A Post-Market Clinical Evaluation of the ReUnion Reversible Fracture (RFX) System
Conditions: Arthroplasty, Hemiarthroplasty, Shoulder Pain
Sponsor: Stryker Trauma and Extremities

ReUnion RFX Protocol – Version 2 
1 
CLINICAL INVESTIGATION PLAN 
CLINICAL INVESTIGATION 
TITLE: 
A Post-Market Clinical Evaluation of the ReUnion Reversible 
Fracture (RFX) System 
MEDICAL DEVICE: 
ReUnion RFX System 
DESIGN: 
Post-Market, Multicenter, Prospective, Two Arms, Non- 
Randomized 
INDICATIONS: 
This study will adhere to the indications and contraindications 
for the ReUnion RFX System as are detailed in the device’s 
Instructions for Use. 
REGULATORY STATUS: 
510(k) Clearance received on 23Nov2016 
PHASE: 
Post-Approval Clinical Investigation 
SPONSOR: 
Stryker Orthopaedics 
325 Corporate Drive 
Mahwah, NJ 07430 
AUTHOR: 
Emily Arndt 
INVESTIGATORS: 
Investigators’ information is on file at the Sponsor 
MEDICAL EXPERT: 
Dr. Stefan Maartense, MD, PhD 
COMPLIANCE STATEMENT: 
This study will be conducted in compliance with the 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 study devices and surgical 
techniques prior to implanting study subjects. 
CONFIDENTIALITY 
STATEMENT: 
This protocol contains confidential information and its’ use is 
limited to investigational staff intending to conduct the study, 
Institutional Review Boards (IRBs) and any others charged 
with reviewing the study. 
VERSION: 
2 
DATE: 
08Aug2018 
NCT04089371

ReUnion RFX Protocol – Version 2 
 
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Approval Page 
 
 
 
 
 
 
 
1:19 AM PD 
 
 
 
 
 
 
:44 AM ED
 
 
 
 
 
 
 
12:05 AM P 
 
 
 
 
 
 
12:08 AM P 
APPROVERS 
Role 
Name 
Signature 
Date 
Medical Expert 
Dr. Stefan Maartense 
09-aug-2019 | 
Clinical Research 
Head (CRH) 
Georgia Mitchell 
12-Aug-2019 | 1
Regulatory Affairs 
(RA) 
Heike Gustke 
12-Aug-2019 | 
Statistician 
Claudia Beimel 
19-Aug-2019 | 

ReUnion RFX Protocol – Version 2 
 
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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 
7 
5. 
RISKS AND BENEFITS 
7 
6. 
INTRODUCTION 
7 
7. 
CLINICAL INVESTIGATION DESIGN 
7 
8. 
OBJECTIVE 
7 
9. 
SELECTION OF STUDY POPULATION 
8 
10. CLINICAL INVESTIGATION EVALUATIONS, PROCEDURES AND ASSESSMENTS 
10 
11. STATISTICAL METHODS 
11 
12. CLINICAL INVESTIGATION PLAN DEVIATIONS 
21 
13. ADVERSE EVENTS 
21 
14. REVISIONS, REMOVALS AND REOPERATIONS 
23 
15. ETHICS 
23 
16. DATA COLLECTION PROCESS 
24 
17. CLINICAL INVESTIGATION MONITORING 
24 
18. DATA HANDLING AND RECORD KEEPING 
24 
19. REPORTS 
24 
20. COMPLETION OF THE CLINICAL INVESTIGATION 
24 
21. ESSENTIAL DOCUMENTS 
25 
22. PUBLICATION POLICY 
25 
23. REFERENCES 
25 
24. CLINICAL INVESTIGATION PLAN SIGNATURE PAGE 
27 
25. DOCUMENT VERSION HISTORY 
28 

ReUnion RFX Protocol – Version 2 
 
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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 
ORIF 
Open Reduction Internal Fixation 
PP 
Per Protocol 
RFX 
Reversible Fracture 
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 
 
Study Title: 
A Post-Market Clinical Evaluation of the ReUnion Reversible Fracture (RFX) 
System 
Study Treatment: 
ReUnion RFX System 
Study Design: 
• 
Post-Market 
• 
Multicenter 
• 
Prospective 
• 
Two arms 
• 
Non-Randomized 
Objectives 
The objective of this clinical investigation is to demonstrate the safety and 
efficacy/performance of the ReUnion RFX System. 
Efficacy/performance of the procedure will be measured by the American 
Shoulder and Elbow Surgeons (ASES) Shoulder Score. 
Safety of the ReUnion RFX System will be demonstrated through reporting of 
device-related intraoperative and postoperative Adverse Events (AEs). 

