A Prospective, Multi-center Clinical Study to Evaluate the Safety and Performance of the FAST-FIX FLEX System for Meniscal Repairs (MR) and Meniscal Allograft Transplantations (MAT)
Conditions: Meniscus Tear
Sponsor: Smith & Nephew, Inc.

Clinical Protocol 
Study Number: FAST-FIX 
FLEX.2020.09 
A Prospective, Multi-center Clinical Study to Evaluate the Safety 
and Performance of the FAST-FIX FLEX System for Meniscal Repairs 
(MR) and Meniscal Allograft Transplantations (MAT) 
Version: 3.0, 05/May/2023 
Page: 1 of 151   
CONFIDENTIAL AND PROPRIETARY 
TMP-800052 Clinical Protocol - Device  Revision 4; PRO-201725 Clinical Protocols 
Sponsor Name and Address: 
Smith & Nephew Inc. 
1450 E. Brooks Road 
Memphis, TN 38116  
USA   
Investigational Product(s) 
FAST-FIX FLEX Meniscal Repair System 
Single Identification Number of 
Clinical Investigation 
N/A 
Protocol Author(s): 
, Clinical Study Manager 
Rupali Soeters, Clinical Strategy Lead 
Michelle Foster, Senior Biostatistician 
Summary of Revision History 
Version 2.0, 23 Nov 2021 
Version 1.0, 28 Apr 2021 

 
Clinical Protocol  
Study Number: FAST-FIX 
FLEX.2020.09 
A Prospective, Multi-center Clinical Study to Evaluate the Safety 
and Performance of the FAST-FIX FLEX System for Meniscal Repairs 
(MR) and Meniscal Allograft Transplantations (MAT) 
Version: 3.0, 05/May/2023 
Page: 2 of 151   
 
 
CONFIDENTIAL AND PROPRIETARY 
TMP-800052 Clinical Protocol - Device  Revision 4; PRO-201725 Clinical Protocols 
1 SIGNATURES 
1.1  Principal Investigator Signature Page 
This page will be returned to Smith & Nephew Inc. and a copy retained at the investigational site. 
I have read the attached protocol entitle
A Prospective, Multi-center Clinical Study to Evaluate 
the Safety and Performance of the FAST-FIX FLEX System for Meniscal Repairs (MR) and Meniscal 
Allograft Transplantations (MAT) , version 3.0, dated 05/May/2023, and agree to abide by all 
provisions set forth herein. 
n 22.8 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. 
 
Name, Address, Professional 
Position 
       Signature and Date / DocuSign Stamp 
 
 
 
 
 
 
 
 

Clinical Protocol 
Study Number: FAST-FIX 
FLEX.2020.09
A Prospective, Multi-center Clinical Study to Evaluate the Safety 
and Performance of the FAST-FIX FLEX System for Meniscal Repairs 
(MR) and Meniscal Allograft Transplantations (MAT)
Version: 3.0, 05/May/2023
Page: 3 of 151
CONFIDENTIAL AND PROPRIETARY
TMP-800052 Clinical Protocol - Device 
Revision 4; PRO-201725 Clinical Protocols
1.2 Coordinating Investigator Approval
I have read the attached protocol entitled A Prospective, Multi-center Clinical Study to Evaluate 
the Safety and Performance of the FAST-FIX FLEX System for Meniscal Repairs (MR) and Meniscal 
, version 3.0, dated 05/May/2023, and agree to abide by all 
provisions set forth therein.
Name, Address, Professional 
Position
      Signature and Date / DocuSign Stamp
Jorge Chahla, M.D., Ph.D.
Rush University Medical Center,
1611 West Harrison Street
Chicago, IL, USA 
Sports Medicine Division, 
Orthopaedic Surgery

Clinical Protocol 
Study Number: FAST-FIX 
FLEX.2020.09
A Prospective, Multi-center Clinical Study to Evaluate the Safety 
and Performance of the FAST-FIX FLEX System for Meniscal Repairs 
(MR) and Meniscal Allograft Transplantations (MAT)
Version: 3.0, 05/May/2023
Page: 4 of 151
CONFIDENTIAL AND PROPRIETARY
TMP-800052 Clinical Protocol - Device 
Revision 4; PRO-201725 Clinical Protocols
1.3 Sponsor Approval
Name and Title
Signature and Date / DocuSign Stamp
Rachael Winter 
Senior Director, Global Clinical 
Operations
(Head of Global Clinical 
Operations)
Lori Fontaine
VP, Global Clinical Strategy -
Orthopaedics, Sports Med & ENT
(Global Clinical Strategy 
Franchise Head or 
Representative)
Jay Jantz
Director of Global Biostatistics 
and Data Science
(Head of Global Data Analytics)
Martin Ma
Medical Director, Medical Affairs
(Medical Affairs Representative)
Sam Timson
Senior Clinical Compliance and 
Training Specialist 
(Clinical Compliance and 
Training/Clinical Quality 
Assurance)

 
Clinical Protocol  
Study Number: FAST-FIX 
FLEX.2020.09 
A Prospective, Multi-center Clinical Study to Evaluate the Safety 
and Performance of the FAST-FIX FLEX System for Meniscal Repairs 
(MR) and Meniscal Allograft Transplantations (MAT) 
Version: 3.0, 05/May/2023 
Page: 5 of 151   
 
 
CONFIDENTIAL AND PROPRIETARY 
TMP-800052 Clinical Protocol - Device  Revision 4; PRO-201725 Clinical Protocols 
2 SYNOPSIS 
Title of Study: 
A prospective, multi-center clinical study to evaluate the safety and 
performance of the FAST-FIX FLEX System for Meniscal Repairs (MR) and 
Meniscal Allograft Transplantations (MAT). 
Sponsor and Funding 
Source 
Smith & Nephew Inc, 1450 E. Brooks Road, Memphis, Tennessee 38116, 
USA   
Study Design: 
A prospective, multi-center, clinical study, 2 study arms, 12 months 
follow up, with a minimum of 62 and maximum of 68 subjects (53
subjects for MR and a minimum of 9 and maximum of 15 subjects for 
MAT).   
Study Type: 
Observational, prospective clinical follow-up study. 
Study Product:  
The FAST-FIX FLEX Meniscal Repair System is an all-inside meniscal 
repair device. Each device includes two non-absorbable polymer 
implants, pretied with #2-0 non-absorbable suture and preloaded into a 
needle delivery system. The adjustable depth penetration limiter is 
preset to approximately 16 mm from the tip of the needle. The device
can be adjusted in 4 mm increments between 12mm and 20mm. The 
FAST-FIX FLEX Meniscal Repair System is indicated for use in meniscal 
repairs and allograft transplant procedures. 
Comparison Group(s)*: 
(*if applicable) 
There is no comparison group in this study. 
Study Purpose: 
The purpose of this study is to collect safety and clinical outcomes data 
from patients who underwent meniscal repair or meniscal allograft 
transplantation with the next generation FAST-FIX FLEX System.  

 
Clinical Protocol  
Study Number: FAST-FIX 
FLEX.2020.09 
A Prospective, Multi-center Clinical Study to Evaluate the Safety 
and Performance of the FAST-FIX FLEX System for Meniscal Repairs 
(MR) and Meniscal Allograft Transplantations (MAT) 
Version: 3.0, 05/May/2023 
Page: 6 of 151   
 
 
CONFIDENTIAL AND PROPRIETARY 
TMP-800052 Clinical Protocol - Device  Revision 4; PRO-201725 Clinical Protocols 
Primary Objective: 
The primary objective of this study is to assess the clinical success rate 
of FAST-FIX FLEX meniscal repair at 12 months.  
Failure of the repair is defined as revision surgery at the site of the 
primary tear at 12 months. 
Secondary Objective(s): 
The secondary objectives are: 
To assess the clinical success rate of FAST-FIX FLEX meniscal repair at 
6 months; 
To assess the meniscal allograft transplantation success rate at 6 
months & 12 months. Failure is defined as a revision of the 
transplantation and/or removal of the allograft; 
To evaluate the meniscus healing for both clinical indications as 
measured by magnetic resonance imaging (MRI) at 6 months and 12 
months in comparison to pre op; 
To assess the clinical performance for both indications as measured by 
Patient-Reported Outcome (PROs) Scores at baseline, 6 months and 12 
months: International Knee Documentation Committee (IKDC) scores, 
Lysholm scores, & EuroQol 5 Dimension 5 Level (EQ-5D-5L). 
Other Objective(s): 
To assess safety with reported complications, adverse events, adverse 
device effects, unanticipated serious adverse device effects and device 
deficiencies. 
Sample Size: 
A minimum of 62 and maximum of 68 subjects will be enrolled into the 
study:  
 
53 MR subjects 

 
Clinical Protocol  
Study Number: FAST-FIX 
FLEX.2020.09 
A Prospective, Multi-center Clinical Study to Evaluate the Safety 
and Performance of the FAST-FIX FLEX System for Meniscal Repairs 
(MR) and Meniscal Allograft Transplantations (MAT) 
Version: 3.0, 05/May/2023 
Page: 7 of 151   
 
 
CONFIDENTIAL AND PROPRIETARY 
TMP-800052 Clinical Protocol - Device  Revision 4; PRO-201725 Clinical Protocols 
 
A minimum of 9 and maximum of 15 MAT subjects 
The sample size for this study is precision-based and not based on 
statistical power considerations. Thus, no formal statistical hypothesis is 
formulated.  The sample size for this study is determined based on the 
feasibility of recruitment, enrolment and follow-up considerations.  
The 
primary endpoint upon which sample size is determined is 
meniscal repair success rate in the study device at 12 months. The 
publication upon which this is based, is the systematic literature review 
Clinical performance of FAST-FIX family
Paul 
Souter (2022) the repair success rate was reported to be 90% for all-
inside meniscal repair. This recent systematic literature review provides 
sufficient evidence to increase the success rate from 85% (as defined in 
previous protocol version) to 90% for all-inside meniscal repair. For the 
full report please refer to appendix 22.10. 
Assuming an overall success rate of at least 90%, 45 subjects are 
sufficient to obtain at least 80% probability of estimating the two-sided 
95% confidence interval around the success rate to within 10%.  
Assuming a 15% drop out rate at the end of the 12 months, 53 MR 
subjects will be enrolled.    
Additionally, secondary endpoints in this study assess success rate, 
meniscus healing and clinical performance of PROs for meniscal allograft 
transplantation (MAT). To have sufficient evidence to support European 
Medical Device Regulation (EU MDR) requirements, a minimum of 9 and 
maximum of 15 subjects will be recruited to provide sufficient evidence 
on this indication. Furthermore, internal evidence generated and 

