A Post-Market Clinical Evaluation of the ReUnion TSA System
Conditions: Shoulder Arthroplasty
Sponsor: Stryker Trauma and Extremities

ReUnion TSA CIP – Version 1 
1 
CLINICAL INVESTIGATION PLAN 
CLINICAL INVESTIGATION 
TITLE: 
A Post-Market Clinical Evaluation of the ReUnion TSA 
System 
MEDICAL DEVICE: 
ReUnion TSA System 
STUDY DESIGN: 
Post-Market, Multicenter, Prospective, Non-Randomized 
INDICATIONS: 
This study will adhere to the indications and contraindications 
for the ReUnion TSA System as are detailed in the device’s 
Instructions for Use. 
REGULATORY STATUS 
510(k) Clearance received on 05May2011 
CLINICAL INVESTIGATION 
PLAN PHASE: 
Post-Approval Clinical Investigation 
SPONSOR: 
Stryker Orthopaedics 
325 Corporate Drive 
Mahwah, NJ 07430 
AUTHOR: 
Lindsay Mattfolk 
INVESTIGATORS: 
Investigators’ information is on file at the Sponsor 
MEDICAL EXPERT: 
Dr. Helmut Mueckter, M.D. 
COMPLIANCE STATEMENT: 
This clinical investigation will be conducted in compliance 
with the clinical investigation plan / protocol, International 
Conference of Harmonisation Good Clinical Practice (ICH- 
GCP), and all other applicable regulatory requirements, 
including the retention of essential documents. Investigators 
will be trained on the clinical investigation devices and surgical 
techniques prior to implanting clinical investigation subjects. 
CONFIDENTIALITY 
STATEMENT: 
This clinical investigation plan / protocol contains confidential 
information and its’ use is limited to investigational staff 
intending to conduct the clinical investigation, Institutional 
Review Boards (IRBs) and any others charged with reviewing 
the clinical investigation. 
VERSION: 
1 
DATE: 
12Oct2018 
NCT03858517

ReUnion TSA CIP – Version 1 
 
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Approval Page 
 
 
 
 
 
 
 
 
55 AM PDT
 
 
 
 
 
 
8:59 AM PD 
 
 
 
 
 
 
57 AM PDT
 
 
 
 
 
 
 
:50 AM PD
APPROVERS 
Role 
Name 
Signature 
Date 
Medical Expert 
Dr. Helmut Mueckter, MD 
15-Okt-2018 | 8
Clinical Research 
Head (CRH) 
Georgia Mitchell 
15-Oct-2018 | 
Regulatory Affairs 
(RA) 
Jemin Dedania 
16-Oct-2018 | 6
Statistician 
Claudia Beimel 
16-Oct-2018 | 1

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Table of Contents 
1. 
LIST OF ABBREVIATIONS 
4 
2. 
SYNOPSIS 
4 
3. 
GENERAL INFORMATION AND ADMINISTRATIVE STRUCTURE 
6 
4. 
PRODUCT INFORMATION 
6 
5. 
RISKS AND BENEFITS 
6 
6. 
INTRODUCTION 
7 
7. 
CLINICAL INVESTIGATION DESIGN 
7 
8. 
OBJECTIVE 
7 
9. 
SELECTION OF CLINICAL INVESTIGATION POPULATION 
7 
10. CLINICAL INVESTIGATION EVALUATIONS, PROCEDURES AND ASSESSMENTS 
9 
11. STATISTICAL METHODS 
10 
12. CLINICAL INVESTIGATION PLAN DEVIATIONS 
17 
13. ADVERSE EVENTS 
17 
14. REOPERATIONS 
19 
15. ETHICS 
19 
16. DATA COLLECTION PROCESS 
19 
17. CLINICAL INVESTIGATION MONITORING 
20 
18. DATA HANDLING AND RECORD KEEPING 
20 
19. REPORTS 
20 
20. COMPLETION OF THE CLINICAL INVESTIGATION 
20 
21. ESSENTIAL DOCUMENTS 
20 
22. PUBLICATION POLICY 
21 
23. REFERENCES 
21 
24. CLINICAL INVESTIGATION PLAN SIGNATURE PAGE 
22 
25. DOCUMENT VERSION HISTORY 
23 
 

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1. List of Abbreviations 
Acronym 
Definition 
ADE 
Adverse Device Event 
AE 
Adverse Event 
ASES 
American Shoulder and Elbow Surgeons 
CI 
Confidence Interval 
CIP 
Clinical Investigation Plan 
CRF 
Case Report Form 
eCRF 
Electronic Case Report Form 
EDC 
Electronic Data Capture 
HA 
Hemi-Shoulder Arthroplasty 
ICF 
Informed Consent Form 
IFU 
Instructions for Use 
IRB 
Institutional Review Board 
ITT 
Intent-to-Treat 
LTFU 
Lost to Follow-Up 
PP 
Per Protocol 
RSA 
Reverse Shoulder Arthroplasty 
SADE 
Serious Adverse Device Effect 
SAE 
Serious Adverse Event 
SAP 
Statistical Analysis Plan 
TSA 
Total Shoulder Arthroplasty 
UADE 
Unanticipated Adverse Device Effect 
 
2. Synopsis 
 
Title 
A Post-Market Clinical Evaluation of the ReUnion Total Shoulder Arthroplasty 
(TSA) System 
Treatment 
ReUnion TSA System 
Design 
• 
Post-Market 
• 
Multicenter 
• 
Prospective 
• 
Non-Randomized 
Objectives 
The objective of this clinical investigation is to demonstrate the safety and 
efficacy/performance of the ReUnion TSA System. 
Efficacy/performance of the procedure will be measured the American Shoulder 
and Elbow Surgeons (ASES) Shoulder Score. 
Safety of the ReUnion TSA System will be demonstrated through reporting of 
device-related intra-operative and post-operative Adverse Events (AEs). 
Target Population 
100 subjects are to be enrolled in this clinical investigation. Enrolled subjects will 
be assessed at Pre-Operative, Operative/Discharge, and at 6 Weeks, 6 Months, 12 