ReUnion RFX Protocol – Version 2 
 
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Target Population 
100 subjects are to be enrolled in this clinical investigation. Enrolled subjects will 
be assessed at Preoperative, Operative/Discharge, and at 6 Weeks, 6 Months, 12 
Months, 24 Months and annually thereafter up to 10 years following the index 
procedure. 
Endpoints 
Primary Endpoint – Arm A (Total Shoulder Arthroplasty / 
Hemiarthroplasty): 
The objective of the clinical investigation is to demonstrate non-inferiority of the 
ASES Shoulder Score at 24 months postoperative compared to the benchmark 
literature for Arm A. 
Primary Endpoint – Arm B (Reverse Shoulder Arthroplasty): 
The objective of the clinical investigation is to demonstrate non-inferiority of the 
ASES Shoulder Score at 24 months postoperative compared to the benchmark 
literature for Arm B. 
Secondary Endpoints (for both Arm A and B): 
Information on the following outcomes will be assessed: 
• 
Safety: Incidence of device-related intraoperative and postoperative 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 postoperative scheduled 
clinical evaluations. 
c. 
Subject is male or non-pregnant female and 18 years or older at the time 
of surgery. 
d. 
When used with ReUnion Total Shoulder Arthroplasty (TSA) Humeral & 
Glenoid components as a Hemiarthroplasty or Total Shoulder 
Replacement, subject has one or more of the following: 
• 
Aseptic necrosis of humeral head 
• 
Painful, disabling joint disease of the shoulder resulting from 
degenerative arthritis, rheumatoid arthritis or post-traumatic 
arthritis 
• 
Proximal humeral fracture and/or dislocation 
• 
Clinical management problems where arthrodesis or alternative 
reconstructive techniques are less likely to achieve satisfactory 
results 
• 
Previous unsuccessful total shoulder replacement, resurfacing or 
other procedure 
e. 
When used with ReUnion RSA Humeral & Glenoid Components as a 
primary, fracture or revision total shoulder replacement, 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 
• 
Proximal humeral fracture 
• 
Previously failed shoulder joint replacement 

ReUnion RFX Protocol – Version 2 
 
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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. 
For Total Shoulder Arthroplasty and Hemi-Shoulder Arthroplasty: 
Subject has absent, irreparable or non-functioning rotator cuff and other 
essential muscles. 
 
 
3. General Information and Administrative Structure 
3.1. 
SPONSOR 
Stryker Orthopaedics 
325 Corporate Drive 
Mahwah, NJ 07430 
3.2. 
KEY SPONSOR PERSONNEL 
Emily Arndt 
Study Manager 
Role: Clinical Investigation Manager 
Email: Emily.arndt@stryker.com 
Phone: +1 269 303 7578 
Hanna Schlyter 
Senior Director Clinical Affairs Trauma & Extremities 
Role: Clinical Research Head 
Dr. Stefan Maartense, MD, PhD 
Role: Medical Expert 
3.3. 
EDC SYSTEM 
Name: IBM Clinical Development 
Email: icdhelp@us.ibm.com 
Phone: +1 888 500 4247 

ReUnion RFX Protocol – Version 2 
 
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4. Product Information 
All components of the ReUnion RFX 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 23Nov2016. 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 RFX 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 RFX 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 
Proximal humerus fractures currently represent one of the most difficult surgical procedures in the upper 
extremity. Besides conservative treatment and open reduction and internal fixation (ORIF) with plates or 
intramedullary nails, shoulder arthroplasty represents an alternative treatment option for certain indications. 
Industry currently provides modular options allowing for easy, streamlined intraoperative decision making 
between anatomical hemiarthroplasty (HA), anatomical total shoulder arthroplasty (TSA) and reverse 
shoulder arthroplasty (RSA) as well as the option for later conversion or revision utilizing a prior well- 
fixed humeral stem. 
The ReUnion RFX System is indicated for use as a HA, TSA or RSA. It includes a humeral fracture stem 
component which can be used in conjunction with the ReUnion TSA or ReUnion RSA humeral and glenoid 
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 5-10 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 patients, 
which entails clinical evaluation on a regular ongoing basis, or as needed should the patient become 
symptomatic in the treated joint. The enrollment period is expected to occur over 20 months. 
 