 
Clinical Protocol  
Study Number: FAST-FIX 
FLEX.2020.09 
A Prospective, Multi-center Clinical Study to Evaluate the Safety 
and Performance of the FAST-FIX FLEX System for Meniscal Repairs 
(MR) and Meniscal Allograft Transplantations (MAT) 
Version: 3.0, 05/May/2023 
Page: 8 of 151   
 
 
CONFIDENTIAL AND PROPRIETARY 
TMP-800052 Clinical Protocol - Device  Revision 4; PRO-201725 Clinical Protocols 
prepared by the Smith+Nephew Research and Development (R&D) 
provides evidence that the procedural technique, device use, and 
resulting suture placement is identical for meniscus MR and MAT (see 
Appendix 22.11). It will be at the discretion of the Sponsor when
enrolment to the MAT indication is completed (between 9 and 15 
subjects). 
Number of Study Sites: 
Up to 5 sites 
Targeted Global Regions: United States, United Kingdom, France and Australia  
Meniscal Repair Inclusion 
Criteria: 
1. Subject provides written informed consent for study participation 
using an independent ethical committee (IEC) / institutional review 
board (IRB) approved consent form; 
2. Subject is between sixteen (16) and seventy (70) years of age,
inclusive at the time of screening; 
3. Subject is willing and able to participate in required follow-up visits 
and is able to complete study activities; 
4. Subject requires a meniscal repair;  
5. Subject is suitable to participate in the study in the opinion of the 
Investigator; 
6. Subject requires a meniscus repair concerning the red-red or red-
white zones for acute or chronic 1-, 2- or 3-segment lesions, with or 
without associated anterior cruciate ligament (ACL) reconstruction. 
Meniscal Repair Exclusion 
Criteria: 
1. Contraindications (per the FAST-FIX FLEX IFU) or hypersensitivity to 
the use of the FAST-FIX FLEX implant material. Where material 
sensitivity is suspected, appropriate tests should be made and 
sensitivity ruled out prior to implantation; 
2. Enrolled in the treatment period of another clinical trial within thirty 
(30) days of operative visit, or during the study; 

 
Clinical Protocol  
Study Number: FAST-FIX 
FLEX.2020.09 
A Prospective, Multi-center Clinical Study to Evaluate the Safety 
and Performance of the FAST-FIX FLEX System for Meniscal Repairs 
(MR) and Meniscal Allograft Transplantations (MAT) 
Version: 3.0, 05/May/2023 
Page: 9 of 151   
 
 
CONFIDENTIAL AND PROPRIETARY 
TMP-800052 Clinical Protocol - Device  Revision 4; PRO-201725 Clinical Protocols 
3. Women who are pregnant or nursing; 
4. Any subject that meets the definition of a Vulnerable Subject per ISO 
14155 Section 3.55 (except for subjects aged sixteen (16) or 
seventeen (17) years of age with consent from their legally authorized 
representative); 
5. Subjects with a history of poor compliance with medical treatment, 
physical therapy (PT)/rehabilitation, or clinical study participation; 
6. Patients with irreparable meniscal tears (i.e. multiple tears); 
7. Subjects with full thickness cartilage defects greater than 10mm in 
diameter and/or serious defects; 
8. Patients with concomitant ligament injuries that do not require 
surgical repair (i.e. ACL with Grade 3 lateral collateral ligament (LCL) 
injury or medial collateral ligament (MCL) injury); 
9. Performance of a significant concomitant procedure, specifically a 
cartilage repair or restoration (excluding ACL reconstruction or repair, 
lateral extra-articular tenodesis, 
anterolateral ligament (ALL)
reconstruction) intended as a therapeutic intervention on the study 
knee; 
10.History of ipsilateral knee surgery, septic joint, or fracture;  
11.Pathological conditions in the soft tissue that would prevent secure 
fixation of the device; 
12.Physical conditions which would eliminate, or tend to eliminate, 
adequate anchor support or retard healing; 
13.The presence of infection; 
14.
restrict activities or follow directions during the healing period; 
15.Malalignment: genu varus and genu valgus angles greater than 5° as 
as per their standard of care;  
16.Patients who have an Ahlback grade greater than II;  

 
Clinical Protocol  
Study Number: FAST-FIX 
FLEX.2020.09 
A Prospective, Multi-center Clinical Study to Evaluate the Safety 
and Performance of the FAST-FIX FLEX System for Meniscal Repairs 
(MR) and Meniscal Allograft Transplantations (MAT) 
Version: 3.0, 05/May/2023 
Page: 10 of 151   
 
 
CONFIDENTIAL AND PROPRIETARY 
TMP-800052 Clinical Protocol - Device  Revision 4; PRO-201725 Clinical Protocols 
17.Patients with a body mass index larger than 35; 
18.Subjects with a medical or physical condition that, in the opinion of 
the Investigator, would preclude safe subject participation in the 
study. 
Meniscal Allograft 
Transplantation Inclusion 
Criteria: 
1. Subject provides written informed consent for study participation 
using an independent ethical committee (IEC) / institutional review 
board (IRB) approved consent form; 
2. Subject is between sixteen (16) and seventy (70) years of age, 
inclusive at the time of screening; 
3. Subject is willing and able to participate in required follow-up visits 
and is able to complete study activities; 
4. Subject requires a meniscal allograft transplantation;  
5. Subject is suitable to participate in the study in the opinion of the 
Investigator. 
6. Subject requires a MAT for symptomatic meniscal insufficiency (load-
related pain and swelling in the compartment post meniscectomy) for 
which conservative treatment has failed, with or without cartilage 
repair or restoration (including ACL reconstruction or repair). 
Meniscal Allograft 
Transplantation Exclusion 
Criteria: 
1. Contraindications (per the FAST-FIX FLEX IFU) or hypersensitivity to 
the use of the FAST-FIX FLEX implant material. Where material 
sensitivity is suspected, appropriate tests should be made and 
sensitivity ruled out prior to implantation; 
2. Enrolled in the treatment period of another clinical trial within thirty 
(30) days of operative visit, or during the study; 
3. Women who are pregnant or nursing; 
4. Any subject that meets the definition of a Vulnerable Subject per ISO 
14155 Section 3.55 (except for subjects aged sixteen (16) or 

 
Clinical Protocol  
Study Number: FAST-FIX 
FLEX.2020.09 
A Prospective, Multi-center Clinical Study to Evaluate the Safety 
and Performance of the FAST-FIX FLEX System for Meniscal Repairs 
(MR) and Meniscal Allograft Transplantations (MAT) 
Version: 3.0, 05/May/2023 
Page: 11 of 151   
 
 
CONFIDENTIAL AND PROPRIETARY 
TMP-800052 Clinical Protocol - Device  Revision 4; PRO-201725 Clinical Protocols 
seventeen (17) years of age with consent from their legally authorized 
representative); 
5. Subjects with a history of poor compliance with medical treatment, 
physical therapy (PT)/rehabilitation, or clinical study participation; 
6. Patients with concomitant ligament injuries that do not require 
surgical repair (i.e. ACL with Grade 3 lateral collateral ligament (LCL) 
injury or medial collateral ligament (MCL) injury); 
7. Performance of a significant concomitant procedure (excluding ACL 
reconstruction 
or 
repair, 
lateral 
extra-articular 
tenodesis, 
anterolateral ligament (ALL) reconstruction) intended as a therapeutic 
intervention on the study knee; 
8. History of ipsilateral knee surgery, septic joint, or fracture (excluding 
MAT indication);  
9. Pathological conditions in the soft tissue that would prevent secure 
fixation of the device; 
10.Physical conditions which would eliminate, or tend to eliminate, 
adequate anchor support or retard healing; 
11.The presence of infection; 
12.
restrict activities or follow directions during the healing period; 
13.Malalignment: genu varus and genu valgus angles greater than 5° as 
;  
14.Patients who have an Ahlback grade greater than II;  
15.Patients with a body mass index larger than 35; 
16.Subjects with a medical or physical condition that, in the opinion of 
the Investigator, would preclude safe subject participation in the 
study. 

 
Clinical Protocol  
Study Number: FAST-FIX 
FLEX.2020.09 
A Prospective, Multi-center Clinical Study to Evaluate the Safety 
and Performance of the FAST-FIX FLEX System for Meniscal Repairs 
(MR) and Meniscal Allograft Transplantations (MAT) 
Version: 3.0, 05/May/2023 
Page: 12 of 151   
 
 
CONFIDENTIAL AND PROPRIETARY 
TMP-800052 Clinical Protocol - Device  Revision 4; PRO-201725 Clinical Protocols 
Study Duration: 
It is anticipated to take 39 months (21 months for subject enrolment and 
14 months follow-up period).  
Primary endpoint: 
Rate of reoperation due to meniscal repair failure at 12 months 
postoperative. Failure is defined as a revision surgery at the primary site 
of the tear.  
Secondary endpoint(s): 
 
Rate of reoperation due to meniscal repair failure at 6 months post-
operative;  
 
Rate of reoperation due to meniscal allograft transplantation failure 
at 6 months & 12 months post-operative. Failure is defined as a 
revision of the transplantation and/or removal of the allograft. 
 
