Safety and Performance of PEEK Anchors (DYNOMITE, SPYROMITE, RAPTOMITE, FOOTPRINT Ultra PK SL) in Extremities
Conditions: Medial or Lateral Instability Repairs/Reconstructions, Hallux Valgus Repairs, Achilles Tendon Repairs/Reconstructions, Midfoot Reconstructions, Metatarsal Ligament/Tendon Repairs/Reconstructions, Bunionectomy, Scapholunate Ligament Reconstructions, Ulnar, Lateral Epicondylitis Repair, Bicep Tendon Reattachments
Sponsor: Smith & Nephew, Inc.

Study Protocol
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Version: 2.0 05Dec2018 
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CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and is 
intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith & Nephew. 
 
TMP-CD-05-01  Clinical Protocol-Device  Revision A; SOP-CD-05 Clinical Protocols  
RAPTOR
, 
FOOTPRINT  ULTRA PK SL) in Extremities 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Protocol Number: 
2018.15.SMD.PEEK.RET.EXT 
Protocol Version: 
Version 2.0 
Date: 
05Dec2018 
Sponsor Name and 
Address: 
 
Smith & Nephew Orthopaedics 
7135 Goodlett Farms Parkway 
Cordova, TN 38016 
USA 
 
Investigational Product(s) 
 
PEEK Extremity Suture Anchors 
RAPTORMITE  3.0 PK W/NDL, 2 0 ULTRABRA 
DYNOMITE  2.0 PK W/NDL,1 2-0 ULTRABRAID 
-0 ULTRABRAID WH 
FOOTPRINT ULTRA PK 4.5 mm, SL 
FOOTPRINT ULTRA PK 5.5 mm, SL 

Study Protocol
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CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and is 
intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith & Nephew. 
 
TMP-CD-05-01  Clinical Protocol-Device  Revision A; SOP-CD-05 Clinical Protocols  
 
SIGNATURES 
 
PROTOCOL SIGNATURE PAGE 
This page will be returned to Smith & Nephew Inc. and a copy retained at the investigational site. 
Safety 
RAPTOR
, 
ULTRA PK SL) in Extremities
ersion 2.0, dated 05Dec2018, 
and agree to abide by all provisions set forth herein. I agree to ensure that the confidential information 
contained in this document will not be used for any purpose other than the conduct of the described 
clinical investigation without the prior written consent of Smith & Nephew, Inc. 
 
 
 
Name, Address,  
Professional Position 
Signature 
Date Signed 
(DD/MMM/YYYY) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Study Protocol
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Page: Page 3 of 54 
 
 
CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and is 
intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith & Nephew. 
 
TMP-CD-05-01  Clinical Protocol-Device  Revision A; SOP-CD-05 Clinical Protocols  
 SIGNATURE APPROVAL 
 
Role 
Approver Name 
Approver Signature 
Date Approved 
(DD/MMM/YYYY) 
Medical Writer 
Esvanhnelly 
Podany (Author) 
 
 
Senior Vice 
President / Chief 
Medical Officer, 
Global R&D 
Andy Weymann 
(Owner) 
 
 
Vice President 
Clinical, Scientific 
& Medical Affairs 
Beate Hanson 
 
 
 
 

Study Protocol
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Page: Page 4 of 54 
 
 
CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and is 
intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith & Nephew. 
 
TMP-CD-05-01  Clinical Protocol-Device  Revision A; SOP-CD-05 Clinical Protocols  
 
 
Job title 
DocuSign Stamp 
Head of Global 
Clinical Operations 
SVP / CMO, Global R&D 
 
Head of Global 
Clinical Strategy 
Vice President Clinical 
Strategy, Scientific & 
Medical Affairs 
 
 
Head of Global 
Biostatistics or 
Designee 
Director Biostatistics and 
Data Management, 
Global Clinical Strategy 
 
 
 
 
 
 
Medical Affairs 
Representative 
Vice President Medical 
Affairs, Scientific & 
Medical Affairs 
 
 
 
 
 
 

Study Protocol
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Page: Page 5 of 54 
 
 
CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and is 
intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith & Nephew. 
 
TMP-CD-05-01  Clinical Protocol-Device  Revision A; SOP-CD-05 Clinical Protocols  
 SYNOPSIS 
Title of Study: 
Safety and 
RAPTORMITE , 
ULTRA PK SL) in Extremities 
Study Design: 
Multi-center, retrospective case series 
Study Type: 
Post-market, clinical follow-up 
Study Product: 
PEEK Extremity Suture Anchors 
 
-0 ULTRABRAID 
2-0 ULTRABRAID WH 
FOOTPRINT ULTRA PK 4.5 mm, SL 
FOOTPRINT ULTRA PK 5.5 mm, SL 
Study Purpose: 
Assess safety and performance post-market of the PEEK suture 
anchor devices to address clinical data gaps for Medical Device 
Regulations (MDR). 
Primary Objective: 
Safety and performance of the study devices in extremities over a 
time period of 6 months after intervention. 
Secondary Objective: 
Safety and performance of the study devices in extremities over a 
time period of 12 months after intervention. 
Statistical Rationale: 
The sample size for this study is determined based on the feasibility 
of recruitment, enrollment and follow-up considerations. The study is 
therefore not powered for any statistical hypothesis testing but will be 
able to estimate a clinical success rate of 91% with a 95% confidence 
interval (CI) of 80% to 100%. 
Sample Size: 
Minimum, n= 80 
Maximum, n= 480 
Enrollment distribution: 
PEEK Anchor 
Minimum 
Maximum 
 
20 
120 
 (If 
available)
20 
120 

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CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and is 
intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith & Nephew. 
 
TMP-CD-05-01  Clinical Protocol-Device  Revision A; SOP-CD-05 Clinical Protocols  
SPYROMI
 (If 
available) 
20 
120 
FOOTPRINT ULTRA 
PK SL (If available) 
20 
120 
 
Number of Study Sites: Up to 15 sites 
Targeted Global 
Regions: 
United States and/or Outside United States 
Inclusion Criteria: 
1. Subjects who have undergone extremity joint repair using the 
study devices. 
2. Subjects aged 18 years and older at the time of surgery. 
Exclusion Criteria: 
1. Subject is entered in another investigational drug, biologic, or 
device study or has been treated with an investigational product 
within 12 months post-operative. 
2. Subjects who are < 3 months post-operative. 
Study Duration: 
Twelve month follow up. 
Primary endpoint: 
Clinical success rate (%) of the study devices in extremities at 6 
months post-operative. Clinical success is defined as extremity 
repairs without signs of device failure and/or re-intervention as 
assessed by the surgeon. 
Secondary endpoint(s): Clinical success rate (%) of the study devices in extremities at 12 
months post-operative. Clinical success has previously been defined. 
Other exploratory 
endpoint(s): 
medical chart as standard of care at study sites. This may include but 
not limited to the following: 
 
 Range of Motion (ROM) 
 Pain assessed by Visual Analogue Scale (VAS) 
Safety Data 
 All AEs, SAEs and complications including intra-operative 
adverse events and complications. 

Study Protocol
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, FOOTPRINT  ULTRA PK SL) in 
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CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and is 
intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith & Nephew. 
 
TMP-CD-05-01  Clinical Protocol-Device  Revision A; SOP-CD-05 Clinical Protocols  
 Device related intervention. 
 Device deficiency. 
 Concomitant medications/therapy. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and is 
intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith & Nephew. 
 
TMP-CD-05-01  Clinical Protocol-Device  Revision A; SOP-CD-05 Clinical Protocols  
 
STUDY SCHEDULE 
Table 1:  Schedule of Events 
Schedule of Events 
Chart Review 
6 months 
(182 days) post-op 
(+/- 90 days) 
12 months 
(365 days) post-op 
(+/- 90 days) 
Informed Consent 
X 
N/A if waiver of consent 
approved by IRB 
 
Inclusion/Exclusion 
X 
 
Demographics/Medical History 
X 
 
Operative/Discharge Data Collection 
X 
 
Implant Status 
X 
X 
Pain assessed by VAS 
X 
X 
ROM 
X 
X 
Concomitant Medications or Therapies1 
* 
* 
Serious Adverse Event (SAE)/Adverse 
Device Effect (ADE)/ Device Deficiency 
(DevD) Assessment 
* 
* 
AE Assessment 
* 
* 
End of Study/Subject Disposition 
* 
* 
1Any concomitant medications associated with an AE, SA(D)E will be recorded. 
*As Needed 
 
 
 
 
 

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CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and is 
intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith & Nephew. 
 
TMP-CD-05-01  Clinical Protocol-Device  Revision A; SOP-CD-05 Clinical Protocols  
 TABLE OF CONTENTS 
 
Signatures ............................................................................................................................. 2 
 
Protocol Signature Page ................................................................................................ 2 
 
Signature Approval ............................................................................................................... 3 
 
Synopsis ............................................................................................................................... 5 
 
STUDY SCHEDULE.......................................................................................................... 8 
 
Table of Contents .................................................................................................................. 9 
 
Table of Tables .............................................................................................................. 11 
 
List of Abbreviations ..................................................................................................... 12 
 
Introduction .......................................................................................................................... 14 
 
Background .................................................................................................................. 14 
 
Study Purpose .............................................................................................................. 15 
 
Safety Considerations .................................................................................................. 15 
 
Study Related Risks .............................................................................................................. 15 
 
Study Possible risks ..................................................................................................... 15 
 
Study Related Benefits ................................................................................................. 16 
 
Objective(s) .......................................................................................................................... 16 
 
Primary Objective ......................................................................................................... 16 
 
Secondary Objective .................................................................................................... 16 
 
Study Product(s) ................................................................................................................... 16 
 
eedles ......................................................... 16 
 
 ........................................................... 17 
 
 ........................................................ 18 
 
Footprint Ultra  PK  SL Suture Anchor ........................................................................... 18 
 
Indications for use ........................................................................................................ 19 
 
Product Use ................................................................................................................. 20 
 
Surgical Technique ....................................................................................................... 21 

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CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and is 
intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith & Nephew. 
 