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Months, 24 Months and annually thereafter up to 10 years following the index 
procedure. 
Endpoints 
Primary Endpoint: 
The 
objective 
of 
the 
clinical 
investigation 
is 
to 
demonstrate 
the 
efficacy/performance of the device at 24 months, as measured by the ASES 
Shoulder Score. 
Secondary Endpoints: 
• 
Safety: Incidence of device-related intra-operative and post-operative 
AEs 
• 
Efficacy/Performance: Implant survivorship will be monitored 
Inclusion Criteria: 
a. 
Subject is willing to sign the informed consent. 
b. 
Subject is willing and able to comply with post-operative scheduled 
clinical assessments. 
c. 
Subject is male or non-pregnant female and 18 years or older at the time 
of surgery. 
d. 
Subject has one or more of the following: 
• 
Aseptic necrosis of the humeral head 
• 
Painful, disabling joint disease of the shoulder resulting from 
degenerative arthritis, rheumatoid arthritis or post-traumatic 
arthritis 
• 
Failed previous total shoulder replacement, resurfacing or other 
procedure 
Exclusion Criteria: 
a. 
Subject has an active or suspected latent infection in or about the shoulder 
joint. 
b. 
Subject has mental or neuromuscular disorder which would create an 
unacceptable risk of prosthesis instability, prosthesis fixation failure or 
complications in postoperative care. 
c. 
Subject has bone stock compromised by disease, infection or prior 
implantation which cannot provide adequate support and/or fixation to the 
prosthesis. 
d. 
Subject has anticipated activities which would impose high stresses on the 
prosthesis and its fixation. 
e. 
Subject is obese such that he/she produces a load on the prosthesis which 
can lead to failure of fixation of the device or to failure of the device itself. 
f. 
Subject has absent, irreparable or non-functioning rotator cuff and other 
essential muscles. 
g. 
Subject has concomitant disease(s) which may significantly affect the 
clinical outcome. 
h. 
Subject has traumatic or pathologic fracture of the proximal humerus. 

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3. General Information and Administrative Structure 
3.1. 
SPONSOR 
Stryker Orthopaedics 
325 Corporate Drive 
Mahwah, NJ 07430 
3.2. 
KEY SPONSOR PERSONNEL 
Lindsay Mattfolk 
Clinical Study Manager 
Role: Clinical Investigation Manager 
Email: Lindsay.mattfolk@stryker.com 
Phone: +1 617 417 2956 
Hanna Schlyter 
Senior Director Clinical Affairs Trauma & Extremities 
Role: Clinical Research Head 
Dr. Helmut Mueckter, M.D. 
Role: Medical Expert 
3.3. 
EDC SYSTEM 
Name: IBM Clinical Development 
Email: icdhelp@us.ibm.com 
Phone: +1 888 500 4247 
 
4. Product Information 
All components of the ReUnion TSA System have been cleared and approved for sale and use in the 
United States prior to starting the clinical investigation. 510(k) Clearance was received on 05May2011. 
This system is to be used only for indications for which it has been approved. Please see the approved 
Instructions for Use (IFU) and Operative Technique manuals for a detailed description of the medical 
device(s) and instrumentation as well as the intended use information. 
Medical device product traceability will be achieved by capturing the implant lot number. 
 
5. Risks and Benefits 
This prospective, multicenter clinical investigation is designed to examine the safety and performance of 
the ReUnion TSA System in accordance with the approved IFU, labelling and instrumentation. The 
potential risks to subjects are described in the approved IFU and Operative Technique manuals. 
Potential benefits resulting for the ReUnion TSA System over other devices and procedures as 
demonstrated by superior scoring on the outcome survey and positive results on other clinical evaluation 
measurements would suggest affirmative clinical efficacy. 

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6. Introduction 
The ReUnion TSA System is designed as an anatomical total shoulder or hemi-shoulder endoprosthesis 
to address advanced arthritic disorders affecting the shoulder joint in subjects having intact or repairable 
rotator cuff function. The ReUnion TSA System consists of a completely modular shoulder platform 
including a Humeral Stem, Humeral Head and Glenoid. The intended purposes of the ReUnion TSA 
System are to achieve pain relief, improvement of range of motion and restoration or improvement of the 
shoulder function while ensuring long-term replacement of the shoulder joint with sufficient stability of 
all endoprosthesis components. 
 
7. Clinical Investigation Design 
This investigation is a prospective, multicenter clinical investigation. It is anticipated that a total of one 
hundred (100) subjects will be enrolled at approximately 4-7 sites. Neither subjects nor investigators are 
blinded to treatment and the clinical investigation does not include a contemporaneous control. The 
clinical investigation has been designed to follow the surgeon’s standard of care for joint arthroplasty 
subjects, which entails clinical evaluation on a regular ongoing basis, or as needed should the subject 
become symptomatic in the treated joint. The enrollment period is expected to occur over 14 months. 
 
8. Objective 
8.1. 
PRIMARY ENDPOINT 
The primary endpoint of the clinical investigation is to demonstrate non-inferiority of the device to the 
selected literature controls, as measured by the ASES Shoulder Score at 24 Months post-operative. 
8.2. 
SECONDARY ENDPOINT 
In addition to the principal endpoint, information on the following outcomes will be assessed up to 10 
years after the index procedure: 
Safety: Incidence of device-related intra-operative and post-operative AEs 
Efficacy: Implant survivorship 
 
9. Selection of Clinical Investigation Population 
Subjects participating in this clinical investigation will be recruited from the investigator’s standard 
subject population, where all subjects presenting for primary or revision total shoulder replacement will 
be evaluated for clinical investigation participation based on the eligibility criteria listed below. 
9.1. 
INCLUSION CRITERIA 
a. Subject is willing to sign the informed consent. 
b. Subject is willing and able to comply with postoperative scheduled clinical and radiographic 
evaluations. 
c. Subject is male or non-pregnant female and 18 years or older at the time of surgery. 
d. Subject has one or more of the following: 
• 
Aseptic necrosis of the humeral head 