MRI to assess meniscal healing at 6 months and 12 months; 
 
Patient-Reported Outcome (PRO) data will be collected at baseline, 6
months & 12 months: IKDC scores, Lysholm scores, & EQ-5D-5L. 
Other exploratory 
endpoint(s): 
 
Analysis of reoperation rate and PROs by meniscal repair procedure 
(i.e., MR alone vs. MR with ACL repair), location of the repair 
(posterior horn, body, anterior horn) and type of tear (bucket 
handle, longitudinal, horizontal, radial, complex); 
 
Healing status at 6 months and 12 months by repair procedure, 
location of tear and tear type;   
 
Surgical technique details (curvature of the distal needle: bender 
tool used vs bender tool not used);  
 
Procedural details for MR (S+N instruments used with FAST-FIX 
FLEX) and MAT (hybrid vs non-hybrid approach and types of devices 
used with FAST-FIX FLEX); 
 
Analysis of the change in extrusion and joint space narrowing for 
meniscal allograft transplantations on MRI at baseline, 6 months and 
12 months; 

 
Clinical Protocol  
Study Number: FAST-FIX 
FLEX.2020.09 
A Prospective, Multi-center Clinical Study to Evaluate the Safety 
and Performance of the FAST-FIX FLEX System for Meniscal Repairs 
(MR) and Meniscal Allograft Transplantations (MAT) 
Version: 3.0, 05/May/2023 
Page: 13 of 151   
 
 
CONFIDENTIAL AND PROPRIETARY 
TMP-800052 Clinical Protocol - Device  Revision 4; PRO-201725 Clinical Protocols 
 
Rate of mechanical symptoms as defined by PROs (Lysholm: section 
3 & 4 and IKDC scores: question 6) and radiological evidence of 
repair failure at 6 months and 12 months. 
Safety Data 
 
Device-related re-intervention; 
 
All adverse events (AEs) occurring from the time of surgery until 
revision or study completion; 
 
Devices related Aes and serious adverse events (SAEs); 
 
Device deficiencies (DDs).  

 
 
Clinical Protocol  
Study Number: FAST-FIX 
FLEX.2020.09 
A Prospective, Multi-center Clinical Study to Evaluate the Safety 
and Performance of the FAST-FIX FLEX System for Meniscal Repairs 
(MR) and Meniscal Allograft Transplantations (MAT) 
Version: 3.0, 05/May/2023 
Page: 14 of 151   
 
 
CONFIDENTIAL AND PROPRIETARY 
TMP-800052 Clinical Protocol - Device  Revision 4; PRO-201725 Clinical Protocols 
  
  
 
Schedule of Events 
Visit 1  
Screening  
< 8 weeks 
pre-op 
Visit 2  
Procedure 
Visit 3 -        
2 weeks 
(± 5 days) 
Visit 4 -        
3 Months 
(+ 30 days) 
Visit 5 -        
6 Months 
(± 45 days) 
Visit 6 -      
12 Months 
(± 75 days) 
Unscheduled 
Visit  
Informed Consent 
X 
  
 
  
  
  
Inclusion/Exclusion  
X1 
  
 
  
  
  
Demographics/ Medical History 
X 
  
 
  
  
  
Details of Surgery Procedure CRF 
 
X 
 
 
 
 
 
Details of Pathology CRF 
 
X 
 
 
 
 
 
Post-op Surgery Failure CRF 
  
  
X 
X 
X 
X 
X 
MRI assessment 
X2 
 
 
 
X3 
X3 
X 
PRO: IKDC subjective 
X 
  
 
 
X 
X 
X 
PRO: Lysholm  
X 
  
 
 
X 
X 
X 
EQ-5D-5L CRF 
X 
 
 
X 
X 
X 
Concomitant Medication/ Therapy  
X 
X 
X 
X 
X 
X 
X 
Safety Assessment 
(AE/SAE/ADE/DevD) 
 
X 
X 
X 
X 
X 
X 
End of Study/Exit   
X4 
X4 
X4 
X4 
X4 
X4 
X4 
1 Inclusion/exclusion confirmation will be performed at the time of screening and study procedure to confirm the subject meets eligibility criteria.  
2 MRI to confirm eligibility criteria must be within 6 months of surgery 
3 MRI 1.5 T or greater, no contrast preferred, to be reviewed by independent radiologist appointed 
4 As applicable 

 
Clinical Protocol  
Study Number: FAST-FIX 
FLEX.2020.09 
A Prospective, Multi-center Clinical Study to Evaluate the Safety 
and Performance of the FAST-FIX FLEX System for Meniscal Repairs 
(MR) and Meniscal Allograft Transplantations (MAT) 
Version: 3.0, 05/May/2023 
Page: 15 of 151   
 
 
CONFIDENTIAL AND PROPRIETARY 
TMP-800052 Clinical Protocol - Device  Revision 4; PRO-201725 Clinical Protocols 
3 CONTENTS  
3.1 Table of Contents 
1 SIGNATURES ...............................................................................................................2 
1.1 Principal Investigator Signature Page ........................................................................2 
1.2 Coordinating Investigator Approval ...........................................................................3 
1.3 Sponsor Approval ...................................................................................................4 
2 SYNOPSIS ...................................................................................................................5 
3 CONTENTS ................................................................................................................ 15 
3.1 Table of Contents ................................................................................................. 15 
3.2 List of Tables ....................................................................................................... 18 
3.3 List of Figures ...................................................................................................... 18 
3.4 List of Abbreviations/Acronyms and Definitions ......................................................... 19 
4 INTRODUCTION ......................................................................................................... 21 
4.1 Background ......................................................................................................... 21 
4.2 Literature Summary ............................................................................................. 23 
4.3 Study Purpose ..................................................................................................... 24 
4.4 Safety Consideration ............................................................................................. 25 
5 OBJECTIVE(S) ........................................................................................................... 27 
5.1 Primary Objective ................................................................................................. 27 
5.2 Secondary Objective(s) ......................................................................................... 27 
5.3 Other Objective(s) ................................................................................................ 27 
5.4 Claims ................................................................................................................ 28 
6 INVESTIGATIONAL PRODUCT(S) ................................................................................... 28 
6.1 Identification ....................................................................................................... 28 
6.2 Product Use ......................................................................................................... 31 
6.3 Packaging and Labelling ........................................................................................ 32 
6.4 Product Accountability Procedures ........................................................................... 33 
6.5 Surgical Technique/Medical Procedures .................................................................... 33 
7 SUBJECT ENROLLMENT AND WITHDRAWAL .................................................................... 34 
7.1 Subject Population ............................................................................................... 34 
7.2 Inclusion Criteria  Meniscal Repair ONLY ................................................................. 35 

 
Clinical Protocol  
Study Number: FAST-FIX 
FLEX.2020.09 
A Prospective, Multi-center Clinical Study to Evaluate the Safety 
and Performance of the FAST-FIX FLEX System for Meniscal Repairs 
(MR) and Meniscal Allograft Transplantations (MAT) 
Version: 3.0, 05/May/2023 
Page: 16 of 151   
 
 
CONFIDENTIAL AND PROPRIETARY 
TMP-800052 Clinical Protocol - Device  Revision 4; PRO-201725 Clinical Protocols 
7.3 Exclusion Criteria  Meniscal Repair ONLY ................................................................ 35 
7.4 Inclusion Criteria  Meniscal Allograft Transplantation ONLY ........................................ 37 
7.5 Exclusion Criteria  Meniscal Allograft Transplantation ONLY ....................................... 38 
7.6 Screening ........................................................................................................... 39 
7.7 Informed Consent ................................................................................................ 40 
7.8 Enrollment .......................................................................................................... 41 
7.9 Lost to Follow-up ................................................................................................. 42 
7.10 Withdrawal ........................................................................................................ 42 
8 STUDY DESIGN .......................................................................................................... 44 
8.1 Study Design ....................................................................................................... 44 
8.2 Allocation and Blinding .......................................................................................... 47 
8.3 Data Management ................................................................................................ 47 
8.4 Study Endpoints ................................................................................................... 48 
8.5 Methods Used to Minimize Bias and Maximize Validity ................................................ 50 
9 STUDY PROCEDURES .................................................................................................. 51 
9.1 Visits and Examinations ........................................................................................ 51 
9.2 Study Methods and Measurements .......................................................................... 58 
9.3 Health Economics/Quality of Life ............................................................................. 60 
10 STATISTICAL DESIGN ............................................................................................... 60 
10.1 General............................................................................................................. 60 
10.2 Analysis Populations ........................................................................................... 61 
10.3 Baseline Data .................................................................................................... 61 
10.4 Efficacy Analysis ................................................................................................. 61 
10.5 Safety Analyses ................................................................................................. 63 
10.6 Interim Analyses ................................................................................................ 64 
11 SAMPLE SIZE JUSTIFICATION ..................................................................................... 64 
12 ADVERSE EVENTS AND DEVICE DEFICIENCIES .............................................................. 65 
12.1 Definitions (ISO 14155) ....................................................................................... 65 
12.2 AE Coding Dictionary ........................................................................................... 69 
12.3 Reporting procedures .......................................................................................... 69 
12.4 Unblinding of Investigational Product ..................................................................... 72 
12.5 Follow-up of Subjects with Adverse Events ............................................................. 72 

 
Clinical Protocol  
Study Number: FAST-FIX 
FLEX.2020.09 
A Prospective, Multi-center Clinical Study to Evaluate the Safety 
and Performance of the FAST-FIX FLEX System for Meniscal Repairs 
(MR) and Meniscal Allograft Transplantations (MAT) 
Version: 3.0, 05/May/2023 
Page: 17 of 151   
 
