A Post-Market Clinical Evaluation of the ReUnion Reverse Shoulder Arthroplasty (RSA) System
Conditions: Shoulder Arthroplasty
Sponsor: Stryker Trauma and Extremities

ReUnion RSA CIP – Version 1 
1 
CLINICAL INVESTIGATION PLAN 
CLINICAL INVESTIGATION 
TITLE: 
A Post-Market Clinical Evaluation of the ReUnion Reverse 
Shoulder Arthroplasty (RSA) System 
DEVICE NAME: 
ReUnion RSA System 
CLINICAL INVESTIGATION 
DESIGN: 
Post-Market, Multicenter, Prospective, Non-Randomized 
INDICATIONS: 
This clinical investigation will adhere to the indications and 
contraindications for the ReUnion RSA System as are detailed 
in the device’s Instructions for Use. 
REGULATORY STATUS: 
510(k) Clearance received on 27Dec2013 
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 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 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 
NCT03880955

ReUnion RSA CIP – Version 1 
 
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Approval Page 
 
 
 
 
 
 
 
 
8:53 AM P
 
 
 
 
 
 
 
7:56 AM P
 
 
 
 
 
 
6:56 AM P
 
 
 
 
 
 
12:42 AM 
APPROVERS 
Role 
Name 
Signature 
Date 
Medical Expert 
Dr. Helmut Mueckter, MD 
15-Okt-2018 | 
Clinical Research Head (CRH) 
Georgia Mitchell 
15-Oct-2018 | 
Regulatory Affairs (RA) 
Jemin Dedania 
16-Oct-2018 | 
Statistician 
Claudia Beimel 
16-Oct-2018 | 

ReUnion RSA CIP – Version 1 
 
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Table of Contents 
1. 
LIST OF ABBREVIATIONS 
4 
2. 
SYNOPSIS 
4 
3. 
GENERAL INFORMATION AND ADMINISTRATIVE STRUCTURE 
5 
4. 
PRODUCT INFORMATION 
6 
5. 
RISKS AND BENEFITS 
6 
6. 
INTRODUCTION 
6 
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 
20 
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 
21 
22. PUBLICATION POLICY 
21 
23. REFERENCES 
21 
24. CLINICAL INVESTIGATION PLAN SIGNATURE PAGE 
23 
25. DOCUMENT VERSION HISTORY 
24 
 

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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 
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 Reverse Shoulder Arthroplasty 
(RSA) System 
Treatment 
ReUnion RSA 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 RSA System. 
Efficacy/performance of the procedure will be measured the American Shoulder 
and Elbow Surgeons (ASES) Shoulder Score. 
Safety of the ReUnion RSA System will be demonstrated through reporting of 
device-related intra-operative and post-operative Adverse Events (AEs). 
Target Population 
80 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 
Months, 24 Months and annually thereafter up to 10 years following the index 
procedure. 

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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’s joint has gross rotator cuff deficiency, a functional deltoid 
muscle and is anatomically and structurally suited to receive the implant 
and subject has one or more of the following: 
• 
Painful, disabling joint disease of the shoulder resulting from 
degenerative arthritis or rheumatoid arthritis 
• 
Failed previous shoulder joint replacement 
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 concomitant disease(s) which may significantly affect the 
clinical outcome. 
g. 
Subject has traumatic or pathologic fracture of the proximal humerus. 
 
 
3. General Information and Administrative Structure 
3.1. 
SPONSOR 
Stryker Orthopaedics 
325 Corporate Drive 
Mahwah, NJ 07430 
3.2. 
KEY SPONSOR PERSONNEL 

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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 Affairs 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 RSA 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 27Dec2013. 
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 
efficacy/performance of the ReUnion RSA 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 RSA 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. 
 
6. Introduction 
The ReUnion RSA System is designed as a reverse total shoulder endoprosthesis to address unrepairable 
gross rotator cuff tear, rotator cuff arthropathy with pseudoparalysis of the shoulder joint, advanced 
arthritic and rheumatic disorders affecting the shoulder joint, and failed previous shoulder arthroplasty. 
The ReUnion RSA System is comprised of a Humeral Cup, Humeral Insert, Glenosphere, Glenoid 
Baseplate and Screws. It is used with the humeral stems from the ReUnion Total Shoulder Arthroplasty 
(TSA) System. The intended purposes of the ReUnion RSA 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. 

