TSolution One® Total Knee Arthroplasty Clinical Trial
Phase: NA
Conditions: Osteoarthritis, Knee
Sponsor: Think Surgical Inc.

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1 
TSolution One® Total Knee Arthroplasty Clinical Trial 
 
 
Protocol Number: 16-PROTO-01 
 
 
Sponsor:  
Think Surgical, Inc.  
47201 Lakeview Blvd. 
Fremont, CA 94538 
 
Contact:  
Valentina Campanelli 
Office Phone: 510-249-2314 
Cell Phone: 530-220-3245 
Office Fax: 510-249-2396 
E-mail: vcampanelli@thinksurgical.com 
Version 6.0: 09 SEP 2019 
 
 

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2 
REVISION HISTORY 
Ver. 
Date 
Summary of Changes 
1.0 
05 JUL 2016 
Original Version 
2.0 
13 JAN 2017 
Increased time permitted between baseline and surgery from 30 
days to 90 days. 
3.0 
12 JUL 2017 
Moved comparison of pre- and post-op alignment from a 
secondary effectiveness endpoint to a primary effectiveness 
endpoint to address study design considerations. 
3.1 
18 SEP 2017 
Added clarification to state that post-operative alignment 
outcomes will be compared to surgeon’s pre-operative alignment 
goals versus neutral alignment. 
4.0 
24 OCT 2017 
Increased subject follow-up time from 3 months to a minimum of 
6 months and a maximum of 12 months. Clarified that all patients 
with AEs at the final study visit (6M or 12M) will be followed until 
AE resolution or termination of study. Added clarification for 
patients who are to be excluded under Exclusion Criterion ‘c’. 
Added Change Summary table after title page. 
5.0 
07 DEC 2018 
Update contact information. Corrected footnote (b) under the 
Schedule of Procedures to reflect standard of care pre-operative 
and post-operative blood work.  
6.0 
09 SEP 2019 
Add Continued Access arm to study design. Update Sections 1.0, 
5.0, 5.1, 5.2, 6.5, 7.0, 7.1, 7.3, 7.4, 7.5, 7.6, 7.7, 9.1, 9.2, 9.3 and 
15.0 to clarify requirements for Continued Access arm. Add Table 
3 with Schedule of Procedures for Continued Access arm. Update 
MCRA CRO address in Section 16.0. Add administrative 
clarification regarding treatment of patients that withdraw 
consent or are withdrawn by the PI before surgery in Section 6.5.  
Add administrative clarification regarding data collection 
requirements for Unscheduled Visits in Section 7.8. Add 
administrative clarifications regarding Adverse Event follow up 
requirements in Schedule of Procedures (Tables 2 and 3) and 
Sections 8.1, 10.2 and 10.8.  Add administrative clarifications 
regarding stopping rules for safety concerns in Sections 8.5 and 
10.7.   
 
   
 
 
 

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3 
PROTOCOL APPROVAL SIGNATURE PAGE 
Protocol Number: 16-PROTO-01 
Protocol Title:  TSolution One Total Knee Arthroplasty Clinical Trial 
Protocol Version: Version 6.0 
Protocol Date: 09-SEP-2019 
 
This protocol has been read and approved by: 
 
SPONSOR: 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Joel Zuhars 
 
 
 
 
 
 
 
Date (dd/mmm/yyyy) 
Director of Engineering, THINK Surgical Inc.  
 
 
 
CRO: 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 Iman Ahmad   
 
 
 
 
 
 
Date (dd/mmm/yyyy) 
 Director, Clinical Affairs, MCRA, LLC 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 Dave McGurl   
 
 
 
 
 
  
Date (dd/mmm/yyyy) 
 Director, Regulatory Affairs, MCRA, LLC 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 Greg Tullo 
 
 
 
 
 
 
 
Date (dd/mmm/yyyy) 
 Director, Data Management & Biostatistics, MCRA, LLC 
 

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INVESTIGATOR SIGNATURE PAGE 
I have read and understand the “TSolution One® Total Knee Arthroplasty Clinical Trial” protocol 
(16-PROTO-01), and will conduct the study in accordance with this protocol, all attachments 
and amendments, applicable Food and Drug Administration regulations, HIPAA, and local 
regulations, and the policies of local IRB and institutions where the study will take place.  
 
In my formal capacity as Investigator, my duties include ensuring the safety of the study 
patients enrolled under my supervision and providing THINK Surgical, Inc.™ with complete and 
timely information, as outlined in the protocol.  It is understood that all information pertaining 
to the study will be held strictly confidential and that this confidentiality requirement applies to 
all study staff at this site. 
 
Protocol Number:  16-PROTO-01 
 
Protocol Title:  TSolution One Total Knee Arthroplasty Clinical Trial 
 
Protocol Version: Version 6.0 
 
Protocol Date:  09 SEP 2019 
 
 
Principal Investigator: 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 Print Name 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Signature 
 
 
 
 
 
 
Date (dd/mmm/yyyy) 
 
 
Sponsor: 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 Print Name 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Signature 
 
 
 
 
 
 
Date (dd/mmm/yyyy) 
 
 

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TABLE OF CONTENTS 
 
REVISION HISTORY .............................................................................................................................2 
PROTOCOL APPROVAL SIGNATURE PAGE ............................................................................................3 
1. 
STUDY SUMMARY ......................................................................................................................7 
2. 
INTRODUCTION ........................................................................................................................ 12 
2.1. 
Background ....................................................................................................................... 12 
2.2. 
Investigational Device ....................................................................................................... 13 
2.3. 
Investigational Procedure .................................................................................................. 14 
3. 
RISK ANALYSIS .......................................................................................................................... 17 
3.1. 
Risks ................................................................................................................................. 17 
3.2. 
Methods to Minimize Risk ................................................................................................. 18 
3.3. 
Potential Benefits .............................................................................................................. 20 
3.4. 
Justification of the Clinical Investigation ............................................................................ 20 
4. 
STUDY OBJECTIVES ................................................................................................................... 21 
4.1. 
Primary Objectives ............................................................................................................ 21 
4.2. 
Secondary Objective .......................................................................................................... 22 
5. 
STUDY DESIGN ......................................................................................................................... 22 
5.1. 
Primary Effectiveness Endpoint ......................................................................................... 22 
5.2. 
Primary Safety Endpoint .................................................................................................... 23 
5.3. 
Secondary Endpoints ......................................................................................................... 23 
6. 
SELECTION OF STUDY POPULATION .......................................................................................... 26 
6.1. 
Inclusion Criteria ............................................................................................................... 26 
6.2. 
Exclusion Criteria ............................................................................................................... 26 
6.3. 
Screening .......................................................................................................................... 27 
6.4. 
Informed Consent ............................................................................................................. 27 
6.5. 
Study Enrollment .............................................................................................................. 28 
7. 
STUDY PROCEDURES ................................................................................................................ 28 
7.1. 
Baseline Visit (≤90 days prior to Date of Surgery) ............................................................. 28 
7.2. 
Surgical Visit ..................................................................................................................... 29 
7.3. 
Hospital Discharge............................................................................................................. 31 
7.4. 
6 Week Follow Up Visit (± 2 weeks) .................................................................................... 31 
7.5. 
3 Month Follow Up Visit (± 2 weeks) .................................................................................. 32 
7.6. 
6 Month Follow Up Visit (± 2 weeks) .................................................................................. 33 
7.7. 
12 Month Follow Up Visit (± 2 weeks) ................................................................................ 33 
7.8. 
Unscheduled Visits ............................................................................................................ 34 
8. 
STUDY COMPLETION & EARLY DISCONTINUATION .................................................................... 37 
8.1. 
Criteria for Study Completion & Early Discontinuation ....................................................... 37 
8.2. 
Documentation of Early Discontinuation ............................................................................ 37 
8.3. 
Use of Data from Early Discontinuation Cases .................................................................... 37 
8.4. 
Treatment for Early Discontinuation Cases ......................................................................... 38 
8.5. 
Stopping Rules .................................................................................................................. 38 
9. 
STATISTICAL PLAN .................................................................................................................... 38 
9.1. 
Determination of Sample Size for Safety Endpoint ............................................................. 38 
9.2. 
Determination of Sample Size for Effectiveness  Endpoint .................................................. 39 

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9.3. 
Analysis Plan ..................................................................................................................... 40 
10. SAFETY REPORTING .................................................................................................................. 41 
10.1. 
Definitions..................................................................................................................... 41 
10.2. 
Adverse Event Documentation ....................................................................................... 41 
10.3. 
Assessment of Severity .................................................................................................. 42 
10.4. 
Assessment of Relationship to Use of the Investigational Device ..................................... 42 
10.5. 
Serious Adverse Event Reporting ................................................................................... 43 
10.6. 
Determination and Reporting of Unanticipated Adverse Device Effects ........................... 43 
10.7. 
Study Termination for Safety Concerns  .......................................................................... 44 
10.8. 
Treatment of Adverse Events ......................................................................................... 44 
11. PROTOCOL DEVIATIONS............................................................................................................ 45 
12. DEVICE LABELING ..................................................................................................................... 45 
13. ETHICAL REVIEW, REGULATORY CONSIDERATIONS, AND CONFIDENTIALITY ............................... 45 
13.1. 
Ethical Review ............................................................................................................... 45 
13.2. 
Regulatory Considerations ............................................................................................. 45 
13.3. 
Confidentiality ............................................................................................................... 46 
14. DATA HANDLING & RECORD KEEPING ....................................................................................... 46 
14.1. 
Data Management ......................................................................................................... 46 
14.2. 
Record Keeping ............................................................................................................. 47 
15. RADIOGRAPHIC ENDPOINT ASSESSMENT .................................................................................. 47 
16. STUDY MONITORING ................................................................................................................ 48 
16.1. 
Monitoring Activities ..................................................................................................... 48 
16.2. 
Frequency of Visits ........................................................................................................ 49 
17. AUDITS AND INSPECTIONS ........................................................................................................ 49 
18. RECORD RETENTION ................................................................................................................. 49 
19. PUBLICATION PLAN .................................................................................................................. 49 
20. REFERENCES ............................................................................................................................. 50 
 
 
 
 

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1. 
STUDY SUMMARY 
Title 
TSolution One Total Knee Arthroplasty Clinical Trial 
Sponsor 
THINK Surgical, Inc. 
Short Title 
TSolution One TKA 
Protocol Number 
16-PROTO-01 
Lead Investigator 
Bernard N. Stulberg, MD 
Methodology 
Multi-center, prospective, non-randomized clinical trial 
Study Type 
Observational  
Study Duration 
Patients will be consented to participate for a period of no less than 6 
months and no more than 12 months. Each study arm will terminate once 
the last enrolled patient of the study arm completes their 6 month study 
visit. Patients who are not expected to reach their 12 month visit prior to 
study arm termination will be exited at 6 months; all others will be exited at 
12 months.   
Objectives 
The goal of this study is to evaluate the safety and effectiveness of robotic-
assisted total knee arthroplasty, and to document clinical and radiological 
outcomes for TCAT-assisted implantation using the TSolution One System 
for TKA compared to a literature control. 
Diagnosis and Main 
Inclusion Criteria 
Primary osteoarthritis of the knee requiring a primary unilateral total knee 
arthroplasty (TKA) 
Number of Patients 
IDE Study Arm: The total sample size to be enrolled is 115 patients (103 
patients plus 10% for possible loss to follow-up).   
Continued Access Arm: Once the IDE enrollment is completed, up to 50 
patients will be enrolled in a separate arm of the study (Continued Access 
arm).  