 
CONFIDENTIAL AND PROPRIETARY 
TMP-800052 Clinical Protocol - Device  Revision 4; PRO-201725 Clinical Protocols 
13 INVESTIGATOR OBLIGATIONS .................................................................................... 73 
14 SPONSOR AND MONITOR RESPONSIBILITIES ................................................................ 74 
14.1 Site Qualification Visit ......................................................................................... 74 
14.2 Site Initiation Visit .............................................................................................. 74 
14.3 Interim Monitoring Visit ....................................................................................... 74 
14.4 Sponsor Audits and Regulatory Inspection .............................................................. 75 
14.5 Close-Out Visit ................................................................................................... 75 
15 PROTOCOL DEVIATIONS ............................................................................................ 75 
16 PROTOCOL AMENDMENTS .......................................................................................... 76 
17 CONFIDENTIALITY OF THE STUDY ............................................................................... 76 
18 STATEMENTS OF COMPLIANCE ................................................................................... 76 
19 END OF STUDY ......................................................................................................... 77 
20 PUBLICATION POLICY ................................................................................................ 78 
20.1 Publication of Study Data ..................................................................................... 78 
20.2 Data Sharing ..................................................................................................... 78 
21 REFERENCES ........................................................................................................... 79 
22 APPENDICES ............................................................................................................ 83 
22.1 Protocol Amendment 1 ........................................................................................ 83 
22.2 Protocol Amendment 2 ........................................................................................ 85 
22.3 Sponsor Details ................................................................................................ 138 
22.4 Instructions for Use .......................................................................................... 138 
22.5 Equipment and Special Instructions ..................................................................... 138 
22.6 Health Economic Outcome Measures/Quality of Life measures ................................. 138 
22.7 Additional Information ....................................................................................... 138 
22.8 Principal Investigator Obligations (ISO 14155) ...................................................... 139 
22.9 Clinical Study Sites ........................................................................................... 149 
22.10 Evidence Analysis Report ................................................................................. 150 
22.11 R&D Internal Evidence for MAT Indication ........................................................... 151 
 
 

 
Clinical Protocol  
Study Number: FAST-FIX 
FLEX.2020.09 
A Prospective, Multi-center Clinical Study to Evaluate the Safety 
and Performance of the FAST-FIX FLEX System for Meniscal Repairs 
(MR) and Meniscal Allograft Transplantations (MAT) 
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3.2 List of Tables 
 
Table 8.1-1  Overview of Study Groups .............................................................................. 44
Table 9.1-1 Study Procedures by Visit ................................................................................ 51
Table 12.1-1 Categories of Adverse Event ........................................................................... 65
 
3.3  List of Figures 
Figure 6-1-1 A-B: Images of the Fast-Fix Flex A) Curved & B) Reversed-Curved inserter, bender, 
cannula set. ................................................................................................................... 29
Figure 8-1-1: Study Flowchart 1 ........................................................................................ 46
Figure 8-1-8-2: Study Stages ........................................................................................... 47
Figure 12.3-1: Evaluation and Reporting of AE ..................................................................... 71
Figure 12.3-2: Evaluation and Reporting of DD .................................................................... 72

 
Clinical Protocol  
Study Number: FAST-FIX 
FLEX.2020.09 
A Prospective, Multi-center Clinical Study to Evaluate the Safety 
and Performance of the FAST-FIX FLEX System for Meniscal Repairs 
(MR) and Meniscal Allograft Transplantations (MAT) 
Version: 3.0, 05/May/2023 
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3.4  List of Abbreviations/Acronyms and Definitions 
Abbreviation 
Definition 
ACL
Anterior Cruciate Ligament 
ADE 
Adverse Device Effect(s) 
AE
Adverse Event(s) 
ALL 
Anterolateral Ligament 
BMI
Body Mass Index 
CE
Conformité Européene  
CRF 
Case Report Form(s) 
CV 
Curriculum Vitae 
DD 
Device Deficiency(ies) 
EQ-5D-5L 
EuroQol 5 Dimension 5 Level 
FAS
Full Analysis Set Population 
FDA
Food and Drug Administration 
FU 
Follow-Up 
GCP 
Good Clinical Practice 
HIPAA 
Health Information Portability Accountability Act 
ICH
International Conference on Harmonisation  
IEC
Independent Ethics Committee 
IFU 
Instructions for Use 
IKDC 
International Knee and Documentation Committee  
Interventional study 
A type of clinical study in which participants are assigned to groups that 
receive one or more intervention/treatment so that researchers can 
evaluate the effects of the interventions on biomedical or health-related 
outcomes. 
IP 
Investigational Product  
IRB 
Institutional Review Board 
ISF
Investigator Site File 
ITT 
Intention to Treat population 
LCL 
Lateral Collateral Ligament 

 
Clinical Protocol  
Study Number: FAST-FIX 
FLEX.2020.09 
A Prospective, Multi-center Clinical Study to Evaluate the Safety 
and Performance of the FAST-FIX FLEX System for Meniscal Repairs 
(MR) and Meniscal Allograft Transplantations (MAT) 
Version: 3.0, 05/May/2023 
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MAT
Meniscal Allograft Transplantation 
MCL
Medial Collateral Ligament 
MedDRA 
Medical Dictionary for Regulatory Activities  
MR 
Meniscal Repair 
NA or N/A 
Not Applicable 
N (or n) 
Total Sample Size (or subgroup sample size) 
PEEK
Polyether Ether Ketone 
PRO 
Patient-reported Outcome  
PI 
Principal Investigator 
PP
Per-protocol Population  
S+N 
Smith & Nephew Inc. 
SADE 
Serious Adverse Device Effect(s) 
SAE 
Serious Adverse Event(s) 
SAF
Safety population 
SAP 
Statistical Analysis Plan 
TGA 
Therapeutic Goods Administration  
USADE 
Unanticipated Serious Adverse Device Effect(s) 
 
 
 

 
Clinical Protocol  
Study Number: FAST-FIX 
FLEX.2020.09 
A Prospective, Multi-center Clinical Study to Evaluate the Safety 
and Performance of the FAST-FIX FLEX System for Meniscal Repairs 
(MR) and Meniscal Allograft Transplantations (MAT) 
Version: 3.0, 05/May/2023 
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4 INTRODUCTION 
4.1  Background 
Each knee has a pair of semi-lunar wedge-shaped menisci consisting of fibrocartilage, located both 
laterally and medially between the tibial plateaus and the femoral condyles.1,2 Because of their 
location, menisci are highly susceptible to injury, the medial meniscus being two to three times more 
likely to be injured than the lateral meniscus.2,3 The most common mechanism of injury is trauma 
during sports activity and often occurs in combination with anterior cruciate ligament (ACL) injury.4-
6 Degenerative injury is also possible and may signify the onset of osteoarthritis (OA).7 Traumatic 
knee injuries more associated with radial and vertical tears, whereas degenerative tears are more 
associated with horizontal and complex tears.3 
Tears along the outer edge of the meniscus (red zone) have superior healing potential as blood supply 
is more available in that area than in the inner two-thirds of the meniscus (red-white and white 
zones).2,8 Tears can be described as horizontal, vertical, or bucket handle. Horizontal cleavage tears 
are primarily degenerative in nature, but can result from trauma.9 The tear itself extends from the 
inner free margin of the meniscus into the intra-meniscal substance and is typically treated with 
partial meniscectomy.10 These tears typically extend into the avascular zone, vascularity is poor which 
can affect their ability to heal, and have been historically treated with partial meniscectomy.10 
Historically, the removal of the meniscus, known as a total meniscectomy, was the approach for 
managing tears of the meniscus.11,12 However, a direct relationship between total meniscectomy and 
the worse clinical outcomes such as the development of early osteoarthritis, degenerative knee 
changes, and increased pressure loads compared to modern techniques, was observed, causing this 
treatment method to be largely abandoned.11,13-16 In a multi-center study cited by Beaufils et al.,17, 
10-year osteoarthritis rates were 31% in patients treated with meniscectomy and 11% in patients 
treated with a meniscal repair or non-surgical treatment. At 20 years, the rates increased to 46% 
and 17%, respectively.17 
Meniscal repair attempts to suture the meniscus back together, achieve meniscal healing, and avoid 
the effects of meniscectomy. This technique was introduced to preserve knee function and limit the 

 
Clinical Protocol  
Study Number: FAST-FIX 
FLEX.2020.09 
A Prospective, Multi-center Clinical Study to Evaluate the Safety 
and Performance of the FAST-FIX FLEX System for Meniscal Repairs 
(MR) and Meniscal Allograft Transplantations (MAT) 
Version: 3.0, 05/May/2023 
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TMP-800052 Clinical Protocol - Device  Revision 4; PRO-201725 Clinical Protocols 
accelerated degenerative changes associated with surgical techniques mentioned above.18,19 The 
most recently developed technique is the all-inside repair technique. The all-inside technique is 
typically used within the meniscal body and for posterior horn tears.20 In this approach, the surgeon 
uses posterior accessory portals and suture hooks to shuttle sutures through meniscal tears of the 
posterior horn that were not easily repairable using the other approaches. This approach can reduce 
surgical time,21 speed up patient recovery,11 does not require an open incision, and can prevent 
complications seen with external approaches. 
In an attempt to optimize the healing capacity of the meniscus following meniscal repair, 
augmentation techniques have been developed and investigated to varying extents.23 Advances, such 
as the use of biologics such as platelet-rich plasma (PRP),24 biomaterial augmentation,25 stem cell-
based therapy,26 and allograft transplantation.22 Meniscal allograft transplantation (MAT) can be 
performed in patients who present with affected compartment-specific pain and have pain and 
swelling secondary to chondral overload after a subtotal meniscectomy.22 The ideal patient age for 
this treatment is younger than 40 years, however no specific upper age limits have been identified.22 
Meniscal allografts are available in various forms which include, frozen, lyophilized, fresh and 
cryopreserved. Frozen allografts are most commonly used. Allografts need to be sized appropriately 
the fit the 
. 
Currently, a plethora of devices for all-inside meniscal repair is being used. One highly coveted device 
is the FAST-FIX 360 Meniscal Repair System (Smith & Nephew, Andover, MA, U.S.A.); this device 
combines the advantages of the all-inside technique with strong biomechanical properties, 12, 13 and 
is a modification of the previous Smith & Nephew T-FIX device. This system can be used for vertical, 
horizontal, or oblique meniscal tears. FAST-FIX FLEX Meniscal Repair System 
-
generation meniscal repair device that will improve on the FF-360 design and will encompass: 1) 
reliable deployment of implants, 2) minimal disruption to the meniscus (via a smaller needle tip) and 
3) more accessibility to tear locations (ability to bend the shaft to access a variety of locations, 
particularly the body and anterior horn). This all-inside meniscal repair device is intended to be used 
by healthcare professionals to repair meniscal tears and by anchoring the allograft to the capsular 
rim during allograft transplant procedures. The proposed study aims to evaluate the safety and 

