAL OXINIUM LT SZ4 
7402-1165 
JOURNEY II CR  FEMORAL OXINIUM LT SZ5 
7402-1166 
JOURNEY II CR  FEMORAL OXINIUM LT SZ6 
7402-1167 
JOURNEY II CR  FEMORAL OXINIUM LT SZ7 
7402-1168 
JOURNEY II CR  FEMORAL OXINIUM LT SZ8 
7402-1169 
JOURNEY II CR  FEMORAL OXINIUM LT SZ9 
7402-1170 
JOURNEY II CR  FEMORAL OXINIUM LT SZ10 
7402-1251 
JOURNEY II CR FEMORAL COCR RT SZ 1 
7402-1252 
JOURNEY II CR FEMORAL COCR RT SZ 2 
7402-1253 
JOURNEY II CR FEMORAL COCR RT SZ 3 
7402-1254 
JOURNEY II CR FEMORAL COCR RT SZ 4 
7402-1255 
JOURNEY II CR FEMORAL COCR RT SZ 5 
7402-1256 
JOURNEY II CR FEMORAL COCR RT SZ 6 
7402-1257 
JOURNEY II CR FEMORAL COCR RT SZ 7 
7402-1258 
JOURNEY II CR FEMORAL COCR RT SZ 8 
7402-1259 
JOURNEY II CR FEMORAL COCR RT SZ 9 
7402-1261 
JOURNEY II CR FEMORAL COCR LT SZ 1 
7402-1262 
JOURNEY II CR FEMORAL COCR LT SZ 2 
7402-1263 
JOURNEY II CR FEMORAL COCR LT SZ 3 
7402-1264 
JOURNEY II CR FEMORAL COCR LT SZ 4 
7402-1265 
JOURNEY II CR FEMORAL COCR LT SZ 5 
7402-1266 
JOURNEY II CR FEMORAL COCR LT SZ 6 
7402-1267 
JOURNEY II CR FEMORAL COCR LT SZ 7 
7402-1268 
JOURNEY II CR FEMORAL COCR LT SZ 8 
7402-1269 
JOURNEY II CR FEMORAL COCR LT SZ 9 

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JOURNEY II Tibia baseplates 
Catalog Item Number 
Description 
7402-2211 
JOURNEY Tibial Baseplate Nonporous Right Size 1 
7402-2212 
JOURNEY Tibial Baseplate Nonporous Right Size 2 
7402-2213 
JOURNEY Tibial Baseplate Nonporous Right Size 3 
7402-2214 
JOURNEY Tibial Baseplate Nonporous Right Size 4 
7402-2215 
JOURNEY Tibial Baseplate Nonporous Right Size 5 
7402-2216 
JOURNEY Tibial Baseplate Nonporous Right Size 6 
7402-2217 
JOURNEY Tibial Baseplate Nonporous Right Size 7 
7402-2218 
JOURNEY Tibial Baseplate Nonporous Right Size 8 
7193-3635 
JOURNEY Tibial Baseplate Nonporous Right Size 9 
7402-2221 
JOURNEY Tibial Baseplate Nonporous Left Size 1 
7402-2222 
JOURNEY Tibial Baseplate Nonporous Left Size 2 
7402-2223 
JOURNEY Tibial Baseplate Nonporous Left Size 3 
7402-2224 
JOURNEY Tibial Baseplate Nonporous Left Size 4 
7402-2225 
JOURNEY Tibial Baseplate Nonporous Left Size 5 
7402-2226 
JOURNEY Tibial Baseplate Nonporous Left Size 6 
7402-2227 
JOURNEY Tibial Baseplate Nonporous Left Size 7 