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Outcome 
Measurements 
Primary Effectiveness Endpoint - The primary effectiveness endpoint is 
alignment of coronal mechanical axis at 3 months defined as achieving varus-
valgus alignment less than ±3° in the frontal plane after TKA. A review of 
1,376 patients undergoing conventional TKA with manual instrumentation 
showed a 32% malalignment for mechanical axis greater than 3° (Mason).   
This study is designed to demonstrate that the investigational device is 
capable of reducing the malalignment rate by 50%, that is, to 16%. 
Primary Safety Endpoint - The primary safety endpoint is a composite safety 
endpoint that includes a number of relevant adverse events identified in a 
literature search, each having an expected incidence ≤2.7%. The sum of 
these relatively rare complications is equal to 7.6%.  The percentage of 
patients with TCAT-assisted implantation using the TSolution One System for 
TKA experiencing the composite safety event will be compared to 7.6%. 
Secondary Safety Endpoints  
• 
Bleeding complications are not rare and will be assessed separately as a 
secondary safety endpoint based on the incidence of transfusions 
(allogeneic or autologous).  
• 
Complications related to excessive bleeding that require surgical 
intervention will be assessed and summarized as a subset of the bleeding 
complications above.  
• 
Other secondary safety endpoints include the incidence of the individual 
adverse events comprising the composite.  
Secondary Effectiveness Endpoints 
Effectiveness endpoints are considered secondary for this study and are 
summarized below: 
• 
Postoperative function will be evaluated by collecting Knee Society 
Scores at 3, 6, and 12 (if available) months. 
• 
Health related quality-of-life will be assessed by collecting Short Form 12 
(SF-12) Health Survey scores at 3, 6, and 12 (if available) months. 
• 
Post-operative alignment outcomes will be compared to pre-operative 
alignment goals at 3 months. 
Success/Failure Criteria 
The study success criterion is to simultaneously demonstrate that the 
malalignment rate is less than or equal to 0.16 (effectiveness endpoint) and 
that the composite safety event rate is less than 0.136 (safety endpoint) 
based on one-sided exact binomial tests with type 1 error rate equal to 0.05.  
A p-value ≤ 0.05 for both tests will indicate study success. 

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Hypotheses  
IDE Study Arm 
The primary effectiveness hypothesis for this study is that the probability 
of malalignment for patients undergoing TCAT-assisted implantation using 
the TSolution One System for TKA is 50% smaller than the reference rate of 
32%, that is, less than or equal to 16%.  
 
H0: πI ≥ 0.16 (50% of reference rate = 32%) 
HA: πI < 0.16 
In this formulation, πI is the true malalignment probability for the 
investigational device.  
A one-sided type 1 error of α=0.05 was assumed.  Using industry standard 
software (nQuery Advisor 7.0, Module POT0x-1), it was determined that 
statistical power to reject the null hypothesis in favor of the alternative 
hypothesis is equal to 89.3% with a sample size of N=103 patients if the true 
malalignment rate is 0.07. 
 
The primary safety hypothesis for this study is that the probability of 
experiencing the composite safety endpoint for patients undergoing TCAT-
assisted implantation using the TSolution One System for TKA is not 
clinically significantly elevated relative to the historic control value of 7.6% 
for manual TKA. Symbolically, the primary safety hypotheses regarding non-
inferiority relative to historical control may be represented as follows:   
  
H0: πI ≥ πC + δ (clinically inferior safety) 
HA: πI < πC + δ (not clinically inferior safety) 
In this formulation, πI and πC are the true event rates when using the 
investigational device and manual TKA, respectively. As noted above, based 
on a literature review, πc = 0.076.  A non-inferiority margin of 0.06 was 
selected.  Therefore, these hypotheses reduce to:  
H0: πcomposite  ≥  0.076 + 0.06 = 0.136  
HA: πcomposite <   0.076 + 0.06 = 0.136  
A one-sided type 1 error of α=0.05 was assumed.  Using industry standard 
software (nQuery Advisor 7.0, Module POT0x-1), it was determined that 
statistical power to reject the non-inferiority hypothesis was equal to 82.5% 
with a sample size of N=103 patients.  
Continued Access Study Arm 
There will be no formal hypothesis testing with the Continued Access Arm 
of the study. Patients will be followed for safety and to gain additional 
information on device use, therefore, no power analysis has been 
performed to estimate sample size. The Continued Access Arm will enroll up 
to 50 patients.  

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Statistical Methodology 
Demographic, baseline, peri-operative and postoperative characteristics for 
all recruited cases will be assessed from data which is collected on the 
relevant case report forms. Continuous variables included in demographic, 
baseline, peri-operative and postoperative summaries, will be evaluated 
using descriptive statistics (N, mean, median, standard deviation, minimum, 
and maximum). Dichotomous and polychotomous variables included in 
demographic, baseline, peri-operative and postoperative summaries, will be 
described as frequencies and percentages at each level of the categorical 
variable. 
The primary effectiveness and safety hypotheses will be tested using exact 
tests for a single proportion with one-sided type 1 error rate set to α=0.05.  
The study success criterion requires rejection of both the effectiveness and 
safety null hypotheses. 
The primary effectiveness endpoint, the safety endpoint and all secondary 
endpoints including bleeding and the individual components of the 
composite safety endpoint, will each be summarized by counts, percentages, 
and the upper bounds of one-sided 95% exact binomial confidence intervals 
(CI). Patient function and health related quality-of-life will be described by 
summarizing baseline, 3-month, 6 month, 12 month (if available) and change 
scores at each time point in the Knee Society Scores and SF-12 Health Survey 
Physical and Mental Health Composite Scores (PCS & MCS), using descriptive 
statistics including mean, standard deviation, median, minimum, and 
maximum. The ITT analysis set will be used in primary analyses.  Specific 
analyses may be repeated in a Per Protocol analysis set that requires 
completion of the index procedure and no clinically significant protocol 
violations. 
Continued Access Study Arm  
The continued access study arm will not include any hypothesis testing and 
will not be part of the primary or secondary endpoint analysis. Data from 
the continued access arm will be provided as descriptive statistics, which 
can include counts, percentages, mean, standard deviation, median, 
minimum, and maximum and the upper bounds of one-sided 95% exact 
binomial confidence intervals (CI). This will include an analysis of safety, 
patient function, and health related quality-of-life data described by 
summarizing baseline, 6 week, 3-month, 6 month, 12 month (if available) 
and change scores at each time point, as applicable. 

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Clinical Research 
Organization (CRO) 
Musculoskeletal Clinical Regulatory Advisers, LLC  
1050 K St NW, Suite 1000 
Washington, DC 20001 
 
Core Imaging Lab 
Medical Metrics, Inc. 
2121 Sage Road, Suite 300 
Houston, Texas 77056 
Phone: 713-850-7500, x202 
www.medicalmetrics.com 
 
 
 

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2. 
INTRODUCTION 
2.1. Background 
End-stage osteoarthritis of the knee is typically treated with total knee arthroplasty (TKA) in 
which the articulating surfaces of the distal femur and proximal tibia are replaced with prosthetic 
components.  It is very successful in terms of relieving patients’ pain and restoring joint function 
(1), (2), (3).  However, the mechanical alignment of the knee after TKA and the ability to balance 
soft tissue play a major role in the longevity and success of the implant (4), (5), (6).  It has been 
suggested that errors in surgical technique may be the most common reason for failure of TKAs 
(7), (1), (8).  Thus, one of a surgeon’s goals is to achieve accurate alignment of the tibial and 
femoral components in the frontal, sagittal, and transverse planes (9). 
Manufacturers have traditionally recommended positioning the knee implant such that the 
“ideal” mechanical axis of the knee is restored.  This mechanical axis is defined as a straight line 
passing through the center of the femoral head, the center of the knee joint, and the midpoint of 
the ankle (10), (11).   Implant manufacturers have developed complex instrumentation sets to 
help achieve this ideal implant placement.  However, every mechanical instrumentation system 
relies on visual inspection and the feel of a surgeon to confirm the accuracy of limb and implant 
alignment, and implant misalignment is still a problem.  Despite a surgeon’s best intentions, this 
results in anywhere from 15-72% of conventional TKA’s having an error in mechanical axis 
alignment of greater than 3° (12), (13).  A misalignment of greater than 3° varus-valgus has 
traditionally been considered the threshold past which implant longevity decreases.    Several 
studies have suggested that if the error in varus-valgus alignment exceeds 3° after TKA, the 
patients are more likely to experience increased pain, poor biomechanics, reduced function, and a 
decreased longevity of the implants (14), (10), (15), (5).  Jeffery et al. (10) has reported that the 
rate of loosening was 24% when mechanical axis alignment error exceeded 3° compared to only 
3% when mechanical axis alignment was less than 3°.  Loosening is the second leading cause for 
revision surgery with 24.1% of revisions being attributed to aseptic loosening (1).  Thus, achieving 
ideal implant alignment with minimal error is essential for long term surgical success. 
A variety of computer assisted navigation systems have been developed to improve alignment 
accuracy, and have resulted in a reduction in alignment errors (16), (17).  However, although 
these navigation systems are successful at aligning the cutting guides, there still exists an 
inaccuracy that results from the cutting blocks and oscillating jigs used to prepare the bone (18), 
(19). 
To address the issues with imprecise cutting, robotic systems were developed to combine the 
placement and alignment accuracy of navigation with the precision of computer controlled 
machining.  Several systems have been developed specifically to address the implementation of 
TKA by accurately executing the preoperative plan (20), (21), (22), (23).  The ROBODOC® Surgical 
System, an earlier, predicate of TSolution One that has been FDA-cleared for Total Hip 
Arthroplasty also has an application intended for assisted TKA.  This system has been approved in 

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Korea and other countries outside the US for this intended use has been shown to contribute to 
improved alignment, fewer outliers, and to allow accurate preoperative planning when compared 
to conventional TKA (24), (25), (26). 
2.2. Investigational Device 
The TSolution One Surgical System consists of a three-dimensional graphical preoperative planner 
and an implementation tool for treatment of patients who require a total knee arthroplasty 
procedure.  With application specific tools and software, it provides stereotactic guidance during 
orthopedic surgical procedures by using patient CT data to assist a surgeon with presurgical 
planning and bone preparation.  Surgical application specific modules such as total knee 
arthroplasty are added to the base operating platform. 
The TSolution One Surgical System platform includes: 
• 
TPLAN®: a Preoperative Planning Workstation 
• 
TCATTM: an electromechanical robotic arm with a display monitor, operating software, 
tools and accessories (e.g., cutters, drapes, irrigation sets, probes and markers) 
TPLAN 
 TPLAN is a PC-based workstation with proprietary software 
that enables the surgeon to select appropriate prosthetic 
implant(s) and preoperatively determine the optimal 
positioning in or on the patient’s bone.  Computed 
Tomography (CT) scan data of the patient’s bone/joint 
provides input to TPLAN.  The TPLAN software combines 
several individual scan slices to create patient specific 
three-dimensional images from the CT data. 
TPLAN allows the surgeon to select an implant model from a library of implant types and sizes.  
TPLAN displays three-dimensional (3D) views of selected implant models for computerized 
templating with the patient specific 3D images from the CT data.  The surgeon virtually places the 
implant in the desired position with respect to the patient image data.  In the case of a knee or 
hip arthroplasty, TPLAN also allows surgeons to preoperatively measure and determine plan 
characteristics such as Femoral and Tibial Mechanical Axis (FMA, TMA), implant size, shape, 
implant placement, and measure bone cuts for THA and or TKA.  The output from a TPLAN 
planning session provides TCAT with the planned implant type, size, shape, orientation and 
position (placement) data.  The output is saved onto data transfer media, which is loaded onto 
TCAT prior to surgery. 
 
 

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  TCAT 
TCAT is comprised of an electromechanical arm, 
computers and electronic controls within the base, a 
display monitor, and a surgeon’s pendant control.  The 
electromechanical arm has 5 degrees of freedom (5-DOF) 
and is mounted on top of a base which houses the 
computers and electronic controls and acts as an elevator 
for the arm.  The system is equipped with two bone 
motion monitors (BMMs), one on each side of the TCAT 
arm, and a digitizer.  The User Interface consists of a 
display monitor, a hand-held pendant for controlling the 
arm, operator controls (switches/buttons), and indicator 
lights.  Additional peripheral devices include a Force 
Sensor, Cutter Drive Assembly and Irrigation Pump.  The 
function of the TCAT is to precisely execute the 
preoperative plan developed by the surgeon using TPLAN. 
 
2.3. Investigational Procedure 
Preoperative CT for TCAT Planning 
A preoperative CT scan is required to create a 3D model of the patient’s anatomy in TPLAN for 
accurate implant planning, bone resection, and implant placement. A motion rod is scanned with 
the joint to ensure that the patient did not move during the CT scan. 
Preoperative Implant Planning Using TPLAN 
Using CT data as an input, the surgeon uses TPLAN to determine the implant sizing, bone 
resection, and implant placement.  TPLAN allows the surgeon to produce a 3D surface model of 
the bones from the CT data.  The surgeon can then select an implant model from the library of 
510(k) cleared joint replacement implants available in TPLAN and manipulate the 3D 
representations of the implant together with the bone to optimally place the implant within the 
bone.  Once the surgeon is satisfied with the implant size and location, the data is written to 
transfer media for use with the TCAT during surgery. The transfer media created by TPLAN 
contains the patient scan data, implant data, positioning information, and images to aid in 
registration point collection during the surgery.   
 