 
Clinical Protocol  
Study Number: FAST-FIX 
FLEX.2020.09 
A Prospective, Multi-center Clinical Study to Evaluate the Safety 
and Performance of the FAST-FIX FLEX System for Meniscal Repairs 
(MR) and Meniscal Allograft Transplantations (MAT) 
Version: 3.0, 05/May/2023 
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performance of arthroscopic meniscal repairs and meniscus allograft transplants using the FAST-FIX 
Flex System.  
A summary of known and potential risks and benefits to humans of the investigational product can 
be found in the Instructions For Use (IFU). 
4.2  Literature Summary 
In the published literature, meniscal repair, allograft transplantation, and/or meniscal scaffolding 
using the subject devices may be concurrently performed with other procedures (such as ACL 
reconstruction and/or allograft transplant or meniscectomy), in combination with other techniques 
(such as inside-out, outside-in, meniscal root, all-inside repair), and/or using other devices (such as 
sutures, Endobuttons, plates or screws).  
Meniscal Repair  
Improvements in Lysholm scores in patients who underwent meniscal repairs using the Fast-Fix 
device ranged from 25-40.1 points, with a mean postop score ranging from 87.4 to 95.4, indicating 
good outcomes.27-29 Improvements in IKDC Subjective scores ranged from 33 to 61.3 points, with 
postoperative scores ranging from 87 to 92.26,27 Barber et al.30 reported a 3.8 point improvement 
(minimal detectable change is 1) in Tegner Activity Scores, with a mean postoperative score of 7.2, 
and a 44.1 point improvement in Cincinnati score with a mean postoperative score of 82.8. Kamimura 
et al.31 reported full recovery (per Tegner scores) in 6 cases and recovery to 1 level below preop in 
6 cases, but individual specific scores were not reported.  
Two studies reported pooled outcomes of the FAST-FIX or ULTRA FAST-FIX device.,33 Improvements 
in Lysholm scores in patients who received the ULTRA FAST-FIX or FAST-FIX device ranged from 
32.1 to 34 points, with mean postoperative scores ranging from 93.1 to 95.3 points, indicating good 
outcomes.32,33 Improvements in IKDC Subjective scores ranged from 21.8 to 28.1 points, with 
postoperative scores ranging from 79.6 to 82.6 points, Hirtler et al.34 reported postop objective IKDC 
as
 

 
Clinical Protocol  
Study Number: FAST-FIX 
FLEX.2020.09 
A Prospective, Multi-center Clinical Study to Evaluate the Safety 
and Performance of the FAST-FIX FLEX System for Meniscal Repairs 
(MR) and Meniscal Allograft Transplantations (MAT) 
Version: 3.0, 05/May/2023 
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Improvements in Lysholm scores in patients who received the FAST-FIX 360 device ranged from 38.4 
to 44.4 points, with mean postoperative scores ranging from 87.3 to 92, indicating good 
outcomes.69,91 A 35.82 point improvement in IKDC Subjective score was reported, with a mean postop 
score of 88.19.35 In patients treated for Meniscal Repair with the Fast-Fix 360, the repair was clinically 
successful in 38 (88.3%) of the cases at final follow up.69 Laurendon et al.35 reported IKDC Objective 
scores were reported in one study as A/B (normal/nearly normal) in 85 (97.7%) patients and C/D 
(abnormal/severely abnormal) in 2 (2.2%) patients. 
Meniscal Transplant 
Two studies by Gelber et al.36,37 reported the use of the ULTRA FAST-
have improved as well, but were not explicitly stated. 
Improvement in Lysholm Scores ranged from 45.7 to 56.7 in patients treated with Ultra Fast-Fix for 
meniscal scaffolding.36,37 Western Ontario Meniscal Evaluation Tool (WOMET) scores were reported 
in two studies, and improved postoperatively by 53.482 and 41.390 points.  
Alentorn-Geli et al.38 reported 2 cases (6%) where patients reported a decreased Lysholm and IKDC 
score after surgery and one patient had decreased Lysholm Scores. No patients reported decreased 
VAS scores, however, two patients had scores that remained the same. The authors
further information on why the scores decreased or did not change, still the authors reported 
-op in the overall study cohort. 
4.3  Study Purpose 
The purpose of this study is to collect post-market safety and clinical outcomes data from patients 
who underwent meniscal repair or meniscal allograft transplantation with the next generation FAST-
FIX Flex System. This is the first case-series study describing the clinical results and complications 
of the FAST-FIX FLEX Meniscal Repair System. 

 
Clinical Protocol  
Study Number: FAST-FIX 
FLEX.2020.09 
A Prospective, Multi-center Clinical Study to Evaluate the Safety 
and Performance of the FAST-FIX FLEX System for Meniscal Repairs 
(MR) and Meniscal Allograft Transplantations (MAT) 
Version: 3.0, 05/May/2023 
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4.4  Safety Consideration 
4.4.1 Intended Users 
The FAST-FIX FLEX Meniscal Repair System is intended to be used by healthcare professionals in 
accordance with these instructions for use. The use environment is an operating room. 
4.4.2 Indications 
The FAST-FIX FLEX Meniscal Repair System is indicated for use in meniscal repairs, allograft 
transplant procedures, and anchoring the allograft to the meniscal rim during allograft transplant 
procedures. 
4.4.3 Contraindications 
The contraindications listed in the IFU include:  
 
Pathological conditions in the soft tissue that would prevent secure fixation of the device. 
Known hypersensitivity to the implant material. Where material sensitivity is suspected, 
appropriate tests should be made and sensitivity ruled out prior to implantation. 
 
4.4.4 Potential Adverse Events 
The Potential Adverse Effects listed in the IFU include: 
 
Mild inflammatory and foreign body reactions 
 
Warnings and Precautions stated in the IFU:  
 
Do not use if package is damaged. Do not use if the product sterilization barrier or its packaging 
is compromised. 
The device is supplied sterile and is for SINGLE USE ONLY. Do not clean, resterilize, or reuse 
the device, as this may damage or compromise the performance resulting in product 

 
Clinical Protocol  
Study Number: FAST-FIX 
FLEX.2020.09 
A Prospective, Multi-center Clinical Study to Evaluate the Safety 
and Performance of the FAST-FIX FLEX System for Meniscal Repairs 
(MR) and Meniscal Allograft Transplantations (MAT) 
Version: 3.0, 05/May/2023 
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malfunction, failure, or patient injury. Cleaning, resterilization, or reuse of the device may also 
expose the patient to the risk of transmitting infectious diseases. 
to use of this device. 
Only bend the needle with the provided bend tool. 
Do not bend the needle along area indicated by black retaining tube. Excessive bending of the 
delivery needle may make it difficult or impossible to deliver the T1 and T2 implants. 
If resistance is encountered during deployment, a new delivery device may be needed. 
Do not push the deployment slider twice or the implants will deploy prematurely. 
Do not push the deployment slider until the needle is fully penetrated through the meniscus 
to the preset depth or T1 and T2 will deploy prematurely. 
The patient should be warned that the device does not replace normal healthy tissue, and that 
the implant can break or become damaged as a result of strenuous activity or trauma, and 
has a finite expected functional life and may need to be replaced in the future. 
Bending the needle:  
Only use the bend tool provided in the carton with the needle. 
Do not bend the needle along area indicated by black retaining tube. 
 
Deploy the first implant (T1): 
Do not push the deployment slider twice or the second implant will deploy prematurely. 
 
Deploy the first implant (T2): 
Do not push the deployment slider until the needle is fully penetrated through the meniscus 
to the preset depth or T2 will deploy prematurely. 
 
 
 

 
Clinical Protocol  
Study Number: FAST-FIX 
FLEX.2020.09 
A Prospective, Multi-center Clinical Study to Evaluate the Safety 
and Performance of the FAST-FIX FLEX System for Meniscal Repairs 
(MR) and Meniscal Allograft Transplantations (MAT) 
Version: 3.0, 05/May/2023 
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5 OBJECTIVE(S) 
The primary, secondary and safety objectives of this study are listed as follows.  
5.1  Primary Objective 
The primary objective of this study is to assess the clinical success rate of FAST-FIX FLEX meniscal 
repair at 12 months. Failure of the repair is defined as revision surgery at the site of the primary 
tear.   
5.2  Secondary Objective(s) 
The secondary objectives are to: 
To assess the clinical success rate of FAST-FIX FLEX meniscal repair at 6 months; 
To assess the meniscal allograft transplantation success rate at 6 months & 12 months. 
Failure is defined as a revision of the transplantation and/or removal of the allograft; 
To evaluate the meniscus healing for both clinical indications as measured by magnetic 
resonance imaging (MRI) at 6 months and 12 months in comparison to pre op; 
To assess the clinical performance for both clinical indications by Patient-Reported Outcome 
(PROs) scores at baseline 6 months and 12 months: International Knee and Documentation 
Committee (IKDC) scores, Lysholm knee scores and EQ-5D-5L. 
5.3 Other Objective(s) 
To assess safety with reported complications, adverse events, adverse device effects, unanticipated 
serious adverse device effects and device deficiencies. 
 