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7. Clinical Investigation Design 
This investigation is a prospective, multicenter clinical investigation. It is anticipated that a total of eighty 
(80) 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 12 months. 
7.1. 
CLINICAL INVESTIGATION RATIONALE 
This clinical investigation will evaluate the safety and efficacy/performance of the ReUnion RSA 
System. 
 
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/Performance: Implant survivorship will be monitored 
 
9. Selection of Clinical Investigation Population 
Subjects participating in this clinical investigation will be recruited from the investigator’s standard subject 
population, where all patients 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’s joint has gross rotator cuff deficiency, a functional deltoid muscle and is anatomically 
and structurally suited to receive the implant and subject has one or more of the following: 
• 
Painful, disabling joint disease of the shoulder resulting from degenerative arthritis or 
rheumatoid arthritis 
• 
Failed previous shoulder joint replacement 
9.2. 
EXCLUSION CRITERIA 
a. Subject has an active or suspected latent infection in or about the shoulder joint. 

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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 concomitant disease(s) which may significantly affect the clinical outcome. 
g. 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: 
a. 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. 
b. 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. 
c. Removal of Device or AE/Incident: The discontinuation of a subject’s participation in 
the clinical investigation due to the removal of the ReUnion RSA 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. 
d. 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 
directly caused by, or attributable to, the ReUnion RSA System. Data collected up until 
the point of death will be included in the final analysis. 
e. 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. 

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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 RSA 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 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 (23 weeks – 29 weeks), 12 Months (48 weeks- 56 weeks), 24 
Months (100 weeks – 108 weeks) and annually thereafter. 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 
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. 

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Benchmark and Objectives for Clinical Investigation 
 
 
Table 1: Schedule of Events 
 
11. Statistical Methods 
The 24 months post-operative results for subjects implanted with the ReUnion RSA 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 RSA System 
subjects. 
Hypotheses are developed to allow for a comparison of 24 months post-operative ASES 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 71.27 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 71.27 points with a standard deviation of 
19.40 points. The observed value will be tested against a theoretical value (lower limit -θ) of 51.87 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 (four) to reflect the underlying subject 
population adequately. 
11.1. DETERMINATION OF SAMPLE SIZE 
The determination of sample size is based on benchmark sources and values. 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 to reflect the underlying subject population adequately. For details, 
please see Table 2. 
 
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. 

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Endpoint 
The 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 
Nolan et al. [2] 2011 
71 
76.1 
NA 
NA 
2 
Naveed et al. [3] 2011 
49 
65 
NA 
NA 
3 
Kelly 2nd et al. [4] 2012 
30 
71.8 
12.7 
Revision Arthroplasty in failed 
arthroplasty 
4 
Patel et al. [5] 2012 
28 
66.2 
21.3 
Revision Arthroplasty in failed 
arthroplasty 
5 
Cuff et al. [6] 2012 
76 
75 
NA 
NA 
6a 
Wiater et al. [7] 2014 
37 
84.9 
18.9 
Cemented humeral stem 
6b 
Wiater et al. [7] 2014 
64 
77.1 
18.3 
Cement-less humeral stem 
7a 
Black et al. [8] 2014 
33 
74 
23.8 
NA 
7b 
Black et al. [8] 2014 
32 
69.7 
18 
NA 
8a 
Poon et al. [9] 2014 
27 
70 
NA 
Concentric 
8b 
Poon et al. [9] 2014 
23 
68 
NA 
Eccentric 
9 
Kiet et al. [10] 2015 
53 
77 
19 
NA 
10 
Steen et al. [11] 2015 
24 
79.9 
20.2 
NA 
11 
Wagner et al. [12] 2015 
154 
65.0 
NA 
Revision Arthroplasty in failed 
arthroplasty 
12a 
Crosby et al. [13] 2017 
73 
55 
25 
Stem exchanged 
12b 
Crosby et al. [13] 2017 
29 
68 
20 
Stem retention 
13 
Vourazeris et al. [14] 2017 
86 
77.7 
NA 
NA 
14a 
Otto et al. [15] 2017 
32 
58.6 
NA 
NA 
14b 
Otto et al. [15] 2017 
35 
40.8 
NA 
Revision Arthroplasty in failed 
arthroplasty 
15a 
Mollon et al. [16] 2017 
428 
84.1 
17.1 
Patients without scapular notching 
15b 
Mollon et al. [16] 2017 
48 
78.1 
21.8 
Patients with scapular notching 
16 
Holschen et al. [17] 2017 
44 
65.3 
20.9 
Revision Arthroplasty in failed 
arthroplasty 
17a 
Friedmann et al. [18] 2017 
340 
86.7 
15.8 
Patients with subscapularis repair 
17b 
Friedmann et al. [18] 2017 
251 
82.1 
18.2 
Patients without subscapularis repair 
18 
Williams et al. [19] 2017 
17 
65.6 
NA 
Revision Arthroplasty in failed 
arthroplasty 
Identified Cleared Indications 
No. 
Indication 
1 
Gross rotator cuff deficiency 
2 
Degenerative arthritis 
3 
Rheumatoid arthritis 
4 
Revision of previously failed shoulder joint replacement 
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 (19.40) 
71.27 – 19.40 = 51.87 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 RSA (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 