TCAT Setup & Start-Up Diagnostics 
Prior to each TCAT surgery, various startup diagnostics must be performed to ensure that the 
TCAT system is in proper working order.   

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• 
TCAT kinematics - The kinematic accuracy of the electromechanical arm is verified using a 
fixture with previously measured reference points upon which TCAT locates points and 
compares them with the measured values.  This test will verify that the electromechanical 
arm is positioning to specifications and has not been damaged. 
• 
Digitizer kinematics – the digitizer is used to locate the 3D locations of points within the 
workspace of the electromechanical arm.  The accuracy of the digitizer is verified prior to 
every procedure.  During diagnostics, the digitizer is tested against the same kinematic 
fixture in the arm verification above to ensure that the ability of the digitizer to locate 
specific known points on the fixture is within a specified tolerance. 
• 
Base lift accuracy – the accuracy of the base is verified by measuring the known location of 
a post on a standard kinematic fixture at two different base heights to ensure that the 
error between the two measurements is within a specified tolerance. 
• 
Tool calibration verification – Prior to making contact with a patient, the TCAT system is 
covered with a sterile drape to protect both the patient and system during bone 
preparation.  The system performs a test after sterile draping that verifies that the sterile 
tools have been correctly installed and calibrated.  
• 
Arm to digitizer registration verification – The accuracy of the transformation between the 
electromechanical arm and the digitizer is verified during sterile diagnostics to ensure that 
the error is within specification. 
• 
Digitizer calibration verification – The accuracy of the digitizer with a sterile tip is verified to 
be within the calibrated tolerances required to ensure that the digitized points collected 
are precisely identified to the best ability of this device. 
• 
Pendant operation - The monitor prompts the users to verify the proper functioning of 
each button upon installation of a new pendant.  After verification, the system may allow 
the procedure to continue. 
• 
Force sensor operation – The end-effector of the TCAT electromechanical arm is equipped 
with a six degree-of-freedom force sensor.  The accuracy of the force sensor is verified 
using a tool of known weight that is reoriented by TCAT while forces and torques are 
measured. 
• 
Redundant encoder operation – Each joint of the TCAT arm is equipped with dual positional 
encoders.  This redundant position monitoring system serves as a safety mechanism that 
can continuously monitors the commanded arm position.  During diagnostics, this system is 
tested to ensure its functionality and accuracy. 

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• 
Bone motion monitor operation – TCAT is equipped with two bone motion monitors 
(BMMs) that can detect when bones involved in the surgery move after being fixated.  The 
accuracy of the BMMs is verified by placing the BMM test probe in contact with the 
electromechanical arm ball probe, moving the probe through prescribed locations and 
comparing the BMM-determined distances to the electromechanical arm-computed 
distances. 
Start-up diagnostics must be performed prior to anesthetizing the patient. In the event that any of 
the diagnostics tests fails, TCAT notifies the surgeon and prevents the procedure from continuing.   
Surgical Exposure 
The surgeon proceeds with surgical exposure for the TCAT surgery in the same manner as a 
conventional TKA procedure.   
 
Fixation  
Although the TCAT system incorporates a BMM system to detect motion of the bone, proper 
fixation of the femur and tibia reduces this motion and keeps surgical time to a minimum.  The 
surgeon fixes the operative joint using a clamp on the femur and pin on the tibia to ensure that 
there is no motion during bone cutting.  Bone motion recovery markers are placed on the femur 
and tibia to recover the 3D location and orientation of each bone in the event of bone motion.  If 
bone motion occurs during registration or cutting, the BMMs will immediately pause the 
procedure and require that the bone be re-registered before the procedure can continue. 
 
Registration 
Registration serves as the link between the preoperative plan created in TPLAN and the bone 
cutting during surgery performed by TCAT.  Once the bone is registered in the coordinate system, 
TCAT can accurately machine the bone according to the predefined surgical plan. TCAT uses an 
accurate point-to-surface technique for registration. Once the joint has undergone fixation, the 
surgeon will use the digitizer to collect points on the bone with respect to the electromechanical 
arm coordinate system. The TCAT software will check to ensure that the registration of the bone is 
within specifications before allowing the surgeon to proceed.  
 
Bone Preparation 
The surgeon will ensure that the soft tissue is properly retracted and the electromechanical arm 
proceeds with cutting of the bone.  During cutting, the OR Display Monitor shows a continuously 
updated graphical representation of cutting progress superimposed on top of the CT data.   
Throughout this process, the surgeon remains in control of the process and can pause, stop, or 
abort the use of TCAT at any point if needed.   
 
 

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Implant Fitting & Insertion 
The OR Display Monitor prompts the surgeon to move TCAT away from the operating table once 
TCAT has finished preparing the bone.  The surgeon removes the recovery markers and fixation 
system and proceeds with implant fitting and insertion in the same manner as conventional TKA.   
 
Joint Closure 
Once the implant components are cemented (if applicable), the surgeon reviews the execution of 
the plan. If satisfactory, the exposed joint is closed per standard of care.  
3. 
RISK ANALYSIS  
The TCAT system, presented in this clinical protocol, is based on the ROBODOC® Surgical System. 
The ROBODOC® Surgical System was cleared under K072629 for use in total hip arthroplasty 
procedures. The ROBODOC System has had a total knee arthroplasty application that has been 
used extensively outside the U.S. The TSolution One® system incorporates the same operating 
principles and basic design as the ROBODOC® Surgical System but includes upgrades to the 
hardware and software. Thus, it shares, for the most part, similar risks and benefits in its 
technology and use. For total knee arthroplasty procedures, the ROBODOC® Surgical System has 
been used extensively in a clinical setting outside the US. 
 
3.1. Risks 
The possible adverse effects of the clinical study can be broken down into several groups: 
• General Surgical Risks 
• TKA Specific Risks 
• TSolution One® System Specific Risks 
 
General Surgical Risks 
TKA Specific Risks 
TSolution One® System 
Specific Risks 
• Infection 
• Seroma 
• Renal/Urinary 
• Arrhythmias 
• GI 
• Pulmonary Embolism 
• Rash 
• Hyponatremia 
• Deep vein thrombosis 
• Delayed Wound Healing 
• Reaction to wear debris 
• Allergy to implants 
• Loosening/Migration/Fracture of 
components 
• Breakage/Cracking/Fracture of 
implants 
• Pain;  
• Poor Range of Motion 
• Dislocation/Subluxation due to 
inadequate fixation, 
• Surgical Delay 
• Soft Tissue Damage 
• Electrical Shock 
• Overcutting of Bone 
• Bone Fracture 
• Additional Radiation 
Exposure 

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• General Cardiovascular 
Disorders 
• Temporary or permanent 
neuropathies 
malalignment, malposition, 
excessive use 
• Fretting and crevice corrosion  
• Valgus-varus deformity 
• Laxity of the joint  
• Leg length discrepancy 
• Fractures of the femur or tibia 
 
3.2. Methods to Minimize Risk 
The risks and adverse events associated with general surgery and knee arthroplasty are well 
understood. These risk are generally well mitigated through typical clinical practices. The risk 
associated with a TKA have also improved over time with advances in technology and surgical 
techniques.  
 
The risks from implantation using the TSolution One® System are described below. In addition to 
the risk mitigation described in the table, subject selection criteria, study methods, evaluations, 
follow-up periods, facilities and investigator selection are intended to minimize risk to subjects 
participating. In this study, subjects will be monitored throughout the study (Day 0 to a maximum 
of 12 months following the procedure) for the detection of adverse events. Finally, all subjects will 
be informed of the potential risks through a detailed informed consent.  
 
TSolution One® 
System Specific Risks 
 
Risk Mitigation 
Surgical Delay 
 
Navigation systems are known to have an increased operative time 
of anywhere from 10 to 20 minutes (27) (28)  but are not associated 
with an increased risk of infection. No studies have shown that an 
increase in time of only 20 to 30 minutes is associated with an 
increased risk of infection. The ROBODOC system has been shown to 
have an increased surgical time of approximately 25 minutes per 
case. As the TCAT system has similar workflow to the ROBODOC 
system, we expect that there may be an increase in time for these 
cases, but in all of the previous studies, this has not resulted in 
adverse patient risk.  

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TSolution One® 
System Specific Risks 
 
Risk Mitigation 
Soft Tissue Damage 
 
The risk of soft tissue damage is quite similar to a traditional TKA 
procedure. Labeling and training specifically focus on ensuring 
retraction of ligaments and soft tissue is adequate to provide clear 
access for the cutter. During cutting, the surgeon monitors the 
cutter and can determine if additional soft-tissue retractions is 
necessary. 
Electrical Shock 
 
The TSolution One® system was tested for electrical safety 
appropriate for an electromedical system and all tests past in 
accordance with IEC 60601-1: 2005 + CORR. 1 (2006) + CORR. 2 
(2007). 
Overcutting of Bone 
 
The TSolution One® system reduces the risk of overcutting when 
compared to a manual sawing technique. During manual sawing, the 
surgeon is placing the saw through a guide and has nothing to limit 
how far the cuts are made. TSolution One® is designed prepare the 
bone according to the specific implant that is selected. The cutter 
follows a predetermined cut path that only cuts according to the 
implant shape and preclinical testing (PV/TR 16-070) has verified 
that the system cuts within the specified tolerance. 
Bone Fracture 
 
Intraoperative bone fracture during TKA typically occurs during 
impaction of the implants. The TSolution One® procedure only 
assists with preparation of the bony surfaces and not during 
impaction. Impaction is handled in the same manner as a manual 
case. Postoperative fractures can occur at pin sites especially in the 
diaphysis. The TSolution One® system has minimized the risk of 
postoperative bone fracture by fixating the femur with a clamp that 
does not result in a hole in the bone and reducing the size of the pin 
required for tibial fixation to 3mm, which greatly reduces the risk of 
postoperative fracture, Furthermore, patients with poor bone 
quality are contraindicated as adequate bone quality is necessary to 
support fixation. 

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TSolution One® 
System Specific Risks 
 
Risk Mitigation 
Additional Radiation 
Exposure 
The TSolution One® System does require a preoperative CT scan 
upon which the surgical plan is based. This does expose the patient 
to additional radiation. However, these types of CT scans are 
common to other surgical robotic systems including the MAKO 
system (Stryker, Mahwah, NJ) and patient specific cutting guide 
systems (Trumatch, Depuy Synthes, Warsaw, IN). The potential 
benefits in terms of accuracy and precision can outweigh the risks 
associated with additional radiation. Without a preoperative CT, 
conventional alignment jigs and navigation systems rely on the 
surgeon’s ability to locate bony landmarks, which has been known to 
show large variability (8). 
 
3.3. Potential Benefits 
There are clear potential benefits to using the TSolution One® system for assistance during TKA. 
With current instrumentation, technical errors frequently occur in the implantation of TKA’s. 
These include errors in implant placement, sizing, alignment of the femoral and tibial implants, 
bone cutting, and issues with implant to bone fixation. The current system has the potential to 
minimize such errors. Based on preclinical testing and older versions of the system, the TSolution 
One® system excels in terms of both precision and accuracy when it comes to correctly placing 
the implant. The TSolution One® system improves the surgeon’s ability to align the knee through 
accurate preoperative planning. During surface registration of the bone in surgery, the surgeon is 
not asked to identify specific landmarks, but rather select a set of points which are collected in 
specified regions of the bony surface. The TSolution One® System makes cuts accurately in all 
planes. These accurate cuts result in an elimination of misaligned implants clinically as stated in 
the previous section. The method of fixing the implant to the bone is not affected by the 
TSolution One® system. Bone cement can still be used after the bone has been machined. In the 
case of cementless implants, because TSolution One® machines such precise cuts, the implants 
are likely to be more stable and achieve greater bone-implant fixation since there are minimal 
gaps at the interface.  
 
3.4. Justification of the Clinical Investigation 
Based on the potential benefits listed above, and the anticipated risks, Think Surgical believes this 
study is justified for the following reasons: 
• 
The TSolution One® System has undergone extensive non-clinical testing. 
o Software validation has shown the software to be reliable and safe for use.  