8. Objective 
8.1. 
PRIMARY ENDPOINT – ARM A (TOTAL SHOULDER ARTHROPLASTY / 
HEMIARTHROPLASTY (TSA/HA)) 
Degenerative, rheumatoid or post-traumatic arthritis of the shoulder joint and proximal humerus 
fractures: 

ReUnion RFX Protocol – Version 2 
 
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The primary objective of the clinical investigation is to demonstrate non-inferiority of the ASES Shoulder 
Score at 24 months postoperative compared to the benchmark literature for Arm A. The 24 months mean 
ASES Shoulder Score result of the RFX System (TSA/HA) will be compared to the pooled postoperative 
mean estimate of the control group (58.74 points). The pooled standard deviation of the postoperative 
ASES Shoulder Score result of the benchmark (20.33 points) was used to determine lower limit. The 
lower maximum acceptable difference (-θ) is 38.41 points (mean of control - θ or 58.74 – 20.33 = 38.41 
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 postoperative ASES Shoulder Score results of the ReUnion RFX System (TSA/HA) against the 
value of 38.41 points. 
8.2. 
PRIMARY ENDPOINT – ARM B (REVERSE SHOULDER ARTHROPLASTY (RSA)) 
Degenerative, rheumatoid or post-traumatic arthritis, and gross rotator cuff deficiency of the 
shoulder joint and proximal humerus fractures: 
The primary objective of the clinical investigation is to demonstrate non-inferiority of the ASES Shoulder 
Score at 24 months postoperative compared to the benchmark literature for Arm B. The 24 months mean 
ASES Shoulder Score result of the RFX System (RSA) will be compared to the pooled postoperative 
mean estimate of the control group (74.48 points). The pooled standard deviation of the postoperative 
ASES Shoulder Score result of the benchmark (11.08 points) was used to determine the lower limit. The 
lower maximum acceptable difference (-θ) is 63.40 points (mean of control - θ or 74.48 – 11.08 = 63.40 
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 postoperative ASES Shoulder Score results of the ReUnion RFX System (RSA) against the value 
of 63.40 points. 
8.3. 
SECONDARY ENDPOINTS (FOR BOTH ARM A AND B) 
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 intraoperative and postoperative 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 patient 
population. Subjects will be enrolled onto the study by rolling enrollment until approximately 100 target 
patients are enrolled. All patients 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 evaluations. 
c. Subject is male or non-pregnant female and 18 years or older at the time of surgery. 

ReUnion RFX Protocol – Version 2 
 
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d. When used with ReUnion TSA Humeral & Glenoid components as a Hemiarthroplasty or Total 
Shoulder Replacement, subject has one or more of the following: 
• 
Aseptic necrosis of humeral head 
• 
Painful, disabling joint disease of the shoulder resulting from degenerative arthritis, 
rheumatoid arthritis or post-traumatic arthritis 
• 
Proximal humeral fracture and/or dislocation 
• 
Clinical management problems where arthrodesis or alternative reconstructive 
techniques are less likely to achieve satisfactory results 
• 
Previous unsuccessful total shoulder replacement, resurfacing or other procedure 
e. When used with ReUnion RSA Humeral & Glenoid Components as a primary, fracture or revision 
total shoulder replacement, 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 
• 
Proximal humeral fracture 
• 
Previously failed shoulder joint replacement 
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 severe concomitant disease(s) which may significantly affect the clinical outcome. 
g. For Total Shoulder Arthroplasty and Hemiarthroplasty: Subject has absent, irreparable or non- 
functioning rotator cuff and other essential muscles. 
9.3. 
WITHDRAWAL CRITERIA 
If during the clinical investigation a subject must be prematurely withdrawn, 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. 