TMP-CD-05-01  Clinical Protocol-Device  Revision A; SOP-CD-05 Clinical Protocols  
 
Subject Enrollment and Withdrawal ..................................................................................... 21 
 
Subject Population ........................................................................................................ 21 
 
Inclusion Criteria ........................................................................................................... 21 
 
Exclusion Criteria ......................................................................................................... 22 
 
Screening .................................................................................................................... 22 
 
Informed Consent ........................................................................................................ 22 
 
Enrollment .................................................................................................................... 23 
 
Lost to Follow-Up ......................................................................................................... 24 
 
Withdrawal ................................................................................................................... 24 
 
Study Design ....................................................................................................................... 25 
 
Study Design ............................................................................................................... 25 
 
Study Endpoints........................................................................................................... 25 
 
Study Procedures ................................................................................................................ 26 
 
Retrospective Data Collection: 6 Months Post-Operative (±90 Days) ......................... 26 
 
Retrospective: 12 Months Post-Operative (±90 days) ................................................. 27 
 
Concomitant Medications and Therapies .................................................................... 27 
 
Statistical Design ................................................................................................................ 27 
 
General ........................................................................................................................ 28 
 
Analysis Populations ................................................................................................... 28 
 
Efficacy Analysis .......................................................................................................... 28 
 
Safety Analyses ........................................................................................................... 29 
 
Interim Analyses .......................................................................................................... 30 
 
Sample Size Justification .................................................................................................... 30 
 
Adverse Events and Device Deficiencies ............................................................................. 31 
 
Definitions .................................................................................................................... 31 
 
Reporting Procedures .................................................................................................. 35 
 
Follow-up of Subjects with Adverse Events ................................................................. 37 

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CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and is 
intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith & Nephew. 
 
TMP-CD-05-01  Clinical Protocol-Device  Revision A; SOP-CD-05 Clinical Protocols  
 
Investigator Obligations ...................................................................................................... 37 
 
Sponsor and Monitor Responsibilities ................................................................................ 37 
 
Site Qualification Visit .................................................................................................. 38 
 
Site Initiation Visit ........................................................................................................ 38 
 
Sponsor Audits and Regulatory Inspection ................................................................. 38 
 
Close-out Visit ............................................................................................................. 39 
 
Protocol Amendments ........................................................................................................ 39 
 
Confidentiality of the Study ................................................................................................. 39 
 
Statements of Compliance .................................................................................................. 39 
 
End of Study ........................................................................................................................ 40 
 
Publication Policy ................................................................................................................ 40 
 
Publication of Study Data ............................................................................................ 40 
 
Data Sharing ................................................................................................................ 40 
 
References .......................................................................................................................... 42 
 
Appendices ......................................................................................................................... 43 
 
Protocol Amendment Version 1.0 to 2.0 ...................................................................... 43 
 
TABLE OF TABLES 
Table 1:  Schedule of Events ............................................................................................................ 8 
Table 2:  Instructions for Use Reference Numbers ......................................................................... 15 
Table 3: Product Specification, structural composition and description ........................................ 19 
Table 4:  Summary of indications for PEEK Anchors (
) in extremities ...................................................................................... 20 
Table 5: Categories of Adverse Event ........................................................................................... 32 
Table 4: Product Specification, structural composition and description ....................................... 48 
Table 3: Product Specification, structural composition and description (see table in protocol) .... 48 

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CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and is 
intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith & Nephew. 
 
TMP-CD-05-01  Clinical Protocol-Device  Revision A; SOP-CD-05 Clinical Protocols  
 
 
LIST OF ABBREVIATIONS 
Abbreviation 
Definition 
ADE 
Adverse Device Effect(s) 
AE 
Adverse Event(s) 
AOL 
Activities of Daily Living 
ASADE 
Anticipated Serious Adverse Device Effect 
CI 
Confidence Interval 
CRF 
Case Report Form(s) 
CSR 
Clinical study Report 
CTA 
Clinical Trial Agreement 
CV 
Curriculum Vitae 
DevD 
Device Deficiency(ies) 
EC 
Ethics Committee  
FU 
Follow-Up 
GCP 
Good Clinical Practice 
IBT 
Iliotibial Band Syndrome 
ICF 
Informed Consent Form 
ICH 
International Conference on Harmonisation 
IEC 
International Ethics Committee 
ICMJE 
International Committee of Medical Journal Editors 
IFU 
Instructions for Use 
IP 
Investigational Product 
IRB 
Institutional Review Board 
ISF 
Investigator Site File 

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CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and is 
intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith & Nephew. 
 
TMP-CD-05-01  Clinical Protocol-Device  Revision A; SOP-CD-05 Clinical Protocols  
Abbreviation 
Definition 
ISO 
International Organization for Standardization 
MEDDEV 
Master Control European Medical Device Vigilance System 
MDD 
Medical Device Directive 
NA or N/A 
Not Applicable 
NSAIDs 
Nonsteroidal anti-inflammatory drugs 
NSAE 
Non-Serious Adverse Event(s) 
PI 
Principal Investigator 
PP 
Per-Protocol Population 
ROM 
Range of Motion 
S&N 
Smith & Nephew, Inc. 
SADE 
Serious Adverse Device Effect(s) 
SAE 
Serious Adverse Event(s) 
SAF 
Safety population 
SAP 
Statistical Analysis Plan 
SOP 
Standard Operating Procedures 
SLAP 
Superior Labral Tear from Anterior to Posterior 
UHMWPE 
Ultra-high molecular weight polyethylene 
USADE 
Unanticipated Serious Adverse Device Effect(s) 
VAS 
Visual Analog Scale 

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CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and is 
intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith & Nephew. 
 
TMP-CD-05-01  Clinical Protocol-Device  Revision A; SOP-CD-05 Clinical Protocols  
 INTRODUCTION 
 
BACKGROUND 
Suture Anchors are small fixation devices used in surgical procedures for attaching or reattaching 
tendons and ligaments to bone. The size and type of anchor use
density and the procedure performed. 
Suture anchors are made up of three components: the anchor - which is inserted into the bone; 
the eyelet  which is a hole or a loop in the anchor which the suture passes through to link the 
anchor to the suture; and the suture  which is attached to the anchor through the eyelet of the 
anchor. An anchor-receiving hole is first drilled in the bone at the desired point of tissue 
reattachment. A suture anchor is deployed in the hole using an appropriate installation tool. This 
effectively locks the suture to the bone, with the free end(s) of the suture extending out of the bone.  
Soft tissue is then moved into position over the hole containing the deployed suture anchor. As 
this is done, the free end(s) of the suture is (are) passed through or around the soft tissue so that 
the free end(s) of the suture reside(s) on the far (i.e., non-bone) side of the soft tissue. The suture 
is now used to tie the soft tissue securely to the bone. 
Smith & Nephew (S&N) offers a variety of suture anchors including several polyetheretherketone 
(PEEK) suture anchors soft tissue to bone repair. The PEEK devices included in this review are all 
single use, sterile devices comprised of machined component anchor bodies that are 
manufactured from PEEK-OPTIMA Polymer (LT1). This material meets ISO 10993 biocompatibility 
requirements for implant devices, bone/tissue contact, and permanent contact. The anchor tips 
are molded components which are also manufactured from PEEK-OPTIMA Polymer (LT3). PEEK-
OPTIMA polymers provide an ideal combination of strength, biocompatibility, revisability and 
inherent radiolucent characteristics. Smith & Nephew also provides a variety of reusable and 

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CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and is 
intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith & Nephew. 
 
TMP-CD-05-01  Clinical Protocol-Device  Revision A; SOP-CD-05 Clinical Protocols  
disposable instrumentation used in conjunction with the suture anchors including awls, dilators, 
drills, guides, obturators and wires. 
 
STUDY PURPOSE 
This is a retrospective study to evaluate intra-operative, 6 months and 12 months safety and 
performance of the PEEK anchors (
RAPTORMITE
 
SL) for extremities to meet existing MDD/MEDDEV requirements. 
 
SAFETY CONSIDERATIONS 
The PEEK suture anchor family, which include the following products: DYNOMITE
RAPTORMITE  and 
ULTRA PK SL, are intended for reattachment of soft tissue to bone 
fixation in the joint extremities such as elbow, wrist, hand, foot and ankle.  Representative language 
of the contraindications and potential adverse events can be found in the Instructions for Use (IFU) 
for each product. 
Table 2:  Instructions for Use Reference Numbers 
PEEK Suture Anchor 
IFU 
DYNOMITE  
01/2017 10600401 Rev. D 
 
01/2017 10600400 Rev. D 
RAPTORMITE  
03/2017 10600402 Rev. E 
 SL  
2017 10601001 REV. B 
 
 STUDY RELATED RISKS 
 
STUDY POSSIBLE RISKS 
As a result of participating in the study, there could be a risk of loss of protected subject information 
confidentiality. All applicable confidentiality standards and data protection and privacy laws will be 

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CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and is 
intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith & Nephew. 
 
TMP-CD-05-01  Clinical Protocol-Device  Revision A; SOP-CD-05 Clinical Protocols  
followed by the Sponsor to ensure that data collected is handled in confidence. Data will be coded 
and handled only by appropriately qualified and authorized personnel. 
 
STUDY RELATED BENEFITS 
Because the surgery and all the follow-up visits are the same as if the subject would not participate 
in this study, there are no additional medical benefits associated with participating in this study. 
The information gained from this study may help improve the treatment of people in the future that 
need to undergo any of the procedures included in this study. 
 
OBJECTIVE(S) 
 
PRIMARY OBJECTIVE 
The primary objective of this study is to assess the safety and performance post-market of the 
PEEK Anchors (
RAPTORMITE
 SL)  in extremities 
over a time period of 6 months after intervention. 
 