7402-2228 
JOURNEY Tibial Baseplate Nonporous Left Size 8 
7193-3634 
JOURNEY Tibial Baseplate Nonporous Left Size 9 
JOURNEY II TKA Inserts 
Catalog Item Number 
Description 
7402-7211 
JOURNEY II BCS XLPE ARTICULAR INSERT SZ 1-2 RIGHT 9MM 
7402-7212 
JOURNEY II BCS XLPE ARTICULAR INSERT SZ 1-2 RIGHT 10MM 
7402-7213 
JOURNEY II BCS XLPE ARTICULAR INSERT SZ 1-2 RIGHT 11MM 
7402-7214 
JOURNEY II BCS XLPE ARTICULAR INSERT SZ 1-2 RIGHT 12MM 
7402-7215 
JOURNEY II BCS XLPE ARTICULAR INSERT SZ 1-2 RIGHT 13MM 
7402-7216 
JOURNEY II BCS XLPE ARTICULAR INSERT SZ 1-2 RIGHT 15MM 
7402-7217 
JOURNEY II BCS XLPE ARTICULAR INSERT SZ 1-2 RIGHT 18MM 
7402-7218 
JOURNEY II BCS XLPE ARTICULAR INSERT SZ 1-2 RIGHT 21MM 
7402-7221 
JOURNEY II BCS XLPE ARTICULAR INSERT SZ 1-2 LEFT 9MM 
7402-7222 
JOURNEY II BCS XLPE ARTICULAR INSERT SZ 1-2 LEFT 10MM 
7402-7223 
JOURNEY II BCS XLPE ARTICULAR INSERT SZ 1-2 LEFT 11MM 
7402-7224 
JOURNEY II BCS XLPE ARTICULAR INSERT SZ 1-2 LEFT 12MM 
7402-7225 
JOURNEY II BCS XLPE ARTICULAR INSERT SZ 1-2 LEFT 13MM 
7402-7226 
JOURNEY II BCS XLPE ARTICULAR INSERT SZ 1-2 LEFT 15MM 
7402-7227 
JOURNEY II BCS XLPE ARTICULAR INSERT SZ 1-2 LEFT 18MM 
7402-7228 
JOURNEY II BCS XLPE ARTICULAR INSERT SZ 1-2 LEFT 21MM 

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JOURNEY II TKA Inserts 
7402-7231 
JOURNEY II BCS XLPE ARTICULAR INSERT SZ 3-4 RIGHT 9MM 
7402-7232 
JOURNEY II BCS XLPE ARTICULAR INSERT SZ 3-4 RIGHT 10MM 
7402-7233 
JOURNEY II BCS XLPE ARTICULAR INSERT SZ 3-4 RIGHT 11MM 
7402-7234 
JOURNEY II BCS XLPE ARTICULAR INSERT SZ 3-4 RIGHT 12MM 
7402-7235 
JOURNEY II BCS XLPE ARTICULAR INSERT SZ 3-4 RIGHT 13MM 
7402-7236 
JOURNEY II BCS XLPE ARTICULAR INSERT SZ 3-4 RIGHT 15MM 
7402-7237 
JOURNEY II BCS XLPE ARTICULAR INSERT SZ 3-4 RIGHT 18MM 
7402-7238 
JOURNEY II BCS XLPE ARTICULAR INSERT SZ 3-4 RIGHT 21MM 
7402-7241 
JOURNEY II BCS XLPE ARTICULAR INSERT SZ 3-4 LEFT 9MM 
7402-7242 
JOURNEY II BCS XLPE ARTICULAR INSERT SZ 3-4 LEFT 10MM 
7402-7243 
JOURNEY II BCS XLPE ARTICULAR INSERT SZ 3-4 LEFT 11MM 
7402-7244 
JOURNEY II BCS XLPE ARTICULAR INSERT SZ 3-4 LEFT 12MM 
7402-7245 
JOURNEY II BCS XLPE ARTICULAR INSERT SZ 3-4 LEFT 13MM 
7402-7246 