ReUnion RFX Protocol – Version 2 
 
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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 RFX 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 
directly caused by, or attributable to, the ReUnion RFX 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 the eligibility criteria 
will be enrolled in this clinical investigation. 
10.2. PROCEDURES 
Subjects in the clinical investigation will undergo placement of the ReUnion RFX System. Please see the 
approved Instructions for Use 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 Preoperative, 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 – 108 weeks) and annually thereafter. The follow-up evaluations will include assessment 
of device-related AEs/incidents, radiographs and ASES Shoulder Score. 

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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, 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 
(+/- 4 weeks) 
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. 
a. 
Follow-up visit schedule to reflect Institution’s 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. Visit windows are calculated from 
index event, and not from previous visit. 
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 
By clinical investigation arm, the 24 months postoperative results for subjects implanted with the ReUnion 
RFX 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 RFX System subjects. Hypotheses are developed for each of the two clinical investigation arms. 
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. 

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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 (benchmark), as measured by the ASES Shoulder Score at 24 Months post- 
operative. 
11.1. DETERMINATION OF SAMPLE SIZE 
The determination of sample size is based on benchmark sources and values. 
 
11.1.1. Sample Size Justification - Arm A (TSA/HA) 
 
Benchmark and Objectives for Clinical Investigation 
Endpoint 
Non-inferiority (equal or better) of the ASES Shoulder Score in relation to the 
officially cleared indications in comparison to respective clinical outcome data 
in the scientific literature. 
Meta-analysis by Shukla et. al., 2016 [1] 
Estimated drop-out 
rate 
56% (confirmed by Medical Expert, see Cuff et al. [2]) 
Benchmark Sources & Values ASES [points] for Arm A (TSA/HA) 
Values from Shukla et. al used that were given for Hemiarthroplasty 
Source 
Mean 
Std. Dev. 
Comments 
No. 
Title 
1 
Sebastia-Forcada, 2014 [3] 
N/A 
N/A 
No ASES score 
2 
Baudi, 2014 [4] 
51.3 
25.4 
3 
Chalmers, 2014 [5] 
66.0 
31.0 
4 
Cuff, 2013 [6] 
62.0 
14.0 
5 
Garrigues, 2012 [7] 
47.4 
12.75 
6 
Young, 2010 [8] 
67.0 
18.5 
7 
Gallinet, 2009 [9] 
N/A 
N/A 
No ASES score 
Identified Cleared Indications (Arm A & B) 
No. 
Indication 
1 
Aseptic necrosis of the humeral head 
2 
Painful, disabling joint disease of the shoulder resulting from degenerative arthritis, rheumatoid 
arthritis or post-traumatic arthritis 
3 
Proximal humeral fractures and/or dislocation 
4 
Clinical management problems where arthrodesis or alternative reconstructive techniques are less 
likely to achieve satisfactory results 
5 
Revision of previous unsuccessful total shoulder replacement, resurfacing or other procedure 
Explorative Analysis - ASES (single group) - for Arm A (TSA/HA) 
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 std. dev. ASES 
58.74 – 20.33 = 38.41 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 RFX Arm A (TSA/HA) (A) ≥ 
Benchmark (B, explorative analysis in this document) 
Hypotheses Pair 
Null (H0) 
A – B < -θ 
Alternative (H1) 
A – B ≥ -θ 
Benchmark Timepoint 
24 months postoperative 
Benchmark no. of sources 
5 
Benchmark Mean 
58.74 (pooled mean ASES [points]) 
Benchmark Std. Dev. 
20.33 (pooled std. dev. ASES [points]) 
Benchmark Value 
Non-Inferiority Margin (-θ) 
Pooled mean ASES minus pooled std. dev. ASES 
58.74 – 20.33 = 38.41 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 58.74 
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 58.74 points with a standard deviation 
of 20.33 points. The observed value will be tested against a theoretical value (constant, non-inferiority 
margin) of 38.41 points. 