 

 
Clinical Protocol  
Study Number: FAST-FIX 
FLEX.2020.09 
A Prospective, Multi-center Clinical Study to Evaluate the Safety 
and Performance of the FAST-FIX FLEX System for Meniscal Repairs 
(MR) and Meniscal Allograft Transplantations (MAT) 
Version: 3.0, 05/May/2023 
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TMP-800052 Clinical Protocol - Device  Revision 4; PRO-201725 Clinical Protocols 
5.4 Claims 
The proposed Marketing Claims for this study include, but are not limited to, the following: 
Meniscal tears repaired with FAST-FIX FLEX lead to an improvement in patient symptom 
scores (PROs). 
The FAST-FIX FLEX Meniscal Repair System provides an increased access to tear location and 
increased zone of repair. 
6 INVESTIGATIONAL PRODUCT(S) 
The Meniscal repair device used in the investigation will be the FAST-FIX FLEX Meniscal Repair 
System, a suture retention device to facilitate percutaneous or endoscopic soft tissue procedures. 
The system is 510(k) cleared in the United States and includes two non-absorbable polymer implants, 
pre-tied with #2-0 non-absorbable suture and preloaded into a needle delivery system. 
6.1  Identification 
6.1.1  Investigational Product 
The FAST-FIX FLEX Meniscal Repair System devices are intended to provide a secure repair of soft 
tissue tears, particularly meniscal tears, or to support meniscal allograft transplantation (Fig 1.A-B). 
Four device configurations having different distal needle curvature are being offered. Two are  with 
a Bend Tool and Slotted Cannula and two configurations are packaged without a Bend Tool and 
Slotted Cannula. 
 

 
Clinical Protocol  
Study Number: FAST-FIX 
FLEX.2020.09 
A Prospective, Multi-center Clinical Study to Evaluate the Safety 
and Performance of the FAST-FIX FLEX System for Meniscal Repairs 
(MR) and Meniscal Allograft Transplantations (MAT) 
Version: 3.0, 05/May/2023 
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A
B
 
Figure 6-1-1 A-B: Images of the Fast-Fix Flex A) Curved & B) Reversed-Curved inserter, 
bender, cannula set. 
Each device includes two non-absorbable polymer implants, pre-tied with #2-0 non-absorbable 
suture and preloaded into a needle delivery system. The adjustable depth penetration limiter is preset 
to approximately 16mm from the tip of the needle. It can be adjusted in 4mm increments between 
12mm and 20mm.  
The system is supplied sterile and is for SINGLE USE ONLY.  
SKUs 72205324 and 72205325 contain the following:  
(1) Single-use delivery needle assembly preloaded with  
-tied with #2-0 non-absorbable suture made 
of uncoated ultrahigh-molecular-weight polyethylene fiber braided with polypropylene monofilament 
fiber 
(1) Single-use FAST-FIX FLEX Slotted Delivery Cannula 
(1) Single-use Bend Tool 
SKUs 72205676 and 72205677 contain the following:  

 
Clinical Protocol  
Study Number: FAST-FIX 
FLEX.2020.09 
A Prospective, Multi-center Clinical Study to Evaluate the Safety 
and Performance of the FAST-FIX FLEX System for Meniscal Repairs 
(MR) and Meniscal Allograft Transplantations (MAT) 
Version: 3.0, 05/May/2023 
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(1) Single-use delivery needle assembly preloaded with  
polyetheretherketone) implants pre-tied with #2-0 non-absorbable suture made 
of uncoated ultrahigh-molecular-weight polyethylene fiber braided with polypropylene monofilament 
fiber 
SKU 
Component 
Description 
72205324 
FAST-FIX FLEX  
CURVED INSERTER, 
BENDER, CANNULA SET 
Inserter: The device user interface includes a 
handle and deployment knob used to deploy two 
PEEK implants in the joint space. The handle and 
deployment knob are designed such that they are 
easy to hold/grip onto, allow for single-handed 
deployment, and provide tactile feedback for 
implant deployment.  
Bender: Used to adjust the curvature of the distal 
needle. Design is textured on either side of the 
bend tool to enhance grip.  
Cannula: Used for ease of insertion of the device 
into joint space. 
72205325 
FAST-FIX FLEX  
REVERSE CURVED 
INSERTER, BENDER, 
CANNULA SET 
72205676 
FAST-FIX FLEX CURVED 
INSERTER 
Inserter: The device user interface includes a 
handle and deployment knob used to deploy two 
PEEK implants in the joint space. The handle and 
deployment knob are designed such that they are 
easy to hold/grip onto, allow for single-handed 
deployment, and provide tactile feedback for 
implant deployment 
72205677 
FAST-FIX FLEX 
REVERSE CURVED 
INSERTER 
 
Refer to the Fast-Fix Flex Instructions for Use for more information.  
 

 
Clinical Protocol  
Study Number: FAST-FIX 
FLEX.2020.09 
A Prospective, Multi-center Clinical Study to Evaluate the Safety 
and Performance of the FAST-FIX FLEX System for Meniscal Repairs 
(MR) and Meniscal Allograft Transplantations (MAT) 
Version: 3.0, 05/May/2023 
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6.1.2 Ancillary Products 
Individual compatible instruments and accessories for the FAST-FIX FLEX Meniscal Repair System 
are sold separately and are provided sterile. Read the Instructions for Use that are enclosed with the 
instruments and accessories prior to use. 
 
6.2  Product Use 
Typically, total meniscal repair procedure time runs for approximately 45 minutes, during which the 
FAST-FIX FLEX is used in the knee for approximately 5-30 minutes. The devices are provided sterile 
and fully assembled to the operating room. Each device is single use only. The inserter is used to 
access the joint space and repair site. Once in the joint space, the inserter is used to deploy two 
polyether ether ketone (PEEK) implants into the soft tissue at the repair site, which will stay 
permanently in t
marketed with the FF360 product line) is used for ease of insertion into the joint space. The Bend 
Tool provides the ability to adjust the distal needle  curvature, if desired by the surgeon for improved 
access in the joint space. The functionality of the FAST-FIX FLEX inserters is similar to that of the 
predicate FF360 product line. 
SKU 
Component 
Description 
CTX-C001 
NOVOCUT Suture 
Manager 
Used to push knots in size 2-0 or 0 suture 
created during arthroscopic surgery, cut 
the resulting suture tails, and retrieve or 
manage suture arthroscopically. 
015186 
Meniscal Depth Probe 
Used to measure meniscus and then set 
the appropriate needle exposure. 
014549 
Diamond Rasp 
Used to prepare the tear prior to suturing. 
014550 
 

 
Clinical Protocol  
Study Number: FAST-FIX 
FLEX.2020.09 
A Prospective, Multi-center Clinical Study to Evaluate the Safety 
and Performance of the FAST-FIX FLEX System for Meniscal Repairs 
(MR) and Meniscal Allograft Transplantations (MAT) 
Version: 3.0, 05/May/2023 
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Refer to the FAST-FIX FLEX IFU for detailed information on contraindications, warnings, adverse 
reactions and precautions. 
6.3 Packaging and Labelling 
Packaging and labelling will be as per commercially available product and will meet regulatory 
requirements. 
6.3.1 Labelling of Investigational Product 
The FAST-FIX FLEX Meniscal Repair System has received 510(k) clearance in the United States, CE 
marking in Europe, Australian Register of Therapeutic Goods (ARTG) approval in Australia and is 
commercially available on the market. All devices used in this study will be procured in standard 
commercial packaging, ordered via usual and customary Smith + Nephew procedures and managed 
per study site processes. The labels on FAST-FIX FLEX Meniscal Repair system contain the following 
information: 
Lot Number  
Catalogue Number 
Unique Device Identifier  
Package contents  
Use by Date  
Date of Manufacture  
Distributor information: Smith + Nephew, Inc.  
Manufacturer name and address  
Product name 
Customer service contact information  
Product sale restriction 
 
 

 
Clinical Protocol  
Study Number: FAST-FIX 
FLEX.2020.09 
A Prospective, Multi-center Clinical Study to Evaluate the Safety 
and Performance of the FAST-FIX FLEX System for Meniscal Repairs 
(MR) and Meniscal Allograft Transplantations (MAT) 
Version: 3.0, 05/May/2023 
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6.3.2 Ancillary Products 
The labels on the ancillary products contain the following information: 
Lot Number  
Catalogue Number 
Unique Device Identifier  
Package contents  
Use by Date  
Date of Manufacture  
Distributor information: Smith + Nephew, Inc.  
Manufacturer name and address  
Product name 
Product sale restriction 
6.4 Product Accountability Procedures 
All devices used in this study will be procured in standard commercial packaging, ordered via usual 
and customary Smith + Nephew procedures and managed per study site processes. Therefore, 
product accountability / inventory 
 
6.5 Surgical Technique/Medical Procedures 
All study-related procedures with the FAST-FIX FLEX Meniscal Repair System must be performed 
according to the recommended surgical technique described in the IFU (10601463 / 10601589). In 
addition to the IFU, the FAST-FIX FLEX device must be the only suture retention device used in this 
study to perform meniscal repairs. Furthermore, a notch microfracture/venting procedure should be 
performed for all isolated meniscal repairs. For meniscal allograft transplantations, the variability of 
surgical technique is open, allowing a hybrid repair to be performed. However, the FAST-FIX FLEX 
device must be the only all-inside device used in this study during the meniscal allograft 
transplantation procedure. 

 
Clinical Protocol  
Study Number: FAST-FIX 
FLEX.2020.09 
A Prospective, Multi-center Clinical Study to Evaluate the Safety 
and Performance of the FAST-FIX FLEX System for Meniscal Repairs 
(MR) and Meniscal Allograft Transplantations (MAT) 
Version: 3.0, 05/May/2023 
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Investigators participating in this study must be proficient in meniscal repairs and/or meniscal 
allograft transplantations. Prior to using the FAST-FIX FLEX Meniscal Repair System, medical 
professionals may be trained by a sales representative on the product or they will be introduced to 
the product at a medical education lab. In addition, a minimum of three procedures with the device 
under study in this protocol must be completed prior to enrolling subjects in the study. 
7 SUBJECT ENROLLMENT AND WITHDRAWAL 
7.1 Subject Population 
A minimum 62 and maximum of 68 subjects between the ages of 16 and 70 years of age will be 
enrolled into the study. The subjects will be recruited from up to 5 sites in the United States, United 
Kingdom, France and Australia. Sites failing to enroll may be replaced.  
53 subjects will be enrolled for meniscal repair with the use of the FAST-FIX FLEX system 
A minimum of 9 and maximum of 15 subjects will be enrolled for meniscal allograft 
transplantation with the use of the FAST-FIX FLEX system 
For the two subgroups, the clinician has decided the subject  best treatment is a meniscal repair or 
meniscal allograft transplantation facilitated with the FAST-FIX FLEX system as routine medical care. 
This decision will be made irrespectively of study participation.  
7.1.1 Vulnerable subjects 
Subjects aged 16 and 17 years of age 
 can be enrolled in this study. The rationale for 
inclusion of this age group is to better align with the Investigational Product
, which does not 
restrict use in this age group, and strengthen the evidence required for European Medical Device 
Regulation (EU MDR). Also, the study sites use the Investigational Product in this age group as per 
standard care and therefore should improve recruitment rates in this study. As this is a post-
market clinical follow-up (PMCF) study, any minors who are enrolled in this study may receive the 
Investigational Product regardless of their participation. 
 