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Benchmark n 
25 
Benchmark Mean 
71.27 (pooled mean ASES [points]) 
Benchmark Std. Dev. 
19.40 (pooled std. dev. ASES [points]) 
Benchmark Value 
Non-Inferiority Margin (-θ) 
Pooled mean ASES minus pooled std. dev. ASES (19.40) 
71.27 – 19.40 = 51.87 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 71.27 
points. The criterion for significance (alpha) has been set at 0.05. The test is 2-tailed, which means 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 71.27 points with a standard deviation 
of 19.40 points. The observed value will be tested against a theoretical value (constant, non-inferiority 
margin) of 51.87 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 
Overall number of subjects to be enrolled: 16 subjects (rounded 
up to 20 subjects) 
Overall Sample Size (multiplied 
by number of indications) 
80 subjects 
Table 2: Sample Size Justification 
In conclusion, the calculated number of subjects to be enrolled (ten) plus the estimated overall drop-out 
rate of 56%, leads Stryker to enroll 20 subjects per cleared indication (four) to reflect the underlying 
subject population adequately. As a result, an enrollment target of 80 subjects in total will be aspired. 
11.2. ANALYSIS POPULATIONS 
It is expected during this clinical investigation only one population for ReUnion RSA 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. 

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• 
Per Protocol Population 
The PP Population is defined to be all subjects in the ITT Population with no major protocol 
violations. The protocol deviations that will exclude a subject are as follows: 
• 
The subject does not receive the ReUnion RSA System 
• 
The subject does not meet all eligibility criteria 
• 
The subject has a protocol deviation that is considered likely to affect subject outcomes. 
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 also are optional. 
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 the 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 
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 RSA 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 RSA System subjects. 
Higher ASES Shoulder Score results are linked to better subject results and vice versa. 

ReUnion RSA CIP – Version 1 
 
15 
 
 
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 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. 
Hypotheses are developed to allow for a comparison of the 24 months post-operative ASES 
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 RSA System – Control 
(Benchmark) < -θ 
Alternative (H1) 
A – B ≥ -θ 
Central tendency of A is non- 
inferior to the central tendency 
of B. 
ReUnion RSA 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 RSA 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 RSA 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 RSA 
System group will be compared to the mean estimate of the control group (71.27 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 19.40 points). 

ReUnion RSA CIP – Version 1 
 
16 
 
 
The lower maximum acceptable difference (-θ) is 51.87 points (mean of control - θ or 71.27 – 
19.40 = 51.87 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 RSA 
System against the value of 51.87 points. 
11.3.3. Secondary Endpoints 
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 Total ASES Shoulder 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 a 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 Sore. 

ReUnion RSA CIP – Version 1 
 
17 
 
 
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. 
 