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IBM SPSS Sample Power Output – Screenshot 
 
Estimated overall drop-out rate is 56% which leads to the requirement of enrolling an 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 = 5) 
100 subjects 
Table 2a: Sample Size Justification Arm A (TSA/HA) 
 
11.1.2. Sample Size Justification - Arm B (RSA) 
 
Benchmark and Objectives for Clinical Investigation 
Endpoint 
Non-inferiority (equal or better) of the ASES Shoulder Score in relation to the 
officially cleared indications in comparison to respective clinical outcome data 
in the scientific literature. 
Meta-analysis by Shukla et al., 2016 [1] 
Estimated drop-out 
rate 
56% (confirmed by Medical Expert, see Cuff et al. [2]) 
Benchmark Sources & Values ASES [points] for Arm B (RSA) 
Source 
Mean 
Std. Dev. 
Comments 
No. 
Title 
1 
Sebastia-Forcada, 2014 [3] 
N/A 
N/A 
No ASES score 
2 
Baudi, 2014 [4] 
69.3 
25.4 
3 
Chalmers, 2014 [5] 
80.0 
11.0 
4 
Cuff, 2013 [6] 
77.0 
3.75 
5 
Garrigues, 2012 [7] 
81.1 
3.25 
6 
Young, 2010 [8] 
65.0 
12.0 
7 
Gallinet,2009 [9] 
N/A 
N/A 
No ASES score 
Identified Cleared Indications (Arm A & B) 
No. 
Indication 
1 
Aseptic necrosis of the humeral head 
2 
Painful, disabling joint disease of the shoulder resulting from: degenerative arthritis, rheumatoid 
arthritis, or post-traumatic arthritis 
3 
Proximal humeral fractures and/or dislocation 
4 
Clinical management problems where arthrodesis or alternative reconstructive techniques are less 
likely to achieve satisfactory results 
5 
Revision of previous unsuccessful total shoulder replacement, resurfacing or other procedure 
Explorative Analysis - ASES (single group) - for Arm B (RSA) 
Acceptance Criteria 

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Confidence Interval (CI) 
0.95 (95%) two-sided 
Software Used 
IBM SPSS V20 
 
 
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 
74.48 – 11.08 = 63.40 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 RFX Arm B (RSA) (A) ≥ Benchmark 
(B, explorative analysis in this document) 
Hypotheses Pair 
Null (H0) 
A – B < -θ 
Alternative (H1) 
A – B ≥ -θ 
Benchmark Timepoint 
24 months postoperative 
Benchmark no. of sources 
5 
Benchmark Mean 
74.48 (pooled mean ASES [points]) 
Benchmark Std. Dev. 
11.08 (pooled std. dev. ASES [points]) 
Benchmark Value 
Non-Inferiority Margin (-θ) 
Pooled mean ASES minus pooled std. dev. ASES 
74.48 – 11.08 = 63.40 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 74.48 
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 

ReUnion RFX Protocol – Version 2 
 
16 
 
 
 
that the population from which the sample will be drawn has a mean of 74.48 points with a standard deviation 
of 11.08 points. The observed value will be tested against a theoretical value (constant, non-inferiority 
margin) of 63.40 points. 
IBM SPSS Sample Power Output – Screenshot 
 
Estimated overall drop-out rate is 56% which leads to the requirement of enrolling an 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 = 5) 
100 subjects 
 
Table 2b: Sample Size Justification (RSA) 
In conclusion, the calculated number of subjects to be enrolled (10) plus the estimated overall drop-out 
rate of 56% predicts enrollment of 16 subjects (rounded up to 20) per indication. Since the five cleared 
indications and the proposed sample sizes are identical for the two clinical investigation arms, the 
sample size of one indication (n=20) will be multiplied by five to reflect the total underlying subject 
population adequately. As a result, an enrollment target of 100 subjects in total will be aspired (ideally, 
but not necessarily, composed with 20 subjects per indication). 
 
