Post-Market Evaluation of the Rotation Medical Rotator Cuff System
Phase: NA
Conditions: Partial Thickness Supraspinatus Tendon Tear, Full Thickness Supraspinatus Tendon Tear
Sponsor: Smith & Nephew, Inc.

CONFIDENTIAL                                                                
Protocol No. 2014.05.12, Rev. C 
 
 
 
 
 
 
Post-Market Evaluation of the Rotation 
Medical Rotator Cuff System 
 
 
Protocol Number 2014.05.12 
 
 
REVISION C 
 
January 2018 
 
 
 
 
 
 
 
Rotation Medical, Inc. 
 
15350 25th Avenue North 
Plymouth MN 55447 
 
 
 
 
This study will be conducted in accordance with the protocol and applicable regulatory requirements. 
 
 
 
 
CONFIDENTIAL INFORMATION 
No use or disclosure of information contained within this document is permitted without prior written 
authorization from Rotation Medical, Inc. 
 

CONFIDENTIAL                                                                
Protocol No. 2014.05.12, Rev. C 
 
 
 
 
 
 
 
 
 
 
2
STUDY CONTACT INFORMATION 
 
 
 
 
Study Sponsor: 
 
 
 
Rotation Medical, Inc. 
 
 
 
 
15350 25th Avenue North 
 
 
 
Plymouth, MN 55447 
 
 
 
Study Contact: 
 
 
 
Jeff Grebner 
 
 
 
Rotation Medical, Inc. 
 
 
 
 
15350 25th Avenue North 
 
 
 
Plymouth, MN 55447 
 
 
 
Phone: (763) 746-7502 
 
 
 
Fax: 
(763) 746-7501 
E-mail: jgrebner@rotationmedical.com 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

CONFIDENTIAL                                                                
Protocol No. 2014.05.12, Rev. C 
 
 
 
 
 
 
 
 
 
 
3
ROTATION MEDICAL, INC. 
PROTOCOL SIGNATURE PAGE 
 
 
Post-Market Evaluation of the Rotation Medical 
Rotator Cuff System 
 
PROTOCOL NO. 2014.05.12 
 
 
Revision C 
 
 
January 2018 
 
 
 
I have read this study protocol and the signature below constitutes approval of this protocol and 
any attachments, and provides the necessary assurances that this study will be conducted in 
accordance to all stipulations of the protocol and in compliance with applicable local legal and 
regulatory requirements and applicable U.S. federal regulations including 21 CFR Part 50 
(Protection of Human Subjects) and 21 CFR Part 56 (Institutional Review Boards).    
 
 
 
 
 
 
 
 
 
 
____________________________________ 
Clinical Site Name 
 
 
 
 
_____________________________________ 
 
              _____________________ 
Site Principal Investigator Signature  
 
 
              Date 
 
 
 
_____________________________________ 
Site Principal Investigator Printed Name  

CONFIDENTIAL                                                                
Protocol No. 2014.05.12, Rev. C 
 
 
 
 
 
 
 
 
 
 
4
PROTOCOL STUDY SYNOPSIS 
Title: 
Post-Market Evaluation of the Rotation Medical Rotator Cuff System 
Study Devices: 
Rotation Medical Rotator Cuff System™ 
(Cleared for commercial use by the U.S. Food and Drug Administration: 
K140300; K131637; K131635; K122048) 
Study Design: 
Prospective, non-randomized, post-market study 
Enrollment: 
Up to 150 subjects will be treated  
Inclusion 
Criteria: 
1. At least 21 years of age 
2. Rotator cuff tear requiring surgery that meets either criterion A or B: 
A. Medium or large partial-thickness tear or very small full-thickness tear 
of the supraspinatus tendon planned for standalone treatment (no surgical 
repair with sutures/suture anchors) with the bioinductive implant 
B. Medium or large full-thickness tear primarily of the supraspinatus tendon 
planned for treatment with the bioinductive implant adjunctive to 
surgical repair 
3. Chronic shoulder pain lasting longer than 3 months unresponsive to 
conservative therapy including, but not limited to, pain medication, physical 
therapy and injections 
4. MRI of the shoulder within 60 days prior to the study procedure 
5. Willing to comply with the prescribed post-operative rehabilitation program 
6. Willing to be available for each protocol-required follow-up examination 
7. Able to understand the informed consent process, including regulatory 
requirements such as HIPAA authorization, and document informed consent 
prior to completion of any study-related procedures 
8. Ability to read, understand, and complete subject-reported outcomes in 
English 
Exclusion 
Criteria: 
1. Massive rotator cuff tears (≥ 5 cm) 
2. Acute rotator cuff tears less than 12 months from injury 
3. Previous rotator cuff surgery on the index shoulder 
4. Instability of the index shoulder 
5. Chondromalacia of index shoulder ≥ Grade 3 
6. Fatty infiltration of the index shoulder rotator cuff muscle ≥ Grade 2 
7. Calcification of the index shoulder rotator cuff 
8. Genetic collagen disease 
9. History of insulin dependent diabetes 
10. History of auto-immune or immunodeficiency disorders 
11. History of chronic inflammatory disorders 
12. Oral steroid use in last 2 months or injectable steroid use in last 4 weeks 
13. History of heavy smoking (> 1 pack per day) within last 6 months 
14. Hypersensitivity to bovine-derived materials 
15. Females of child-bearing potential who are pregnant or plan to become 
pregnant during the course of the study 
16. Currently involved in any injury litigation or worker’s compensation claims 
relating to the index shoulder 

CONFIDENTIAL                                                                
Protocol No. 2014.05.12, Rev. C 
 
 
 
 
 
 
 
 
 
 
5
17. Enrolled, or plans to enroll, in another clinical trial during this study that 
would affect the outcomes of this study 
18. History of non-compliance with medical treatment, physical 
therapy/rehabilitation, or clinical study participation 
19. History of cognitive or mental health status that interferes with study 
participation 
Study 
Objective: 
To evaluate bioinduction of new tissue and tendon healing after implantation of 
the Rotation Medical Bioinductive Implant used as either a standalone device or 
adjunct to surgical repair in the treatment of supraspinatus tendon tears. 
Primary 
Outcomes: 
MRI assessment of the following: 
1. Increase in tendon thickness 
2. Integration of induced tissue with the underlying tendon and maturation of 
the induced tissue  
3. Amount of defect fill-in and characteristics of both the filled-in tissue within 
the tendon tear and underlying tendon (nonsurgically-repaired tears only) 
4. Rotator cuff re-tear rate 
Secondary 
Outcomes: 
1. Safety 
2. Procedure parameters 
3. Change in American Shoulder and Elbow Society (ASES) scale 
4. Change in Constant-Murley Shoulder score 
5. Recovery 
6. Subject satisfaction 
Study 
Assessments 
Baseline 
Procedure 
Post-procedure follow-up: 3 months, 1 year, 2 years 
Sponsor: 
Rotation Medical, Inc. 
15350 25th Avenue North 
Plymouth MN 55447 
Data 
Management 
and 
Monitoring: 
Rotation Medical, Inc. 
15350 25th Avenue North 
Plymouth MN 55447 