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o A Full System Run-Through demonstrates a functional process that can be performed by 
the surgeon.   
o Registration Accuracy demonstrates the accuracy of the system.  
o Registration Recovery Accuracy demonstrates the ability of the system to recover during 
the procedure.  
o Implant cutting testing show the ability of the system to make accurate cuts.  
o TKA Usability testing validate the ability of the system to be used in a simulated 
operation with real world user. 
o Electrical Safety Testing demonstrate testing and compliance with international 
standards.   
o Sterility and cleaning validation demonstrate the patient contacting instruments can be 
properly cleaned and sterilized according to a recommended protocol.  
o Biocompatibility evaluations show the materials to be safe for use.  
• 
The risks identified above have been minimized to the furthest extent possible, through pre-
clinical bench testing, training, and proper labeling. In addition, all patients will be informed of 
the potential risks during the informed consent.  
• 
The principles of operation are the same as the ROBODOC system which has been used 
successfully in a clinical setting outside the US for thousands of cases. 
• 
The clinical protocol is designed to yield valid scientific evidence to support a 510(k) 
submission.  
• 
Study subjects are selected according to specific inclusion/exclusion criteria and evaluated 
frequently. 
• 
Think Surgical will closely monitor the study, and adverse events will be recorded and 
reported promptly to Think Surgical. 
Therefore, given the information provided throughout this submission, Think Surgical has 
adequately evaluated the safety of the device and put into place adequate clinical controls to 
initiate the start of an IDE study. 
 
4. 
STUDY OBJECTIVES 
The goal of this prospective, non-randomized, multicenter clinical trial is to evaluate the safety 
and effectiveness of robotic-assisted total knee arthroplasty, and to document the clinical and 
radiographic outcomes for TCAT-assisted implantation using the TSolution One System for TKA, 
and to compare these outcomes to those reported in the literature.  
4.1. Primary Objectives  
The primary objective of this study is to demonstrate that the TSolution One System is safe and 
effective for use as an alternative to manual planning and sawing/cutting techniques. The primary 
effectiveness objective of this study is to demonstrate that the TSolution One System is effective 
for use as an alternative to conventional manual techniques by comparing the rate of 

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malalignment for mechanical axis greater than 3° at 3 months to the rate reported in the 
literature (i.e. 32%) and to demonstrate significant clinical benefit by reducing the number of 
malaligned patients by at least 50% (i.e. from 32% to ≤16%). The safety objective of this study will 
be based on the rate of intra-operative and postoperative TKA complications, and will compare 
this rate to the rate reported in the literature.  
4.2. Secondary Objective  
The secondary objective of this study is to summarize the distribution of improvements in 
patients’ self-reported assessment of postoperative function and quality-of-life from baseline to a 
maximum of 12 months. Additionally, other pre-operative planning alignment goals (e.g. Knee V-V 
Alignment; Femoral Joint Line Alignment Angle; Tibial Joint Line Alignment Angle; Tibial Slope 
Angle) will be compared to the post-operative alignment. 
5. 
STUDY DESIGN 
This clinical investigation will be conducted as a prospective, non-randomized, multicenter study. 
Investigators will recruit patients from patients in their practice who require unilateral total knee 
arthroplasty. Patients will be screened to identify eligible candidates based on the inclusion and 
exclusion criteria described in Sections 6.1 and 6.2.  A total of one hundred fifteen (115) patients 
will be enrolled in the study across the participating sites.  All patients will sign an informed 
consent form prior to participating in the study. Prior to the investigational procedure, they will 
complete baseline surveys of function and quality of life and have baseline radiographs. Each 
patient will undergo robotic-assisted total knee arthroplasty with the TSolution One System. The 
Investigator will evaluate intra- and postoperative complications. Postoperative radiographs will 
be used to measure limb alignment using a standardized radiographic evaluation protocol for the 
IDE Study Arm (Attachment K of the IDE application).  Each patient will complete a postoperative 
Knee Society Score survey and the SF-12 Health Survey to assess functional outcomes and quality-
of-life following the investigational procedure.  
The clinical study will have two arms: the IDE Study Arm, and the Continued Access Arm. Once 
enrollment is complete in the IDE Study Arm, subjects will be enrolled into the Continued Access 
Arm. Up to an additional 50 patients will be enrolled in this arm.  
The TSolution OneTM Total Knee Arthroplasty Clinical Trial will be conducted in compliance with 
this protocol, Good Clinical Practice (GCP) guidelines, and applicable US regulatory requirements. 
5.1. Primary Effectiveness Endpoint 
The primary effectiveness endpoint is alignment of coronal mechanical axis at 3 months defined as 
achieving varus-valgus alignment less than or equal to ±3°in the frontal plane after TKA compared 
to the pre-operative plan. A review of 1,376 patients undergoing conventional TKA with manual 
instrumentation showed a 32% malalignment for mechanical axis greater than 3° (Mason). This 

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study is designed to demonstrate that the investigational device is capable of reducing the 
malalignment rate by 50%, i.e. to 16%. 
 
Note: The primary effectiveness endpoint will be evaluated utilizing only the IDE Study Arm. 
 
5.2. Primary Safety Endpoint 
The primary endpoint is a composite endpoint that includes a number of relevant adverse events 
associated with manual TKA that were defined and published by the Knee Society (Healy et al. 
2011), each having an expected incidence ≤2.7% based on a literature search summarized in 
Table 1. The sum of these relatively rare complications is equal to 7.6%.  The percentage of 
patients with TCAT-assisted implantation experiencing the composite safety event will be 
compared to 7.6% plus a non-inferiority margin of 7.0%.   
Note: The primary safety endpoint will be evaluated utilizing only the IDE Study Arm. 
 
5.3. Secondary Endpoints 
Bleeding complications have an expected incidence of 36% for unilateral TKA (Bierbaum et al. 
1999), and are not rare. These will be assessed separately as a secondary safety endpoint at 
discharge based on the incidence of transfusions required (autologous or allogenic) as a result of 
bleeding.   
Descriptive safety analyses for the incidence of the individual adverse events comprising the 
composite will also be performed.  
The secondary endpoints also include a comparison of post-operative alignment outcomes other 
than coronal mechanical axis to the pre-operative alignment goals, and assessment of 
improvements in Knee Society Scores and SF-12 Health Survey scores. 

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  Table 1: Summary of Primary TKA Complications Assessed in the Primary Safety Endpoint 
Complications of Primary 
TKA (29) 
Knee Society Definition (29) 
Literature-Based Incidence 
Rate for Primary TKA 
Method for Assessing Complications  
1. Medial Collateral 
Ligament Injury 
Intraoperative or early 
postoperative medial collateral 
ligament injury requiring repair, 
reconstruction, a change in 
prosthetic constraint, revision 
surgery, or TKA protocol  
 
2.7% (30) 
Incidence of intraoperative or 
postoperative MCL transection or 
avulsion leading to repair, 
reconstruction, change in prosthetic 
constraint, or revision TKA. 
 
2. Extensor Mechanism 
Disruption 
Disruption of the extensor 
mechanism (surgical repair and/or 
extensor lag should be recorded) 
 
2.1% (31) 
Incidence of iatrogenic extensor 
mechanism disruption.  
 
3. Neural Deficit 
Postoperative neural deficit 
(sensory or motor) related to the 
index TKA  
 
1.3% (32) 
Incidence of sensory or motor neural 
deficit (complete or incomplete) related 
to the TKA procedure. 
 
4. Periprosthetic 
Fracture 
Periprosthetic fracture of the distal 
femur, proximal tibia or patella 
(operative or nonoperative 
treatment should be recorded)  
 
0.68% (32) 
Incidence of periprosthetic fracture of 
the distal femur, proximal tibia or 
patella.  
Operative and nonoperative treatment 
for the fracture will also be recorded.  
 
5. Patellofemoral 
Dislocation 
Dislocation of the patella from the 
femoral trochlea (direction of 
instability should be recorded)  
 
0.5% (33) 
Incidence of patella dislocation from the 
femoral trochlea due to postoperative 
instability.  
The direction of instability will also be 
recorded. 
 

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Complications of Primary 
TKA (29) 
Knee Society Definition (29) 
Literature-Based Incidence 
Rate for Primary TKA 
Method for Assessing Complications  
6. Tibiofemoral 
Dislocation 
Dislocation of the tibiofemoral joint 
(direction of instability should be 
recorded)  
 
0.2% (34) 
Incidence of iatrogenic tibiofemoral joint 
dislocation.  
The direction of instability will also be 
recorded. 
 
7. Vascular Injury 
Intraoperative vascular injury 
requiring surgical repair, bypass 
grafting, or stenting (compartment 
syndrome or amputation should be 
reported)  
 
0.15% (32) 
Incidence of iatrogenic vascular injury 
requiring surgical repair, bypass, 
grafting, or stenting.  
Incidents of compartment syndrome or 
amputation will also be recorded. 
 
 

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6. 
SELECTION OF STUDY POPULATION 
6.1. Inclusion Criteria 
In order to be eligible for the study, candidates must meet the following criteria: 
a) Is at least 21 years of age. 
b) Is skeletally mature, as evidenced by closed epiphyses.  
c) Is eligible for primary unilateral TKA due to osteoarthritis defined radiographically by 
a Kellgren-Lawrence Grade of 3 or higher. 
d) Is able to understand and willing to comply with the requirements of the study. 
e) Is able to give voluntary, written informed consent to participate and has signed an 
Informed Consent Form specific to this study. 
6.2. Exclusion Criteria 
Candidates will be excluded if they meet any of the following criteria: 
a) Has undergone previous open knee surgery in the operative knee. 
b) Has a body mass index (BMI) > 40 kg/m2. 
c) Is a candidate for bilateral TKA.*  
*In the opinion of the Investigator, simultaneous bilateral TKA or staged bilateral TKA 
(where the second surgical procedure is to be scheduled within 6 months of the first 
procedure) is determined to be either: (i) clinically necessary or (ii) advised as the 
treatment plan to address acute symptoms and/or quality of life.  
d) Has a coronal deformity greater than 20° or a sagittal flexion contracture greater than 
15°. 
e) Has an active systemic infection or an active local infection in or near the operative 
knee joint, or has a previous history of joint infection. 
f) Has a pathological skeletal condition or skeletal immaturity which would significantly 
compromise the ability of the bone to withstand the stress required for preparation 
of the bones and proper implantation of the prostheses (e.g., severe osteoporosis, 
Paget's disease, renal osteodystrophy, AVN, sickle cell disease, etc.). 
g) Has femoral or tibial bone stock that is of poor quality or inadequate to provide 
stability for femoral or tibial fixation. 
h) Has any type of metallic implant in the operative leg. 
i) 
Has a known or suspected sensitivity to any of the materials in the investigational 
device or implant components (i.e. cobalt, chromium, titanium, stainless steel, 
titanium nitride, aluminum, polyethylene, PVC plastic)  

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j) 
Has a systemic illness or a neuromuscular, neurosensory, or musculoskeletal 
deficiency that would render the patient unable to perform appropriate 
postoperative rehabilitation. 
k) Has a neuromuscular disorder that would create an unacceptable risk of prosthesis 
instability or fixation failure. 
l) 
Has significant comorbidities or conditions associated with high risk for surgical or 
anesthetic survival (e.g. peripheral vascular disease, unstable cardiac disease, poorly 
controlled diabetes, immunosuppression, etc.). 
m) Is pregnant or intends to become pregnant during the course of the study. 
n) Has previously experienced a stroke. 
o) Is participating concurrently in another clinical trial, or has participated in a clinical 
trial within the last 90 days, or intends to during the course of the study. 
p) Has a medical or psychiatric condition which, in the opinion of the investigator, poses 
a risk of the patient being unable to complete the study or presents risks associated 
with study participation. 
6.3. Screening 
The study population will be recruited from patients in the Investigators’ practice who need 
unilateral total knee arthroplasty.  Patients in this group will be screened for eligibility based on 
the inclusion and exclusion criteria described in Sections 6.1 and 6.2.  All patient eligibility 
assessments will be initiated after completing the informed consent process. The screening 
process may include but will not be limited to a review of the patient’s demographics, medical 
history, physical exam, standing long-leg AP x-rays, standard lateral x-rays, and current 
medications and therapies.  
 
6.4. Informed Consent  
Eligible patients will be recruited for the study by the Investigator and/or approved site staff. The 
Investigator or designee will provide eligible patients with a verbal overview of the study 
procedures and requirements, including all follow-up visit requirements. If the patient is willing to 
participate in the study, they will be asked to review the Informed Consent Form before they are 
officially enrolled in the study and asked to undergo any screening procedures or assessments. 
Each patient will be allowed sufficient time to decide whether they wish to participate in the 
study. If they agree to participate, they must sign and date the IRB-approved Informed Consent 
Form at or prior to the Baseline Visit. A copy of the signed Informed Consent Form will be given to 
the patient to take home for their records, and the original copy will be filed in the patient’s study 
records.   

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Patients will be informed that they may decide to withdraw consent and discontinue their 
participation in the study for any reason at any time without facing any impact to their regular 
course of treatment at the study center. 
 