SECONDARY OBJECTIVE 
The secondary objective of this study is to assess the safety and performance post-market of the 
PEEK Anchors (
RAPTORMITE
 SL)  in extremities 
over a time period of 12 months after intervention. 
 STUDY PRODUCT(S) 
 
DYNOMITE  2.0 PK SUTURE ANCHOR WITH NEEDLES 
The Smith & Nephew DYNOMITE  2.0 PK Suture Anchor with Needles is a push/tap-in fixation 
device intended to provide secure attachment of soft tissue to bone. The device consists of a 
suture anchor with attached non-absorbable suture(s) and stainless steel needles preassembled 

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CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and is 
intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith & Nephew. 
 
TMP-CD-05-01  Clinical Protocol-Device  Revision A; SOP-CD-05 Clinical Protocols  
to an insertion device. The suture anchor is provided sterile, for single use only. DYNOMITE  2.0 
PK Suture Anchor with Needles contains: Non-absorbable suture anchor, 2.0 mm diameter  
PEEK-OPTIMA® from Invibio® (polyetheretherketone), Insertion device  stainless steel shaft with 
ABS and polycarbonate handle. Non-absorbable suture(s) with attached stainless steel needles. 
Non-absorbable suture options: 
 White  braided, uncoated, UHMW polyethylene 
 White/blue  braided, uncoated, UHMW polyethylene with monofilament polypropylene 
cobraid 
 White/black  braided, uncoated, UHMW polyethylene with monofilament nylon cobraid 
 Braided, silicone, or PTFE-impregnated polyester (USP), non-absorbable  
 
 3.0 SUTURE ANCHOR WITH NEEDLES  
The Smith & Nephew RAPTORMITE  Suture Anchor is a fixation device intended to provide secure 
attachment of soft tissue to bone. The device consists of a suture anchor with attached non-
absorbable suture(s) and stainless steel needles preassembled to an insertion device. The suture 
anchor is provided sterile, for single use only. RAPTORMITE  3.0 Suture Anchor with Needles 
contains: non-absorbable suture anchor, 3.0 mm diameter  PEEK-OPTIMA® from Invibio® 
(polyetheretherketone), Insertion device  stainless steel shaft with ABS and polycarbonate handle. 
Non-absorbable suture(s) with attached stainless steel needles. Refer to individual suture anchor 
product labels for suture size and type, and quantity. 
Non-absorbable suture options: 
 White  braided, uncoated, UHMW polyethylene 
 White/blue  braided, uncoated, UHMW polyethylene with monofilament polypropylene 
cobraid 

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CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and is 
intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith & Nephew. 
 
TMP-CD-05-01  Clinical Protocol-Device  Revision A; SOP-CD-05 Clinical Protocols  
 White/black  braided, uncoated, UHMW polyethylene with monofilament nylon cobraid 
 White/green  braided, silicone-coated, polyester (USP), non-absorbable 
 
 2.0 PK SUTURE ANCHOR WITH NEEDLES 
The Smith & Nephew SPYROMITE  2.0 PK Suture Anchor with Needles is a screw-in fixation device 
intended to provide secure attachment of soft tissue to bone. The device consists of a suture 
anchor with attached non-absorbable suture(s) and stainless steel needles preassembled to an 
insertion device. The suture anchor is provided sterile, for single use only. SPYROMITE  2.0 PK 
Suture Anchor with Needles contains: Non-absorbable suture anchor, 2.0 mm diameter  PEEK-
OPTIMA® from Invibio® (polyetheretherketone), Insertion device  stainless steel shaft with ABS 
and polycarbonate handle. Non-absorbable suture(s) with attached stainless steel needles. 
Non-absorbable suture options: 
 White  braided, uncoated, UHMW polyethylene 
 White/blue  braided, uncoated, UHMW polyethylene with monofilament polypropylene 
cobraid 
 White/black  braided, uncoated, UHMW polyethylene with monofilament nylon cobraid, 
 Braided, silicone, or PTFE-impregnated polyester (USP), non-absorbable  
 
FOOTPRINT ULTRA  PK  SL SUTURE ANCHOR 
The Smith & Nephew FOOTPRINT ULTRA PK SL (PEEK-OPTIMA® from Invibio®) Suture Anchor is 
non-absorbable, attached to an insertion device, and available in 4.5 mm and 5.5 mm. The 
suture anchor is intended to provide secure reattachment of soft tissue to bone. Attachment of 
  
 Non-absorbable suture options PEEK-OPTIMA® from Invibio® 

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CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and is 
intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith & Nephew. 
 
TMP-CD-05-01  Clinical Protocol-Device  Revision A; SOP-CD-05 Clinical Protocols  
 Suture (USP #2-0). 
 Retention suture- braided polyester non-absorbable suture (USP #2-0). 
 
Table 3 demonstrates the model, and product description of the devices. Refer to individual suture 
anchor product labels for suture size, type, and quantity. 
Table 3: Product Specification, structural composition and description 
Product  # 
72201806 
72201881 
72201882 
72203776 
72203783 
Specification
RAPTORMITE  3.0 PK 
W/NDL, 2 0 ULTRABRA 
DYNOMITE  2.0 PK 
W/NDL,1 2-0 
ULTRABRAID 
 
SPYROMITE  2.0 PK 
W/1 2-0 ULTRABRAID 
WH 
FOOTPRINT ULTRA PK 
SUTURE ANCH SL 
Diagram
 
Product 
description 
3.0 mm diameter 
PEEK-OPTIMA® from 
Invibio®suture anchor 
2.0 mm diameter PEEK-
OPTIMA® from 
Invibio® suture anchor 
2.0 mm diameter PEEK-
OPTIMA® from 
Invibio® suture anchor 
4.5 mm and 5.5 mm 
PEEK-OPTIMA® from 
Invibio® suture anchor 
 
 
INDICATIONS FOR USE 
The following Table 4 identifies the Indications for Use for the Smith & Nephew PEEK Suture 
Anchors. 
 
 
 
 

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CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and is 
intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith & Nephew. 
 
TMP-CD-05-01  Clinical Protocol-Device  Revision A; SOP-CD-05 Clinical Protocols  
Table 4:  Summary of indications for PEEK Anchors (
RAPTORMITE  
ULTRA PK SL) in extremities  
 
 
PRODUCT USE 
All study related procedures using the PEEK suture anchors in the extremities have been 
performed according to the recommended surgical technique described in the labelling and the 
instructions for use.  
 
DYNOMITE  
RAPTORMITE  
SPYROMITE  
FOOTPRINT  
ULTRA PK SL 
Foot & Ankle 
Hallux valgus repairs 
X 
X 
X 
X 
Medial or lateral instability 
repairs/reconstructions 
X 
X 
X 
X 
Achilles tendon 
repairs/reconstructions 
X 
X 
X 
X 
Midfoot reconstructions 
X 
X 
X 
X 
Metatarsal 
ligament/tendon 
repairs/reconstructions 
X 
X 
X 
X 
Bunionectomy 
X 
X 
X 
N/A 
Elbow, Wrist & Hand 
Scapholunate ligament 
reconstructions 
X 
N/A 
X 
N/A 
Ulnar or radial collateral 
ligament reconstructions 
X 
X 
X 
N/A 
Lateral epicondylitis repair X 
X 
X 
N/A 
Biceps tendon 
reattachment 
X 
X 
X 
N/A 

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CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and is 
intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith & Nephew. 
 
TMP-CD-05-01  Clinical Protocol-Device  Revision A; SOP-CD-05 Clinical Protocols  
 
SURGICAL TECHNIQUE 
The operative visit of this study is retrospective. The use of the PEEK Anchors (
RAPTORMITE
ULTRA PK SL) in extremities was performed per standard 
of care at the participating study sites. 
 SUBJECT ENROLLMENT AND WITHDRAWAL 
Investigators will screen all subjects that have undergone usage of the PEEK suture anchors in the 
extremities using only the existing information in the medical records. 
Investigators will conduct a chart review after IRB approval has been granted. All subjects whose 
chart undergoes the screening process will be documented on a Screening and Enrollment Log, 
with the reason for exclusion noted, if applicable. The Investigator or designee must notify the 
Sponsor upon subject enrollment. 
 
SUBJECT POPULATION 
To minimize the potential for selection bias, Investigators will screen and subsequently enroll 
subjects (after fulfilling all inclusion and exclusion criteria) on whom 
SPYROMITE and 
ULTRA PK SL in the extremities were implanted.  
Enrollment will be in sequential order based on the date of their surgical procedure with the 
investigational device, i.e. earliest to latest. 
 
INCLUSION CRITERIA 
Subjects will be considered qualified for enrollment if they meet the following criteria: 
1. 
Subjects who have undergone extremity joint repair using the study devices. 
2. 
Subjects aged 18 years and older at the time of surgery. 

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CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and is 
intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith & Nephew. 
 
TMP-CD-05-01  Clinical Protocol-Device  Revision A; SOP-CD-05 Clinical Protocols  
 
EXCLUSION CRITERIA 
Any one (1) of the following criteria will disqualify a potential subject from participation in the 
study: 
1. Subject is entered in another investigational drug, biologic, or device study or has been 
treated with an investigational product within 12 months post-operative. 
2. Subjects who are < 3 months post-operative. 
 
SCREENING 
Participating study sites are required to document all screened subjects considered for inclusion 
in this study. If a subject is excluded from the study, the reasons for exclusion will be documented 
in the subject's source documents and noted on the Screening and Enrollment Log. 
 
INFORMED CONSENT 
Study sites will obtain Institutional Review Board (IRB/Ethics Committee (EC)) approval for this study 
before any study specific activities are performed.  
Due to the retrospective nature of the study, a waiver of informed consent for study participation 
will be requested from the IRB/EC for those subjects who meet eligibility criteria as only 
retrospective data set will be collected for these subjects. No prospective visits will be performed. 
A waiver or alteration of the requirements for obtaining informed consent can occur under any of 
the following three provisions set forth by the Department of Health and Human Health Services: 
Research in general: an IRB may waive or alter the requirement of informed consent under 45 CFR 
46.116(d), provided that the IRB finds and documents that all of the following four conditions are 
met: 

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CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and is 
intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith & Nephew. 
 