CONFIDENTIAL 
 
Protocol No. 2014.05.12, Rev. C 
 
 
 6 
TABLE OF CONTENTS 
1 
INTRODUCTION & RATIONALE .................................................................................................................. 8 
2 
DEVICE DESCRIPTION ................................................................................................................................... 9 
2.1 
DEVICE DESCRIPTION ..................................................................................................................................... 9 
2.2 
PRINCIPLES OF OPERATION ........................................................................................................................... 10 
3 
STUDY OBJECTIVE ........................................................................................................................................ 10 
4 
STUDY DESIGN ............................................................................................................................................... 11 
4.1 
SAMPLE SIZE ................................................................................................................................................ 11 
4.2 
STUDY DURATION ........................................................................................................................................ 11 
4.3 
PRIMARY OUTCOME MEASURES ................................................................................................................... 11 
4.3.1 
Increase in Tendon Thickness .............................................................................................................. 11 
4.3.2 
Integration and Maturation of New Tissue .......................................................................................... 11 
4.3.3 
Fill-In of Partial-Thickness Tears and Underlying Tendon Quality .................................................... 11 
4.3.4 
Re-tear Rate ......................................................................................................................................... 11 
4.4 
SECONDARY OUTCOME MEASURES .............................................................................................................. 12 
4.4.1 
Safety ................................................................................................................................................... 12 
4.4.2 
Procedure Parameters ......................................................................................................................... 12 
4.4.3 
Change in American Shoulder and Elbow Society (ASES) Scale ........................................................ 12 
4.4.4 
Change in Constant-Murley (Constant) Shoulder score ...................................................................... 12 
4.4.5 
Recovery .............................................................................................................................................. 13 
4.4.6 
Subject Satisfaction .............................................................................................................................. 13 
5 
STATISTICAL ANALYSIS PLAN ................................................................................................................. 13 
5.1 
HYPOTHESIS TESTING, SAMPLE SIZE AND POWER ........................................................................................ 13 
5.2 
INTERIM ANALYSES ...................................................................................................................................... 14 
6 
ELIGIBILITY CRITERIA ............................................................................................................................... 14 
6.1 
INCLUSION CRITERIA .................................................................................................................................... 14 
6.2 
EXCLUSION CRITERIA ................................................................................................................................... 14 
7 
STUDY ASSESSEMENTS ............................................................................................................................... 15 
TABLE 7-1: SCHEDULE OF STUDY ASSESSMENTS ....................................................................................... 16 
7.1 
ELIGIBILITY ASSESSMENT ............................................................................................................................ 16 
7.2 
ENROLLMENT ............................................................................................................................................... 16 
7.3 
BASELINE ASSESSMENT ................................................................................................................................ 17 
7.4 
PROCEDURE ASSESSMENT ............................................................................................................................ 17 
7.5 
PROCEDURE RULES ...................................................................................................................................... 17 
7.6 
POST-OPERATIVE CARE ................................................................................................................................ 18 
TABLE 7-2: POST-OPERATIVE REHABILITATION GUIDELINES ............................................................. 18 
7.7 
FOLLOW-UP ASSESSMENTS ........................................................................................................................... 19 
7.7.1 
3-Month (± 15 Days) Follow-Up ......................................................................................................... 19 
7.7.2 
1-Year (± 45 Days) Follow-Up ............................................................................................................ 19 
7.7.3 
2-Year (± 90 Days) Follow-Up ............................................................................................................ 20 
7.8 
UNSCHEDULED FOLLOW-UP ......................................................................................................................... 20 
7.9 
REVISION/ADDITIONAL SHOULDER SURGERY .............................................................................................. 20 
7.10 
EARLY WITHDRAWAL OR LOST TO FOLLOW-UP .......................................................................................... 21 
7.11 
END OF STUDY ............................................................................................................................................. 21 
8 
ADVERSE EVENT DEFINITIONS AND REPORTING.............................................................................. 21 
8.1 
DEFINITION OF ADVERSE EVENT (AE) ......................................................................................................... 21 

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Protocol No. 2014.05.12, Rev. C 
 
 
 7 
8.2 
SERIOUS ADVERSE EVENT (SAE) ................................................................................................................. 21 
8.3 
UNANTICIPATED ADVERSE DEVICE EFFECT (UADE) ................................................................................... 22 
8.4 
ASSESSING, RECORDING AND REPORTING AES, SAES, AND UADES ........................................................... 22 
9 
MALFUNCTIONS ............................................................................................................................................ 22 
10 
PROTOCOL DEVIATIONS ........................................................................................................................ 22 
11 
REPORTING REQUIREMENTS ............................................................................................................... 23 
12 
RISKS AND BENEFITS ............................................................................................................................... 23 
12.1 
RISKS AND RISK MITIGATION ....................................................................................................................... 23 
12.2 
BENEFITS ...................................................................................................................................................... 24 
13 
DATA MANAGEMENT ............................................................................................................................... 24 
13.1 
DATA COLLECTION ...................................................................................................................................... 24 
13.2 
DATA PROCESSING ....................................................................................................................................... 24 
14 
ADMINISTRATIVE RESPONSIBILITIES ............................................................................................... 25 
14.1 
SITE AND INVESTIGATOR SELECTION ........................................................................................................... 25 
14.2 
TRAINING ..................................................................................................................................................... 25 
14.3 
INSTITUTIONAL REVIEW BOARD (IRB) / ETHICS COMMITTEE (EC).............................................................. 25 
14.4 
INFORMED CONSENT FORM (ICF) ................................................................................................................ 25 
14.5 
CONFIDENTIALITY ........................................................................................................................................ 26 
14.6 
AMENDING THE PROTOCOL .......................................................................................................................... 26 
14.7 
CRITERIA FOR TERMINATING STUDY ............................................................................................................ 26 
14.8 
CRITERIA FOR TERMINATING AN INVESTIGATIONAL CENTER ....................................................................... 26 
14.9 
SPONSOR RESPONSIBILITIES ......................................................................................................................... 27 
14.10 INVESTIGATOR RESPONSIBILITIES ................................................................................................................ 27 
15 
MONITORING AND AUDITING ............................................................................................................... 28 
16 
REPORTS AND RECORDS ........................................................................................................................ 28 
16.1 
REPORTS ....................................................................................................................................................... 28 
16.2 
RECORDS ...................................................................................................................................................... 28 
17 
USE OF INFORMATION AND PUBLICATION ...................................................................................... 28 
18 
REFERENCES .............................................................................................................................................. 28 
 
 

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Protocol No. 2014.05.12, Rev. C 
 
 
 8 
1 
INTRODUCTION & RATIONALE 
Musculoskeletal disorders are one of the most common causes of disability in the United 
States with approximately 50% of the adult population having experienced a chronic 
musculoskeletal condition lasting longer than 3 months.1  After knee-related disorders, 
shoulders are the second most common joint causing chronic pain with an estimated 18.9 
million adults affected.  The direct cost of treating shoulder pain is approximately $7 
billion annually and this figure excludes the indirect cost burden (i.e., missed work, lost 
productivity).1  With age, the prevalence of rotator cuff disease increases with an 
estimated 50% of individuals over 66 years of age having bilateral rotator cuff tears.2,3 
Recent demographic and morphological studies of rotator cuff tears also show that these 
defects increase in size with time and painful tears tend to be larger than asymptomatic 
tears.2,4 
Persistent shoulder pain concomitant with a rotator cuff tendon tear is currently treated 
with arthroscopic subacromial decompression (ASD) with or without cuff repair 
depending on the size and morphology of the cuff tear. Decompression alone leaves the 
tendon tear structurally unmodified and does not prevent rotator cuff tear progression.5,6,7  
Cuff repair as a treatment for rotator cuff tears often requires the resection of tendon from 
the bone and re-attachment using suture anchors.8,9,10  Estimates of re-tear rates following 
the completion and repair of small tears have been reported between 10% and 36%.8,9,11 
Peri-operative morbidity and post-operative rehabilitation associated with rotator cuff 
tendon repair is more extensive for the patient than ASD alone.7 
The Rotation Medical Bioinductive Implant is a bioabsorbable device that provides a 
layer of collagen over injured tendons.  This device is indicated for the management and 
protection of tendon injuries in which there has been no substantial loss of tendon tissue 
and can be implanted either during mini-open or arthroscopic procedures.  The device 
was first evaluated in a preclinical study of 23 sheep that was approved by the Colorado 
State University Institutional Animal Care and Use Committee.  The device did not elicit 
an inflammatory response or a foreign body reaction and histological analyses confirmed 
the device was completely absorbed after six months with integration of the new 
tendinous tissue to the underlying host tendon and a fibrocartilagenous transition zone at 
the tendon-to-bone insertion site.  Tendon thickness at the implant site increased by 
approximately 2.5 millimeters due to induction of new tendinous tissue and remained 
stable one year after surgery.12 
The Rotation Medical Bioinductive Implant was further evaluated in a clinical study of 
24 subjects who underwent implantation of the device and completed a minimum of one 
year follow-up.  This study was approved by the Northern Sydney Central Coast Ethics 
Committee and registered in the Australian New Zealand Clinical Trials Registry 
[#ACTRN12611001082998].  The procedure was performed arthroscopically in 14 
subjects while the other 10 subjects underwent a mini-open procedure. The median 
implant time was 15 minutes and all subjects were successfully implanted with no intent-
to-treat failures.  One patient experienced a return to pain 12 months after surgery that 
was associated with significant bursitis and an arthroscopic clean-up procedure was 
performed to debride the bursa.  Despite the bursal reaction in this patient, tendon healing 
and tissue induction were not compromised. 