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• 
Painful, disabling joint disease of the shoulder resulting from degenerative arthritis, 
rheumatoid arthritis or post-traumatic arthritis 
• 
Failed previous total shoulder replacement, resurfacing or other procedure 
9.2. 
EXCLUSION CRITERIA 
a. Subject has an active or suspected latent infection in or about the shoulder joint. 
b. Subject has mental or neuromuscular disorder which would create an unacceptable risk of 
prosthesis instability, prosthesis fixation failure or complications in postoperative care. 
c. Subject has bone stock compromised by disease, infection or prior implantation which cannot 
provide adequate support and/or fixation to the prosthesis. 
d. Subject has anticipated activities which would impose high stresses on the prosthesis and its 
fixation. 
e. Subject is obese such that he/she produces a load on the prosthesis which can lead to failure of 
fixation of the device or to failure of the device itself. 
f. Subject has absent, irreparable or non-functioning rotator cuff and other essential muscles. 
g. Subject has concomitant disease(s) which may significantly affect the clinical outcome. 
h. Subject has traumatic or pathologic fracture of the proximal humerus. 
9.3. 
WITHDRAWAL CRITERIA 
If during the clinical investigation a subject must be withdrawn prematurely, then the procedures outlined 
in this section must be followed. These procedures should not interfere with the initiation of any new 
treatments that are necessary to treat a subject’s condition. Information on all withdrawn subjects will be 
documented. 
Subjects may be withdrawn from the clinical investigation for any of the following reasons: 
i. 
Subject Withdrawal: A subject may voluntarily withdraw from the clinical investigation 
at any time and for any reason. The subject should be asked when possible, and without 
any form of coercion, the reason for his/her decision. If the participant withdraws from 
the clinical investigation completely, then data collected up until the point of 
withdrawal will be included in the final analysis. 
ii. 
Lost to Follow-Up (LTFU): A subject will be considered LTFU after all reasonable 
efforts have been made to contact the subject and request his/her continued participation 
in the clinical investigation. All attempts to contact the subject must be documented and 
should include at least two attempts to contact the subject by phone and one attempt via 
a certified letter. Data collected up until the point where the subject is LTFU will be 
included in the final analysis. 
iii. 
Removal of Device or AE/Incident: The discontinuation of a subject’s participation in 
the clinical investigation due to the removal of the ReUnion TSA System or 
AE/incident that prohibits his/her continued participation must be fully explained. All 
available information concerning the removal of the device or AE/incident should be 
provided. Data collected up until the point of removal or AE/incident will be included 
in the final analysis. 
iv. 
Death: The discontinuation of a subject’s participation in the clinical investigation due 
to death must be fully explained. All available information concerning the death or AE 
should be provided. Removal of a subject from continued follow-up in the clinical 
investigation due to death will not be considered a device failure unless the death is 

ReUnion TSA CIP – Version 1 
 
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directly caused by, or attributable to, the ReUnion TSA System. Data collected up until 
the point of death will be included in the final analysis. 
v. 
Other: A subject may be withdrawn by the investigator if he/she believes it is in the best 
interest of the subject, or if it is determined by the IRB that a subject’s continued 
participation in the clinical investigation represents an unacceptable risk to the subject. 
The Sponsor must be notified immediately if this occurs. All data collected up until the 
point of withdrawal or IRB determination will be included in the final analysis. 
A subject may also be withdrawn if the subject is non-compliant with the clinical 
investigation procedures or visits, or if a selection criteria violation is noted after the 
subject received the clinical investigation treatment and it is determined that the subject 
should be discontinued. All data collected up until the point of withdrawal will be 
included in the final analysis. 
 
10. Clinical Investigation Evaluations, Procedures and Assessments 
10.1. METHOD OF ASSIGNING SUBJECTS 
No specific methods (e.g. randomization, blinding, or stratification) for assigning subjects are used in 
this clinical investigation plan (CIP). Consecutive subjects at each site meeting all eligibility criteria will 
be enrolled in this clinical investigation. 
10.2. PROCEDURES 
Subjects in the clinical investigation will undergo placement of the ReUnion TSA System. Please see the 
approved IFU and Operative Technique manuals for a detailed description of the medical device(s) and 
instrumentation, intended use information and associated risk. Any additional clinically indicated 
procedures are permitted as deemed necessary by the clinical investigation investigator. 
10.3. FOLLOW-UP EVALUATIONS 
Subjects in this clinical investigation will be evaluated at Pre-Operative, Operative/Discharge, and at 6 
Weeks (4 weeks – 8 weeks), 6 Months (24 weeks – 28 weeks), 12 Months (48 weeks- 56 weeks), 24 
Months (100 weeks – 108 weeks) and annually after the index procedure. The follow-up evaluations will 
include assessment of device-related AEs/incidents, radiographs and ASES Shoulder Score. 
Investigative site personnel will contact subjects prior to their scheduled follow-up evaluations to 
encourage compliance with clinical investigation visits and participation. 
If a subject misses a visit and is outside of the visit window, then every effort should be made to collect 
data instead of noting the visit as missed. 
10.4. SCHEDULE OF EVENTS 
 
Assessment 
Pre-Operative 
Operative/ 
Discharge 
6 Weeks a, b 
(+/- 2 weeks) 
6 Months a, b 
(+/- 3 weeks) 
12 Months a, b 
(+/- 4 weeks) 
24 Months a, b 
(+/- 4 weeks) 
Annually b 
Informed Consent 
X 
Demographics & Medical 
History 
X 

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Inclusion/Exclusion 
X 
Physical Exam 
X 
Xc 
Xc 
Xc 
Xc 
Xc 
Surgical Procedure 
X 
ASES Shoulder Score 
X 
Xd 
Xd 
X d 
X d 
X d 
Image Evaluation e, f 
X 
X 
X 
X 
X 
X 
X 
Subject Disposition g 
X 
X 
X 
X 
X 
Device-Related AEs/Incidents & Reoperations will be collected throughout the course of the 
clinical investigation. 
a. 
Follow-up visit schedule to reflect Institutions’ Standard of Care practices 
b. If the subject misses a visit and is outside of the visit window, then every effort should be 
made to collect data instead of noting visit as missed. 
c. 
Evaluation may be collected when subject presents in-clinic for study visit. 
d. Evaluation can be collected via phone. 
e. 
Radiograph collection should follow Institution’s Standard of Care practices and no 
additional x-rays should be made for study purposes. 
f. 
CT scans may be collected if part of Institution’s Standard of Care practices. 
g. Subject Disposition assessment will occur at any time point for subject withdrawal prior to 
the completion of the clinical investigation. 
Table 1: Schedule of Events 
 