TMP-CD-05-01  Clinical Protocol-Device  Revision A; SOP-CD-05 Clinical Protocols  
1. the research involves no more than minimal risk to the participants; 
2. the waiver or alteration will not adversely affect the rights and welfare of the participants; 
3. the research could not practicably be carried out without the waiver or alteration; and 
4. Whenever appropriate, the participants will be provided with additional pertinent 
information after participation. 
If an IRB/EC waiver is not granted, then informed consent shall be obtained from all study subjects 
according to ISO 14155 guidelines and all applicable national regulations. If waiver of consent is 
not approved, potential subjects must be informed as to the purpose of the study and the potential 
risks and benefits known or that can be reasonably predicted or expected as described in the 
written consent form. The subject, or their legally authorized representative, will then read, sign, 
and personally date the IRB/EC approved informed consent document(s) (see below for difficulties 
with reading and writing). Additionally, the individual who obtains consent from the subject will 
sign and date the informed consent document. A copy of the signed informed consent 
documentation will be provided to the subject, a copy will be placed in the subj
and the original filed in the Investigator Site File (ISF). 
If a subject refuses participation, no further information will be collected. Reason for exclusion 
should be noted on the Screening and Enrollment Log. 
 
ENROLLMENT 
For screening, only information available in the medical records will be reviewed. Once a potential 
subject has been identified, all inclusion criteria and none of the exclusion criteria have been met, 
and the informed consent process has been completed or a waiver of consent has been granted 
by IRB/EC, the subject will be considered enrolled and assigned a consecutive Subject 

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CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and is 
intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith & Nephew. 
 
TMP-CD-05-01  Clinical Protocol-Device  Revision A; SOP-CD-05 Clinical Protocols  
Identification (ID) number. Enrollment and assigned Subject ID will be documented on the 
Screening and Enrollment Log. For bilateral subjects, only one Subject ID will be assigned. 
Any subject who signs an informed consent or has a waiver of informed consent and is 
subsequently identified as not meeting the required entry criteria is considered to be a screen 
failure. Demographic information must be captured in the appropriate Case Report Form (CRF) and 
the reason for screen failure will be documented on the Screening and Enrollment Log. 
 
LOST TO FOLLOW-UP 
A subject will be considered lost to follow-up if he/she did not return for follow-up per the study 
Investigator  standard of care follow-up schedule.  Information will be documented on the Case 
Report Form (CRF). 
 
WITHDRAWAL 
9.8.1 Withdrawal from the Study 
The Investigator may withdraw subjects from the study for many reasons, including but not limited 
to the following: 
 At the discretion of the Investigator. 
 If the Investigator or the Sponsor stops the study for any reason and decides to withdraw 
subject(s) from the study. 
 
For each case, information will be documented in the source document and the Case Report Form 
(CRF), detailing circumstances leading to the withdrawal. Subjects who are withdrawn will not be 
re-entered into the study at a later date. Data collected up to the point of withdrawal may be used 
but no additional data for that subject may be collected.  

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CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and is 
intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith & Nephew. 
 
TMP-CD-05-01  Clinical Protocol-Device  Revision A; SOP-CD-05 Clinical Protocols  
 STUDY DESIGN 
 
STUDY DESIGN 
This is a retrospective, multi-center, case series study to collect clinical data that will evaluate post-
market PEEK 
 
 and 
ULTRA PK SL in 
extremities. A minimum of 80 subjects and a maximum of 480 subjects who underwent surgery 
for 
 and 
ULTRA PK SL in 
extremities are planned to be enrolled into the study after the fulfilment of all inclusion and 
exclusion criteria. It is also planned that any of the investigational sites will enroll a minimum of 10 
subjects into the study. Data from eligible subjects will be recorded on case report forms (CRFs). 
 
STUDY ENDPOINTS 
10.2.1 Primary Endpoint 
Clinical success rate (%) of the study devices in extremities at 6 months post-operative with clinical 
success defined as extremity repairs without signs of device failure and/or re-intervention as 
assessed by the surgeon. 
10.2.2 Secondary Endpoints 
Clinical success rate (%) of the study devices in extremities at 12 months post-operative. Clinical 
success has previously been defined. 
10.2.3 Safety Endpoints 
 

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CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and is 
intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith & Nephew. 
 
TMP-CD-05-01  Clinical Protocol-Device  Revision A; SOP-CD-05 Clinical Protocols  
 All adverse events (AEs) and complications occurring from the time of subject enrollment 
until study termination or study completion including intra-operative adverse events and 
complications. 
 Device related re-intervention. 
 Device deficiency. 
10.2.4 Other Endpoints 
Surgeon Reported Outcomes would constitute other endpoints and may include but not be 
restricted to the following: 
 Range of Motion (ROM) 
 Pain assessed by Visual Analogue Scale (VAS) 
Surgeon reported outcomes are optional and will be definitively specified in collaboration with 
the Investigators once sites have been identified for the conduct of the study.  
 STUDY PROCEDURES 
 
RETROSPECTIVE DATA COLLECTION: 6 MONTHS POST-OPERATIVE (±90 DAYS) 
Given the retrospective study design, data will be collected from the medical chart to the extent it 
is available. 
1. Subject should undergo the informed consent process and sign the informed consent 
only if a waiver of consent has not been approved by the IRB. 
2. 
 
3. Obtain demographic information and a medical history. 
4. VAS, ROM. 
5. Operative Data Collection  review operative case notes. 

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CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and is 
intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith & Nephew. 
 
TMP-CD-05-01  Clinical Protocol-Device  Revision A; SOP-CD-05 Clinical Protocols  
6. Implant Status/ Disposition. 
7. Document concomitant medications and/or therapies associated with an AE, SA(D)E. 
8. 
es, including inter-
operative. AEs, SAEs and DevDs should be documented from the time of surgery through 
the study duration. 
 
RETROSPECTIVE: 12 MONTHS POST-OPERATIVE (±90 DAYS) 
Given the retrospective study design, data will be collected from the medical chart to the extent it 
is available. 
1. VAS, ROM. 
2. Implant Status/Disposition. 
3. Document concomitant medications and/or therapies associated with an AE, SA(D)E. 
4. 
-
operative. AEs, SAEs and DevDs should be documented from the time of surgery 
through the study duration. 
5. Complete the End of Study CRF. 
 
CONCOMITANT MEDICATIONS AND THERAPIES 
Any concomitant medications associated with an AE, SAE or SADE will be recorded. 
 STATISTICAL DESIGN 
A Statistical Analysis Plan (SAP) based on the contents of the protocol will be written and 
finalized prior to database lock. The SAP will account for any changes or deviations from the 
projected analyses in this protocol. 

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CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and is 
intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith & Nephew. 
 
TMP-CD-05-01  Clinical Protocol-Device  Revision A; SOP-CD-05 Clinical Protocols  
 
 GENERAL 
iostatistics group will conduct the statistical analysis for this study. 
Unless otherwise stated, all significance tests will be two-sided, performed at the 5% significance 
level. Resulting p-values will be quoted and 95% two-sided confidence intervals will be generated 
where appropriate. 
Where data summaries are specified, categorical and ordinal variables will be summarized with 
frequencies and percentages. Continuous variables will be summarized with the following 
summary statistics: number of observations, mean, median, standard deviation, minimum and 
maximum values. All analyses will be performed in Statistical Analysis System (SAS) version 9.3 
(or later). 
 
 ANALYSIS POPULATIONS 
The following analysis populations will be used for this study: 
 Safety Population (SAF): This includes all subjects who enroll in the study who had 
previously undergone repair in the extremities using any of the PEEK anchors: 
 SPYROMITE and FOOTPRINT
 SL. 
 Per-Protocol Population (PP): This includes all subjects in the Safety Population, who have 
no significant protocol deviations and who meet all the inclusion/exclusion criteria. 
Deviations considered as significant will be defined and finalized prior to database lock. 
 
EFFICACY ANALYSIS 
   Analysis of Primary Endpoint 

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CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and is 
intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith & Nephew. 
 
TMP-CD-05-01  Clinical Protocol-Device  Revision A; SOP-CD-05 Clinical Protocols  
The rate (%) of clinical success of all the anchor devices combined at 6 months post-operative will 
be summarized as a frequency and a percentage. A 95% two-sided exact CI for a single proportion 
will be presented using Clopper-
of analysis will be carried 
out for each of the anchors used in the study. These analyses will be carried out using the per 
protocol population as the primary analysis population with the safety population used for 
sensitivity analysis. 
12.3.2 
Analysis of Secondary Endpoints 
The analysis of the following secondary endpoint will be carried out using the safety population: 
 The rate (%) of clinical success of all the anchors combined at 12 months post-operative 
will be summarized as described for the analysis of the primary endpoint. This analysis 
will also be repeated for each of the anchors used in the study.  
   SAFETY ANALYSES 
 All safety endpoints will be summarized using the safety population. The incidence of 
events encountered on-study will be summarized using frequencies and percentages.  
An overall AE table will summarize the overall AE incidence according to subjects with 
at least one AE; subjects with at least one AE by worst severity (mild, moderate, or 
severe); subjects with at least one AE by worst outcome; subjects with at least one AE 
that led to study discontinuation; subjects with at least one AE by relatedness to 
investigational device; SAEs; ADEs; ASADEs; USADEs and; SADEs as applicable.  A 
cumulative summary by the number of adverse events encountered overall and within 
each classification will also be summarized. The incidence of subjects reporting device 
deficiencies will additionally be summarized. 

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CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and is 
intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith & Nephew. 
 