CONFIDENTIAL 
 
Protocol No. 2014.05.12, Rev. C 
 
 
 9 
Magnetic resonance imaging (MRI) at 3, 6, and 12 months after surgery provided 
evidence that the device consistently induced the formation of new, tendinous tissue that 
appeared well-integrated with each patient’s native tendon tissue and showed progressive 
maturation over time.  MRI observations were consistent with the histological results 
from prior sheep studies.13 Shoulder function and pain was also assessed at 3, 6 and 12 
months after treatment using the ASES (American Shoulder and Elbow Surgery) and 
Constant (Constant-Murley) standard shoulder surveys.14,15  All of the scores at 12 
months were significantly improved from baseline (p < 0.05) and improvement was 
comparable to published literature.16   
2 
DEVICE DESCRIPTION 
2.1 
DEVICE DESCRIPTION 
There are three implantable components in the Rotation Medical Rotator Cuff System™ 
(Figure 2-1). 
1. Bioinductive implant:  The device is made from highly purified reconstituted 
collagen fibers derived from bovine tendon and manufactured for Rotation Medical, 
Inc. by Collagen Matrix, Inc. (Oakland, New Jersey, USA). It is contraindicated for 
use in patients with a history of hypersensitivity to bovine-derived materials and this 
is an exclusion criterion for study participation. The device is designed to completely 
absorb within six to 12 months. 
2. Tendon staples:  The tendon staples are made from poly(L-lactide-co-D,L-lactide) in 
a molar ratio of 70% L-lactide to 30% D,L-lactide.  Polylactide materials have been 
used in a variety of medical devices, such as bone anchors, bone pins, screws, plates, 
and spinal fusion cages. The tendon staples are designed to completely absorb within 
approximately 12 months. 
3. Bone staples:  The bone staples are made from polyetheretherketone (PEEK), which 
is a common polymer used for bone anchors in orthopedic surgery. The bone staples 
are not bioabsorbable. 
The Rotation Medical Rotator Cuff System has been cleared by the U.S. Food and Drug 
Administration (FDA) [K140300; K122048; K131635; K131637].  The purpose of this 
post-market study is to collect and analyze outcomes data under a common protocol. 
 
 

CONFIDENTIAL 
 
Protocol No. 2014.05.12, Rev. C 
 
 
 10 
Figure 2-1: Rotation Medical Implantable System Components 
 
 
The tendon and bone staplers used to affix the bioinductive implant to tendon tissue and 
the head of the humerus respectively are shown in Figure 2-2.  These are designed as 
single-use devices. 
Figure 2-2: Rotation Medical Single-Use Disposable Staplers 
 
 
Tendon stapler 
Bone stapler 
 
2.2 
PRINCIPLES OF OPERATION 
No investigational devices or procedures will be used in this post-market study and all 
devices will be used according to their indications for use.  Operation, indication, and 
instructions for use are described in the Instructions for Use (IFUs). 
3 
STUDY OBJECTIVE 
To evaluate bioinduction of new tissue and tendon healing after implantation of the 
Rotation Medical Bioinductive Implant used as either a standalone device or adjunct to 
surgical repair in the treatment of supraspinatus tendon tears. 
Bioinductive 
implant 
Tendon 
staple 
Bone 
staple 

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Protocol No. 2014.05.12, Rev. C 
 
 
 11 
4 
STUDY DESIGN 
This is a prospective, non-randomized, single-arm multi-center study conducted under a 
common protocol designed to evaluate long-term outcomes following arthroscopic or 
mini-open implantation of the Rotation Medical Bioinductive Implant to treat high-grade 
partial thickness or small/medium/large (i.e. non-massive) full-thickness rotator cuff tears 
primarily involving the supraspinatus tendon. 
4.1 
SAMPLE SIZE 
Up to 150 subjects will be enrolled and treated with the Rotation Medical Rotator Cuff 
System at up to 15 study sites in the United States. 
4.2 
STUDY DURATION 
Enrollment is anticipated to take up to 12 months and all subjects will be followed for 
two years after surgery.  Therefore, the overall study duration is estimated to be 36 
months. 
4.3 
PRIMARY OUTCOME MEASURES 
4.3.1 Increase in Tendon Thickness 
Supraspinatus tendon thickness will be measured pre-operatively (baseline) and the total 
thickness of the tendon and any newly induced tissue at the implant site will be measured 
at each follow-up visit using magnetic resonance imaging (MRI).  The mean (± SD) 
change in post-operative supraspinatus tendon thickness will be calculated at each 
follow-up interval.  
4.3.2 Integration and Maturation of New Tissue 
Integration and maturation of the newly induced tissue will be assessed by MRI at each 
post-operative follow-up. This outcome will assess, at a minimum, the following 
characteristics of the newly induced tissue: (i) presence or absence of a clear boundary 
between the device and the underlying tendon; (ii) presence or absence of a clear 
boundary between the newly induced tissue and the overlying deltoid muscle; (iii) 
maturation of newly induced tissue to resemble characteristics of underlying tendon 
tissue (versus debris or artifact). 
4.3.3 Fill-In of Partial-Thickness Tears and Underlying Tendon Quality 
For tendon defects treated by standalone use of the device (i.e., implantation without 
surgical repair using sutures/suture anchors), post-operative follow-up MRIs will be used 
to estimate the amount of defect fill-in with newly induced tissue and the quality of the 
filled-in tissue.  In the absence of fill-in with newly induced tissue, defect progression 
(i.e., change in size relative to previous MRIs) will be assessed. 
4.3.4 Re-tear Rate 
Re-tear following rotator cuff repair will be assessed at each follow-up visit using MRI. 
Any new observable defect (i.e. loss in supraspinatus tendon continuity) will be classified 
as a re-tear. 

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Protocol No. 2014.05.12, Rev. C 
 
 
 12 
4.4 
SECONDARY OUTCOME MEASURES 
4.4.1 Safety 
Safety will be evaluated by any of the following adverse events that occur over the 
duration of the study:  
1. Any death 
2. All serious adverse events (SAE) regardless of relation to the device or procedure 
3. Any non-serious adverse event (AE) that is classified as either device or procedure-
related  
4. Any unanticipated adverse device effect (UADE) 
Adverse events will be summarized by relation to the study devices or study procedure.  
Overall occurrence rate by event type will also be calculated. 
4.4.2 Procedure Parameters 
The following procedural parameters will be recorded on all subjects: 
1. Device implant time: Mean (± SD) implant time defined as follows: 
Arthroscopic procedure: Time from introduction of the guide wire instrument into the 
subacromial space to completion of last staple 
Mini-open procedure: Time from introduction of the bioinductive implant into the 
subacromial space to completion of the last staple 
2. Procedure technical success: The proportion of subjects where the device was 
successfully delivered and affixed to target tendon location. 
3. Device implant position: An intra-operative photograph(s) or video recording 
showing the implant location of the device and all tendon and bone staples will be 
obtained. 
4.4.3 Change in American Shoulder and Elbow Society (ASES) Scale 
The mean (± SD) overall patient-reported ASES score (Range: 0 to 100) will be 
calculated at baseline and each subsequent follow-up.  In addition, matched-pair analyses 
between baseline and successive follow-up visits will be performed to determine the 
mean (± SD) change in overall ASES score after surgery.  Mean (± SD) overall shoulder 
pain from the ASES survey (Range: 0-10) will also be analyzed separately at baseline and 
each post-operative follow-up visit. 
4.4.4 Change in Constant-Murley (Constant) Shoulder score 
The mean (± SD) overall Constant score (Range: 0 to 100) will be calculated at baseline 
and each subsequent follow-up.  In addition, matched-pair analyses between baseline and 
successive follow-up visits will be performed to determine the mean (± SD) change in 
overall Constant score after surgery.  Mean (± SD) overall shoulder pain from the 
Constant survey (Range: 0-15) will also be analyzed separately at baseline and each post-
operative follow-up visit. 
 