6.5. Study Enrollment 
Each Investigator shall maintain a Screening & Enrollment Log for all primary TKA patients that are 
recruited for the clinical trial and screened for eligibility.  This log will be used to document all 
patients who agree to be screened, including the ones that withdraw consent during the 
screening process or are determined not to meet the eligibility criteria. If a patient is excluded 
from the study, the reason for exclusion will be recorded on the log.  Patients who meet the 
eligibility criteria and consent to participate shall be assigned a unique Subject Identification 
Number that will be captured on the Screening & Enrollment Log and used to identify them on all 
source documents and Case Report Forms thereafter.  Patients will be considered to be enrolled 
once they have signed the Informed Consent Form and been assigned a Subject Identification 
Number.  Enrolled patients that elect to withdraw consent prior to treatment with the 
investigational device will be considered screen failures under inclusion criteria (e). 
Patients who do not meet eligibility criteria will have the primary reason for ineligibility captured 
in the study database on the Eligibility Criteria eCRF. No other CRFs will be completed for these 
patients.  
Once enrollment is complete in the IDE Study Arm, subjects will be enrolled into the Continued 
Access Arm. 
7. 
STUDY PROCEDURES 
Unless otherwise noted, the procedures below apply to both the IDE Study and the Continued Access 
arms of the study. 
7.1. Baseline Visit (≤90 days prior to Date of Surgery) 
A preoperative baseline clinical visit will be performed within 90 days prior to the patient’s surgery, and 
will serve as a Standard of Care evaluation by the Investigator to confirm patient eligibility. Baseline Visit 
procedures may be completed in multiple clinic visits if required, but must be completed within 90 days 
prior to the date of surgery and the preoperative CT scan for surgical planning must be taken within 30 
days prior to the date of surgery. Visit procedures will be recorded in the subject’s study records and on 
the Baseline Visit eCRF.  
 
Informed Consent 
Prior to initiating any study-related procedures, the Investigator will ensure that the patient has signed a 
copy of the IRB-approved informed consent form.   
 
Clinical Evaluation  

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Patient eligibility will be confirmed by reviewing the patient’s demographics, medical history, physical 
exam, and current medications and therapies. 
 
Preoperative Radiographs 
Each patient must have preoperative standing long-leg AP x-rays and standard lateral x-rays of the 
investigational knee per the TSolution One IDE Study Radiographic Evaluation Protocol.   
 
Preoperative CT for TCAT Planning 
A preoperative CT scan will be taken of the investigational knee for preoperative planning in TPLAN per 
the TSolution One IDE Study Radiographic Evaluation Protocol. A motion rod will be scanned with the 
joint to ensure that the patient did not move during the CT scan.  If motion is detected during the scan, 
the scan will be repeated. This scan must be performed within 30 days prior to the date of surgery.  
 
Surveys 
The following surveys will also be completed at this visit to capture baseline data related to function and 
quality of life:  
o Knee Society Score (KSS) – completed by the Investigator and patient 
o SF-12 Health Survey – completed by the patient 
o Forgotten Joint Score (FJS) Survey – completed by the patient (Continued Access Arm only) 
 
Preoperative Implant Planning Using TPLAN 
Following the Baseline Visit, the Investigator (or designee) will upload the CT data in TPLAN to determine 
(i) the desired model and size for the femoral implant, model and size for the tibial base plate and initial 
trial thickness of the tibial liner insert, (ii) femoral and tibial resection plan, and (iii) implant positioning.  
The Investigator (or designee) will select an implant model from the library of implants available in 
TPLAN and will manipulate the 3D representations of the implant together with the bone to optimally 
place the implant within the bone.  Once the Investigator is satisfied with the implant size and location, 
the data will be written to a transfer media for use with the TCAT during surgery.  
 
7.2. Surgical Visit 
Surgical Visit procedures will be recorded in the subject’s study records and on the Operative Summary 
& Discharge eCRF. 
Preoperative Labwork 
Standard of care tests will be conducted to prepare the patient for surgery, including bloodwork to 
assess their preoperative hemoglobin and hematocrit levels. This labwork can be collected any time 
within 30 days prior to the day of surgery.  
 
TCAT Setup & Start-Up Diagnostics 
Non-sterile and sterile start-up diagnostics will be performed prior to anesthetizing the patient. The 
surgeon will also confirm that a full back-up of manual instruments is available in the OR. If any of the 
diagnostics tests fail, the Investigator will restart the TCAT diagnostics procedure.  
Anesthesia and Surgical Exposure 

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Once the diagnostic procedures have been successfully completed, the patient will be anesthetized. The 
Investigator will proceed with surgical exposure for the TCAT surgery in the same manner as a 
conventional TKA procedure.   
 
Fixation 
The Investigator will fix the operative joint to ensure that there is no motion during bone cutting.  Once 
fixation has been established, bone motion recovery markers will be placed on the femur and tibia.  If a 
bone motion occurs during registration or cutting, the procedure will be paused to allow the 
Investigator to re-register the bone before proceeding. 
 
Registration 
Once the joint has undergone fixation, the Investigator will use the digitizer to collect reference points 
on the bone as guided by the TCAT software to assure that the points being collected are properly 
located and will wait for the system to confirm that the registration of the bone is within specifications.  
If the registration meets the specifications, he/she will accept the registration and proceed to cutting. 
 
Bone Preparation 
The Investigator will ensure that the soft tissue is properly retracted and provide confirmation that the 
electromechanical arm may proceed with cutting the femur and tibia.  During cutting, the OR Display 
Monitor will show a continuously updated graphical representation of cutting progress superimposed on 
top of the CT data.  The Investigator will remain in control of the process and will pause, stop, or abort 
the use of TCAT at any point if needed.  If the patella is to be resurfaced, the Investigator will prepare 
the patella using conventional tools and techniques. 
 
Implant Fitting & Insertion 
Once TCAT has finished preparing the bone, the Investigator will move TCAT away from the operating 
table, remove the recovery markers and fixation system and proceed with implant fitting and insertion 
in the same manner as conventional TKA.  Once the Investigator is satisfied with the placement of the 
implants and stability of the knee, the implants are impacted or cemented as needed.  
 
Joint Closure 
Once the implant components are cemented (if applicable), the Investigator will review the execution of 
the plan. If satisfactory, the exposed joint will be closed per standard of care.  
Operative Summary  
During the immediate postoperative period, the Investigator’s standard postoperative care procedures 
should be followed. Once the investigational procedure and all post-operative care has been completed, 
the Investigator will document procedure details in the source documents, including but not limited to 
the following:  
• 
Surgery duration: measured via the surgery start time (start of anesthesia) and surgery stop 
time (dressing complete) 
• 
Skin-to-skin time: measured via the time of first incision and time of completion of closure  
• 
TCAT procedural time: measured via the time of insertion of bone motion recovery markers and 
time of removal of the TCAT system from the operating table  
• 
Use of tourniquet, and estimated time of use  

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• 
Use of cement, and specific components that were cemented, if applicable  
• 
Implant details (individual component size, manufacturer, model and implant lot number)  
• 
Use of anesthesia  
• 
Confirmation that the procedure was successfully archived within TCAT and on a transfer media 
after each procedure  
• 
Documentation of intra- and immediate post-operative complications, if applicable  
• 
Documentation of device malfunctions, if applicable  
• 
Documentation of any instances where the Investigator switched to manual instrumentation 
• 
Archival of the completed case data 
 
7.3. Hospital Discharge  
Following discharge, information regarding the patient’s hospital stay will be recorded in the subject’s 
study records and on the Operative Summary & Discharge eCRF.  
Safety Evaluation & Concomitant Medications/Therapies  
All postoperative complications and adverse events will be recorded and assessed as specified under 
Section 10.0 (Safety Reporting). Concomitant medications and therapies will also be documented during 
this visit. For the Continued Access Arm, any medications that are administered prophylactically for the 
surgical procedure (e.g., anesthesia, antibiotics, anti-emetics) are not required to be captured in the 
Concomitant Medication Log in the study database, with the exception of any medications that are 
administered post-operatively for pain management.  
 
Postoperative Labwork & Transfusion Summary 
Patients will undergo venipuncture to assess their postoperative hemoglobin and hematocrit levels 
within 3 days after the procedure. The use of autologous or allogeneic blood transfusions and the total 
number of units that were transfused will also be recorded.  
 
NOTE: Patients who are discharged on the date of surgery will have their hemoglobin and hematocrit 
levels measured and their transfusion summary documented prior to leaving the hospital.   
 
Additional Assessment 
When available the following data will be recorded for patients in the Continued Access Arm of the 
study: 
• 
Pain Scores on Days 0-3 Post-op  - measured with a Pain Numerical Rating Scale (NRS) 0 to 10  
• 
Range of Motion at Discharge for the operative knee 
 
7.4. 6 Week Follow Up Visit (± 2 weeks) 
A postoperative clinical visit will be scheduled 6 weeks after the surgery to allow the Investigator to 
assess the patient’s progress. Visit data will be recorded in the subject’s study records and on the 6 
Week Follow Up Visit eCRF. 
Surveys 
The following surveys will also be completed at this visit to capture postoperative data related to 
function and quality of life:  

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o Knee Society Score (KSS) – completed by the Investigator and patient 
o SF-12 Health Survey – completed by the patient 
o Forgotten Joint Score (FJS) Survey – completed by the patient (Continued Access Arm only) 
 
These surveys should be administered prior to any other study visit assessments or procedures being 
performed to prevent information from the examination biasing the patient’s responses.  
Radiographs 
Standard AP and lateral x-rays of the knee will be collected at this visit per the TSolution One IDE Study 
Radiographic Evaluation Protocol.  
 
Safety Evaluation & Concomitant Medications/Therapies  
All postoperative adverse events and complications will be recorded and assessed as specified under 
Section 10.0 (Safety Reporting). Concomitant medications and therapies will also be documented during 
this visit.  
 
 
7.5. 3 Month Follow Up Visit (± 2 weeks) 
A second postoperative clinical visit will be scheduled 3 months after the surgery to allow the 
Investigator to assess the patient’s progress. Visit data will be recorded in the subject’s study records 
and on the 3 Month Follow Up Visit eCRF. 
 
Surveys 
The following surveys will be completed at this visit to capture postoperative data related to function 
and quality of life:  
o Knee Society Score (KSS) – completed by the Investigator and patient 
o SF-12 Health Survey – completed by the patient 
o Forgotten Joint Score (FJS) Survey – completed by the patient (Continued Access Arm only) 
 
These surveys should be administered prior to any other study visit assessments or procedures being 
performed to prevent information from the examination biasing the patient’s responses.  
 
Radiographs 
Standing long-leg AP x-rays and standard lateral x-rays of the knee will be collected at this visit per the 
TSolution One IDE Study Radiographic Evaluation Protocol.  
 
CT Imaging  
Patients will have 3D CT images at this visit to collect supplemental outcomes regarding postoperative 
implant positioning. CT imaging will be collected per the TSolution One IDE Study Radiographic 
Evaluation Protocol. 
 
Safety Evaluation & Concomitant Medications/Therapies  
All postoperative complications and adverse events will be recorded and assessed as specified under 
Section 10.0 (Safety Reporting). Concomitant medications and therapies will also be documented during 
this visit.  
 

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7.6. 6 Month Follow Up Visit (± 2 weeks)  
A third postoperative clinical visit will be scheduled 6 months after the surgery to allow the Investigator 
to assess the patient’s progress. Visit data will be recorded in the subject’s study records and on the 6 
Month Follow Up Visit eCRF.  
 
Surveys 
The following surveys will be completed at this visit to capture postoperative data related to function 
and quality of life:  
o Knee Society Score (KSS) – completed by the Investigator and patient 
o SF-12 Health Survey – completed by the patient 
o Forgotten Joint Score (FJS) Survey – completed by the patient (Continued Access Arm only) 
 
These surveys should be administered prior to any other study visit assessments or procedures being 
performed to prevent information from the examination biasing the patient’s responses.  
 
Radiographs 
Standing long-leg AP and standard lateral x-rays of the knee will be collected at this visit per the 
TSolution One IDE Study Radiographic Evaluation Protocol.  
 
Safety Evaluation & Concomitant Medications/Therapies  
All postoperative complications and adverse events will be recorded and assessed as specified under 
Section 10.0 (Safety Reporting). Concomitant medications and therapies will also be documented during 
this visit.  
 