JOURNEY II BCS XLPE ARTICULAR INSERT SZ 3-4 LEFT 15MM 
7402-7247 
JOURNEY II BCS XLPE ARTICULAR INSERT SZ 3-4 LEFT 18MM 
7402-7248 
JOURNEY II BCS XLPE ARTICULAR INSERT SZ 3-4 LEFT 21MM 
7402-7251 
JOURNEY II BCS XLPE ARTICULAR INSERT SZ 5-6 RIGHT 9MM 
7402-7252 
JOURNEY II BCS XLPE ARTICULAR INSERT SZ 5-6 RIGHT 10MM 
7402-7253 
JOURNEY II BCS XLPE ARTICULAR INSERT SZ 5-6 RIGHT 11MM 
7402-7254 
JOURNEY II BCS XLPE ARTICULAR INSERT SZ 5-6 RIGHT 12MM 
7402-7255 
JOURNEY II BCS XLPE ARTICULAR INSERT SZ 5-6 RIGHT 13MM 
7402-7256 
JOURNEY II BCS XLPE ARTICULAR INSERT SZ 5-6 RIGHT 15MM 
7402-7257 
JOURNEY II BCS XLPE ARTICULAR INSERT SZ 5-6 RIGHT 18MM 
7402-7258 
JOURNEY II BCS XLPE ARTICULAR INSERT SZ 5-6 RIGHT 21MM 
7402-7261 
JOURNEY II BCS XLPE ARTICULAR INSERT SZ 5-6 LEFT 9MM 
7402-7262 
JOURNEY II BCS XLPE ARTICULAR INSERT SZ 5-6 LEFT 10MM 
7402-7263 
JOURNEY II BCS XLPE ARTICULAR INSERT SZ 5-6 LEFT 11MM 
7402-7264 
JOURNEY II BCS XLPE ARTICULAR INSERT SZ 5-6 LEFT 12MM 
7402-7265 
JOURNEY II BCS XLPE ARTICULAR INSERT SZ 5-6 LEFT 13MM 
7402-7266 
JOURNEY II BCS XLPE ARTICULAR INSERT SZ 5-6 LEFT 15MM 
7402-7267 
JOURNEY II BCS XLPE ARTICULAR INSERT SZ 5-6 LEFT 18MM 
7402-7268 
JOURNEY II BCS XLPE ARTICULAR INSERT SZ 5-6 LEFT 21MM 
7402-7271 
JOURNEY II BCS XLPE ARTICULAR INSERT SZ 7-8 RIGHT 9MM 
7402-7272 
JOURNEY II BCS XLPE ARTICULAR INSERT SZ 7-8 RIGHT 10MM 
7402-7273 
JOURNEY II BCS XLPE ARTICULAR INSERT SZ 7-8 RIGHT 11MM 
7402-7274 
JOURNEY II BCS XLPE ARTICULAR INSERT SZ 7-8 RIGHT 12MM 
7402-7275 
JOURNEY II BCS XLPE ARTICULAR INSERT SZ 7-8 RIGHT 13MM 
7402-7276 
JOURNEY II BCS XLPE ARTICULAR INSERT SZ 7-8 RIGHT 15MM 
7402-7277 
JOURNEY II BCS XLPE ARTICULAR INSERT SZ 7-8 RIGHT 18MM 
7402-7278 
JOURNEY II BCS XLPE ARTICULAR INSERT SZ 7-8 RIGHT 21MM 
7402-7281 
JOURNEY II BCS XLPE ARTICULAR INSERT SZ 7-8 LEFT 9MM 
7402-7282 
JOURNEY II BCS XLPE ARTICULAR INSERT SZ 7-8 LEFT 10MM 
7402-7283 
JOURNEY II BCS XLPE ARTICULAR INSERT SZ 7-8 LEFT 11MM 

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JOURNEY II TKA Inserts 
7402-7284 
JOURNEY II BCS XLPE ARTICULAR INSERT SZ 7-8 LEFT 12MM 
7402-7285 
JOURNEY II BCS XLPE ARTICULAR INSERT SZ 7-8 LEFT 13MM 
7402-7286 
JOURNEY II BCS XLPE ARTICULAR INSERT SZ 7-8 LEFT 15MM 