CONFIDENTIAL 
 
Protocol No. 2014.05.12, Rev. C 
 
 
 13 
4.4.5 Recovery 
The following post-operative recovery parameters will be reported after discharge 
from the from study procedure: 
1. Sling time: cumulative number of days (mean ± SD) index shoulder is in a sling 
2. Rehabilitation time: cumulative number of completed rehabilitation or physical 
therapy (PT) visits (mean ± SD) to treat index shoulder 
3. Return to work: cumulative number of days (mean ± SD) between discharge and 
return to work (employed subjects only) 
4. Return to normal daily activities (i.e. full, unrestricted activity): cumulative number 
of days (mean ± SD) between discharge and return to normal daily activity 
4.4.6 Subject Satisfaction 
Subject satisfaction is a self-reported measure of satisfaction with the outcome of the 
index surgery.  The level of satisfaction is assessed with a 5-point Likert scale.  Each 
subject will also be asked to indicate whether (s)he would recommend the study 
procedure to a friend (“yes/no”).  
5 
STATISTICAL ANALYSIS PLAN 
5.1 
HYPOTHESIS TESTING, SAMPLE SIZE AND POWER 
This is a single-arm, non-blinded study.  The primary, quantitative endpoint is increase in 
thickness of the supraspinatus tendon at the device implant location. 
The hypothesis being tested is that the overall thickness of the supraspinatus tendon 
increases by a minimum threshold identified as the objective performance criterion 
(OPC): 
HO:  d ≤ OPC 
HA:  d > OPC; 
where “d” is the difference in supraspinatus tendon thickness at the location of the device 
at each follow-up interval (Follow-Up – Baseline). 
Based upon finite element analysis (FEA) modelling, the theoretical reduction in tendon 
microstrains from the addition of 2 millimeters of new tendinous tissue at the tear site is 
40% for articular-sided, partial thickness tears and 47% for bursal-sided tears.  Data from 
clinical use of the device demonstrated a mean increase in tendon thickness of 2.39 ± 
0.95 millimeters at one year.13 
Sample size was estimated using PASS 200817 and a one-sided one-sample t-test.  The 
one-sided alpha level was set at 0.025.  The value of d (mean of outcome measure) was 
set at 2 millimeters.  Sample size calculations were made using powers of 80%, 85% and 
90% and a one-sided alpha of 0.025 (non-inferiority; alpha-splitting) using a one-sample t-
test. 
 
Using a minimum OPC of 1.0 millimeter, a standard deviation of 1.0 millimeter, and 90% 
power, a total sample size of 13 subjects is adequate to test this hypothesis.  Although 
adequate power is obtained with 13 subjects, to adjust for attrition and allow up to 30 
evaluable subjects at 24-month follow-up meeting inclusion criterion 2A and another 30 
evaluable subjects meeting inclusion criterion 2B, up to 150 subjects will be enrolled. 

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Protocol No. 2014.05.12, Rev. C 
 
 
 14 
5.2 
INTERIM ANALYSES 
Interim analyses may be conducted any time to ensure site compliance with the protocol, 
evaluate outcomes, meet applicable reporting requirements (e.g., possible IRB annual 
reports, etc.), or present/publish interim results.  Subgroup analyses may be performed to 
assess outcomes based upon subject demographics, type/size of rotator cuff tear, type of 
procedure performed, or other variables that may affect study outcomes.  Additionally, 
analyses may be stratified by study site or Investigator as necessary to support Sponsor, 
Investigator, or site publication plans (Section 17). 
6 
ELIGIBILITY CRITERIA 
Subjects who meet all inclusion criteria (Section 6.1) and none of the exclusion criteria 
(Section 6.2) will be eligible to participate in the study. 
Enrollment in the study occurs upon intra-operative confirmation that the subject meets 
all of the inclusion criteria and none of the exclusion criteria.  Subjects who meet 
eligibility criteria and are enrolled will be followed per protocol through the end of the 
study (i.e., intent-to-treat).  Subjects who do not meet the study eligibility criteria at the 
time of surgery will not be enrolled.  
6.1 
INCLUSION CRITERIA 
Subjects enrolled in the study MUST meet all of the following criteria: 
1. At least 21 years of age 
2. Rotator cuff tear requiring surgery that meets either criterion A or B: 
A. Medium or large partial-thickness tear or very small full-thickness tear of the 
supraspinatus tendon planned for standalone treatment (no surgical repair with 
sutures/suture anchors) with the bioinductive implant 
B. Medium or large full-thickness tear primarily of the supraspinatus tendon planned 
for treatment with the bioinductive implant adjunctive to surgical repair 
3. Chronic shoulder pain lasting longer than 3 months unresponsive to conservative 
therapy including, but not limited to, pain medication, physical therapy and injections 
4. MRI of the shoulder within 60 days prior to the study procedure 
5. Willing to comply with the prescribed post-operative rehabilitation program 
6. Willing to be available for each protocol-required follow-up examination 
7. Able to understand the informed consent process, including regulatory requirements 
such as HIPAA authorization, and document informed consent prior to completion of 
any study-related procedures 
8. Ability to read, understand, and complete subject-reported outcomes in English 
6.2 
EXCLUSION CRITERIA 
Subjects enrolled in the study MUST NOT meet any of the following criteria: 
1. Massive rotator cuff tears (≥ 5 cm) 
2. Acute rotator cuff tears less than 12 months from injury 
3. Previous rotator cuff surgery on the index shoulder 
4. Instability of the index shoulder 
5. Chondromalacia of index shoulder ≥ Grade 3 
6. Fatty infiltration of the index shoulder rotator cuff muscle ≥ Grade 2 

CONFIDENTIAL 
 
Protocol No. 2014.05.12, Rev. C 
 
 
 15 
7. Calcification of the index shoulder rotator cuff 
8. Genetic collagen disease 
9. History of insulin dependent diabetes 
10. History of auto-immune or immunodeficiency disorders 
11. History of chronic inflammatory disorders 
12. Oral steroid use in last 2 months or injectable steroid use in last 4 weeks 
13. History of heavy smoking (> 1 pack per day) within last 6 months 
14. Hypersensitivity to bovine-derived materials 
15. Females of child-bearing potential who are pregnant or plan to become pregnant during 
the course of the study 
16. Currently involved in any injury litigation or worker’s compensation claims relating to 
the index shoulder 
17. Enrolled, or plans to enroll, in another clinical trial during this study that would affect 
the outcomes of this study 
18. History of non-compliance with medical treatment, physical therapy/rehabilitation, or 
clinical study participation 
19. History of cognitive or mental health status that interferes with study participation  
 
7 
STUDY ASSESSEMENTS 
The schedule of protocol-required study assessments is provided in Table 7.1.  Adverse 
event (AE) reporting as required and defined in Section 8 begins at the time of enrollment 
(i.e. intra-operative confirmation of eligibility) and concludes at the end of the study. 
 