 
Clinical Protocol  
Study Number: FAST-FIX 
FLEX.2020.09 
A Prospective, Multi-center Clinical Study to Evaluate the Safety 
and Performance of the FAST-FIX FLEX System for Meniscal Repairs 
(MR) and Meniscal Allograft Transplantations (MAT) 
Version: 3.0, 05/May/2023 
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7.2 Inclusion Criteria  Meniscal Repair ONLY 
Subjects will be considered qualified for enrollment in the MR arm if they meet the following criteria: 
1.
Subject provides written informed consent for study participation using an independent ethical 
committee (IEC) / institutional review board (IRB) approved consent form. 
2.
Subject is between sixteen (16) and seventy (70) years of age, inclusive at the time of 
screening. 
3.
Subject is willing and able to participate in required follow-up visits and is able to complete 
study activities. 
4.
Subject requires a meniscal repair. 
5.
Subject is suitable to participate in the study in the opinion of the Investigator. 
6. 
Subject requires a meniscus repair concerning the red-red or red-white zones for acute or 
chronic 1-, 2- or 3-segment lesions, with or without associated anterior cruciate ligament (ACL) 
reconstruction. 
7.3 Exclusion Criteria  Meniscal Repair ONLY 
Any one (1) of the following criteria will disqualify a potential subject from participation in the study: 
1.
Contraindications (per the FAST-FIX FLEX IFU) or hypersensitivity to the use of the FAST-FIX 
FLEX implant material. Where material sensitivity is suspected, appropriate tests should be 
made and sensitivity ruled out prior to implantation. 
2.
Enrolled in the treatment period of another clinical trial within thirty (30) days of the operative 
visit, or during the study. 
3.
Women who are pregnant or nursing. 

 
Clinical Protocol  
Study Number: FAST-FIX 
FLEX.2020.09 
A Prospective, Multi-center Clinical Study to Evaluate the Safety 
and Performance of the FAST-FIX FLEX System for Meniscal Repairs 
(MR) and Meniscal Allograft Transplantations (MAT) 
Version: 3.0, 05/May/2023 
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4.
Any subject that meets the definition of a Vulnerable Subject per ISO 14155 Section 3.55
(except for subjects aged sixteen (16) or seventeen (17) years of age with consent from their 
legally authorized representative).1  
5.
Subjects with a history of poor compliance with medical treatment, physical therapy 
(PT)/rehabilitation, or clinical study participation. 
6.
Patients with irreparable meniscal tears (i.e. multiple tears). 
7. 
Subjects with full thickness cartilage defects greater than 10mm in diameter and/or serious 
defects. 
8.
Patients with concomitant ligament injuries that do not require surgical repair (i.e. ACL with 
Grade 3 lateral collateral ligament (LCL) injury or medial collateral ligament (MCL) injury). 
9.
Performance of a significant concomitant procedure, specifically a cartilage repair or 
restoration (excluding ACL reconstruction or repair, lateral extra-articular tenodesis, 
anterolateral ligament (ALL) reconstruction) intended as a therapeutic intervention on the 
study knee. 
10.
Subjects with a history of ipsilateral knee surgery, septic joint, or fracture. 
11.
Subjects with pathological conditions in the soft tissue that would prevent secure fixation of 
the device. 
12.
Physical conditions that would eliminate, or tend to eliminate, adequate anchor support or 
retard healing. 
13.
The presence of infection. 
 
1. ISO 14155 Section 3.55 States: Vulnerable subject  individual whose willingness to volunteer in a clinical investigation 
could be unduly influenced by the expectation, whether justified or not, of benefits associated with participation or of 
retaliatory response from senior members of a hierarchy in case of refusal to participate.  EXAMPLE: Individuals with a lack 
of or loss of autonomy due to immaturity or through mental disability, persons in nursing homes, children, impoverished 
persons, subjects in emergency situations, ethnic minority groups, homeless persons, nomads, refugees, and those 
incapable of giving informed consent.  Other vulnerable subjects include, for example, members of a group with a 
d laboratory personnel, employees of the 
sponsor, members of the armed forces and persons kept in detention. 

 
Clinical Protocol  
Study Number: FAST-FIX 
FLEX.2020.09 
A Prospective, Multi-center Clinical Study to Evaluate the Safety 
and Performance of the FAST-FIX FLEX System for Meniscal Repairs 
(MR) and Meniscal Allograft Transplantations (MAT) 
Version: 3.0, 05/May/2023 
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14.
directions during the healing period. 
15.
Malalignment: genu varus and genu valgus angles greater than 5° as evaluated by the 
. 
16.
Patients who have an Ahlback grade greater than II. 
17.
Patients with a body mass index larger than 35. 
18.
Subjects with a medical or physical condition that, in the opinion of the Investigator, would 
preclude safe subject participation in the study. 
7.4 Inclusion Criteria  Meniscal Allograft Transplantation 
ONLY 
Subjects will be considered qualified for enrollment in the MAT arm if they meet the following criteria: 
1.
Subject provides written informed consent for study participation using an independent ethical 
committee (IEC) / institutional review board (IRB) approved consent form. 
2.
Subject is between sixteen (16) and seventy (70) years of age, inclusive at the time of 
screening. 
3.
Subject is willing and able to participate in required follow-up visits and is able to complete 
study activities. 
4.
Subject requires a meniscal allograft transplantation. 
5.
Subject is suitable to participate in the study in the opinion of the Investigator. 
6. 
Subject requires a MAT for symptomatic meniscal insufficiency (load-related pain and swelling 
in the compartment post meniscectomy) for which conservative treatment has failed, with or 
without cartilage repair or restoration (including ACL reconstruction or repair). 

 
Clinical Protocol  
Study Number: FAST-FIX 
FLEX.2020.09 
A Prospective, Multi-center Clinical Study to Evaluate the Safety 
and Performance of the FAST-FIX FLEX System for Meniscal Repairs 
(MR) and Meniscal Allograft Transplantations (MAT) 
Version: 3.0, 05/May/2023 
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7.5 Exclusion Criteria 
 Meniscal Allograft Transplantation 
ONLY 
Any one (1) of the following criteria will disqualify a potential subject from participation in the study: 
1.
Contraindications (per the FAST-FIX FLEX IFU) or hypersensitivity to the use of the FAST-FIX 
FLEX implant material. Where material sensitivity is suspected, appropriate tests should be 
made and sensitivity ruled out prior to implantation. 
2.
Enrolled in the treatment period of another clinical trial within thirty (30) days of the operative 
visit, or during the study. 
3.
Women who are pregnant or nursing. 
4.
Any subject that meets the definition of a Vulnerable Subject per ISO 14155 Section 3.55
(except for subjects aged sixteen (16) or seventeen (17) years of age with consent from their 
legally authorized representative).1  
5.
Subjects with a history of poor compliance with medical treatment, physical therapy 
(PT)/rehabilitation, or clinical study participation. 
6.
Patients with concomitant ligament injuries that do not require surgical repair (i.e. ACL with 
Grade 3 lateral collateral ligament (LCL) injury or medial collateral ligament (MCL) injury. 
7.
Performance of a significant concomitant procedure (excluding ACL reconstruction or repair, 
lateral extra-articular tenodesis, anterolateral ligament (ALL) reconstruction) intended as a 
therapeutic intervention on the study knee. 
8.
Subjects with a history of ipsilateral knee surgery, septic joint, or fracture (excluding MAT 
indication). 
9.
Subjects with pathological conditions in the soft tissue that would prevent secure fixation of 
the device. 

 
Clinical Protocol  
Study Number: FAST-FIX 
FLEX.2020.09 
A Prospective, Multi-center Clinical Study to Evaluate the Safety 
and Performance of the FAST-FIX FLEX System for Meniscal Repairs 
(MR) and Meniscal Allograft Transplantations (MAT) 
Version: 3.0, 05/May/2023 
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10.
Physical conditions that would eliminate, or tend to eliminate, adequate anchor support or 
retard healing. 
11.
The presence of infection. 
12.
directions during the healing period. 
13.
Malalignment: genu varus and genu valgus angles greater than 5° as evaluated by the 
. 
14.
Patients who have an Ahlback grade greater than II. 
15.
Patients with a body mass index larger than 35. 
16.
Subjects with a medical or physical condition that, in the opinion of the Investigator, would 
preclude safe subject participation in the study. 
7.6 Screening 
The Investigators will continuously screen subjects during recruitment, which will continue until a 
minimum of 62 and maximum of 68 subjects (53 enrolled for MR and a minimum of 9 and maximum 
of 15 enrolled for MAT) are recruited. It remains the decision of the Sponsor to increase or decrease 
enrollment, as necessary. 
Subjects aged 18 years and over: Once a subject has completed the informed consent procedure 
and signed the Informed Consent Form (ICF), the Principal Investigator (PI), or delegated study 
research staff, can complete the screening process to determine whether they meet all inclusion and 
none of the exclusion criteria.  
Subjects aged 16 and 17 years: Once a subject has completed the informed consent procedure 
(assent), the 
has completed 
the informed consent procedure and signed the relevant ICFs, the Principal Investigator (PI), or 