7402-7287 
JOURNEY II BCS XLPE ARTICULAR INSERT SZ 7-8 LEFT 18MM 
7402-7288 
JOURNEY II BCS XLPE ARTICULAR INSERT SZ 7-8 LEFT 21MM 
7402-5611 
JOURNEY II CR XLPE ARTICULAR INSERT SZ 1-2 RIGHT 9MM 
7402-5612 
JOURNEY II CR XLPE ARTICULAR INSERT SZ 1-2 RIGHT 10MM 
7402-5613 
JOURNEY II CR XLPE ARTICULAR INSERT SZ 1-2 RIGHT 11MM 
7402-5614 
JOURNEY II CR XLPE ARTICULAR INSERT SZ 1-2 RIGHT 12MM 
7402-5615 
JOURNEY II CR XLPE ARTICULAR INSERT SZ 1-2 RIGHT 13MM 
7402-5616 
JOURNEY II CR XLPE ARTICULAR INSERT SZ 1-2 RIGHT 15MM 
7402-5617 
JOURNEY II CR XLPE ARTICULAR INSERT SZ 1-2 RIGHT 18MM 
7402-5621 
JOURNEY II CR XLPE ARTICULAR INSERT SZ 1-2 LEFT 9MM 
7402-5622 
JOURNEY II CR XLPE ARTICULAR INSERT SZ 1-2 LEFT 10MM 
7402-5623 
JOURNEY II CR XLPE ARTICULAR INSERT SZ 1-2 LEFT 11MM 
7402-5624 
JOURNEY II CR XLPE ARTICULAR INSERT SZ 1-2 LEFT 12MM 
7402-5625 
JOURNEY II CR XLPE ARTICULAR INSERT SZ 1-2 LEFT 13MM 
7402-5626 
JOURNEY II CR XLPE ARTICULAR INSERT SZ 1-2 LEFT 15MM 
7402-5627 
JOURNEY II CR XLPE ARTICULAR INSERT SZ 1-2 LEFT 18MM 
7402-5631 
JOURNEY II CR XLPE ARTICULAR INSERT SZ 3-4 RIGHT 9MM 
7402-5632 
JOURNEY II CR XLPE ARTICULAR INSERT SZ 3-4 RIGHT 10MM 
7402-5633 
JOURNEY II CR XLPE ARTICULAR INSERT SZ 3-4 RIGHT 11MM 
7402-5634 
JOURNEY II CR XLPE ARTICULAR INSERT SZ 3-4 RIGHT 12MM 
7402-5635 
JOURNEY II CR XLPE ARTICULAR INSERT SZ 3-4 RIGHT 13MM 
7402-5636 
JOURNEY II CR XLPE ARTICULAR INSERT SZ 3-4 RIGHT 15MM 
7402-5637 
JOURNEY II CR XLPE ARTICULAR INSERT SZ 3-4 RIGHT 18MM 
7402-5641 
JOURNEY II CR XLPE ARTICULAR INSERT SZ 3-4 LEFT 9MM 
7402-5642 
JOURNEY II CR XLPE ARTICULAR INSERT SZ 3-4 LEFT 10MM 
7402-5643 
JOURNEY II CR XLPE ARTICULAR INSERT SZ 3-4 LEFT 11MM 
7402-5644 
JOURNEY II CR XLPE ARTICULAR INSERT SZ 3-4 LEFT 12MM 
7402-5645 
JOURNEY II CR XLPE ARTICULAR INSERT SZ 3-4 LEFT 13MM 
7402-5646 
JOURNEY II CR XLPE ARTICULAR INSERT SZ 3-4 LEFT 15MM 
7402-5647 
JOURNEY II CR XLPE ARTICULAR INSERT SZ 3-4 LEFT 18MM 
7402-5651 
JOURNEY II CR XLPE ARTICULAR INSERT SZ 5-6 RIGHT 9MM 
7402-5652 
JOURNEY II CR XLPE ARTICULAR INSERT SZ 5-6 RIGHT 10MM 
7402-5653 
JOURNEY II CR XLPE ARTICULAR INSERT SZ 5-6 RIGHT 11MM 
7402-5654 
JOURNEY II CR XLPE ARTICULAR INSERT SZ 5-6 RIGHT 12MM 