 
 

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Protocol No. 2014.05.12, Rev. C 
 
 
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Table 7-1: Schedule of Study Assessments  
Study Evaluation 
Baseline 
Procedure 
3-Month 
1 Year 
2 Year 
Within 60 
Days of 
Surgery 
Within 60 
Days of 
Baseline 
± 15 days 
± 45 days 
± 90 days 
Informed Consent 
 
 
 
 
 
Medical History & Exam 
 
 
 
 
 
Eligibility Assessment 
 
1 
 
 
 
Enrollment (Date of Surgery) 
 
 
 
 
 
MRI 
2 
 
2 
2 
2 
ASES Survey 
3 
 
3 
3 
3 
Constant-Murley Survey 
 
 
 
 
 
Procedure Data 
 
 
 
 
 
Medications 
4 
4 
4 
4 
4 
Adverse Events 
 
5 
5 
5 
5 
Recovery/Satisfaction 
Questionnaire 
 
 
 
 
 
Revision/Additional 
Shoulder Surgery 
 
 
6 
6 
6 
1Eligibilty confirmation will be performed at the time of the study surgery to ensure the rotator cuff tear 
location/size meets eligibility criteria.  Patients whose rotator cuff tears do not meet study eligibility 
criteria will not be enrolled in the study. 
2Each study MRI must be performed in accordance with the MRI study guideline. 
3The ASES-Patient Assessment is required.  The ASES-Physician Assessment (ROM; strength) is optional 
as strength and ROM assessments are included in the Constant-Murley survey. 
4Only prescription medications to treat the index shoulder will be recorded. 
5Non-serious AEs will only be recorded if they are classified as either possibly or definitely related to 
either the study device or the study procedure. 
6Any additional surgical intervention performed on the index shoulder will be reported. 
 
7.1 
ELIGIBILITY ASSESSMENT 
Subjects are considered eligible for this study if they meet all of the inclusion criteria and 
none of the exclusion criteria as defined in Section 6.1 and Section 6. 2.  The Investigator, 
co-Investigator, or sub-Investigator performing the study surgery will confirm eligibility at 
the time of the study surgery based upon intra-operative evaluation of the rotator cuff tear 
characteristics.   
7.2 
ENROLLMENT 
Enrollment in the study occurs upon intra-operative confirmation that the subject meets all 
of the inclusion criteria and none of the exclusion criteria.  Patients whose rotator cuff 
tears do not meet study eligibility criteria at the time of the study procedure will 
undergo tendon repair at the discretion of the surgeon (with or without use of the 
Rotation Medical Rotator Cuff System) and will not be enrolled in the study.  
Subjects who meet eligibility criteria will be considered enrolled into the study regardless 
of whether or not the device was successfully implanted.  The date of the study surgery is 

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Protocol No. 2014.05.12, Rev. C 
 
 
 17 
defined as the enrollment date and all subjects who are enrolled in the study will be 
followed per protocol unless voluntary consent is withdrawn.  All subjects enrolled into 
the study will be identified through a unique identifier.   
7.3 
BASELINE ASSESSMENT 
The following activities must be conducted within 60 calendar days prior to enrollment: 
1. Obtain written informed consent. 
2. Obtain a medical history. 
3. Perform an MRI per the Sponsor imaging guidelines. 
• Provide the Sponsor with a de-identified digital copy of, or access to, the MRI. 
4. Assess subject eligibility based on inclusion/exclusion criteria defined in Section 6.1 
and 6.2. 
5. Administer the Constant-Murley shoulder survey. 
• Range of motion (ROM) should be measured with a goniometer and strength 
should be measured with a dynamometer. 
6. Administer the ASES shoulder survey. 
• Completion of the ASES patient assessment section is required.  Completion of 
the ASES physician assessment section is optional since ROM and strength are 
assessed during administration of the Constant-Murley survey. 
7. 
Record prescription medications. 
• Record any prescription medications the subject is taking at the time of the 
baseline visit to treat his/her index shoulder. 
All baseline assessments will be documented on their respective Case Report Forms 
(CRFs). 
7.4 
PROCEDURE ASSESSMENT 
During the study procedure, use of any biological agents or implants aimed at augmenting 
tendon-to-bone healing, excluding the Rotation Medical Rotator Cuff System, are strictly 
prohibited.  Intra-operative data along with the following study-specific procedure 
information will be documented on the Procedure CRF: 
1. Device implant time 
2. Procedure technical success 
3. Device implant position 
• After implantation of the device, an intra-operative photograph(s) or video 
recording showing the implant location of the device and all tendon and bone 
staples will be obtained. 
4. Intra-operative complication (if applicable; per Section 8) 
 
Additionally, health insurance claim forms from the study surgical procedure (e.g., UB-04) 
will be collected by the Sponsor.  Each claim form will be de-identified and serve as its 
own source document. 
7.5 
PROCEDURE RULES 
Subjects should be scheduled to undergo the study procedure within 60 days of baseline 
assessment.  Device implantation will be performed in accordance with the Rotation 
Medical Rotator Cuff System device and instrument Instructions for Use (IFUs) and may 

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Protocol No. 2014.05.12, Rev. C 
 
 
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be performed as either a mini-open or arthroscopic procedure as determined by the 
surgeon and subject.   
Subjects with medium or large partial-thickness tears or very small full-thickness tears of 
the supraspinatus tendon will undergo standalone device implantation without surgical 
repair of the tear. 
Subjects with medium or large full-thickness tears primarily of the supraspinatus tendon 
will undergo device implantation adjunctive to surgical repair of the tear with 
sutures/suture anchors. 
All subjects, regardless of supraspinatus tear size, will undergo acromioplasty and 
bursectomy.  Removal of the periosteum at the lateral edge of the supraspinatus footprint 
is recommended to allow visualization of the footprint and facilitate proper device 
positioning.  Debridement of the tendon may also be performed at the discretion of the 
surgeon. 
Concomitant surgical treatment of the biceps tendon (i.e., tenotomy, tenodesis) and 
coracoacromial ligament (CA) release are also permitted during the study surgery at the 
discretion of the surgeon.  If any other concurrent rotator cuff or shoulder surgeries not 
specified in this protocol are performed after the subject has been enrolled, a protocol 
deviation will be documented on the Protocol Deviation CRF.  Wound closure is 
performed using standard methods. 
If the physician determines intra-operatively that the rotator cuff tendon tear size or 
quality of tissue surrounding the tear does not meet study eligibility criteria, or determines 
additional concomitant surgery beyond what is permitted per protocol is required to 
provide the best surgical outcome for the subject, the subject will not be enrolled in the 
study.  
7.6 
POST-OPERATIVE CARE 
Post-operative care, including discharge instructions, pain management, and 
frequency/duration of physical therapy/rehabilitation regimen are at the discretion of the 
surgeon.  To minimize the likelihood that the integrity or position of the device is 
compromised after implant, recommended rehabilitation guidelines are provided in Table 
7.2.  
 