7.7. 12 Month Follow Up Visit (± 2 weeks)  
Subjects that remain enrolled at the 12 month study timepoint before the last patient completes their 6 
month visit will undergo a final postoperative clinical visit 12 months after the surgery to allow the 
Investigator to assess the patient’s progress. Visit data will be recorded in the subject’s study records 
and on the 12 Month Follow Up Visit eCRF.  
 
Surveys 
The following surveys will be completed at this visit to capture postoperative data related to function 
and quality of life:  
o Knee Society Score (KSS) – completed by the Investigator and patient 
o SF-12 Health Survey – completed by the patient 
o Forgotten Joint Score (FJS) Survey – completed by the patient (Continued Access Arm only) 
 
These surveys should be administered prior to any other study visit assessments or procedures being 
performed to prevent information from the examination biasing the patient’s responses.  
 
Radiographs 
Standard AP and lateral x-rays of the knee will be collected at this visit per the TSolution One IDE Study 
Radiographic Evaluation Protocol.  
 
Safety Evaluation & Concomitant Medications/Therapies  

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All postoperative complications and adverse events will be recorded and assessed as specified under 
Section 10.0 (Safety Reporting). Concomitant medications and therapies will also be documented during 
this visit.  
 
 
7.8. Unscheduled Visits  
Patients may be seen by the investigator or delegated staff for unscheduled postoperative visits as 
needed or SOC. These visits should be documented in the study records and the Unscheduled Visit eCRF. 
Any adverse events and concomitant medication changes that are reported at these unscheduled visits 
should be documented in the study records and entered on the Adverse Event and Medication Log 
eCRFs. Adverse event follow up should be completed as per Section 10.0 (Safety Reporting).   

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Table 2 – Schedule of Procedures (IDE Study Arm) 
 
 
 
 
Baseline 
Visita 
Surgical Visit  
Hospital 
Discharge 
6 Weeks 
 (± 2 weeks) 
3 Months  
(± 2 weeks) 
Primary 
Endpoint 
6 Months 
(± 2 weeks) 
12 Months  
(± 2 weeks) 
Informed Consent  
X 
 
 
 
 
 
 
Inclusion/Exclusion Criteria 
X 
 
 
 
 
 
 
Demographics 
X 
 
 
 
 
 
 
Medical History & Physical Exam 
X 
 
 
 
 
 
 
TPLAN Operative Planning  
X 
 
 
 
 
 
 
TCAT-Assisted TKA (Investigational Procedure) 
 
X 
 
 
 
 
 
Hemoglobin and Hematocrit Assessment  
 
Xb 
Xb 
 
 
 
 
Transfusion Summary 
 
 
Xb 
 
 
 
 
Standing long-leg X-rays  
XAP, WB 
 
 
 
XAP, WB 
XAP, WB 
 
Standard X-ray  
XL,NWB 
XAP/L, NWB* 
 
XAP,WB & L,NWB 
XL,NWB 
XL,NWB 
XAP,WB & L,NWB 
3D CT Imaging  
Xa 
 
 
 
X 
 
 
Knee Society Score (KSS) Survey 
X 
 
 
X 
X 
X 
X 
SF-12 Health Survey 
X 
 
 
X 
X 
X 
X 
Concomitant Medications/Therapies 
X 
X 
X 
X 
X 
X 
X 
Safety Evaluationc 
 
X 
X 
X 
X 
X 
X 
Study Completiond 
 
 
 
 
 
Xd 
Xd 
AP = Anteroposterior View, L = Lateral View, WB = weight bearing, NWB = non-weight bearing 
a. 
Baseline Visit procedures may be completed in >1 clinic visit if required, but must be completed within 90 days prior to the date of surgery. The preoperative CT scan for surgical 
planning must be taken within 30 days prior to the date of surgery. 
b. 
Patients will have their hemoglobin and hematocrit levels measured preoperatively no earlier than 30 days prior to the surgical procedure and postoperatively no more than 3 days 
after the procedure. Patients who are discharged on the date of surgery will have their postoperative hemoglobin and hematocrit levels measured and their transfusion summary 
documented on Day 0 prior to discharge.  
c. 
Patients with ongoing adverse events at their last study visit will be followed until the adverse event is resolved, no further improvement is expected, or the patient has completed 
study participation and is exited from the study 
d. 
Once the last patient of this study arm completes their 6M visit, the study arm will be terminated. Once this last patient is enrolled, all other active patients who are not expected to 
reach 12M prior to this patient’s 6M visit will be exited at their 6M visits.  
* Postoperative x-rays may be collected if required per standard of care but are not required for this investigation. 
 
 
 

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Table 3 – Schedule of Procedures (Continued Access Arm)  
 
 
Baseline 
Visita 
Surgical 
Visit  
Hospital 
Discharge 
6 Weeks 
 (± 2 weeks) 
3 Months  
(± 2 weeks) 
6 Months 
(± 2 weeks) 
12 Months  
(± 2 weeks) 
Unscheduled Visits 
Informed Consent  
X 
 
 
 
 
 
 
 
Inclusion/Exclusion Criteria 
X 
 
 
 
 
 
 
 
Demographics 
X 
 
 
 
 
 
 
 
Medical History & Physical Exam 
X 
 
 
 
 
 
 
 
TPLAN Operative Planning  
X 
 
 
 
 
 
 
 
TCAT-Assisted TKA (Investigational 
Procedure) 
 
X 
 
 
 
 
 
 
Hemoglobin and Hematocrit 
Assessment  
 
Xb 
Xb 
 
 
 
 
 
Transfusion Summary 
 
 
Xb 
 
 
 
 
 
Pain Score (NRS)c 
 
 
X 
 
 
 
 
 
Range of Motionc 
 
 
X 
 
 
 
 
 
Standing long-leg X-ray 
X 
 
 
 
X 
X 
 
 
Standard AP X-ray 
 
X d 
 
X 
 
 
X 
 
Standard Lateral X-ray  
X 
X d 
 
X 
X 
X 
X 
 
3D CT Imaging  
Xa 
 
 
 
X 
 
 
 
Knee Society Score (KSS) Survey 
X 
 
 
X 
X 
X 
X 
 
SF-12 Health Survey 
X 
 
 
X 
X 
X 
X 
 
Forgotten Joint Score (FJS) Survey  
X 
 
 
X 
X 
X 
X 
 
Concomitant Medications/Therapies 
X 
X 
X 
X 
X 
X 
X 
X 
Safety Evaluatione 
 
X 
X 
X 
X 
X 
X 
X 
Study Completionf 
 
 
 
 
 
X 
X 
 
KEY 
a. Baseline Visit procedures may be completed in >1 clinic visit if required, but must be completed within 90 days prior to the date of surgery. The preoperative CT scan for surgical 
planning must be taken within 30 days prior to the date of surgery. 
b. Patients will have their hemoglobin and hematocrit levels measured preoperatively no earlier than 30 days prior to the surgical procedure and postoperatively no more than 3 days 
after the procedure. Patients who are discharged on the date of surgery will have their postoperative hemoglobin and hematocrit levels measured and their transfusion summary 
documented on Day 0 prior to discharge.  
c. Pain Scores and range of motion data may not be available and are not required for this investigation.  
d. Postoperative x-rays may be collected if required per standard of care but are not required for this investigation. 
e. Patients with ongoing adverse events at their last study visit will be followed until the adverse event is resolved, no further improvement is expected, or the patient has completed 
study participation and is exited from the study.  
f. Once the last patient in the Continued Access study arm completes their 6M visit, the study arm will be terminated. Once this last patient is enrolled, all other active patients who are 
not expected to reach 12M prior to this patient’s 6M visit will start being exited at their 6M visits.  

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8. 
STUDY COMPLETION & EARLY DISCONTINUATION  
8.1. Criteria for Study Completion & Early Discontinuation  
For each study arm (IDE and Continued Access), patients are expected to remain in the study for 
6-12 months after undergoing the investigational procedure. Each study arm will be complete 
once the last enrolled patient in that arm of the study reaches 6 months. Patients who complete 
their 12 month follow up visit will be considered to have completed study participation and will 
have their study completion recorded on the End of Study eCRF.  Those patients not expected to 
reach their 12 month visit prior to study termination will be exited at 6 months and will have their 
study completion recorded on the End of Study eCRF.  
All patients with ongoing adverse events must be followed until the adverse event is resolved, no 
further improvement is expected, or the patient completes study participation and is exited from 
the study. The Investigator may discontinue a patient from the study in the event of: 
• 
Any medical event/condition that presents a health or safety risk and prevents the patient 
from continuing in the study  
• 
Patient’s failure to comply with protocol requirements 
• 
Patient withdrawing their consent  
• 
Administrative reasons (e.g. Sponsor’s decision to stop the study) 
 
8.2. Documentation of Early Discontinuation  
In every instance where a patient is treated with the investigational device and does not complete 
the study, the Investigator will document the primary reason for discontinuation in the patient’s 
records and on the End of Study eCRF.  
• 
All patients are free to withdraw from participation at any time, for any reason, specified 
or unspecified, and without prejudice.  However, if a patient expresses a desire to 
withdraw their consent for the study, the site should attempt to obtain written 
documentation for their study records.  
• 
For patients that are discontinued by the Investigator, the Investigator must notify them 
of their discontinuation from the study in writing.  
• 
For patients that are lost to follow up, the site staff should document a minimum of three 
attempts to contact them via phone and one attempt to reach them via certified mail to 
bring them in for a study visit prior to considering them lost to follow up.  
 
8.3. Use of Data from Early Discontinuation Cases 
Study data collected previously for patients who are discontinued from the study by the 
Investigator or lost to follow-up may still be included and used for the study unless the patient 
presents written notification of withdrawal of consent to the Investigator. In the event that a 

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patient withdraws consent to participate in the study, data previously collected for the patient 
may not be included or used for the study.  
8.4. Treatment for Early Discontinuation Cases 
Patients who withdraw voluntarily or are discontinued by the Investigator will remain eligible for 
Standard of Care treatment by the Investigator and study staff.  
8.5. Stopping Rules 
The Sponsor reserves the right to stop the study at any time in the event that there is a device-
related serious adverse event or unanticipated adverse device effect which the Sponsor believes 
signals a safety concern for study participants. The Sponsor also reserves the right to stop the 
study for non-safety related issues, including but not limited to usability failures.  
Refer to Section 10.7 (Study Termination) for additional details regarding study termination 
procedures for any event that leads the sponsor to believe the investigational device presents an 
unreasonable risk to study patients.  
9. 
STATISTICAL PLAN 
9.1. Determination of Sample Size for Safety Endpoint 
IDE Study Arm  
The primary safety hypothesis for this study is that the probability of experiencing the composite 
safety endpoint for patients undergoing TCAT-assisted implantation using the TSolution One 
System for TKA is not clinically significantly elevated relative to the historic control value of 7.6% 
for manual TKA. Symbolically, the primary safety hypotheses regarding non-inferiority relative to 
historical control may be represented as follows:   
  
H0: πI ≥ πC + δ (clinically inferior safety) 
HA: πI < πC + δ (not clinically inferior safety) 
In this formulation, πI and πC are the true event rates when using the investigational device and 
manual TKA, respectively. As noted above, based on a literature review, πc = 0.076.  A non-
inferiority margin of 0.06 was selected.  Therefore, these hypotheses reduce to:  
H0: πcomposite  ≥  0.076 + 0.06 = 0.136  
HA: πcomposite <   0.076 + 0.06 = 0.136  
A one-sided Fisher’s exact test will be used to test the primary safety hypothesis that the 
composite safety event rate is larger than historical control (0.076) plus the non-inferiority margin 
of δ=0.06.   That is, the null hypothesis is that the investigational device event rate is 0.136 or 
larger and the alternative hypothesis is that this event is less than 0.136.  Based on the Sponsor’s 
expectation that the technology is associated with improved outcomes, it was assumed for the 
purpose of sample size determination that that composite safety event rate for patients 
undergoing primary TKA with femoral and tibial preparation by the TSolution OneTM Surgical 
System is 20% smaller than control, or equal to 0.0608.  A one-sided type 1 error of α=0.05 was 

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assumed.  Using industry standard software (nQuery Advisor 7.0, Module POT0x-1), it was 
determined that statistical power to reject the non-inferiority hypothesis was equal to 82.5% with 
a sample size of N=103.   Because of the discreteness of the exact binomial distribution, the power 
curve is not monotonic.  Power for sample sizes of N=102, 103, 104, 105, 106, 107, 108, 109, 110, 
111, 112, 113, 114, 115, 116, 117, 118, 119, 120, 121 and 122 are 71.9%, 82.5%, 81.8%, 81.1%, 
80.3%, 79.6%, 78.9%, 78.1%, 77.3%, 76.6%, 75.8%, 84.9%, 84.3%, 83.7%, 83.1%, 82.5%, 81.8%, 
81.1%, 80.5%, 79.8%, and 87.6%.  The smallest sample size with power ≥80% is 103. For sample 
sizes of N=103 and above, power never falls below 75.8%. The minimum sample size for which 
power remains at least equal to 80% at that value for all larger values is N=113. 
The total sample size to be enrolled is equal to 115 (103 plus 10% for possible loss-to-follow-
up).  
It can be noted that with N=103, the number (%) of patients experiencing the primary composite 
safety event must be no larger than 8 (7.8%) in order to achieve the primary study success 
criterion.  With 8 of 103 patients experiencing the event, the upper bound of the one-sided 95% 
exact binomial confidence interval will be 0.1358 which is less than 0.136, thereby permitting 
rejection of the inferiority hypothesis and a conclusion of no clinically significant increase in the 
incidence of the composite safety endpoint.  
Continued Access Arm 
There will be no formal hypothesis testing for the Continued Access Arm of the study. Patients will 
be followed for safety and to gain additional information on device use, therefore, no power 
analysis has been performed to estimate sample size. The Continued Access Arm will enroll up to 
50 patients. 
9.2. Determination of Sample Size for Effectiveness  Endpoint 
IDE Study Arm  
A review of 1,376 patients undergoing conventional TKA showed a 32% malalignment for 
mechanical axis greater than 3° (13). This proportion will be used as the comparative constant 
proportion for 3-month follow-up for conventional TKA in this study.   
The primary effectiveness hypothesis for this study is that the probability of malalignment for 
patients undergoing TCAT-assisted implantation using the TSolution One System for TKA is 50% 
smaller than the reference rate of 32%, that is, 16%.  
  