7402-5655 
JOURNEY II CR XLPE ARTICULAR INSERT SZ 5-6 RIGHT 13MM 
7402-5656 
JOURNEY II CR XLPE ARTICULAR INSERT SZ 5-6 RIGHT 15MM 

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JOURNEY II TKA Inserts 
7402-5657 
JOURNEY II CR XLPE ARTICULAR INSERT SZ 5-6 RIGHT 18MM 
7402-5661 
JOURNEY II CR XLPE ARTICULAR INSERT SZ 5-6 LEFT 9MM 
7402-5662 
JOURNEY II CR XLPE ARTICULAR INSERT SZ 5-6 LEFT 10MM 
7402-5663 
JOURNEY II CR XLPE ARTICULAR INSERT SZ 5-6 LEFT 11MM 
7402-5664 
JOURNEY II CR XLPE ARTICULAR INSERT SZ 5-6 LEFT 12MM 
7402-5665 
JOURNEY II CR XLPE ARTICULAR INSERT SZ 5-6 LEFT 13MM 
7402-5666 
JOURNEY II CR XLPE ARTICULAR INSERT SZ 5-6 LEFT 15MM 
7402-5667 
JOURNEY II CR XLPE ARTICULAR INSERT SZ 5-6 LEFT 18MM 
7402-5671 
JOURNEY II CR XLPE ARTICULAR INSERT SZ 7-8 RIGHT 9MM 
7402-5672 
JOURNEY II CR XLPE ARTICULAR INSERT SZ 7-8 RIGHT 10MM 
7402-5673 
JOURNEY II CR XLPE ARTICULAR INSERT SZ 7-8 RIGHT 11MM 
7402-5674 
JOURNEY II CR XLPE ARTICULAR INSERT SZ 7-8 RIGHT 12MM 
7402-5675 
JOURNEY II CR XLPE ARTICULAR INSERT SZ 7-8 RIGHT 13MM 
7402-5676 
JOURNEY II CR XLPE ARTICULAR INSERT SZ 7-8 RIGHT 15MM 
7402-5677 
JOURNEY II CR XLPE ARTICULAR INSERT SZ 7-8 RIGHT 18MM 
7402-5681 
JOURNEY II CR XLPE ARTICULAR INSERT SZ 7-8 LEFT 9MM 
7402-5682 
JOURNEY II CR XLPE ARTICULAR INSERT SZ 7-8 LEFT 10MM 
7402-5683 
JOURNEY II CR XLPE ARTICULAR INSERT SZ 7-8 LEFT 11MM 
7402-5684 
JOURNEY II CR XLPE ARTICULAR INSERT SZ 7-8 LEFT 12MM 
7402-5685 
JOURNEY II CR XLPE ARTICULAR INSERT SZ 7-8 LEFT 13MM 
7402-5686 
JOURNEY II CR XLPE ARTICULAR INSERT SZ 7-8 LEFT 15MM 
7402-5687 
JOURNEY II CR XLPE ARTICULAR INSERT SZ 7-8 LEFT 18MM 
Patellar Implants 
J 2 Patella Resurfacing 
Catalog # 
Size (mm) 
74024826 26 
74024829 29 
74024832 32 
74024835 35 
74024838 38 
74024841 41 
J 2 Patella, Biconvex 
74024623 23 
74024626 26 
74024629 29 
74024632 32 
Genesis 2 Patella, Biconvex 
71420566 23 
71420568 26 
71420570 29 

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Patellar Implants 
71420572 32 
Genesis 2 Patella, Resurfacing 
71420580 26 
71420574 29 
71420576 32 
71420578 35 
Genesis 2 Patella, Oval 
Resurfacing 
71421029 29 
71421032 32 
71421035 35 
71421038 38 
71421041 41