11. Statistical Methods 
The 24 months post-operative results for subjects implanted with the ReUnion TSA System will be 
compared to a historical group and results reported by respective clinical outcome data in the scientific 
literature. The benchmark sources and values will serve as the control group for the ReUnion TSA 
System subjects. 
Hypotheses are developed to allow for a comparison of 24 months post-operative ASES Shoulder Score 
results and 24 months effectiveness/performance between these two populations. 
The Statistical Analysis Plan (SAP) lists all variables/questions within this clinical investigation. 
Therefore, no additional “evaluation” chapter is required nor needed for this CIP. 
Data will be captured via IBM Clinical Development electronic data capture (EDC) system and statistical 
analysis will be performed using IBM SPSS. All statistical hypotheses tests will be with confidence levels 
(1-α) of 95% and power (1-β) of 80%. The significance level (α) is 0.05 and the beta-value (β) is set to 
0.20. Therefore, p-values ≤ 0.05 will indicate statistical significance. 
Results will be presented using summary tables and optionally supported by graphs. For detailed 
information per variable, see SAP. 
The primary endpoint of the clinical investigation is to demonstrate non-inferiority of the device to the 
selected literature controls, as measured by the ASES Shoulder Score at 24 Months post-operative. 
Specifically, the proposed study will test the null hypothesis that the population mean is 82.16 points. 
The criterion for significance (alpha) is set at 0.05. With the sample size of 10 cases, the clinical 
investigation will have power of 80.3% to yield a statistically significant result. This computation 
assumes that the population from which the sample will be drawn has a mean of 82.16 points with a 
standard deviation of 16.76 points. The observed value will be tested against a theoretical value (lower 
limit -θ) of 65.40 points. To account for an estimated appropriate overall drop-out rate, Stryker intends 
to enroll the calculated number of subjects, multiplied by the number of cleared indications (5) to reflect 
the underlying subject population adequately. 
11.1. DETERMINATION OF SAMPLE SIZE 

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For details of the sample size determination, see Table 2. 
 
Benchmark and Objectives for Clinical Investigation 
Endpoint 
Non-inferiority (equal or better) of the ASES Score in relationship to the 
officially cleared indications in comparison to respective clinical outcome 
data in the scientific literature. 
Estimated drop-out rate 
56% (confirmed by Medical Expert, see Cuff et al. [1]) 
Benchmark Sources & Values ASES [points] 
Source 
n 
Mean 
Std. 
Dev. 
Comments 
No. 
No. 
Title 
1 
Irlenbusch et al. [2] 
73 
77.9 
N/A 
Conflict related to Follow-Up times 
in abstract vs method vs result 
section. 
2 
Flurin et al. [3] 
73 
90.3 
14.6 
Not clear if SD or 95% CI 
3 
Press et al. [4] 
34 
82.6 
19.4 
4 
Hsu et al. [5] 
25 
94.4 
N/A 
5 
Kiet et al. [6] 
40 
80 
21 
N changed from 45 to 40 
6 
Steen et al. [7] 
96 
80.4 
22.4 
Not clear if SD or 95% CI 
7 
Gulotta et al. [8] 
40 
80.1 
10.1 
8 
Petri et al. [9] 
43 
83.5 
13.1 
9 
Schoch et al. [10] 
78 
88.4 
16.7 
10 
Alentorn-Geli et al. [11] 
38 
64 
N/A 
TSA und HA combined. 
Identified Cleared Indications 
No. 
Indication 
1 
Post-traumatic arthritis 
2 
Degenerative arthritis 
3 
Rheumatoid arthritis 
4 
Revision of previous unsuccessful total shoulder replacement, resurfacing or other procedure 
5 
Aseptic necrosis 
Explorative Meta-Analysis - ASES (single group) 
Acceptance Criteria 
Confidence Interval (CI) 
0.95 (95%) two-sided 
Software Used 
IBM SPSS V20 
 

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Red line: Pooled mean ASES 
Blue lines: 95% CI of pooled mean 
ASES 
Black line: Pooled median pooled 
ASES 
Box: Interquartile Range 
Green Line: Pooled mean ASES 
minus pooled std. dev. ASES 
(16.76) 
82.16 – 16.76 = 65.40 points 
Acceptance Criteria for Sample Size Calculation 
Significance Level (α) 
0.05 (5%) 
Power (1-β) 
0.80 (80%) 
Confidence Interval (CI) 
0.95 (95%) 
Tails 
2 
Path 
Non-inferiority – ReUnion TSA (A) ≥ Benchmark (B, 
explorative meta-analysis in this document) 
Hypotheses Pair 
Null (H0) 
A – B < -θ 
Alternative (H1) 
A – B ≥ -θ 
Benchmark Timepoint 
24 months post-operative 
Benchmark n (sources) 
10 
Benchmark Mean 
82.16 (pooled mean ASES [points]) 
Benchmark Std. Dev. 
16.76 (pooled std. dev. ASES [points]) 
Benchmark Value 
Non-Inferiority Margin (-θ) 
Pooled mean ASES minus pooled std. dev. ASES (16.76) 
82.16 – 16.76 = 65.40 points 
Software Used 
IBM SPSS Sample Power V3.0 
IBM SPSS Sample Power Output 
One goal of the proposed clinical investigation is to test the null hypothesis that the population mean is 
82.16 points. The criterion for significance (alpha) has been set at 0.05. The test is 2-tailed, which means 

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that effects in both directions will be interpreted. With the proposed sample size of 10 cases, the clinical 
investigation will have power of 80.3% to yield a statistically significant result. This computation assumes 
that the population from which the sample will be drawn has a mean of 82.16 points with a standard 
deviation of 16.76 points. The observed value will be tested against a theoretical value (constant, non- 
inferiority margin) of 65.40 points. 
IBM SPSS Sample Power Output – Screenshot 
 