H0: πI ≥ 0.16 (50% of reference rate = 32%) 
HA: πI < 0.16 
In this formulation, πI is the true malalignment probability for the investigational device.  
A one-sided type 1 error of α=0.05 was assumed.  Using industry standard software (nQuery 
Advisor 7.0, Module POT0x-1), it was determined that statistical power to reject the null 
hypothesis in favor of the alternative hypothesis is equal to 89.3% with a sample size of N=103 

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40 
patients if the true malalignment rate is 0.07.  The power for this test remains above 80% as long 
as the sample size is 95 patients or larger.   
 
Continued Access Arm 
There will be no formal hypothesis testing with the Continued Access Arm of the study. Patients will 
mainly be followed for safety and to gain additional information on device use, therefore, no power 
analysis has been performed to estimate sample size. The Continued Access Arm will enroll up to 
50 patients. 
9.3. Analysis Plan 
Demographic, baseline, peri-operative and postoperative characteristics for all recruited cases 
(both study arms) will be assessed from data which is collected on the relevant case report forms. 
Continuous variables included in demographic, baseline, peri-operative and postoperative 
summaries, will be evaluated using descriptive statistics (N, mean, median, standard deviation, 
minimum, and maximum). Dichotomous and polychotomous variables included in demographic, 
baseline, peri-operative and postoperative summaries, will be described as frequencies and 
percentages at each level of the categorical variable.     
 
IDE Study Arm  
The primary effectiveness endpoint, the safety endpoint and all secondary endpoints including 
bleeding and the individual components of the composite safety endpoint, will each be 
summarized by counts, percentages, and the upper bounds of one-sided 95% exact binomial 
confidence intervals (CI).  
Patient function and health-related quality-of-life will be similarly addressed by summarizing 
baseline, 6-week, 3-month, 6-month, and 12-month (if available) reported outcomes and change 
at each time point in the Knee Society Scores and SF-12 Health Survey Physical and Mental Health 
Composite Scores (PCS & MCS), using descriptive statistics including mean, standard deviation, 
median, minimum, and maximum. The ITT analysis set will be used in all safety analysis.   Specific 
analyses may be repeated in a Per Protocol analysis set that requires completion of the index 
procedure and no clinically significant protocol violations.   
Intraoperative and immediate postoperative complication rates will be similarly summarized using 
descriptive statistics.  
In addition to the above analyses, key safety and effectiveness results will be stratified by certain 
baseline characteristics (investigational site, age, gender, and median value of Knee Society Score) 
to confirm that the safety and efficacy of the TSolution OneTM Surgical System is consistent among 
different subgroups. 
Continued Access Study Arm  
The continued access study arm will not include any hypothesis testing and will not be part of the 
primary or secondary endpoint analysis. Data from the continued access arm will be provided as 

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descriptive statistics, which can include counts, percentages, mean, standard deviation, median, 
minimum, and maximum and the upper bounds of one-sided 95% exact binomial confidence 
intervals (CI). This analysis will included safety, patient function, and health related quality-of-life 
described by summarizing baseline, 6 week, 3-month, 6-month, and 12-month (if available) scores, 
and change in scores from baseline at each time point, as applicable. 
 
10. 
SAFETY REPORTING 
10.1. Definitions 
Adverse Event – An adverse event (AE) is any untoward medical occurrence, disease, injury, or 
untoward clinical signs (including abnormal laboratory findings, surgical complications, etc.), 
whether related or unrelated to the investigational device or its use.  
Adverse Device Effect – This is an adverse event related to the use of an investigational device. 
Serious Adverse Event – A Serious Adverse Event (SAE) is an adverse event which: 
1. Led to a death, 
2. Resulted in life threatening illness or injury* 
3. Resulted in patient hospitalization or prolongation of existing hospitalization, 
4. Resulted in patient disability or permanent damage or required intervention to prevent 
permanent impairment/damage 
5. Led to a congenital abnormality or birth defect 
* NOTE: the term “life-threatening” refers to an event in which the patient was at a risk of death 
at the time of the event; it does not refer to an event which hypothetically might have caused 
death if it were more severe. 
Unanticipated Adverse Device Effect (UADE) – An Unanticipated Adverse Device Effect is: 
1. Any serious adverse effect on health or safety or any life threatening problem or death 
caused by, or associated with, a device, if that effect, problem, or death is not identified in 
nature, severity, or degree of incidence in this protocol; or  
2. Any other unanticipated serious problem associated with a device that relates to the rights, 
safety, or welfare of the patients. 
10.2. Adverse Event Documentation  
Adverse event collection will begin from the time of first incision.  All medical events and conditions 
prior to this time point are to be captured as medical history.  
Observed and reported adverse events shall be recorded in the patient’s study records and on the 
Adverse Event eCRF within 72 hours of the site becoming aware of each event, and must include the 
following information at minimum:  

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• 
Event Description 
• 
Date of Onset  
• 
Date of Resolution 
• 
Severity 
• 
Seriousness  
• 
Relationship to Study Device/Procedure  
• 
Outcome 
 
Significant new information and updates should continue to be captured in the patient’s records and on 
the Adverse Event eCRF as they become available and the adverse event should be followed until it is 
resolved, no further improvement is expected, or the patient completes study participation and is exited 
from the study. 
10.3. Assessment of Severity 
Investigators will assess the severity of the adverse event and classify it according to the following 
definitions. 
• 
Mild: Event/symptom is transient and well tolerated by the patient. 
• 
Moderate: Event/symptom causes discomfort and interferes with routine activities of the 
patient. 
• 
Severe: Event/symptom interferes considerably with the routine activities of the patient or 
causes inability to work. 
 
10.4. Assessment of Relationship to Use of the Investigational Device 
Investigators will assess the potential relationship of the adverse event to the use of the investigational 
device and classify the causality of the event according to the following definitions. 
• 
Definitely Related:  An adverse event that has a strong causal relationship.  An adverse event 
that follows a strong temporal relationship to the use of the investigational device, follows a 
known response pattern, and cannot reasonably be explained by known characteristics of the 
patient’s clinical state or other therapies. 
• 
Probably Related: An adverse event that potentially has a causal relationship.  The adverse 
event has a reasonable temporal relationship to the use of the investigational device and 
alternative etiology is less likely compared to the potential relationship to the use of the 
investigational device. 
• 
Possibly Related: An adverse event that potentially has a causal relationship.  The adverse event 
has a reasonable temporal relationship to the use of the investigational device but alternative 

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etiology is equally likely compared to the potential relationship to the use of the investigational 
device.  
• 
Not Related: An adverse event without any apparent causal relationship.  The adverse event is 
due to the underlying disease state or is due to concomitant medication or therapy not related 
to the use of the investigational device. 
• 
Unknown Relationship: If the adverse event cannot be determined to have a causal 
relationship, it will be classified as unknown. 
 
10.5. Serious Adverse Event Reporting  
Adverse events shall be recorded in the patient’s study records and in the EDC on the Adverse 
Event eCRF within 72 hours of the site becoming aware of the event. The study database will be 
configured to notify the Sponsor of all adverse events that are indicated to be ‘serious’. Serious 
Adverse Events (SAEs) will trigger the database to send an email notification to the Sponsor using 
the contact information provided below. 
Sponsor Contact: Valentina Campanelli  
E-mail: vcampanelli@thinksurgical.com  
 
 
The Investigator should provide additional information on the SAE by updating the information on 
the Adverse Event eCRF as updates become available. The Sponsor may also ask for additional 
clinical reports including redacted source documents to be provided by the Investigator to assist 
in the assessment of the event.  Significant new information and updates should continue to be 
submitted promptly to the Sponsor and entered on the Adverse Event eCRF as they become 
available, and the Investigator should follow the SAE until it is resolved or no further 
improvement is expected. 
The Sponsor shall ensure that the Investigator submits safety event notifications to the governing 
Investigational Review Board (IRB) within the timeframe specified by the IRB, when applicable.  
Acceptable means of confirming that the IRB requirements have been met include forwarding a 
copy of the written, signed report that was sent to the IRB to the Sponsor.  Copies of this report 
should be filed in the Investigator’s site files and the Sponsor’s clinical investigation files. 
10.6. Determination and Reporting of Unanticipated Adverse Device Effects  
The Sponsor shall review all reported SAEs to evaluate whether they meet the criteria for an 
Unanticipated Adverse Device Effect. For adverse events that are determined to be UADEs, the 
Sponsor will submit an expedited safety report to the FDA’s Center for Devices and Radiological 
Health (CDRH).  The expedited safety report will consist of a completed Form FDA 3500A and a 
cover letter analyzing the significance of the event. The expedited safety report will be submitted 

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44 
to the FDA as soon as possible and, in no event, later than 10 working days after the Sponsor first 
receives notice of the UADE. A copy of this safety report will be provided to all participating study 
investigators.   
If, following receipt and investigation of follow-up information regarding an adverse event that 
was previously determined not to be a UADE, the Sponsor determines that the event does meet 
the requirements for expedited reporting, the Sponsor will submit a completed Form FDA 3500A 
and cover letter as soon as possible, but in no event later than 10 working days after this is 
determined. 
10.7. Study Termination for Safety Concerns  
The Sponsor, in consultation with the Investigators, shall determine if any reported event 
presents an unreasonable risk to study patients.  If an event is determined to pose an 
unreasonable risk, the Sponsor shall develop procedures to terminate the study within 5 working 
days. 
10.8. Treatment of Adverse Events  
Adverse events that occur during the study shall be handled by established standards of care to 
protect the health and safety of the patient.  Necessary care shall be provided by the Investigator 
or designee. All patients with ongoing adverse events must be followed until the adverse event is 
resolved, no further improvement is expected, or the patient completes their study participation 
and is exited from the study. 
 
 

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45 
11. 
PROTOCOL DEVIATIONS  
All protocol deviations (i.e. any change, divergence or departure from the procedures specified in 
this protocol, including procedures described in the appendices) must be documented with an 
explanation for the deviation on the Protocol Deviation eCRF.   
 
Minor Deviations: A minor deviation does not impact the subjects’ rights, safety, or well-being, or 
the completeness, accuracy or reliability of the study data.  Minor deviations shall be documented 
in the study database along with a full description of the event and outcome.  The Sponsor will 
analyze these deviations and assess their significance.  Minor deviations should be reported to the 
reviewing IRB if required by the IRB’s deviation reporting guidelines. 
 
Major deviations: A major deviation is a deviation from the protocol that impacts the subjects’ 
rights, safety, or well-being, or the completeness, accuracy or reliability of the study data, or a 
deviation from FDA regulations or IRB guidelines. Major deviations should be reported to the 
Sponsor within 24 hours of site awareness of the event and must be documented in the study 
database along with a full description of the event and outcome. The Sponsor will analyze these 
deviations and assess their significance. Major deviations should be reported to the reviewing IRB 
per the IRB’s deviation reporting guidelines. 
 