Table 7-2: Post-operative Rehabilitation Guidelines  
Study Procedure 
Rehabilitation Guidelines 
Device implant 
only; without 
surgical repair 
• Discard sling when comfortable 
• Progression of motion as tolerated (Passive to Active Assisted to Active) 
• 1st 4 Weeks: Forward flexion limited from 0o to 100o 
• 1st 6 Weeks: External rotation with arm by side (No ABER) 
• After 6 Weeks: No restrictions of motion or arm use 
Device implant 
with surgical 
repair 
• Follow protocol for post-op surgical rotator cuff repair 
• No additional requirements for the device 

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Subjects who undergo device implantation without rotator cuff repair should follow a 
rehabilitation course consistent with arthroscopic subacromial decompression (ASD) 
alone, but with limitations on forward flexion and external rotation in abduction (ABER).  
Subjects who undergo device implantation with cuff repair should follow a rehabilitation 
course consistent with standard rotator cuff repair. 
7.7 
FOLLOW-UP ASSESSMENTS 
All subjects will undergo post-operative study assessments at 3 months, 1 year, and 2 years 
after discharge from the study procedure as described below and summarized in Table 7.1. 
7.7.1 3-Month (± 15 Days) Follow-Up 
1. 
Perform an MRI per the Sponsor imaging guidelines. 
• Provide the Sponsor with a de-identified digital copy of, or access to, the MRI. 
2. 
Administer the Constant-Murley shoulder survey. 
• Range of motion (ROM) should be measured with a goniometer and strength 
should be measured with a dynamometer.  NOTE: Strength or ROM testing 
at 3-Month Follow-Up may not be possible due to subject discomfort or 
ongoing rehabilitation and therefore missed or incomplete strength or ROM 
testing at this visit will not be considered as a protocol deviation.  
3. 
Administer the ASES shoulder survey. 
• Completion of the ASES patient assessment section is required.  Completion of 
the ASES physician assessment section is optional since ROM and strength 
are assessed during administration of the Constant-Murley survey. 
4. 
Administer the recovery/satisfaction questionnaire. 
5. 
Record prescription medications. 
• Record any prescription medications the subject is taking at the time of the 
follow-up visit to treat his/her index shoulder. 
6. 
Record any new adverse events and update the status of any ongoing, previously-
reported adverse events. 
7. 
Report any new revision/additional shoulder surgeries performed on the index 
shoulder. 
7.7.2 1-Year (± 45 Days) Follow-Up 
1. 
Perform an MRI per the Sponsor imaging guidelines. 
• Provide the Sponsor with a de-identified digital copy of, or access to, the MRI. 
2. 
Administer the Constant-Murley shoulder survey. 
• Range of motion (ROM) should be measured with a goniometer and strength 
should be measured with a dynamometer. 
3. 
Administer the ASES shoulder survey. 
• Completion of the ASES patient assessment section is required.  Completion of 
the ASES physician assessment section is optional since ROM and strength 
are assessed during administration of the Constant-Murley survey. 
4. 
Administer the recovery/satisfaction questionnaire. 
5. 
Record prescription medications. 

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Protocol No. 2014.05.12, Rev. C 
 
 
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• Record any prescription medications the subject is taking at the time of the 
follow-up visit to treat his/her index shoulder. 
6. 
Record any new adverse events and update the status of any ongoing, previously-
reported adverse events. 
7. 
Report any new revision/additional shoulder surgeries performed on the index 
shoulder. 
7.7.3 2-Year (± 90 Days) Follow-Up 
1. 
Perform an MRI per the Sponsor imaging guidelines. 
• Provide the Sponsor with a de-identified digital copy of, or access to, the MRI. 
2. 
Administer the Constant-Murley shoulder survey. 
• Range of motion (ROM) should be measured with a goniometer and strength 
should be measured with a dynamometer. 
3. 
Administer the ASES shoulder survey. 
• Completion of the ASES patient assessment section is required.  Completion of 
the ASES physician assessment section is optional since ROM and strength 
are assessed during administration of the Constant-Murley survey. 
4. 
Administer the recovery/satisfaction questionnaire. 
5. 
Record prescription medications. 
• Record any prescription medications the subject is taking at the time of the 
follow-up visit to treat his/her index shoulder. 
6. 
Record any new adverse events and update the status of any ongoing, previously-
reported adverse events. 
7. 
Report any new revision/additional shoulder surgeries performed on the index 
shoulder. 
The results of all follow-up assessments will be documented on their respective CRFs.  
Each reportable adverse event (Section 4.1.1) will be documented on an Adverse Event 
CRF. 
7.8 
UNSCHEDULED FOLLOW-UP 
Any unscheduled return visits to the study center/Principal Investigator for non-standard 
of care evaluation for ongoing shoulder-related issues will be documented on a CRF.  The 
reason for the visit and visit outcome will be documented.  If an MRI, ASES survey, or 
Constant-Murley survey is completed, these assessments should also be documented on 
the appropriate CRFs.  Visits required by the protocol or visits for routine post-operative 
follow-up are not considered unscheduled and do not need to be reported as an 
unscheduled visit.  
7.9 
REVISION/ADDITIONAL SHOULDER SURGERY 
If the subject has additional or revision shoulder surgery on the index shoulder at any time 
during the follow-up period, the clinical site should make every effort to collect the 
procedure/operative notes for the procedure and complete the Revision/Additional 
Shoulder Surgery CRF.  One (1) Revision/Additional Shoulder Surgery CRF should be 
completed for all surgeries performed on a single date.  If a subject has multiple surgeries 
on the index shoulder on different dates, the Revision/Additional Shoulder Surgery CRF 
should be completed for each surgery date. 

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7.10 EARLY WITHDRAWAL OR LOST TO FOLLOW-UP 
If a subject wishes to withdraw from the study at any time, (s)he is able to do so 
voluntarily without having to justify it and without affecting her/his relationship with the 
Investigator.  
Also, an Investigator may withdraw a subject from the study at any time if (s)he thinks it is 
in the subject’s best interest.  
The subject’s future management will not be changed by a decision, voluntary or 
otherwise, to withdraw from the study. 
All reasonable efforts should be made to retain the subject in this clinical study until 
completion of the clinical assessments at each follow-up visit.  A subject will be 
considered “lost to follow-up” after a minimum of 2 documented phone calls to the subject 
were completed by a member of the study staff and a certified letter was sent to the last 
known address by a traceable method (e.g., certified mail; courier; commercial 
shipping/transport company). 
Should subject early withdrawal or termination of participation occur, the termination 
information and the date of last contact with the subject should be recorded in the subject’s 
records and included on the End of Study CRF.  
7.11 END OF STUDY  
Subjects will be exited upon successful completion of follow-up assessments or at the 
time of withdrawal or lost-to-follow-up.  An End of Study CRF will be completed at the 
time of study completion or discontinuation. 
8 
ADVERSE EVENT DEFINITIONS AND REPORTING 
Adverse events are to be reported from the time of enrollment through the last study 
follow-up visit. 
8.1 
DEFINITION OF ADVERSE EVENT (AE) 
An Adverse Event (AE) is any undesirable clinical occurrence experienced by the 
subject.  Any underlying disease that was present at the time of enrollment and prior to 
surgery (i.e. rotator cuff tendon tear) that persists after surgery is not considered an AE. 
8.2 
SERIOUS ADVERSE EVENT (SAE) 
A Serious Adverse Event (SAE) includes any of the following events: 
• Results in death 
• Is life threatening 
• Requires subject hospitalization or prolongation of existing hospitalization 
• Requires invasive surgical intervention to fix the problem 
• Results in persistent or significant disability/incapacity 
• Is considered an important medical event 

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An important medical event that may not meet one of the above definitions might be 
considered as an SAE if it jeopardizes the health of the subject or requires surgical 
intervention to prevent one of the outcomes listed in the above definition.  Elective 
hospitalization after the procedure that was planned prior to subject enrollment is not to 
be considered as an SAE.   
8.3 
UNANTICIPATED ADVERSE DEVICE EFFECT (UADE) 
An Unanticipated Adverse Device Effects (UADE) is any serious adverse effect on health 
or safety, or any life-threatening problem or death caused by, or associated with, a device, 
if that effect was not previously identified in nature, severity, or degree of incidence in 
protocol, subject informed consent form, or application, or any other unanticipated 
serious problem associated with a device that relates to the rights, safety, or welfare of 
subjects.  Anticipated adverse events are listed as known risks in Section 12.1. 
8.4 
ASSESSING, RECORDING AND REPORTING AES, SAES, AND UADES 
Only non-serious AEs that are classified by the Investigator as either device-related or 
procedure-related will be reported.  All SAEs, regardless of relationship to the Rotation 
Medical Rotator Cuff System, and all UADEs will be reported. 
An AE may be volunteered spontaneously by the subject or discovered as a result of 
questioning or physical examination by the Investigator or study staff.  The following 
information should be reported on the Adverse Event CRF as soon as the Investigator 
becomes aware of the event and updated as needed until event resolves: 
• Date of AE onset 
• Date the Investigator became aware of the AE 
• Main complaints/symptoms of the AE 
• Relationship to the study device 
• Relationship to the study procedure 
• Status of the adverse event 
Source documents (e.g., procedural notes, treatment notes, or a signed clinical summary) 
may be required as supporting documentation for the reported AE. 
9 
MALFUNCTIONS 
Failure of the Rotation Medical Rotator Cuff System to meet its performance 
specifications or to perform as intended will be documented on the Malfunction CRF.  In 
the event of a malfunction, every effort must be made to return the suspected Rotation 
Medical device or instrument to the Sponsor for analysis.  Malfunctions will be evaluated 
for reportable requirements through the FDA medical device reporting (MDR) system. 
 