Estimated overall drop-out rate is 56% which leads to the requirement of enrolling additional 6 subjects 
into the clinical investigation. 
Sample Size 
Number of subjects to be enrolled: 16 subjects 
(rounded up to 20 subjects) 
Overall Sample Size (multiplied by 
number of indications (=5) 
100 subjects 
Table 2: Sample Size Justification 
In conclusion, the calculated number of subjects to be enrolled (10) plus the estimated overall drop-out 
rate of 56% predicts enrollment of 20 subjects per cleared indication (five) to reflect the underlying 
subject population adequately. As a result, an enrollment target of 100 subjects in total will be aspired. 
11.2. ANALYSIS POPULATIONS 
It is expected that during this clinical investigation only one population for ReUnion TSA System will 
exist and all subjects will be analyzed “Per Protocol” (PP). However, it cannot be fully avoided that in 
theory subjects might need to be excluded from the PP population. In this occasion, there will be two 
groups being fully analyzed to ensure transparency and avoid bias. 
The groups are defined as follows: 
• 
Intent-to Treat Population 
The Intent-to-Treat (ITT) Population is defined to be all enrolled subjects. An enrolled subject is a 
subject that has signed informed consent, all screening procedures have been successfully completed, 
is eligible and can receive treatment. The ITT population will not be analyzed for the annual reports 
and will only be included in the final report. 
• 
Per Protocol Population 
The PP Population is defined to be all subjects in the ITT Population with no major CIP violations. 
The CIP violations that will exclude a subject are as follows: 
• 
The subject does not receive the ReUnion TSA System 
• 
The subject does not meet all eligibility criteria 
• 
The subject has a protocol deviation that is considered likely to affect subject outcomes 

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After the clinical investigation has been completed, a review of the data will be conducted to 
determine which subjects are to be excluded from the PP population. 
11.3. ANALYSIS AND EVALUATION 
11.3.1. Statistical Analysis 
Evaluation elements are defined as the questions on the CRF/eCRF. The SAP lists all evaluation 
elements and secondary elements which will be based on calculations between two or more 
evaluation elements. 
All quantitative variables, including those based on calculations (secondary elements), will be 
analyzed with a case summary evaluation before the detailed characteristics and parameters can 
be evaluated. A case summary contains a listing of the number of valid cases/values, missing 
cases/values (if any) and total cases/values in the specific analysis. In general, as central position 
parameter for quantitative variables the mean, median and mode will be analyzed. As variation 
parameter the standard deviation, 95% confidence interval of the mean, interquartile range and 
range (based on maximum and minimum) will be calculated. All quantitative variables will be 
assessed for normality using the Shapiro-Wilk test. For optional visualization of quantitative 
variables, box-and-whisker plots will be used. Additional analyses like skewness and kurtosis 
measures or standard errors are optional also. 
All qualitative variables, including those based on summaries (secondary elements), will be 
analyzed listing the proportions, frequencies, column and row totals, and missing proportion, if 
any. 
The SAP reflects this approach and specifies the variables characteristics (quantitative or 
qualitative) in detail together with the related analysis strategy. This also includes calculation 
and summaries based on primary elements and the required analysis. 
11.3.2. Primary Analysis / Endpoint 
The objective of the clinical investigation is to demonstrate non-inferiority (equal or better) of 
the ASES Shoulder Score in relationship to the officially cleared indications in comparison to 
respective clinical outcome data in the scientific literature. 
Data collection of ASES Shoulder Score will start pre-operatively and will be collected 
according to schedule in Table 1. This will be repeated annually in all subjects who have the 
total or partial prosthesis with full or partial implant survival (including all subjects without 
removal of all endo-prosthesis components). 
The 24 months post-operative results for subjects implanted with ReUnion TSA System will be 
compared to a historical group and results reported by respective clinical outcome data in the 
scientific literature. The benchmark sources and values will serve as the control group for the 
ReUnion TSA System subjects. 
Higher ASES Shoulder Score results are linked to better subject results and vice versa. 
The clinical investigation endpoint is non-inferiority to the control, meaning the clinical 
investigation result should be equal or better than the control. In this clinical investigation, an 
equal or better ASES Shoulder Score result means equal or more (≥). As only results from 
samples will be captured, results are mostly estimates of the true population parameter. These 
estimates vary by a certain area, where it is expected that the true population parameter falls 
within. Based on this, it is required to specify a lower limit for the acceptable difference or zone 
of indifference, denoted as -θ. 

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Hypotheses are developed to allow for a comparison of the 24 months post-operative ASES 
Shoulder Score effectiveness / performance between the two underlying populations. The 24 
months post-operative ASES Shoulder Score is the primary endpoint of this clinical 
investigation. Hypothesis tests will be one-sided with a significance level α of 5%. 
 
Hypothesis 
Equations 
Interpretation 
Null (H0) 
A – B < -θ 
Central tendency of A is inferior to the 
central tendency of B. 
ReUnion TSA System – 
Control (Benchmark) < -θ 
Alternative (H1) 
A – B ≥ -θ 
Central tendency of A is non-inferior to 
the central tendency of B. 
ReUnion TSA System – 
Control (Benchmark) ≥ -θ 
 
Possible 
Evidence (p) 
Possible 
Decisions 
Possible Conclusions – ASES score 
p-value > α (0.05) 
Fail to reject 
null hypothesis 
(H0) 
ReUnion TSA System < Control (Benchmark) 
Insufficient evidence to reject the null hypothesis 
(H0: A - B < - θ) at the pre-determined significance 
level of 5%. 
p-value ≤ α (0.05) 
Reject null 
hypothesis (H1) 
ReUnion TSA System ≥ Control (Benchmark) 
Sufficient evidence to reject the null hypothesis 
(H0: A - B < - θ) at the pre-determined significance 
level of 5%. 
To test non-inferiority, the 24 months mean ASES Shoulder Score result of the ReUnion TSA 
System group will be compared to the mean estimate of the control group, 82.16 points. 
To be able to identify an acceptable difference or zone of indifference (-θ), the pooled standard 
deviation of the ASES Shoulder Score result at 24 months post-operative in the control group 
(Benchmark) was used as lower limit (pooled standard deviation of control is 16.76 points). 
The lower maximum acceptable difference (-θ) is 51.87 points (mean of control - θ or 82.16 – 
16.76 = 65.40 points). 
Based on the underlying distribution of the data and the result of the normality assessment, 
either the parametric one-sample t-test or the non-parametric one-sample sign test will be used 
to compare the 24 months post-operative ASES Shoulder Score results of the ReUnion TSA 
System against the value of 65.40 points. 
11.3.3. Secondary Endpoints 