TMP-CD-05-01  Clinical Protocol-Device  Revision A; SOP-CD-05 Clinical Protocols  
 Each of the AE classifications will further be summarized by event using frequencies (n) 
and percentage (%) of subjects with each adverse event as well as the cumulative 
adverse events/episodes per classification. 
 A listing of concomitant medications/therapies will be provided by subject. 
Additional summaries of safety endpoints, if applicable, will be described in the SAP. 
 
 INTERIM ANALYSES 
Not applicable. 
 SAMPLE SIZE JUSTIFICATION 
This study is precision-based, thus, the sample size is not based on statistical power calculations. 
The sample size for this study is determined based on the feasibility of recruitment, enrollment 
and follow-up considerations. The study is therefore not powered for any statistical hypothesis 
testing but to have sufficient number of subjects to be able to estimate a clinical success rate of 
91% with a 95% confidence interval (CI) of 80% to 100%.  
With an assumption of a 91% clinical success rate to be obtained in each of the PEEK anchors and 
a corresponding 95% CI between 80% and 100%, enrolling between 20 and 120 subjects for each 
is expected to provide between 15.2% to >95% probability, pending 
that there is sufficient volume of each type of anchor available. Thus, an overall minimum of 80 
and maximum of 480 subjects are to be enrolled into the study, pending that there is sufficient 
volume of each type of anchor available. Additionally, a minimum of 10 subjects will be enrolled at 
any investigational site. 

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CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and is 
intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith & Nephew. 
 
TMP-CD-05-01  Clinical Protocol-Device  Revision A; SOP-CD-05 Clinical Protocols  
 ADVERSE EVENTS AND DEVICE DEFICIENCIES 
Adverse Events (AE) related to the study implant, or procedure including Adverse Device Effects 
(ADE), Serious Adverse Device Effects (SADE), Unanticipated Serious Adverse Device Effect 
(USADE), and Device Deficiencies (DevD) occurring from the time of the surgery until revision or 
study completion must be recorded on the appropriate CRF and reported. If the event is known to 
have been previously reported to Smith & Nephew, this must be noted on the CRF. After 
enrollment, in addition to all adverse events related to the implant or the procedure, all serious 
adverse events (SAE), regardless of causality, must be recorded on the appropriate CRF and 
reported to the Sponsor, and IRB if necessary. Adverse events leading to a revision should be 
reported at all times regardless of causality. 
Adverse Device Effects (ADE) occurring after study completion will be handled as product 
complaints reportable by the Sponsor and will not be entered into the study database. 
 
DEFINITIONS 
The categories of adverse events are shown in table 5. The definitions for each of these categories 
are given in the subsequent sections (see reference within the table). 

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Extremities 
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2018.15.SMD.PEEK.RET.EXT 
Version: 2.0 05Dec2018 
Page: Page 32 of 54 
 
 
CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and is 
intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith & Nephew. 
 
TMP-CD-05-01  Clinical Protocol-Device  Revision A; SOP-CD-05 Clinical Protocols  
Table 5: Categories of Adverse Event 
 
NOT DEVICE- 
RELATED 
DEVICE- OR PROCEDURE-RELATED 
NON-
SERIOUS 
ADVERSE EVENT 
(AE) (SEE 14.1.1) 
ADVERSE DEVICE EFFECT 
(ADE) (SEE 14.1.2) 
SERIOUS 
SERIOUS ADVERSE EVENT 
(SAE) 
(SEE 14.1.3) 
SERIOUS ADVERSE DEVICE EFFECT 
(SADE) (SEE 14.1.3) 
ANTICIPATED 
UNANTICIPATED 
ANTICIPATED SERIOUS ADVERSE 
DEVICE EFFECT 
(ASADE) (SEE 14.1.4) 
UNANTICIPATED SERIOUS 
ADVERSE DEVICE EFFECT 
(USADE) (SEE 14.1.4) 
14.1.1 Adverse Event (AE) 
An AE is any untoward medical occurrence temporally associated with the use of an Investigational 
Product (IP)/Ancillary Product, whether or not considered causally related to that IP/Ancillary 
Product. 
AE is used both to refer to AEs which are non-serious non-IP or procedure-related and as an 
umbrella term referring to adverse events of all classifications. 
14.1.2 Adverse Device Effect (ADE) 
An ADE is an adverse event that, in the opinion of the Investigator, is related to the IP or the 
procedure. 

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CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and is 
intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith & Nephew. 
 
TMP-CD-05-01  Clinical Protocol-Device  Revision A; SOP-CD-05 Clinical Protocols  
Not Related -  An AE is considered to be not related to the use of an IP or the procedure when the 
effect is DEFINITELY UNRELATED or UNLIKELY to have any relationship to the use of 
the IP or the procedure; 
Related   An AE is considered to be related to the use of an IP or the procedure when there is a 
POSSIBLE, PROBABLE, or DEFINITE relationship between the AE and the use of the IP 
or the procedure. 
14.1.3 Serious Adverse Events (SAE) and Serious Adverse Device Effects (SADE) 
An AE or ADE is considered a SAE or SADE if, in the view of either the Investigator or the Sponsor, 
it: 
 Results in death. 
 Is life-threatening (NOTE
-
an event/reaction in which the subject was at risk of death at the time of the 
event/reaction; it does not refer to an event/reaction which hypothetically might have 
caused death if it were more severe). 
 Requires in subject hospitalization or results in prolongation of existing hospitalization. 
 Results in persistent or significant incapacity or substantial disruption of the ability to 
conduct normal life functions. 
 Is a congenital anomaly/birth defect. 
 Is a medically important event or reaction. 
Medical and scientific judgment should be exercised in deciding whether other situations should 
be considered serious such as important medical events that might not be immediately life-
threatening or result in death or hospitalization but might jeopardize the subject or might require 

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Extremities 
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Version: 2.0 05Dec2018 
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CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and is 
intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith & Nephew. 
 
TMP-CD-05-01  Clinical Protocol-Device  Revision A; SOP-CD-05 Clinical Protocols  
intervention to prevent one of the other outcomes listed in the definition above. Examples of such 
events are intensive treatment in an emergency room or at home for allergic bronchospasm, blood 
dyscrasias, or convulsions that do not result in hospitalization; or development of drug 
dependency or drug abuse. 
14.1.4 Anticipated/Unanticipated Serious Adverse Device Effect (ASADE/USADE) 
An USADE is a serious ADE that meets any of the above definitions but is also considered, by the 
Investigator, to be caused by or related to the IP, not previously identified in nature, severity or 
degree in the IFU. 
An Anticipated Serious Adverse Device Effect (ASADE) is a serious ADE that does not meet the 
criteria for a USADE. 
14.1.5 Severity 
The severity of every AE will be assessed by the Investigator or medically qualified site staff to 
whom the responsibility has been delegated and documented on the delegation of authority log. 
AEs should be classified as mild, moderate, or severe, regardless of whether or not the AEs are 
considered to be serious or non-serious. The classification should be based on the following 
definitions: 
Mild - 
 
An event is mild if the subject is aware of, but can easily tolerate the sign or 
symptom; 
Moderate - 
An event is moderate if the sign or symptom results in discomfort significant enough 
 

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CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and is 
intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith & Nephew. 
 
TMP-CD-05-01  Clinical Protocol-Device  Revision A; SOP-CD-05 Clinical Protocols  
Severe -    
An event is severe if the sign or symptom is incapacitating and results in the 
inability to work or engage in their usual activities. 
14.1.6 Device Deficiency 
A Device Deficiency (DevD) is an inadequacy of a medical device with respect to its identity, quality, 
durability, reliability, safety or performance. DevD includes malfunctions, use errors and 
inadequate labelling. 
 
REPORTING PROCEDURES 
AEs of any kind and DevDs will be recorded in the applicable CRF and source notes. The 
Investigator will evaluate all AEs for relationship to the device and procedure, if applicable, 
seriousness, and severity. ADEs, SAEs, and DevDs will be submitted/entered into the CRF and 
reported to the Sponsor within 24 hours of the Investigator being informed about the event (Figure 
1). For ADEs and DevDs, details of the product/procedure related to the event will be recorded in 
the CRF within 24 hours of the retrospective chart review. 
 
All SAEs and ADEs will be reviewed by a medically qualified person appointed by the Sponsor to 
determine which, if any, meet criteria for expedited reporting to the regulatory authorities. The 
Investigator will inform the IRB of AEs according to the IRB requirements. 
Depending on the nature of the AE, the Sponsor 
records, imaging, operative notes, as well as results of any relevant laboratory tests performed or 
other documentation related to the AE. If the subject was hospitalized, a copy of the discharge 
summary may be requested by the Sponsor and should be forwarded as soon as it becomes 

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CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and is 
intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith & Nephew. 
 
TMP-CD-05-01  Clinical Protocol-Device  Revision A; SOP-CD-05 Clinical Protocols  
available. In certain cases, the Sponsor also may request a letter from the Investigator that 
summarizes the events related to the case. 
Figure 1: Evaluation and Reporting of AE and DevD 
 
 
Reference the Investigator Site File Sponsor Contact Information Sheet to report SAEs, 
unanticipated ADEs and SADEs, anticipated SADEs, and DevDs.
Site aware 
of AE
Investigator 
assesses 
seriousness 
Serious
Investigator 
assesses device 
relationship
Related 
Investigator 
assesses whether 
SADE is 
anticipated
Not Related
Serious 
Adverse 
Event (SAE)
unanticipated
Unanticpated 
Serious 
Adverse 
Device Effect 
(USADE)
Anticipated 
Serious 
Adverse 
Device 
Effect 
(ASADE)
Investigator 
assesses device 
relationship
Non-serious
Related
Adverse 
Device 
Effect (ADE)
Not Related
Adverse 
Event (AE)
Complete CRF 
and alert S&N 
within 24 
hours. 
Record details 
medical 
records / 
source notes.
Device 
Deficiency 
Record information 
in patient CRF 
according to usual 
timescales.
Stop

 
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CONFIDENTIAL AND PROPRIETARY 
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intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith & Nephew. 
 