10 PROTOCOL DEVIATIONS 
Investigators are required to adhere to the study protocol, signed Clinical Trial Agreement 
(CTA), applicable national or local laws and regulations, and any conditions required by 
the appropriate IRB/EC or applicable regulatory authorities. 
 
A protocol deviation is used to describe situations in which the protocol was not followed 
(this includes all activities at each scheduled visit or activities occurring outside of the 

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Protocol No. 2014.05.12, Rev. C 
 
 
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study windows).  All attempts should be made to obtain Sponsor approval of the deviation 
prior to their occurrence. 
 
An Investigator must notify the Sponsor and the reviewing IRB/EC of any deviation from 
the Study Protocol that was done to protect the life or physical well-being of a subject 
(medical emergencies).  Such notice should be given within 5 days of the occurrence.  The 
Sponsor will determine if the subject affected is to continue in the study. 
 
Documentation of deviations identified by the investigational center, the monitor, or other 
Sponsor representative(s) will be entered into the Protocol Deviation CRF for the purpose 
of tracking Investigator compliance with the protocol.  The investigational center will be 
required to document actions taken to prevent recurrence of deviations.  The Sponsor 
representative will initiate corrective actions based on individual deviations or trending 
reports as appropriate. 
 
11 REPORTING REQUIREMENTS 
Table 11-1 shows a summary of all reporting requirements.  In addition to this list, 
individual IRBs may add additional reporting requirements and/or require a different 
notification time frame. 
Table 11-1: Summary of Reporting Requirements  
Type of Report 
Prepared by 
Investigator FOR 
Notification Time Frame 
Death1 
Sponsor & IRB 
Within 24 hours of knowledge 
Withdrawal of IRB approval 
Sponsor 
Within 5 working days of knowledge 
Protocol Deviation to Protect 
Subject Life or Physical 
Well-Being 
Sponsor & IRB 
Within 5 working days of knowledge 
Unanticipated Adverse 
Device Effect (UADE) 
Sponsor & IRB 
Within 10 working days of knowledge 
1Copies of death records, medical records for the events that led to the subject’s death, a death 
certificate (if available), and an autopsy report (if performed) should be requested. 
 
12 RISKS AND BENEFITS 
12.1 RISKS AND RISK MITIGATION 
Study patients will be informed of all known potential side effects and complications 
associated with the study assessments and study procedure prior to enrollment in the 
study. 
There are no known incremental risks to the subject for participating in the study.  The 
risks associated with participating in this study are the same as if the patient is treated 
outside of the study using the same commercially-available device and include the 
following potential risks of rotator cuff surgery performed under general or regional 
anesthesia: 

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Protocol No. 2014.05.12, Rev. C 
 
 
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• Tissue inflammation 
• The need for repeated surgery because tendons do not heal properly or tear again 
• Pain or stiffness that won't go away 
• Fever and/or infection 
• Complication from anesthesia 
• Nerve or blood vessel damage  
• Adverse reaction to device 
In addition, subjects will be required to undergo MR imaging.  MRI is generally a well-
tolerated procedure and there is no ionizing radiation involved with MR imaging   The 
potential risks are minimal and include claustrophobia, coil element heating and 
peripheral nerve stimulation, although the latter two are considered highly unlikely, given 
that the subjects will be imaged within preset safety guidelines to eliminate peripheral 
nerve stimulation. Coil element heating ranges from a mild sensation of heat to a 
potential burn.  This is considered highly unlikely, as the coils have all undergone 
extensive testing and clinical use, and special pads are placed surrounding all contact 
points. 
All Investigators will undergo training and subjects will be screened and evaluated for 
medical histories/conditions that may compromise safe, successful completion of any of 
the study assessments or performance of the device.  Subjects with a known 
hypersensitivity to bovine-derived materials will not be enrolled in the study. 
12.2 BENEFITS 
Participation in this study is voluntary.  Subjects can obtain the same treatment without 
participating in this study.  However, information gathered from this study will help the 
Sponsor to continue to evaluate long-term performance of the device when used alone or 
in conjunction with surgical repair to treat partial or full-thickness tears of the 
supraspinatus tendon. 
13 DATA MANAGEMENT 
13.1 DATA COLLECTION 
Case report forms (CRFs) will be completed by the Investigator (or authorized study 
personnel) for each subject enrolled in the study.  Data queries and edit checks will be 
used to reconcile discrepancies between data on the source documents and data entered 
on the CRFs.  The Investigator must assure the accuracy and completeness of the 
recorded data.  For the purpose of this study, the ASES and Constant shoulder surveys, as 
well as the Recovery/Satisfaction form, may act as their own source data. 
13.2 DATA PROCESSING 
All study documentation will be entered and maintained in a central database by the 
Sponsor or Sponsor-authorized representatives.  Automatic and/or manual edit checks 
will be issued as necessary to correct discrepant data.  Appropriate quality control 
measures will be established to ensure accurate and complete transfer of information 
from the study documentation to the central database.  Data files will be exported from 
the central database for statistical analyses. 

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14  ADMINISTRATIVE RESPONSIBILITIES 
The proposed study will be performed in accordance with all requirements set forth in the 
all applicable U.S. regulations, 21 Code of Federal Regulations (CFR) Parts 50 and 56, the 
World Medical Association Declaration of Helsinki, ISO 14155 (1) and (2), and any other 
applicable local laws and regulations. 
14.1 SITE AND INVESTIGATOR SELECTION 
Each site and Investigator selected to participate will be evaluated to ensure each has the 
capacity, volume of surgical candidates, and capability to comply with all informed 
consent and protocol requirements.  In addition, surgeon experience performing mini-open 
and arthroscopic surgeries to treat rotator cuff tears will be evaluated.  Each study site and 
Investigator are required to comply with applicable local legal and regulatory 
requirements and applicable U.S. federal regulations. 
14.2 TRAINING 
All Investigators (Principal, co-Investigator, sub-Investigator) must be Board Certified 
orthopaedic surgeons with experience performing mini-open or arthroscopic rotator cuff 
repairs.  Prior to first enrollment, each participating surgeon will complete Sponsor-
provided training on the Rotation Medical Rotator Cuff System.   
The Sponsor will also be responsible for ensuring each site and Investigator are properly 
trained on the study protocol and applicable regulatory requirements. 
To insure uniform data collection and protocol compliance, the Sponsor or Sponsor-
authorized representatives will train the Study Coordinator(s) and study staff on all 
components of the study including the study protocol, techniques for the identification of 
eligible subjects, instructions for data collection during the procedure, and schedules for 
follow-up. 
14.3 INSTITUTIONAL REVIEW BOARD (IRB) / ETHICS COMMITTEE (EC) 
It is the Investigator’s responsibility to obtain and maintain written approval of the final 
study protocol and Informed Consent from the appropriate IRB or Ethics Committee.  
Investigators are responsible for submitting and obtaining initial and continuing review of 
the trial by their IRB/EC.  It is also the Investigator’s responsibility to notify the IRB/EC 
of any amendments to these documents.  A copy of the written approval must be 
forwarded to the Sponsor prior to first device shipment.  The written approval must 
identify the study and document the date of review. 
The Investigators must keep on file all study-related correspondence with the IRB/EC 
and forward copies of such correspondence to the Sponsor. 
14.4 INFORMED CONSENT FORM (ICF) 
Informed consent must be obtained in accordance with the applicable guidelines on 21 
CFR Part 50, current GCP, the Declaration of Helsinki,  ISO 14155 (1) and (2), or local 
regulations and laws, whichever represents the greater protection of the individual.  The 
subjects must be informed about their right to withdraw from the study at any time and 
for any reason without sanction, penalty, or loss of benefits to which the subject is 
otherwise entitled and also informed that withdrawal from the study will not jeopardize 