ReUnion TSA CIP – Version 1 
 
16 
 
 
The incidence of device-related AEs and implant survivorship will be assessed up to 10 years 
after the index procedure and monitored through collection and analyses. These analyses will 
be part of the annual and final reports. 
Furthermore, time to (earliest) device-related AEs will be analyzed as well. For analysis of the 
time to the (earliest) device-related AEs as well as the time to secondary procedure (revision, 
removal, reoperation), the Kaplan-Meier method will be used. The time between surgery and 
the last available assessment will be used together with the time between date of surgery and 
the date of secondary procedure. Considered variables, the level of measurement and the 
planned analysis steps are listed in detail in the SAP. 
11.3.4. Additional Analyses 
Additional analyses are outlined in the subsequent sections. Analysis details (variables, level of 
measurement, planned steps) are listed in-depth in the SAP. 
o Mortality 
For analysis of the time to death or mortality, the Kaplan-Meier method will be used. 
The times between surgery and the last available assessment will be used together with 
the times between date of surgery and the date of death. This analysis will be part of 
the annual and final reports. 
o ASES Total Score – Within subject changes by visit 
The within subject score changes of the ASES Shoulder Score from visit to visit will 
be analyzed to help identify the changes on the subject level. This analysis will be part 
of the annual and final reports. 
11.4. MISSING DATA / SAP DEVIATIONS 
The intent is to collect as complete dataset as possible. Nevertheless, in some situations missing data 
cannot be avoided. The reports and tables therefore will show the number and percentage of missing 
cases for each analyzed variable in relation to the enrolled cases for each post-operative assessment 
Any deviations from the SAP will be listed in the annual or final reports. 
11.5. REPORTS 
11.5.1. Interim Analysis and Reports 
Interim analyses will be performed on a yearly basis. The progress of the clinical investigation 
will be reported together with the interim results on the variable level according to the analysis 
plan. 
The analysis of the primary endpoint will be part of the related interim / annual report when all 
subjects have completed the 24 months post-operative including the ASES Shoulder Score. 
11.5.2. Final Analysis and Reports 
The full final report with complete analysis including progress and conduct reporting will be 
created at the end of this clinical investigation. 

ReUnion TSA CIP – Version 1 
 
17 
 
 
12. Clinical Investigation Plan Deviations 
A CIP deviation is a departure from the approved CIP that is not implemented or intended as a systemic 
change. All CIP deviations are recorded and reported to each site’s IRB in accordance with the 
respective site’s IRB policies. 
 
13. Adverse Events 
As this CIP is being carried out to satisfy the post-market requirements to support safety and 
efficacy/performance according to the European Medical Device Regulation (EU MDR), categorization 
and definition of device-related adverse events will follow the guidelines outlined in the EU MDR as 
“incident” reporting. 
13.1. DEFINITIONS 
• 
An Adverse Device Effect (ADE) is defined as any untoward or unintended response to the clinical 
investigation treatment; and/or a medical response which may have a causal relationship to the 
treatment. 
• 
An Incident is defined as any malfunction or deterioration in the characteristics or performance of a 
device made available on the market, including use-error due to ergonomic features, as well as any 
inadequacy in the information supplied by the manufacturer and any undesirable side-effect. 
• 
A Serious Adverse Device Effect (SADE) is defined as any ADE that results in consequences 
characteristic of a SAE or might lead to the consequences if suitable action or intervention is not 
taken; causes considerable interference with the subject’s usual activities and may be incapacitating 
or life-threatening, including those events resulting in a subject’s disability or permanent damage, or 
required intervention to prevent disability or permanent damage; results in a life-threatening illness 
or injury; and/or results in death (fatal). 
• 
A Serious Incident is defined as any incident that directly or indirectly led, might have led or might 
lead to any of the following: 
o the death of a patient, user or other person; 
o the temporary or permanent serious deterioration of a patient's, user's or other person's 
state of health; 
o a serious public health threat 
• 
An Unanticipated Adverse Device Effect (UADE) is defined as an AE not described in the 
informed consent, CIP or device labeling which has resulted in any of the consequences of a SAE or 
which might have led to any of the consequences of a SAE if suitable action had not been taken, 
intervention had not occurred, or if circumstances had been less opportune. 
13.2. ADVERSE EVENT SEVERITY 
The severity of all AEs is assessed by the Investigator utilizing the following categories: 
• 
Mild: The AE is transient and easily tolerated by the subject. 
• 
Moderate: The AE causes the subject discomfort and interrupts the subject’s usual activities. 
• 
Severe: The AE causes considerable interference with the subject’s usual activities and may be 
incapacitating or life-threatening, including those events resulting in a subject’s disability or 
permanent damage, and/or required intervention to prevent permanent disability or damage. 

ReUnion TSA CIP – Version 1 
 
18 
 
 
• 
Life-Threatening: The AE results in a life-threatening illness or injury. 
• 
Fatal: The AE results in death. 
13.3. RELATIONSHIP TO THE DEVICE 
Only events considered possibly, probably or definitely related to the device will be captured for this 
clinical investigation. 
13.4. ADVERSE EVENT/INCIDENT REPORTING 
In the event a SADE, UADE or serious incident occurs, the Investigator is required to notify the Sponsor 
within 48 hours of being made aware of the event. The Investigator also is required to notify their IRB 
in accordance with the policies of their local laws and regulations. 
 