TMP-CD-05-01  Clinical Protocol-Device  Revision A; SOP-CD-05 Clinical Protocols  
 
FOLLOW-UP OF SUBJECTS WITH ADVERSE EVENTS 
For subjects who are experiencing an ongoing unresolved AE at the time of their study completion 
or early discontinuation from the study, it is recommended that the investigator follow-up with the 
patient per standard clinical practice.  
Any additional data must be documented and available to the Sponsor who will determine whether 
the data needs to be documented within the CRF/Clinical Study Report. 
14.3.1 Ongoing Adverse Events at Study Discontinuation 
Adverse events which are related to a study procedure or IP 
participation: The event should be followed until it is either resolved or until the event has become 
chronic and is not expected 
 
Adverse events which are not related to a study procedure or IP and are ongoing at end of 
 should be followed for 30 days after discontinuation or if the AE is resolved, 
whichever is sooner. 
At the time of data analysis (e.g. interim or final), an evaluation of ongoing events should take place 
and be listed as ongoing in the safety table. 
 INVESTIGATOR OBLIGATIONS 
The Principal Investigator (PI) will comply with the commitments outlined in the in the Statement of 
Investigator and with GCP, and all applicable regulatory requirements.   
 SPONSOR AND MONITOR RESPONSIBILITIES 
The Sponsor will designate a monitor to conduct the appropriate site visits at the appropriate 
intervals. The clinical investigation will be monitored to ensure that: the rights and wellbeing of the 

 
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CONFIDENTIAL AND PROPRIETARY 
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intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith & Nephew. 
 
TMP-CD-05-01  Clinical Protocol-Device  Revision A; SOP-CD-05 Clinical Protocols  
subjects are protected; the reported data are accurate, complete, and verifiable from the source 
documents; and the study is conducted in compliance with the currently approved protocol, with 
GCP regulations, and with applicable regulatory requirements. 
Detailed monitoring requirements will be documented within the Clinical Monitoring Plan for this 
study. 
 
SITE QUALIFICATION VISIT 
A site qualification visit may be performed by the Sponsor or qualified person designated by the 
Sponsor prior to the execution of a clinical agreement to ensure that all Investigators have the 
appropriate training, staff, facilities, and resources to adequately conduct the study. 
 
SITE INITIATION VISIT 
A site initiation visit to provide training on the specifics of the study, site obligations and 
expectations of study conduct will be performed by the Sponsor or qualified person designated by 
the Sponsor following the execution of the Clinical Trial Agreement (CTA) and documented IRB/EC 
approval. 
 
SPONSOR AUDITS AND REGULATORY INSPECTION 
Quality Assurance auditors, whether an employee of the Sponsor or its designee, may evaluate 
study conduct at the study sites. These parties must have access to any and all study reports and 
source documentation, regardless of location and format. 

 
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CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and is 
intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith & Nephew. 
 
TMP-CD-05-01  Clinical Protocol-Device  Revision A; SOP-CD-05 Clinical Protocols  
 
CLOSE-OUT VISIT 
A study close-out visit will be performed by the Sponsor or designee to retrieve and account for all 
remaining clinical data and to resolve outstanding queries. During study close-out, the monitor will 
review investigator files to ensure required documents and records are on file, confirm the 
disposition of any other ancillary items used for the study, and review regulatory requirements 
regarding records retention and IRB/IEC reporting requirements. 
 PROTOCOL AMENDMENTS 
Amendments should be made only in exceptional cases once the study has started. Protocol 
amendments must be approved by the protocol signatories prior to submission to the IRB. Protocol 
amendments need to be approved by the IRB and Regulatory Authority (ies), as applicable prior to 
implementation at the site. 
 CONFIDENTIALITY OF THE STUDY 
The confidentiality of this study and associated documents is governed by the terms of the CTA. 
 STATEMENTS OF COMPLIANCE 
This clinical study will be performed in compliance with the ethical principles of the Declaration of 
Helsinki; International Organization for Standardization (ISO) 14155: Clinical investigation of medical 
devices  Good Clinical Practice (GCP); and the International Council for Harmonisation (ICH)-E6. 
 
This clinical study will not commence until the required approval/favorable opinion from the IRB or 
regulatory authority has been obtained. Any additional requirements imposed by the IRB or 
regulatory authority will be followed. 

 
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CONFIDENTIAL AND PROPRIETARY 
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intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith & Nephew. 
 
TMP-CD-05-01  Clinical Protocol-Device  Revision A; SOP-CD-05 Clinical Protocols  
 END OF STUDY 
Should circumstances arise which require the termination of the entire study prior to its planned 
completion (e.g. safety concerns) or circumstances arise which mean the end of the participation 
of an individual site (e.g. departure of Investigator, non-compliance), then this will be undertaken 
according to the Standard Operating Procedures (SOP) of the Sponsor. 
 PUBLICATION POLICY 
 
PUBLICATION OF STUDY DATA 
The preparation and submission for publication of manuscripts containing the study results shall 
be in accordance with a process determined by the Clinical Trial Agreements between the study 
Sponsor and participating institutions. The publication or presentation of any study results shall 
comply with all applicable privacy laws, including, but not limited to the Health Insurance Portability 
and Accountability Act of 1996. 
 
DATA SHARING 
Smith & Nephew is committed to upholding the highest ethical and legal standards involved in 
conducting clinical trials. Smith & Nephew therefore supports the data sharing requirements of The 
International Committee of Medical Journal Editors (ICMJE) published on the 6th June 2017. In 
accordance, Smith & Nephew will consider requests to share individual (de-identified) participant 
data that underlie the results of any interventional clinical trial, as presented from the 1st July 2018 
within an ICMJE associated journal. Requests made by researchers who provide a methodologically 
sound proposal will be considered. Requests may include data that underlie results presented in 
text, tables, figures and appendices, together with data dictionaries. Availability of these data will 

 
Study Protocol
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Version: 2.0 05Dec2018 
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CONFIDENTIAL AND PROPRIETARY 
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intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith & Nephew. 
 
TMP-CD-05-01  Clinical Protocol-Device  Revision A; SOP-CD-05 Clinical Protocols  
begin 9 months and end 36 months after article publication. Data supplied may only be used by 
the researcher(s) named in the approved research proposal for the purposes of achieving the aims 
of the analyses specified therein. All proposals should be directed to the Sponsor.  To gain access, 
data requestors will need to sign a data access agreement. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
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intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith & Nephew. 
 
TMP-CD-05-01  Clinical Protocol-Device  Revision A; SOP-CD-05 Clinical Protocols  
 REFERENCES 
1. U.S. Department of Health and Human Services (HHS) Code of Federal Regulation Title 45 
Part 46  (45 CFR 46)  Revised January 15, 2009 
2. Clopper, CJ & Pearson ES. (1934) The use of confidence or fiducial limits illustrated in the 
case of the binomial. Biometrika, 26, 404 413. 
3. IFU- Dynomite
 
4. IFU-
 
5. IFU FOOTPRINT ULTRA PK SL Suture Anchors  10601001-B 
6. PEEK SUTURE Anchors Post Market Surveillance Statement- PMS-140 
7. Clinical Evaluation: PEEK Suture Anchors EOP:14000055 
 
 
 
 

 
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CONFIDENTIAL AND PROPRIETARY 
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intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith & Nephew. 
 
TMP-CD-05-01  Clinical Protocol-Device  Revision A; SOP-CD-05 Clinical Protocols  
 APPENDICES 
 
PROTOCOL AMENDMENT VERSION 1.0 TO 2.0  
23.1.1 
General Purpose 
The protocol changes below are editorial/ administrative updates and do not affect the scientific 
intent, patient risk, or human subject protection. These changes include adding a product 
(
 SL), increasing sample size, adding exclusion criteria, and administrative 
actions to clarify and/or correct typographical errors.  
23.1.2 
Rationale 
The protocol changes below were made to include the product PEEK family 
PK SL, increase sample size to account for the additional product family, and addition of 
exclusion criteria so that subjects have follow-up data (as this is a retrospective study).  
23.1.3 
Effect on Study Status 
 Not applicable; this amendment is to be in effect and implemented prior to subject enrollment. 

 
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CONFIDENTIAL AND PROPRIETARY 
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intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith & Nephew. 
 
TMP-CD-05-01  Clinical Protocol-Device  Revision A; SOP-CD-05 Clinical Protocols  
23.1.4 
Details  
Section 
 
Current Text 12Sept2018 , Version 1.0
 
Revised Text 05Dec2018 , Version 2.0 
 
Throughout 
document 
header 
Safety and Performance of PEEK 
 
 
Version #, Date 
 
 
 
 
 
TMP-110  Clinical Protocol - Devices 
SOP-059 Clinical Protocols 
THROUGHOUT PROTOCOL HEADER- 
Updated information to reflect additional 
product name 
 
 
Typo error corrected for Raptormite 
 
Version #, Date change from 12Sep2018 
to 8/20/2012 
Version change to 1.0 from 2.0 
 
Added Footer: TMP-CD-05-01  Clinical 
Protocol-Device  Revision A; SOP-CD-
05 Clinical Protocols 
Title Page 
Protocol Version : 1.0 
Safety and Performance of PEEK 
, 
 
Updated information to reflect version 
changes and addition of product family 
(FOOTPRINT  ULTRA PK SL) 
 
Updated: Safety and Performance of 
RAPTOR
in Extremities 
 
Added Investigation products:  
FOOTPRINT ULTRA PK 4.5 mm, SL 
FOOTPRINT ULTRA PK 5.5 mm, SL 

 
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CONFIDENTIAL AND PROPRIETARY 
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intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith & Nephew. 
 