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Protocol No. 2014.05.12, Rev. C 
 
 
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their future medical care.  The institutional standard subject consent form does not 
replace the study informed consent form (ICF). 
The Sponsor will provide a study-specific template ICF to each site for IRB/EC 
submission.  This template may be modified to suit the requirements of the individual 
study site.  The Sponsor must pre-approve all changes to the ICF prior to initial 
submission to the IRB/EC.  The Informed Consent Form must be approved by the 
IRB/EC prior to device shipment and a copy must be retained at the investigational site 
along with the other investigational forms.  A signed copy of the consent form must be 
given to each subject enrolled in the study and a signed copy of the consent form must be 
retained for each subject at the investigational site. 
Modifications to the study-specific Informed Consent Form and/or any written 
information distributed to subjects must be approved by the Sponsor, and the IRB/EC as 
necessary. 
14.5 CONFIDENTIALITY 
All information and data sent to the Sponsor concerning subjects or their participation in 
this study will be considered confidential.  All data used in the analysis and reporting of 
this evaluation will be used in a manner without identifiable reference to the subject.  The 
Investigator consents to visits by the staff of the Sponsor and its authorized 
representatives and the U.S. FDA or any other local governmental body to review the 
study subjects’ medical records, including any test or laboratory data that might have 
been recorded on diagnostic test media (e.g., MRI scan). 
14.6 AMENDING THE PROTOCOL 
The Sponsor must write amendments in order to alter the protocol.  Administrative 
changes that do not affect the subject benefit/risk ratio (e.g., editorial changes for clarity) 
may be implemented without any further approvals.  Any change that would require 
alteration of the Informed Consent form must receive approval from all persons who 
approved the original protocol and from the IRB/EC prior to implementation.  Following 
approval, the protocol amendment(s) will be distributed to all protocol recipients with 
instructions to append them to the protocol. 
14.7 CRITERIA FOR TERMINATING STUDY 
The Sponsor reserves the right to terminate the study early but intends only to exercise 
this right for valid scientific or administrative reasons or reasons related to the protection 
of study subjects.  Investigators and associated IRB/EC will be notified in writing in the 
event of termination.  Reasons for study termination include but are not limited to: 
• The discovery of an unexpected, significant, or unacceptable risk to the study subjects. 
• A decision on the part of the Sponsor to suspend or discontinue commercial 
distribution of the Rotation Medical Rotator Cuff System.  
14.8 CRITERIA FOR TERMINATING AN INVESTIGATIONAL CENTER 
The Sponsor reserves the right to stop enrollment of subjects at an investigational center 
at any time for any of the following reasons including but not limited to: 
• Repeated failure to complete case report forms (CRFs) 

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• Failure to obtain Informed Consent 
• Failure to report any study subject deaths, SAEs, or UADEs within the timeframes 
specified in Table 11-1 
• Repeated protocol deviations 
• Lack of study enrollment or study activity 
14.9 SPONSOR RESPONSIBILITIES 
The Sponsor’s responsibilities for this study are to: 
• Provide sufficient training to support study activities per agreements executed with the 
study sites 
• Select all clinical Investigators, study sites, and consultants (e.g., the study monitors) 
who participate in the study 
• Provide financial support to each study site per agreements executed with the study 
sites 
• Follow all regulatory standards per federal regulations for clinical study sites, core 
laboratories, and other participants, and ensure regular site monitoring to assure 
compliance with them 
• Retain ownership of all clinical data generated in this study 
• Work collaboratively with Investigators to present and publish study results 
14.10 INVESTIGATOR RESPONSIBILITIES 
The Investigator for each site is responsible for ensuring the study is conducted according 
to: 
• All signed agreements 
• The study protocol 
• IRB/EC guidelines 
• Applicable FDA regulations 
The Investigator for each site may not begin enrollment until the Sponsor receives and 
approves (when necessary) required documents, including the complete signed 
Investigator Agreement, Protocol Signature Page, IRB/EC and ICF approvals.  
It is acceptable for the Investigator to delegate one or more of the above functions to an 
associate or Co-Investigator or trained Study Coordinator; however, the Investigator 
remains responsible for the proper conduct of the clinical investigation, including 
obtaining the ICF, collecting all required data, submitting accurate and complete CRFs, 
etc. 
At each site, appropriate procedures must be followed to maintain subject confidentiality 
according to HIPAA (Health Insurance Portability Accountability Assurance) regulations.  
Each site may have its own internal procedures or requirements for use and release of 
subject medical information in research studies.  Each Investigator is responsible for 
obtaining appropriate approvals, consents or releases of medical information as dictated 
by their relevant subject privacy regulations. 
The study is not transferable to other sites attended by the Investigator unless prior 

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approval is obtained from the appropriate IRB and the Sponsor.   
15 MONITORING AND AUDITING 
Monitoring visits to the investigational centers will be made frequently during the study 
to ensure that all aspects of the current approved protocol/amendment(s) are followed.  
Source documents will be reviewed for verification of agreement with data entered on the 
CRFs and all regulatory documents will be checked for accuracy including but not 
limited to IRB/EC approvals, study-related correspondence, and subject informed 
consent.  The Investigator/institution guarantees direct access to source documents by 
designated Sponsor personnel and appropriate regulatory authorities.  The site staff must 
agree to be available to meet with the Sponsor during each visit. 
The study may also be subject to a quality assurance audit by the Sponsor or its designees 
as well as inspection by appropriate regulatory authorities. 
16 REPORTS AND RECORDS 
16.1 REPORTS 
Adverse events and Rotation Medical Rotator Cuff System malfunctions will be evaluated 
for reportable requirements through the FDA medical device reporting (MDR) system. 
16.2 RECORDS 
All records pertaining to the clinical study will be kept (in accordance with CFR 
§812.140 subpart d) for a minimum of 3 years following the date on which the study is 
terminated or completed. 
If an Investigator wishes to withdraw from the responsibility of maintaining these study 
records, a transfer of that responsibility to a person willing to accept the responsibility (as 
outlined in CFR §812.140) must occur and be reported to the Sponsor not more than 10 
days after the transfer occurs. 
17 USE OF INFORMATION AND PUBLICATION  
Any previously unpublished information provided to the Investigators by the Sponsor, 
such as patent applications, manufacturing processes and basic scientific data, is 
considered confidential and will remain the sole property of the Sponsor.  The 
Investigator agrees to use this information only in accomplishing this study and will not 
use it for other purposes without the Sponsor’s written consent. 
An Investigator may publish the study experience from his/her site subject to approval by 
the Sponsor.  The Sponsor will work collaboratively with Investigators to support data 
analyses for publication of study results.  The Sponsor reserves the right to review all 
publications in order to verify accuracy of the data.  The Investigator may proceed with 
the publication when notified by the Sponsor. 
For any multi-center publications (if applicable), the number, names, and order of the 
authors will be determined by the Sponsor with input from the Investigators. 
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