13.5. FORESEEABLE ADEs, SADEs and INCIDENTS 
ADEs, SADEs and incidents which may be expected as part of the surgical intervention include: 
o Perioperative complications 
 
Malpositioning of the humeral or glenoidal component 
 
Oversizing of implant components 
 
Undersizing of implant components 
 
Intraoperative fracture of the humerus or glenoid 
 
Cement leakage, if applicable 
 
Nerve injury, mild (minor motor or sensory loss, or spontaneous recovery) 
 
Nerve injury, severe (significant motor or sensory loss or requiring surgical revision) 
 
Vessel injury 
 
Tendon injury 
 
Wound complications (e.g. hematoma, wound healing disturbances) 
 
Superficial infection 
 
Deep infection 
 
Deep vein thrombosis 
 
Pulmonary embolism 
 
o Complications in the follow-up period 
 
Implant dislocation 
 
Other subluxation or instability, symptomatic 
 
Implant component dissociation, humeral head from humeral stem 
 
Implant fretting or crevice corrosion 
 
Implant breakage/wear, humeral or glenoidal 
 
Implant loosening, humeral or glenoidal 
 
Radiographic lucency, humeral or glenoidal 
 
Rotator cuff tear 
 
Pain related to the implant, severe 
 
Late infection (e.g. hematogenous or protracted) 
 
Periprosthetic fracture of the humerus or glenoid 
 
Stiffness 
 
Heterotopic ossification, asymptomatic or symptomatic 
 
Healing disturbances of subscapularis tenotomy, if applicable 
 
Non-union of lesser tuberosity osteotomy, if applicable 
 
Malunion of lesser tuberosity osteotomy, if applicable 

ReUnion TSA CIP – Version 1 
 
19 
 
 
14. Reoperations 
Reoperations and reason(s) for reoperations will be collected throughout the course of the clinical 
investigation. A reoperation may include but not limited to irrigation and debridement, revision surgery 
and/or implant removal. 
 
15. Ethics 
This clinical investigation is to be conducted according to International Conference of Harmonisation of 
Good Clinical Practice (ICH-GCP), applicable regulations, institutional research policies and procedures, 
Declaration of Helsinki and in compliance with the CIP. Investigators will be trained on the clinical 
investigation devices and surgical techniques prior to implanting clinical investigation subjects. 
This CIP and any amendments will be submitted to a properly constituted independent ethics board, in 
agreement with local legal prescriptions, for formal approval of the clinical investigation conduct. The 
decision of the ethics board concerning the conduct of the clinical investigation will be made in writing 
to the Investigator before commencement of this clinical investigation. Clinical investigations shall not 
begin until the governing regulatory authority has provided full, unconditional approval. Off-label use of 
the ReUnion TSA System is not permitted. 
15.1. INSTITUTION REVIEW BOARD (IRB) 
IRB approval will be obtained at each of the investigational sites prior to enrolling clinical investigation 
subjects at that site. In addition, any SAEs and UADEs that meet the reporting criteria of the IRB, will 
be reported to the IRB. During the clinical investigation, the Investigator should promptly provide written 
reports to the IRB of any changes that affect the conduct of the clinical investigation and/or increase risk 
to the subjects, unless otherwise submitted by the Sponsor. 
15.2. INFORMED CONSENT 
The Investigator, or qualified clinical investigation personnel designated to perform this task, will explain 
the nature of the clinical investigation to the subject, and answer all questions regarding participation in 
this clinical investigation. Prior to any clinical investigation procedures being performed, the informed 
consent form (ICF) will be reviewed, signed and dated by the subject, and by the person administering 
the informed consent. A copy of the ICF will be given to the subject, and the original will be placed in 
the subject’s clinical investigation records. Subjects will need to sign updated versions of the ICF if 
required by the Investigator’s IRB during the clinical investigation. 
 
16. Data Collection Process 
The Sponsor will collect clinical data for this clinical investigation utilizing eCRFs through an EDC 
system. All data entered in the eCRFs are supported by source documentation. All clinical data is entered 
into the EDC system by designated personnel at each of the Investigator sites. 
16.1. RADIOGRAPHS 
All radiographs shall be de-identified of personal health information. Radiographs will be uploaded as 
DICOM images into the EDC system. The radiologic analysis shall be based at minimum on an axillary 
lateral radiograph and an anteroposterior radiograph. Additional radiographs (e.g., 30° to 40° posterior 
oblique radiographs in internal and external rotation) may be used where available. For measurements, 
all digital radiographs shall be sized to 100%, based on the diameter of the humeral head or other suitable 
reference sizes. 

ReUnion TSA CIP – Version 1 
 
20 
 
 
17. Clinical Investigation Monitoring 
It is the responsibility of the Investigator to oversee the safety of the clinical investigation at his/her site, 
to include the careful assessment and appropriate reporting of AEs/incidents as noted above as well as 
the implementation of site data safety. The Sponsor, or designee will monitor the site to ensure informed 
consent has been documented appropriately, to ensure the information documented on the completed 
CRFs match the medical records and to resolve any differences. The Sponsor will take all steps necessary 
to ensure data integrity. The Sponsor also will review significant new information, including UADEs 
and ensure that such information is provided to all Investigators, their IRBs, and applicable regulatory 
authorities. Additionally, a quality assurance check will be performed to ensure the investigator is 
complying with the CIP and applicable regulations in the collection of all clinical investigation data. 
 
18. Data Handling and Record Keeping 
Information about clinical investigation subjects will be kept confidential. In the event a subject revokes 
authorization to collect or use protected health information, the Site Investigator, by regulation, retains 
the ability to use all information collected prior to the revocation of subject authorization. The Health 
Insurance Portability and accountability Act (HIPAA) will apply to ensure data protection and document 
anonymization. Records are to be stored in a secure location. Retention of records shall be maintained 
through the clinical investigation duration as well as specified years following the clinical investigation 
completion as required by local regulatory authority. 
 
19. Reports 
Analysis will be performed and interim reports will be prepared on a yearly basis. Upon the completion 
of all subjects’ final post-operative assessment, data freeze will occur, and the final report will be 
prepared. 
 
20. Completion of the Clinical Investigation 
The Investigator will conduct this clinical investigation in compliance with the CIP and will complete 
the clinical investigation within the timeframe specified in the contract. Continuation of the clinical 
investigation beyond this time must be mutually agreed upon in writing by both the Investigator and 
Stryker. The Investigator will provide a summary of the clinical investigation results in accordance with 
the IRB guidelines. 
Stryker may terminate this clinical investigation prematurely, either in its entirety or at this site, for 
reasonable cause provided that written notice is submitted a reasonable time in advance of the intended 
termination. The Investigator also may terminate the clinical investigation at their site for reasonable 
cause, after providing written notice to Stryker a reasonable time in advance of the intended termination. 
If Stryker terminates the clinical investigation for safety reasons, then it will immediately notify the 
Investigator by telephone and subsequently provide written instructions for clinical investigation 
termination. 
 