TMP-CD-05-01  Clinical Protocol-Device  Revision A; SOP-CD-05 Clinical Protocols  
Section 1.1 
Protocol 
Signature 
page 
I have read the attached protocol 
11Sep2018, and agree to abide by all 
provisions set forth herein. I agree to 
Obligations stipulated in Section 23.1 
of the protocol, I agree to ensure that 
the confidential information contained 
in this document will not be used for 
any purpose other than the conduct 
of the described clinical investigation 
without the prior written consent of 
Smith & Nephew, Inc.  
 
Updated version and date. Removed 
Investigator Obligations as this will be 
provided to the site separately: 
I have read the attached protocol entitled 
Safety and Performance of PEEK 
) 
in Extremities
 2.0, dated 
05Dec2018, and agree to abide by all 
provisions set forth herein. I agree to 
ensure that the confidential information 
contained in this document will not be 
used for any purpose other than the 
conduct of the described clinical 
investigation without the prior written 
consent of Smith & Nephew, Inc. 
Section 3 
Protocol 
Synopsis 
Study Product  
No language in prior protocol 
 
 
 
 
 
Sample Size: 
Minimum, n= 60  
Maximum, n= 120  
Enrollment distribution: 
PEEK 
Anchor  
 
Minimu
m  
 
Maximu
m  
Study Product: Updated product family to 
reflect FOOTPRINT ULTRA PK SL 4.5mm 
5.5 mm: 
Safety and Performance of PEEK Anchors 
) in Extremities 
  
Sample Size: Increased the sample size 
to reflect addition of FOOTPRINT  ULTRA 
PK SL and added if available  to reflect 
that there may be limited data for 
DYNOMITE, SPYROMITE, and FOOTPRINT
ULTRA PK SL: 
Minimum, n= 80 
Maximum, n= 480 
Enrollment distribution: 

 
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CONFIDENTIAL AND PROPRIETARY 
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intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith & Nephew. 
 
TMP-CD-05-01  Clinical Protocol-Device  Revision A; SOP-CD-05 Clinical Protocols  
 
RAPTORMITE
 
 20  
 40  
 
 
 20  
 40  
 
 20  
 40  
 
 
 
 
 
Number of Study Sites: 
Up to 6 sites 
 
 
 
Targeted Global Regions: 
United States 
 
 
 
 
Exclusion Criteria: 
1. Subject is entered in another 
investigational drug, biologic, or device 
study or has been treated with an 
investigational product within 12 months 
post-operative. 
 
 
PEEK 
Anchor 
Minimu
m 
Maximu
m 
RAPTORMITE
 
20 
120 
(If available)
20 
120 
(If available) 
20 
120 
FOOTPRINT 
ULTRA PK SL 
(If available) 
20 
120 
 
Number of Study Sites:  
Increased sample size to allow for site 
diversity across regions: 
Up to 15 sites 
 
Targeted Global Regions:  
Added OUS as an option for site 
selections: 
United States and/or Outside United 
States 
 
Exclusion criteria: 
Added exclusion criteria  
Subjects who are < 3 months post-
operative to ensure that subjects have 
follow-up data: 
1. Subject is entered in another 
investigational drug, biologic, or device 
study or has been treated with an 
investigational product within 12 months 
post-operative. 

 
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CONFIDENTIAL AND PROPRIETARY 
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intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith & Nephew. 
 
TMP-CD-05-01  Clinical Protocol-Device  Revision A; SOP-CD-05 Clinical Protocols  
 
 
 
 
 
Study Duration:  
The expected timeline for the study is 
approximately two years from first site 
initiation until final study report.  
 
2. Subjects who are < 3 months post-
operative. 
 
Study Duration: Updated to clarify that 
charts will be abstracted with data up to 
1-year post surgery: 
Twelve month follow up. 
Section 5.0 
Introductio
n 
DYNOMITE  
01/2017 
10600401 
Rev. D 
 
01/2017 
10600400 
Rev. D 
 
03/2017 
10600402 
Rev. E 
5.3 Safety Considerations 
DYNOMITE  
01/2017 
10600401 Rev. 
D 
 
01/2017 
10600400 Rev. 
D 
 
03/2017 
10600402 Rev. 
E 
ULTRA PK SL  
2017 10601001 
REV. B 
Updated overall section to reflect addition 
of FOOTPRINT ULTRA PK SL  
 
Section 8 
Study 
Products 
 
 
 
8.4: 
No language in prior protocol 
 
 
 
 
 
Sections updated to reflect product 
family 
 
8.4  Added FOOTPRINT ULTRA PK SL: 
FOOTRINT ULTRA  PK  SL Suture 
Anchor 
The Smith & Nephew FOOTPRINT ULTRA 
PK SL (PEEK-OPTIMA® from Invibio®) 
Suture Anchor is non-absorbable, 
attached to an insertion device, and 

 
Study Protocol
Device 
R
, FOOTPRINT  ULTRA PK SL ) in 
Extremities 
Number: 
2018.15.SMD.PEEK.RET.EXT 
Version: 2.0 05Dec2018 
Page: Page 48 of 54 
 
 
CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and is 
intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith & Nephew. 
 
TMP-CD-05-01  Clinical Protocol-Device  Revision A; SOP-CD-05 Clinical Protocols  
 
 
 
 
 
 
 
 
 
 
 
 
Table 4: Product Specification, structural 
composition and description  
 
 
 
 
 
Table 3: Summary of indications for 
PEEK Anchors (
) in 
extremities 
 
 
 
 
 
All study related procedures using the 
PEEK suture anchors in the shoulder 
have been performed according to the 
recommended surgical technique 
available in 4.5 mm and 5.5 mm. The 
suture anchor is intended to provide 
secure reattachment of soft tissue to 
bone. Attachment of the soft tissue is 
rred 
technique.  
 Non-absorbable suture options 
PEEK-OPTIMA® from Invibio® 
 Suture (USP #2-0). 
Retention suture- braided polyester 
non-absorbable suture (USP #2-0). 
 
Table 3 updated to reflect addition of 
ULTRA FOOTPRINT PK SL:  
Table 3: Product Specification, structural 
composition and description (see table in 
protocol) 
 
Table 4 updated to reflect addition of 
FOOTPRINT ULTRA PK SL: 
Summary of indications for PEEK Anchors 
(
 ULTRA PK SL) in extremities 
(see table in protocol) 
 
8.6 Changed typo error to clarify study is 
in extremities and not shoulder: 
All study related procedures using the 
PEEK suture anchors in the extremities 
have been performed according to the 
recommended surgical technique 
described in the labelling and the 
instructions for use.  

 
Study Protocol
Device 
R
, FOOTPRINT  ULTRA PK SL ) in 
Extremities 
Number: 
2018.15.SMD.PEEK.RET.EXT 
Version: 2.0 05Dec2018 
Page: Page 49 of 54 
 
 
CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and is 
intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith & Nephew. 
 
TMP-CD-05-01  Clinical Protocol-Device  Revision A; SOP-CD-05 Clinical Protocols  
described in the labelling and the 
instructions for use.  
Section 9. 
Subject 
Enrollment 
and 
Withdrawal
 
Section 9.1 
Subject 
Population 
 
Section 9.3 
Exclusion 
criteria 
 
Section 9.5 
Informed 
Consent 
 
Section 9.6 
Enrollment 
9.  
Investigators will screen all subjects that 
have undergone usage of the PEEK 
suture anchors in the shoulder using 
only the existing information in the 
medical records. 
 
 
9.1: 
To minimize the potential for selection 
bias, Investigators will screen and 
subsequently enroll subjects (after 
fulfilling all inclusion and exclusion 
criteria) on whom PEEK Anchors 
implanted. Enrollment will be in 
sequential order based on the date of 
their surgical procedure with the 
investigational device, i.e. earliest to 
latest. 
 
 
 
9.3: 
1. Subject is entered in another 
investigational drug, biologic, or device 
study or has been treated with an 
investigational product within 12 months 
post-operative. 
 
 
9. Changed typographical error to clarify 
study is in extremities and not shoulder: 
Investigators will screen all subjects that 
have undergone usage of the PEEK 
suture anchors in the extremities using 
only the existing information in the 
medical records. 
 
9.1 Added FOOTPRINT ULTRA PK SL: 
To minimize the potential for selection 
bias, Investigators will screen and 
subsequently enroll subjects (after 
fulfilling all inclusion and exclusion 
criteria) on whom PEEK Anchors 
and 
in the 
extremities were implanted.  Enrollment 
will be in sequential order based on the 
date of their surgical procedure with the 
investigational device, i.e. earliest to 
latest. 
 
9.3 Exclusion Criteria 
Administrative change: Updated to reflect 
synopsis change:  
1. Subject is entered in another 
investigational drug, biologic, or device 
study or has been treated with an 
investigational product within 12 months 
post-operative. 
2. Subjects who are < 3 months post-
operative. 

 
Study Protocol
Device 
R
, FOOTPRINT  ULTRA PK SL ) in 
Extremities 
Number: 
2018.15.SMD.PEEK.RET.EXT 
Version: 2.0 05Dec2018 
Page: Page 50 of 54 
 
 
CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and is 
intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith & Nephew. 
 
TMP-CD-05-01  Clinical Protocol-Device  Revision A; SOP-CD-05 Clinical Protocols  
 
 
 
 
9.5: 
Study sties will obtain Institutional 
Review Board (IRB) approval for this 
study  
An IRB waiver of informed consent for 
study participation should be requested 
for those subjects who meet eligibility 
criteria and have retrospectively 
completed a 6 month postoperative 
visit, are deceased, or are lost to follow-
up, per IRB policy. If allowed, a 
retrospective data set will be collected 
on these subjects. 
 