 
11.2. ANALYSIS POPULATIONS 
It is expected during this clinical investigation only one population for ReUnion RFX System per arm 
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 protocol 
violations. The protocol deviations that will exclude a subject are as follows: 
• 
The subject does not receive the ReUnion RFX System 

ReUnion RFX Protocol – Version 2 
 
17 
 
 
• 
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 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 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 be collected according to the schedule in Table 1, 
Schedule of Events. 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 postoperative results for subjects implanted with ReUnion RFX System will be 
compared to a historical group and results reported by respective clinical outcome data in the 
scientific literature. 
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 

ReUnion RFX Protocol – Version 2 
 
18 
 
 
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 postoperative 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%. 
Table 3a: Arm A (TSA/HA) 
 
Hypothesis 
Equations 
Interpretation 
Null (H0) 
A – B < -θ 
Central tendency of A is 
inferior to the central tendency 
of B. 
ReUnion RFX System (TSA/HA) – 
Control (Benchmark) < -θ 
Alternative (H1) 
A – B ≥ -θ 
Central tendency of A is non- 
inferior to the central tendency 
of B. 
ReUnion RFX System (TSA/HA) – 
Control (Benchmark) ≥ -θ 
 
Possible 
Evidence (p) 
Possible 
Decisions 
Possible Conclusions – ASES score 
p-value > α (0.05) 
Fail to reject 
null hypothesis 
(H0) 
ReUnion RFX System (TSA/HA) < 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 RFX System (TSA/HA) ≥ Control 
(Benchmark) 
Sufficient evidence to reject the null hypothesis 
(H0: A – B < -θ) at the pre-determined 
significance level of 5%. 
 
The primary objective of the clinical investigation is to demonstrate non-inferiority of the ASES 
Shoulder Score at 24 months post-operative compared to the benchmark literature for Arm A. 
The 24 months mean ASES Shoulder Score result of the RFX System (TSA/HA) will be 
compared to the pooled postoperative mean estimate of the control group (58.74 points). The 
pooled standard deviation of the post-operative ASES Shoulder Score result of the benchmark 
(20.33 points) was used to determine lower limit. The lower maximum acceptable difference (- 
θ) is 38.41 points (mean of control - θ or 58.74 – 20.33 = 38.41 points). 

ReUnion RFX Protocol – Version 2 
 
19 
 
 
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 postoperative ASES Shoulder Score results of the ReUnion RFX 
System (TSA/HA) against the value of 38.41 points. 
Table 4a: Arm B (RSA) 
 
Hypothesis 
Equations 
Interpretation 
Null (H0) 
A – B < -θ 
Central tendency of A is 
inferior to the central tendency 
of B. 
ReUnion RFX System (RSA) – 
Control (Benchmark) < -θ 
Alternative (H1) 
A – B ≥ -θ 
Central tendency of A is non- 
inferior to the central tendency 
of B. 
ReUnion RFX System (RSA) – 
Control (Benchmark) ≥ -θ 
 
Possible 
Evidence (p) 
Possible 
Decisions 
Possible Conclusions – ASES score 
p-value > α (0.05) 
Fail to reject 
null hypothesis 
(H0) 
ReUnion RFX System (RSA) < 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 RFX System (RSA) ≥ Control 
(Benchmark) 
Sufficient evidence to reject the null hypothesis 
(H0: A – B < -θ) at the pre-determined 
significance level of 5%. 
 
The primary objective of the clinical investigation is to demonstrate non-inferiority of the ASES 
score at 24 months post-operative compared to the benchmark literature for Arm B. The 24 
months mean ASES Shoulder Score result of the RFX System (RSA) will be compared to the 
pooled postoperative mean estimate of the control group (74.48 points). The pooled standard 
deviation of the post-operative ASES Shoulder Score result of the benchmark (11.08 points) 
was used to determine the lower limit. The lower maximum acceptable difference (-θ) is 63.40 
points (mean of control - θ or 74.48 – 11.08 = 63.40 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 postoperative ASES Shoulder Score results of the ReUnion RFX 
System (RSA) against the value of 63.40 points. 

ReUnion RFX Protocol – Version 2 
 
20 
 
 
11.3.3. Secondary Endpoints 
The incidence of device-related AEs and implant survivorship will be assessed up to ten 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 postoperative 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 postoperative 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 RFX Protocol – Version 2 
 
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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 AEs 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. 
• 
Life-Threatening: The AE results in a life-threatening illness or injury. 
• 
Fatal: The AE results in death. 