21. Essential Documents 
All essential documentation will be stored as specified under the Sponsor’s Standard Operating 
Procedures. 

ReUnion TSA CIP – Version 1 
 
21 
 
 
22. Publication Policy 
Refer to the clinical investigation agreement for the publication policy 
 
23. References 
1. Cuff DJ, Pupello DR, Santoni BG, Clark RE, Frankle MA. Reverse Shoulder Arthroplasty for the 
Treatment of Rotator Cuff Deficiency: A Concise Follow-up, at a Minimum of 10 Years, of 
Previous Reports. J Bone Joint Surg Am. 2017 Nov 15; 99(22):1895-1899. 
2. Irlenbusch U, Blatter G, Gebhardt K, Pap G, Zenz P. Prospective study of double-eccentric hemi 
shoulder arthroplasty in different aetiologies: midterm results. Int Orthop. 2011 Jul;35(7):1015-23. 
3. Flurin PH, Marczuk Y, Janout M, Wright TW, Zuckerman J, Roche CP. Comparison of outcomes 
using anatomic and reverse total shoulder arthroplasty. Bull Hosp Jt Dis (2013). 2013;71 Suppl 
2:101-7. 
4. Press CM, O'Connor DP, Elkousy HA, Gartsman GM, Edwards TB. Glenoid perforation does not 
affect the short-term outcomes of pegged all-polyethylene implants in total shoulder arthroplasty. J 
Shoulder Elbow Surg. 2014 Aug;23(8):1203-7. 
5. Hsu JE, Namdari S, Baron M, Kuntz AF, Abboud JA, Huffman GR, Williams GR, Glaser DL. 
Glenoid perforation with pegged components during total shoulder arthroplasty. Orthopedics. 2014 
Jun;37(6):e587- 91. 
6. Kiet TK, Feeley BT, Naimark M, Gajiu T, Hall SL, Chung TT, Ma CB. Outcomes after shoulder 
replacement: comparison between reverse and anatomic total shoulder arthroplasty. J Shoulder 
Elbow Surg. 2015 Feb;24(2):179-85. 
7. Steen BM, Cabezas AF, Santoni BG, Hussey MM, Cusick MC, Kumar AG, Frankle MA. Outcome 
and value of reverse shoulder arthroplasty for treatment of glenohumeral osteoarthritis: a matched 
cohort. J Shoulder Elbow Surg. 2015 Mar 11. pii: S1058-2746(15)00043-9. 
8. Gulotta LV, Chambers KL, Warren RF, Dines DM, Craig EV. No Differences in Early Results of a 
Hybrid Glenoid Compared With a Pegged Implant. Clin Orthop Relat Res. 2015 Sep 9. 
9. Petri M, Euler SA, Dornan GJ, Greenspoon JA, Horan MP, Katthagen JC, Millett PJ. Predictors for 
satisfaction after anatomic total shoulder arthroplasty for idiopathic glenohumeral osteoarthritis. 
Arch Orthop Trauma Surg. 2016 Jun;136(6):755-62. 
10. Schoch B, Werthel JD, Cofield R, Sanchez-Sotelo J, Sperling JW. Shoulder arthroplasty for 
chondrolysis. J Shoulder Elbow Surg. 2016 Sep;25(9):1470-6. doi: 10.1016/j.jse.2016.01.005. 
Epub 2016 Mar 30. 
11. Alentorn-Geli E, Assenmacher AT, Sperling JW, Cofield RH, Sánchez-Sotelo J. Plication of the 
posterior capsule for intraoperative posterior instability during anatomic total shoulder arthroplasty. 
J Shoulder Elbow Surg. 2017 Jun;26(6):982-989. 

ReUnion TSA CIP – Version 1 
 
22 
 
 
24. Clinical Investigation Plan Signature Page 
 
 
ReUnion TSA System 
I have read this Clinical Investigation Plan and agree that this clinical investigation is ethical. I agree to 
conduct this clinical investigation in accordance with this Clinical Investigation Plan, as well as all 
applicable regulations and guidelines. I agree to maintain the confidentiality of all information received 
or developed in connection with this Clinical Investigation Plan. 
 
 
 
 
 
 
Signature of Investigator 
Date of Signature 
 
 
 
Name of Investigator (Printed) 

ReUnion TSA CIP – Version 1 
 
23 
 
 
25. Document Version History 
 
Version 
Effective Date 
Description 
Revised/Created by 
1 
12Oct2018 
Initial version 
Lindsay Mattfolk 

 
 
Certificate Of Completion 
 
Envelope Id: 2A243EEE64BF44AAB16CC81B0FE3CE9F 
Status: Completed 
Subject: Please DocuSign: 12OCT2018_ReUnion TSA_Protocol Development.pdf 
Source Envelope: 
Document Pages: 23 
Signatures: 4 
Envelope Originator: 
Certificate Pages: 5 
Initials: 0 
Lindsay Mattfolk 
AutoNav: Enabled 
EnvelopeId Stamping: Disabled 
Time Zone: (UTC-08:00) Pacific Time (US & Canada) 
325 Corporate Drive 
New Jersey, NC 07430 
lindsay.mattfolk@stryker.com 
IP Address: 24.94.18.137 
Record Tracking 
 
Status: Original 
10/15/2018 8:28:12 AM 
Holder: Lindsay Mattfolk 
lindsay.mattfolk@stryker.com 
Location: DocuSign 
 
 
Claudia Beimel 
claudia.beimel@stryker.com 
Stryker 
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Signed: 10/16/2018 12:50:25 AM 
 
 
 
 
 
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Not Offered via DocuSign 
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I approve this document 
 
Georgia Mitchell 
georgia.mitchell@stryker.com 
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Electronic Record and Signature Disclosure: 
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Electronic Record and Signature Disclosure: 
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Electronic Record and Signature Disclosure created on: 11/30/2017 9:57:32 AM 
Parties agreed to: Georgia Mitchell, Helmut Mueckter, Jemin Dedania 
 
 
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