 
 
 
 
 
 
9.6: 
For screening, only information in the 
medical records will be reviewed. Once 
a subject has completed the informed 
consent process, if required by the IRB, 
or a waiver of consent is granted, the 
subject will be considered enrolled and 
assigned a consecutive Subject 
Identification (ID) number. Enrollment 
and assigned Subject ID will be 
 
9.5 Informed Consent 
Administrative change: Updated 
language to clarify IRB approval to occur 
before study begins and ICF waiver of 
consent approval: 
Study sites will obtain Institutional Review 
Board (IRB/Ethics Committee (EC)) 
approval for this study before any study 
specific activities are performed.  
Due to the retrospective nature of the 
study, an waiver of informed consent for 
study participation will be requested from 
the IRB/EC for those subjects who meet 
eligibility criteria as only retrospective 
data set will be collected for these 
subjects. No prospective visits will be 
performed. 
 
9.6 Enrollment 
Administrative change: Updated 
language to clarify Enrollment process: 
For screening, only information available 
in the medical records will be reviewed. 
Once a potential subject has been 
identified, all inclusion criteria and none 
of the exclusion criteria have been met, 
and the informed consent process has 
been completed or a waiver of consent 
has been granted by IRB/EC, the subject 
will be considered enrolled and assigned 
a consecutive Subject Identification (ID) 
number. Enrollment and assigned 
Subject ID will be documented on the 

 
Study Protocol
Device 
R
, FOOTPRINT  ULTRA PK SL ) in 
Extremities 
Number: 
2018.15.SMD.PEEK.RET.EXT 
Version: 2.0 05Dec2018 
Page: Page 51 of 54 
 
 
CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and is 
intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith & Nephew. 
 
TMP-CD-05-01  Clinical Protocol-Device  Revision A; SOP-CD-05 Clinical Protocols  
documented on the Screening and 
Enrollment Log.  
 
Any subject who signs an informed 
consent or has a waiver of informed 
consent and is subsequently identified 
not meeting the required entry criteria is 
considered to be a screen failure. 
Demographic information must be 
captured in the appropriate CRF and the 
reason for screen failure will be 
documented on the Screening and 
Enrollment Log 
Screening and Enrollment Log. For 
bilateral subjects, only one Subject ID will 
be assigned. 
 
Any subject who signs an informed 
consent or has a waiver of informed 
consent and is subsequently identified 
as not meeting the required entry criteria 
is considered to be a screen failure. 
Demographic information must be 
captured in the appropriate Case Report 
Form (CRF) and the reason for screen 
failure will be documented on the 
Screening and Enrollment Log. 
Section 10 
Study 
Design 
This is a retrospective, multi-center, 
case series study to collect clinical data 
that will evaluate post-market PEEK 
minimum of 60 subjects and a 
maximum of 120 subjects in the United 
States who underwent surgery PEEK 
planned to be enrolled into the study 
after the fulfilment of all inclusion and 
exclusion criteria. It is also planned that 
any of the investigational sites would 
enroll a minimum of 10 subjects into the 
study.  
 
Data from eligible subjects will have 
their data recorded on case report 
forms. 
Administrative changes: Updated 
product information and sample size to 
reflect inclusion of FOOTPRINT ULTRA PK 
SL: 
This is a retrospective, multi-center, case 
series study to collect clinical data that 
will evaluate post-market PEEK Anchors 
and 
in 
extremities. A minimum of 80 subjects 
and a maximum of 480 subjects who 
underwent surgery for PEEK Anchors 
and 
in 
extremities are planned to be enrolled 
into the study after the fulfilment of all 
inclusion and exclusion criteria. It is also 
planned that any of the investigational 
sites will enroll a minimum of 10 subjects 
into the study. Data from eligible subjects 

 
Study Protocol
Device 
R
, FOOTPRINT  ULTRA PK SL ) in 
Extremities 
Number: 
2018.15.SMD.PEEK.RET.EXT 
Version: 2.0 05Dec2018 
Page: Page 52 of 54 
 
 
CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and is 
intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith & Nephew. 
 
TMP-CD-05-01  Clinical Protocol-Device  Revision A; SOP-CD-05 Clinical Protocols  
will be recorded on case report forms 
(CRFs). 
Section 
12.2 
Analysis 
Population 
Safety Population (SAF): This includes 
all subjects who enroll in the study who 
had previously undergone repair in the 
extremities using any of the PEEK 
 
and SPYROMITE.  
 Per-Protocol Population (PP): This 
includes all subjects in the Safety 
Population, who have no significant 
protocol deviations and who meet all 
the inclusion/exclusion criteria.  
 
12.2 Administrative changes: Updated to 
reflect inclusion of FOOTPRINT ULTRA PK 
SL and clarified per protocol population: 
 Safety Population (SAF): This 
includes all subjects who enroll in 
the study who had previously 
undergone repair in the 
extremities using any of the PEEK 
anchors: 
OMITE and 
FOOTPRINT
. 
 Per-Protocol Population (PP): 
This includes all subjects in the 
Safety Population, who have no 
significant protocol deviations 
and who meet all the 
inclusion/exclusion criteria. 
Deviations considered as 
significant will be defined and 
finalized prior to database lock. 
Section 13 
Sample 
Size 
Justificatio
n  
The study is therefore not powered for 
any statistical testing but will be able to 
estimate a clinical success rate of 91% 
with a 95% confidence interval (CI) of 
80% to 100%.  
With an assumption of a 91% clinical 
success rate to be obtained in each of 
the PEEK anchors and a corresponding 
95% CI between 80% and 100%, 
enrolling between 20 and 40 subjects 
13.0 Increased sample size to account for 
inclusion of  FOOTPRINT ULTRA PK SL: 
The study is therefore not powered for 
any statistical hypothesis testing but to 
have sufficient number of subjects to be 
able to estimate a clinical success rate of 
91% with a 95% confidence interval (CI) of 
80% to 100%. 
With an assumption of a 91% clinical 
success rate to be obtained in each of 
the PEEK anchors and a corresponding 

 
Study Protocol
Device 
R
, FOOTPRINT  ULTRA PK SL ) in 
Extremities 
Number: 
2018.15.SMD.PEEK.RET.EXT 
Version: 2.0 05Dec2018 
Page: Page 53 of 54 
 
 
CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and is 
intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith & Nephew. 
 
TMP-CD-05-01  Clinical Protocol-Device  Revision A; SOP-CD-05 Clinical Protocols  
would provide between 15.2% to 71% 
probability. Thus, an overall minimum of 
60 and maximum of 120 subjects would 
be enrolled into the study. Additionally, 
a minimum of 10 subjects would be 
enrolled at any investigational site. 
95% CI between 80% and 100%, 
enrolling between 20 and 120 subjects 
expected to provide between 15.2% to 
>95% probability, pending that there is 
sufficient volume of each type of anchor 
available. Thus, an overall minimum of 80 
and maximum of 480 subjects are to be 
enrolled into the study, pending that 
there is sufficient volume of each type of 
anchor available. Additionally, a 
minimum of 10 subjects will be 
enrolled at any investigational site. 
 
Section 
14.2  
Reporting 
Procedures
 
Section 
14.3 
Follow-up 
of Subjects 
with 
Adverse 
Events 
14.2: 
For ADEs and DevDs, details of the 
product/procedure related to the event 
will be included and where applicable, 
pictures taken of the device. The 
deficient product should be retained for 
return to the sponsor unless it is 
contaminated (e.g. used dressings must 
not be retained). Updates to submitted 
information will be recorded in the CRF 
within 24 hours of the information being 
available to the Investigator. 
 
14.3: 
For subjects who are experiencing an 
ongoing unresolved AE at the time of 
their study completion or early 
discontinuation from the study, it is 
recommended that the Investigator 
schedule an appropriate follow-up visit 
14.2 Removed language regarding 
pictures and retained product as it is not 
applicable to this retrospective chart 
abstraction study design:  
For ADEs and DevDs, details of the 
product/procedure related to the event 
will be recorded in the CRF within 24 
hours of the retrospective chart review 
 
 
 
 
14.3 Clarified that follow-up is not a study 
procedure as this study is retrospective 
chart abstraction only: 
For subjects who are experiencing an 
ongoing unresolved AE at the time of 
their study completion or early 
discontinuation from the study, it is 
recommended that the investigator 

 
Study Protocol
Device 
R
, FOOTPRINT  ULTRA PK SL ) in 
Extremities 
Number: 
2018.15.SMD.PEEK.RET.EXT 
Version: 2.0 05Dec2018 
Page: Page 54 of 54 
 
 
CONFIDENTIAL AND PROPRIETARY 
This document contains information that is confidential and proprietary to Smith & Nephew PLC and Smith & Nephew, Inc. and is 
intended for use only by Smith & Nephew and its manufacturer. It shall not be reproduced or copied in whole or in part, nor shall the 
contents be disclosed by any means without prior written permission from Smith & Nephew, nor shall anyone make any use of it that 
is contrary to the expressed or implied wishes of Smith & Nephew. 
 
TMP-CD-05-01  Clinical Protocol-Device  Revision A; SOP-CD-05 Clinical Protocols  
 
in order to determine the outcome of 
the event. 
follow-up with the patient per standard 
clinical practice. 
Section 22: 
References
1. U.S. Department of Health and 
Human Services (HHS) Code of 
Federal Regulation Title 45 Part 
46  (45 CFR 46)  Revised 
January 15, 2009 
2. Clopper, CJ & Pearson ES. 
(1934) The use of confidence or 
fiducial limits illustrated in the 
case of the binomial. Biometrika, 
26, 404 413. 
 
 Added additional sources document 
references.  
3. IFU- 
Anchors with Needles, 10600401.
4. IFU-
Anchors with Needles, 
10600400. 
5. IFU FOOTPRINT ULTRA PK SL 
Suture Anchors  10601001-B 
6. PEEK SUTURE Anchors Post 
Market Surveillance Statement- 
PMS-140 
7. Clinical Evaluation: PEEK Suture 
Anchors EOP:14000055 
 
Section 23 
Principal 
Investigator 
Obligations
See Version 1.0 12Oct2018 below. 
Removed section as this will be provided 
to the site separately