12. 
DEVICE LABELING 
In accordance with federal regulations set forth in 21 CFR 812.5, the TSolution OneTM Surgical 
System and User Manual will be labeled with the following statement: 
‘CAUTION – Investigational Device.  Limited by Federal (or United States) law to investigational 
use.’ 
13. 
ETHICAL REVIEW, REGULATORY CONSIDERATIONS, AND CONFIDENTIALITY 
13.1. Ethical Review 
Prior to the start of the study the Investigator will provide the Sponsor or its designee with 
documentation that the IRB has reviewed and approved the protocol and the Informed Consent 
Form. Additional documentation may be submitted pending applicable local requirements. Each 
Investigator must provide at least the following documentation: 
• 
IRB approval of the protocol 
• 
IRB approval of the Informed Consent Form 
• 
IRB annual renewed approval of the protocol 
• 
The IRB approval of any revisions to the Informed Consent Form or amendments to the 
protocol 
 
13.2. Regulatory Considerations 

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This study will be conducted in accordance with the Good Clinical Practice (GCP) guidelines and 
other applicable regulatory requirements including but not limited to: 
• 
Food and Drug Administration (FDA) Regulations on Investigational Device 
Exemption (21 CFR 812) 
• 
FDA Regulations on research with human beings (21 CFR 50, 54 and 56) 
• 
Health and Human Services (DHHS) Regulations on research with human beings 
• 
(45 CFR 46 Subparts A, B, C, and D)  
• 
International Conference on Harmonization (ICH) Guidance for Industry-E6 Good Clinical 
Practice: Consolidated Guideline 
• 
International Organization for Standards (ISO 14155-1 and 2) 
 
The Investigator will ensure that this study is conducted in full conformity with the 1989 or 1996 
revisions of the Declaration of Helsinki. 
 
13.3. Confidentiality 
All data and records generated during this study will be kept confidential in accordance with the 
Privacy Rule (45 CFR Parts 160 and 164) of the Health Insurance Portability and Accountability Act 
of 1996 (HIPAA). In order to maintain subject confidentiality, Subjects will be identified by a site 
number, subject number and subject initials on CRFs and other documentation submitted to the 
Sponsor or designee.  All attempts will be taken to maintain subject confidentiality.  However, the 
following individuals or organizations may require access to protected health information in order 
to monitor and analyze the trial: 
• 
THINK Surgical and designees 
• 
Institutional Review Board 
• 
Office of Human Research Protections (OHRP) or the Food and Drug Administration (FDA)  
• 
Contract Research Organization responsible monitoring the clinical trial 
 
14. 
DATA HANDLING & RECORD KEEPING 
14.1. Data Management 
 
Source documents and electronic Case Report Forms (eCRFs) will be completed in a 21 CFR Part 
11 compliant electronic data capture (EDC) system for each patient enrolled into the clinical 
study.  The Study Coordinator will review and sign off on completed eCRFs to attest that all data 
entered on the eCRFs are complete and accurate after the monitor finishes the source document 
verification process.  The Investigator will sign off on the Eligibility Criteria, all Adverse Event, and 
Protocol Deviation and Study Completion eCRFs and will sign each patient’s casebook once the 
patient completes the study to attest that all data entered on the eCRFs are complete and 
accurate.  All of the above signatures will be completed digitally within the EDC system using the 
system’s Part 11 compliant digital signature system function. 

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Any required data clarifications will be handled within the EDC system’s query management 
system.  The EDC will be programmed to automatically place data clarification queries on missing 
values and values out of acceptable ranges.  Study monitors and data managers will also be able 
to add data clarification queries to data points within the system.  Study coordinators will have 
the opportunity to correct data and/or respond to the query for review by monitors and data 
managers. 
14.2. Record Keeping 
The Investigator and Sponsor will maintain records in accordance with 21 CFR 812, Subpart G, to 
include: 
• 
Current and past versions of the IRB-approved clinical protocol and corresponding IRB-
approved consent form(s) and, if applicable, patient recruitment advertisements 
• 
FDA correspondence related to the IDE application; including supplemental IDE 
applications, current investigator lists, progress reports 
• 
IRB correspondence (including approval notifications)including safety and protocol 
deviation reports, and annual or interim reports 
• 
Signed Investigator Agreements and financial disclosure forms for participating 
investigators 
• 
Curriculum vitae (Investigator and Sub-Investigators) 
• 
Certificates of required training for Investigators and Sub-Investigators, including human 
subject protection and Good Clinical Practice 
• 
Instructions for handling the investigational device and other study-related materials  
• 
Signed informed consent forms 
• 
Source Documents  
• 
Monitoring visit reports 
• 
Copies of relevant Sponsor-Investigator correspondence, including notifications of adverse 
event information 
• 
Screening and Enrollment Log 
• 
Final clinical study report 
15. 
RADIOGRAPHIC ENDPOINT ASSESSMENT 
Radiographic assessment of the efficacy endpoints (i.e. coronal alignment relative to the 
mechanical axis, and post-operative alignment outcomes) will be performed by protocol-trained 
radiologists at an independent core imaging lab per the TSolution One IDE Radiographic 
Evaluation Protocol.  
Medical Metrics, Inc. 
2121 Sage Road, Suite 300 
Houston, Texas 77056 
Phone: 713-850-7500, x202 

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www.medicalmetrics.com 
 
This analysis will only be performed for the IDE Study Arm. The Continued Access Arm will 
continue to collect imaging to monitor safety by the Investigator. Images will be transferred and 
stored with Medical Metrics, Inc., but no formal analysis will be performed for this arm. 
 
16. 
STUDY MONITORING 
Study monitoring functions will be performed by an independent clinical research organization 
(CRO) in compliance with recognized Good Clinical Practices, FDA's IDE guidance documents, and 
federal regulations outlined in 21 CFR 812.43(d) and 21 CFR 812.46.   
 
Musculoskeletal Clinical Regulatory Advisers, LLC (MCRA) 
1050 K St NW, Suite 1000 
Washington, DC 20001 
 
In addition to ensuring adequate communication between the Investigators and the Sponsor, the 
CRO’s duties include on-site visits and review of study documents and reported data.  The CRO 
study representatives will be provided with appropriate device training prior to the study and will 
follow a Monitoring Plan for all study-related monitoring activities. 
 
16.1. Monitoring Activities 
On-site monitoring visits include a pre-study Site Initiation Visit, periodic Interim Monitoring Visits, 
and a Close-Out Visit at the end of the site’s participation in the study.   
Each site’s Investigator will allocate adequate time for monitoring activities.  The Investigator will 
also ensure that the monitor or other compliance or quality assurance reviewer is given access to 
the study-related documents and study related facilities, and has adequate space to conduct the 
monitoring visit. 
Monitoring visits will be documented on monitoring visit reports, and will aim to verify that:  
• 
Compliance with the clinical protocol and applicable regulations is being maintained 
• 
Only authorized individuals are participating in the study 
• 
The investigational device is being used according to the protocol and instructions for use 
• 
Adequacy of staffing and facilities 
• 
Adequate access to eligible patients 
• 
Signed and dated informed consent forms have been obtained from each patient 
• 
eCRFs and queries are complete 
• 
Source data is verified and signed-off upon as accurate 
• 
Patient files are accurate and complete 
• 
All adverse events are reported to the Sponsor 

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• 
All serious and unanticipated adverse device events are reported to the Sponsor and the IRB/EC 
• 
All other required reports, notifications, applications, submissions, and correspondence are 
maintained in the Investigator’s files and are accurate 
• 
Maintenance and calibration of equipment relevant to clinical assessments is appropriately 
performed and documented 
• 
Laboratory certifications/validations are current 
• 
Patient withdrawal has been documented (if applicable) 
• 
Patient non-compliance has been documented (if applicable) 
• 
The Investigator and site staff are informed and knowledgeable of all relevant document 
updates concerning the clinical investigation 
• 
Corrective and preventive actions have been implemented (if applicable) 
 
16.2. Frequency of Visits 
To ensure that the study is conducted in accordance with the terms of the clinical protocol, study 
monitors must visit each study site at routine intervals throughout the duration of the study.  The 
exact frequency of visits shall be determined on an individual site basis as detailed in the 
Monitoring Plan, and shall depend upon the following factors:  
• 
Rate of patient enrollment 
• 
Experience of the Investigator in conducting clinical studies 
• 
Record of previous site compliance 
 
17. 
AUDITS AND INSPECTIONS 
Participation as an investigator in this study implies acceptance of potential inspection by 
government regulatory authorities. The Investigator must also be prepared to permit study-
related audits and inspections by the Sponsor, CRO, IRB/EC and the site’s institutional compliance 
and quality assurance groups. The Investigator will ensure the capability for inspections of 
applicable study-related facilities, records and reports. 
 
18. 
RECORD RETENTION  
The sponsor-investigator will retain the specified records and reports for up to two years after the 
marketing application is approved for the investigational device; or, if a marketing application is 
not submitted or approved for the investigational device, until two years after investigations 
under the IDE have been discontinued and the FDA so notified.  
 
19. 
PUBLICATION PLAN 
Any Investigator involved with this study is obligated to provide the Sponsor with complete test 
results and all data derived from the study.  Investigators are not permitted to publish or share 
the results or any part of the results of this study, nor any of the information provided by the 

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Sponsor for the purposes of performing the study, to any third party without the consent of 
THINK Surgical, Inc.   
The study will be registered on Clinicaltrials.gov in compliance with 42 CFR Part 11. Results of the 
study, including an unanticipated early termination of the trial, will be posted to the 
Clinicaltrials.gov database at the conclusion of the study. In the event that the study is terminated 
early, the posting of these results will be completed within 30 days of completion of data analysis. 
 
20. 
REFERENCES 
1. Sharkey PF, Hozack WJ, Rothman RH, et al: Why are total knee arthroplasties failing today? Clin 
Orthop Rel Res 404:7-13, 2002.  
2. Emmerson KP, Moran CG, Pinder IM: Survivorship analysis of the kinematic stabilizer total knee 
replacement: A 10- to 14-year follow-up. J Bone Joint Surg Br 78:441-445, 1996.  
3. McCalden RW, Robert CE, Howard JL, et al: Comparison of outcomes and survivorship between 
patients of different age groups following TKA, J Arthroplasty 28(Suppl 1):83-86, 2013.  
4. Griffin FM, Insall JN, Scuderi GR, Accuracy of soft tissue balancing in total knee arthroplasty. Journal of 
Arthroplasty, 15: 970-973, 2000.  
5. Ritter MA, Faris PM, Keating EM, Meding JB, Postoperative alignment of total knee replacement. Its 
effect on survival. Clinical Orthopaedics and Related Research, 299: 153-156, 1994.  
6. Takahashi T, Wada Y, Yamamoto H, Soft-tissue balancing with pressure distribution during total knee 
arthroplasty. Journal of Bone and Joint Surgery British, 79B: 235-239, 1997.  
7. Stulberg SD: How accurate is current TKR instrumentation? Clin Orthop Rel Res 416:177-184, 2003.  
8. Siston RA, Giori NJ, Goodman SG, Delp SL: Surgical navigation for total knee arthroplasty: A 
perspective. J Biomech 40:728-735, 2007.  
9. Dorr LD, Boiardo RA, Technical considerations in total knee arthroplasty. Clinical Orthopaedics and 
Related Research, 205: 5-11, 1986.  
10. Jeffery RS, Morris RW, Denham RA, Coronal alignment after total knee replacement. Journal of Bone 
& Joint Surgery British, 73: 709-714, 1991.  
11. Petersen TL, Engh GA, Radiographic assessment of knee alignment after total knee arthroplasty, The 
Journal of Arthroplasty, 3(1): 67-72, 1998.  
12. 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. J Bone Joint Surg Am 
92:2143-2149, 2010.  

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and the recipient by accepting this material agrees that it will not be used other than for the express purpose for which it was delivered.  
Disclosure to others without written permission from THINK Surgical, Inc. is forbidden. 
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Proprietary rights of THINK Surgical, Inc. are involved in the subject matter of this material.  It is submitted in confidence for a specific purpose 
and the recipient by accepting this material agrees that it will not be used other than for the express purpose for which it was delivered.  
Disclosure to others without written permission from THINK Surgical, Inc. is forbidden. 
53 
 
 
 
 
 
 
APPENDIX: Patient Survey Instruments 
 
Knee Society Score (KSS) Survey 
SF-12 Patient Satisfaction Survey 
Forgotten Joint Score