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: 

ReUnion RSA CIP – Version 1 
 
18 
 
 
• 
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. 
• 
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 
 
Humeral 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 cup from humeral stem 
 
Implant component dissociation, humeral insert from humeral cup 
 
Implant component dissociation, glenosphere from baseplate 
 
Implant fretting or crevice corrosion 
 
Implant breakage/wear, humeral or glenoidal 
 
Implant loosening, humeral 
 
Implant loosening, glenoidal with or without screw breakage 
 
Radiographic lucency, humeral or glenoidal 
 
Pain related to the implant, severe 
 
Late infection (e.g. hematogenous or protracted) 

ReUnion RSA CIP – Version 1 
 
19 
 
 
 
Periprosthetic fracture of the humerus or glenoid 
 
Stress fracture of the acromion or the scapular neck 
 
Stress fracture of the coracoid 
 
Scapular notching, asymptomatic or symptomatic 
 
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 
 
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 RSA 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. 

ReUnion RSA CIP – Version 1 
 
20 
 
 
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 glenosphere or other suitable 
reference sizes. 
 
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 sites 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 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. 

ReUnion RSA CIP – Version 1 
 
21 
 
 
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. 
 
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. Nolan BM1, Ankerson E, Wiater JM. Reverse total shoulder arthroplasty improves function in cuff 
tear arthropathy. Clin Orthop Relat Res. 2011 Sep;469(9):2476-82. 
3. Naveed MA1, Kitson J, Bunker TD. The Delta III reverse shoulder replacement for cuff tear 
arthropathy: a single-centre study of 50 consecutive procedures. J Bone Joint Surg Br. 2011 
Jan;93(1):57-61. 
4. Kelly JD 2nd, Zhao JX, Hobgood ER, Norris TR. Clinical results of revision shoulder arthroplasty 
using the reverse prosthesis. J Shoulder Elbow Surg. 2012 Nov;21(11):1516-25. 
5. Patel DN, Young B, Onyekwelu I, Zuckerman JD, Kwon YW. Reverse total shoulder arthroplasty for 
failed shoulder arthroplasty. J Shoulder Elbow Surg. 2012 Nov;21(11):1478-83. 
6. Cuff D, Clark R, Pupello D, Frankle M. Reverse shoulder arthroplasty for the treatment of rotator 
cuff deficiency: a concise follow-up, at a minimum of five years, of a previous report. J Bone Joint 
Surg Am. 2012 Nov 7;94(21):1996-2000 
7. Wiater JM, Moravek JE Jr, Budge MD, Koueiter DM, Marcantonio D, Wiater BP. Clinical and 
radiographic results of cementless reverse total shoulder arthroplasty: a comparative study with 2 to 5 
years of follow-up. J Shoulder Elbow Surg. 2014 Aug;23(8):1208-14. 
8. Black EM, Roberts SM, Siegel E, Yannopoulos P, Higgins LD, Warner JJ. Reverse shoulder 
arthroplasty as salvage for failed prior arthroplasty in patients 65 years of age or younger. Shoulder 
Elbow Surg. 2014 Jul;23(7):1036-42. 
9. Poon PC, Chou J, Young SW, Astley T. A comparison of concentric and eccentric glenospheres in 
reverse shoulder arthroplasty: a randomized controlled trial. J Bone Joint Surg Am. 2014 Aug 
20;96(16):e138. 
10. Zafra M, Uceda P, Flores M, Carpintero P. Reverse total shoulder replacement for nonunion of a 
fracture of the proximal humerus. Bone Joint J. 2014 Sep;96-B(9):1239-43. 
11. 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. 