ReUnion RFX Protocol – Version 2 
 
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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 
 
Insufficient reduction of the greater or lesser tuberosities 
 
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 head 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 or glenoidal 
 
Implant loosening, humeral or glenoidal with or without screw breakage 
 
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 
 
Secondary displacement of the greater or lesser tuberosities 
 
Stiffness 
 
Stress fracture of the acromion or the scapular neck 
 
Stress fracture of the coracoid 
 
Scapular notching, asymptomatic or symptomatic 

ReUnion RFX Protocol – Version 2 
 
23 
 
 
 
Suture granuloma 
 
Heterotopic ossification, asymptomatic or symptomatic 
 
Healing disturbances of subscapularis tenotomy, if applicable 
 
Non-union of lesser tuberosity osteotomy, if applicable 
 
Non-union of primary fracture 
 
Malunion of lesser tuberosity osteotomy, if applicable 
 
Malunion of primary fracture 
 
Wound complications (e.g. hematoma, wound healing disturbances) 
 
Superficial infection 
 
Deep infection 
 
Deep vein thrombosis 
 
Pulmonary embolism 
 
 
14. Revisions, Removals and 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 Site Principal 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 RFX System is not permitted. 
15.1. INSTITUTIONAL 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 RFX Protocol – Version 2 
 
24 
 
 
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, 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 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 postoperative 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/EC guidelines. 

ReUnion RFX Protocol – Version 2 
 
25 
 
 
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 may also 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, 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. Shulka DR, McAnany S, Kim J, Overley S, Parsons BO. Hemiarthroplasty versus reverse shoulder 
arthroplasty for treatment of proximal humeral fractures: a meta-analysis. J Shoulder Elbow Surg. 
2016;25: 330-340. 
2. 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. 
3. Sebastiá-Forcada E, Cebrián-Gómez R, Lizaur-Utrilla A, Gil-Guillén V. Reverse shoulder arthroplasty 
versus hemiarthroplasty for acute proximal humeral fractures. A blinded, randomized, controlled, 
prospective study. J Shoulder Elbow Surg. 2014 Oct;23(10):1419-26. 
4. Baudi P, Campochiaro G, Serafini F, Gazzotti G, Matino G, Rovesta C, Catani F. Hemiarthroplasty 
versus reverse shoulder arthroplasty: comparative study of functional and radiological outcomes in the 
treatment of acute proximal humerus fracture. Musculoskelet Surg. 2014 Apr;98 Suppl 1:19-25. 
5. Chalmers PN, Slikker W 3rd, Mall NA, Gupta AK, Rahman Z, Enriquez D, Nicholson GP. Reverse 
total shoulder arthroplasty for acute proximal humeral fracture: comparison to open reduction-internal 
fixation and hemiarthroplasty. J Shoulder Elbow Surg. 2014 Feb;23(2):197-204. 
6. Cuff DJ, Pupello DR. Comparison of hemiarthroplasty and reverse shoulder arthroplasty for the 
treatment of proximal humeral fractures in elderly patients. J Bone Joint Surg Am. 2013 Nov 
20;95(22):2050-5. 
7. Garrigues GE, Johnston PS, Pepe MD, Tucker BS, Ramsey ML, Austin LS. Hemiarthroplasty versus 
reverse total shoulder arthroplasty for acute proximal humerus fractures in elderly patients. 
Orthopedics. 2012 May;35(5): e703-8. 
8. Young SW, Segal BS, Turner PC, Poon PC. Comparison of functional outcomes of reverse shoulder 
arthroplasty versus hemiarthroplasty in the primary treatment of acute proximal humeral fracture. ANZ 
J Surg. 2010 Nov;80(11):789-93. 
9. Gallinet D, Clappaz P, Garbuio P, Tropet Y, Obert L. Three or four parts complex proximal humerus 
fractures: hemiarthroplasty versus reverse prosthesis: a comparative study of 40 cases. Orthop 
Traumatol Surg Res. 2009 Feb;95(1):48-55. 

ReUnion RFX Protocol – Version 2 
 
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ReUnion RFX Protocol – Version 2 
 
27 
 
 
24. Clinical Investigation Plan Signature Page 
 
 
ReUnion RFX 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 RFX Protocol – Version 2 
 
28 
 
 
25. Document Version History 
 
Version 
Effective Date 
Description 
Revised/Created by 
1 
10Jan2019 
Initial version 
Lindsay Mattfolk 
2 
08Aug2019 
See tracked version for 
description of changes. 
Emily Arndt