ReUnion RSA CIP – Version 1 
 
22 
 
 
12. Wagner ER, Houdek MT, Elhassan BT, Sanchez-Sotelo J, Cofield RH, Sperling JW. What Are Risk 
Factors for Intraoperative Humerus Fractures During Revision Reverse Shoulder Arthroplasty and Do 
They Influence Outcomes? Clin Orthop Relat Res. 2015 Jul 11. 
13. Crosby LA, Wright TW, Yu S, Zuckerman JD. Conversion to Reverse Total Shoulder Arthroplasty 
with and without Humeral Stem Retention: The Role of a Convertible-Platform Stem. J Bone Joint 
Surg Am. 2017 May 3;99(9):736-742. 
14. Vourazeris JD, Wright TW, Struk AM, King JJ, Farmer KW. Primary reverse total shoulder 
arthroplasty outcomes in patients with subscapularis repair versus tenotomy. J Shoulder Elbow Surg. 
2017 Mar;26(3):450-457. 
15. Otto RJ, Clark RE, Frankle MA. Reverse shoulder arthroplasty in patients younger than 55 years: 2- 
to 12-year follow-up. J Shoulder Elbow Surg. 2017 May;26(5):792-797. 
16. Mollon B, Mahure SA, Roche CP, Zuckerman JD3. Impact of scapular notching on clinical outcomes 
after reverse total shoulder arthroplasty: an analysis of 476 shoulders. J Shoulder Elbow Surg. 2017 
Jul;26(7):1253-1261. 
17. Holschen M1, Franetzki B2, Witt KA2, Liem D3, Steinbeck J2. Is reverse total shoulder arthroplasty 
a feasible treatment option for failed shoulder arthroplasty? A retrospective study of 44 cases with 
special regards to stemless and stemmed primary implants. Musculoskelet Surg. 2017 
Aug;101(2):173-180. 
18. Friedman RJ1, Flurin PH2, Wright TW3, Zuckerman JD4, Roche CP5. Comparison of reverse total 
shoulder arthroplasty outcomes with and without subscapularis repair. J Shoulder Elbow Surg. 2017 
Apr;26(4):662-668. 
19. Williams PN1, Trehan SK2, Tsouris N2,Dines JS2, Dines DM2, Craig EV3, Gulotta LV2, Warren 
RF2. Functional Outcomes of Modular Conversion of Hemiarthroplasty or Total to Reverse Total 
Shoulder Arthroplasty. HSS J. 2017 Jul;13(2):102-107. 

ReUnion RSA CIP – Version 1 
 
23 
 
 
24. Clinical Investigation Plan Signature Page 
 
 
ReUnion RSA 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 RSA CIP – Version 1 
 
24 
 
 
25. Document Version History 
 
Version 
Effective Date 
Description 
Revised/Created by 
1 
12Oct2018 
Initial version 
Lindsay Mattfolk 

 
 
Certificate Of Completion 
 
Envelope Id: D3DE7B77CB2948FC801BC84171E5CDCE 
Status: Completed 
Subject: Please DocuSign: 12OCT2018_ReUnion RSA_Protocol Development.pdf 
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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 
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Stryker 
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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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How to contact Stryker Corporation - Trauma & Extremities - Part 11: 
You may contact us to let us know of your changes as to how we may contact you electronically, 
to request paper copies of certain information from us, and to withdraw your prior consent to 
receive notices and disclosures electronically as follows: 
To contact us by email send messages to: rebecca.gibson@stryker.com 
 
To advise Stryker Corporation - Trauma & Extremities - Part 11 of your new e-mail 
address 
To let us know of a change in your e-mail address where we should send notices and disclosures 
electronically to you, you must send an email message to us at rebecca.gibson@stryker.com and 
in the body of such request you must state: your previous e-mail address, your new e-mail 
address. We do not require any other information from you to change your email address.. 
In addition, you must notify DocuSign, Inc to arrange for your new email address to be reflected 
in your DocuSign account by following the process for changing e-mail in DocuSign. 
To request paper copies from Stryker Corporation - Trauma & Extremities - Part 11 
To request delivery from us of paper copies of the notices and disclosures previously provided 
by us to you electronically, you must send us an e-mail to rebecca.gibson@stryker.com and in 
the body of such request you must state your e-mail address, full name, US Postal address, and 
telephone number. We will bill you for any fees at that time, if any. 
To withdraw your consent with Stryker Corporation - Trauma & Extremities - Part 11 
To inform us that you no longer want to receive future notices and disclosures in electronic 
format you may: 
i. decline to sign a document from within your DocuSign account, and on the subsequent 
page, select the check-box indicating you wish to withdraw your consent, or you may; 
ii. send us an e-mail to rebecca.gibson@stryker.com and in the body of such request you 
must state your e-mail, full name, IS Postal Address, telephone number, and account 
number. We do not need any other information from you to withdraw consent.. The 
consequences of your withdrawing consent for online documents will be that transactions 
may take a longer time to process.. 
 
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