 
Clinical Protocol  
Study Number: FAST-FIX 
FLEX.2020.09 
A Prospective, Multi-center Clinical Study to Evaluate the Safety 
and Performance of the FAST-FIX FLEX System for Meniscal Repairs 
(MR) and Meniscal Allograft Transplantations (MAT) 
Version: 3.0, 05/May/2023 
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delegated study research staff, can complete the screening process to determine whether they meet 
all inclusion and none of the exclusion criteria. 
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 recorded in the 
subject's source documents and noted on the Screening and Enrollment Log. All screening activities 
that occur prior to consent shall be referred to as pre-screening.  
7.7 Informed Consent 
Before conducting any study procedures or examinations, the purpose and nature of the study should 
be explained to the subject in their native language. Subjects will have the opportunity to ask any 
questions. 
The subject, or their legally authorized representative, will then read, sign, and personally date 
the IRB/IEC-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 document will be provided to the 
subject, and 
medical record, with the original filed in the ISF. 
If the subject is unable to read, the informed consent document and associated study information 
may be read aloud to the subject in the presence of an impartial witness. If possible, the subject 
shall sign and personally date the ICF. Where this is not possible, due to difficulties in writing, the 
subject shall provide verbal consent to participate in the study. The witness shall then personally sign 
and date the informed consent form, attesting that the information was accurately explained and 
that the informed consent was freely given. 
In the case of vulnerable subjects (minors), the ICF must 
legally authorized representative (parent or legal guardian). Assent to participate in the study should 
be obtained for subjects 16 years of age and 17 years of age if allowed by local regulations. If the 

 
Clinical Protocol  
Study Number: FAST-FIX 
FLEX.2020.09 
A Prospective, Multi-center Clinical Study to Evaluate the Safety 
and Performance of the FAST-FIX FLEX System for Meniscal Repairs 
(MR) and Meniscal Allograft Transplantations (MAT) 
Version: 3.0, 05/May/2023 
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legally authorized representative is unable to read/write, a witness signature is required as described 
previously. 
The minor shall participate in the informed consent process in a way suitable for their age and mental 
maturity. Minors will receive the study information in a way adapted to their age and mental maturity 
from investigators or members of the investigating team who are trained or experienced in working 
with children. If minors express a wish or an opinion with regards to study participation this needs 
to be respected by the Investigator. If during the study, the minor reaches the age of 18 years (legal 
competence), the informed consent shall be obtained again, before the subject can continue to 
participate in the clinical investigation. ICFs will comply with Health Information Portability 
Accountability Act (HIPAA) regulations the EU Global Data Protection Regulation (GDPR), The Privacy 
Act 1988 in Australia and the New Zealand Privacy Act 1993 and or applicable national regulations 
and laws. 
If new information becomes available during the course of the study that can significantly affect a 
provided to the subject(s) affected in written form and if relevant, all affected subjects shall be asked 
to confirm their continuing consent in writing. 
7.8 Enrollment 
Subjects for whom the consent process has been completed and have been treated with the study 
product are considered enrolled. Any subjects who have provided consent but do not receive 
treatment or withdraw consent prior to surgery will be considered a screen failure. 
Subjects will be assigned a Subject ID at the time of consent. Subjects requiring a bilateral meniscal 
repair will not be enrolled. 

 
Clinical Protocol  
Study Number: FAST-FIX 
FLEX.2020.09 
A Prospective, Multi-center Clinical Study to Evaluate the Safety 
and Performance of the FAST-FIX FLEX System for Meniscal Repairs 
(MR) and Meniscal Allograft Transplantations (MAT) 
Version: 3.0, 05/May/2023 
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7.9 Lost to Follow-up 
A subject will be considered lost to follow-up if he/she does not appear for the scheduled study visit 
for two consecutive visits and does not return for a final visit, and study personnel are unable to 
contact the subject. 
Some actively enrolled subjects will not return for follow-up exams on time due to a variety of 
reasons. Study personnel must make a reasonable effort to contact the subject and document the 
following contact attempts before declaring a subject to be lost to follow-up (LTFU): the subject has 
been contacted according to the site's policies, but no fewer than two documented phone contacts 
and one certified letter without response. Copies of all attempts to reach the subjects by mail or 
email and/or the attempts to contact the subject via other means should be documented, and that 
 
7.10  Withdrawal 
7.10.1 Withdrawal from Treatment 
Subjects may be withdrawn from having the related procedures with the FAST-FIX FLEX Meniscal 
Repair System at a date close to surgery or during surgery for the following reasons: 
At the discretion of the Investigator due to: 
o A change in treatment is clinically warranted 
o An adverse event 
o Any other significant reason identified by the Investigator 
 
 

 
Clinical Protocol  
Study Number: FAST-FIX 
FLEX.2020.09 
A Prospective, Multi-center Clinical Study to Evaluate the Safety 
and Performance of the FAST-FIX FLEX System for Meniscal Repairs 
(MR) and Meniscal Allograft Transplantations (MAT) 
Version: 3.0, 05/May/2023 
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7.10.2 Any subjects who have provided consent but do not receive 
treatment or withdraw consent prior to surgery will be 
considered a screen failure.Withdrawal from Study 
The Investigator may withdraw subjects from the study for many reasons, including but not limited 
to the following: 
Subject noncompliance (e.g., did not follow instructions, took disallowed medications) 
Subject lost to follow-up 
If the Investigator or the Sponsor stops the study for any reason and decides to withdraw 
subject(s) from the study 
concurrent illness 
Adverse Events/Adverse Device Effects that affect the ability to evaluate the study product 
without bias 
Any other significant reason identified by the Investigator 
If a subject receives a revision surgery of the study knee, or experiences an AE/SAE/DD, the subject 
shall continue to have follow-
 any adverse 
events/adverse device events are resolved, is lost to follow-up, or until 12 months post-surgery. 
Potential data following the revision surgery will not be included as study data but presented 
separately as safety data. Revision subjects will not be replaced. 
For each case, the information will be obtained in the source document and the Case Report Form 
(CRF), detailing circumstances leading to the withdrawal.  
Subjects who drop out or are withdrawn will not be re-entered into the study at a later date.  
7.10.3 
 
Study participation is voluntary, and subjects may withdraw at any point during the study without 
giving their reason for doing so. Where subjects withdraw consent, the investigator should make a 

 
Clinical Protocol  
Study Number: FAST-FIX 
FLEX.2020.09 
A Prospective, Multi-center Clinical Study to Evaluate the Safety 
and Performance of the FAST-FIX FLEX System for Meniscal Repairs 
(MR) and Meniscal Allograft Transplantations (MAT) 
Version: 3.0, 05/May/2023 
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reasonable effort to ascertain the reason(s), while fully re
for withdrawal will be recorded in the CRF and source documents. 
If withdrawal is after the surgical procedure, the Investigator should inform the subject of any 
recommended follow-up visits to monitor subject safety. 
7.10.4 Use of Data Following Withdrawal 
In cases where the subject withdraws consent, the data collected up to the point of withdrawal may 
be used, but no additional data for that subject may be collected.  
8 STUDY DESIGN 
8.1  Study Design 
This is a prospective, multi-center, non-randomized clinical study intended to evaluate the safety and 
performance of the FAST-FIX FLEX Meniscal Repair system for meniscal repairs and meniscal allograft 
transplantations. Up to 5 sites will participate within United States, United Kingdom, France, and 
Australia.  
Subjects will be enrolled in one of two (2) groups based on medical indication and general practice 
at the site, as shown in Table 8.1-1. 
 
Table 8.1-1  Overview of Study Groups 
 
 
 
 
Group 
Surgical Technique 
Number of Subjects 
Meniscal Repair 
Smith+Nephew FAST-
FIX FLEX System 
53 
Meniscal Allograft 
Transplantations 
Smith+Nephew FAST-
FIX FLEX System 
A minimum of 9 and 
maximum of 15 

 
Clinical Protocol  
Study Number: FAST-FIX 
FLEX.2020.09 
A Prospective, Multi-center Clinical Study to Evaluate the Safety 
and Performance of the FAST-FIX FLEX System for Meniscal Repairs 
(MR) and Meniscal Allograft Transplantations (MAT) 
Version: 3.0, 05/May/2023 
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The study is expected to be 39 months in duration, but this will depend on the enrollment rate. These 
include: 
21 months for enrollment 
14 months for follow-up 
o The final visit is 12 months post-surgery and includes a +/- 75 day window period. 
 
The study's treatment will occur once, in the form of surgery to repair the torn portion of the meniscus 
or provide allograft transplantation to replace the irreparable meniscus or for patients who have had 
a meniscectomy. 
 
The primary outcome measures that will be examined include whether the repair success rate at 12 
months will be similar or less than historical rates (90% for all-inside meniscal repair)39; whether the 
FAST-FIX FLEX system increases access to tear location and zone of repair; whether a significant 
proportion of the subjects will show meniscus healing at 6 months; and whether Patient-Reported 
Outcomes (PROs) will be improved up to 12 months following the procedure.  
 
 
 
 
 
 
 
 
 
 
 

 
Clinical Protocol  
Study Number: FAST-FIX 
FLEX.2020.09 
A Prospective, Multi-center Clinical Study to Evaluate the Safety 
and Performance of the FAST-FIX FLEX System for Meniscal Repairs 
(MR) and Meniscal Allograft Transplantations (MAT) 
Version: 3.0, 05/May/2023 
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Figure 8-1-1: Study Flowchart 1 
 
 
 
 
 
 

Clinical Protocol 
Study Number: FAST-FIX 
FLEX.2020.09
A Prospective, Multi-center Clinical Study to Evaluate the Safety 
and Performance of the FAST-FIX FLEX System for Meniscal Repairs 
(MR) and Meniscal Allograft Transplantations (MAT)
Version: 3.0, 05/May/2023
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Revision 4; PRO-201725 Clinical Protocols
Figure 8-1-8-2: Study Stages
8.2 Allocation and Blinding
8.2.1 Treatment Allocation
This study is not randomized.
8.2.2 Blinding
This study is not blinded.
8.3 Data Management
This study utilizes a validated, 21 CFR Part 11 compliant, electronic data capture system. Access to 
the electronic data capture system is controlled through Smith and Nephew procedures.
A Data Management Plan (DMP) is written according to Smith and Nephew procedures containing 
details of the data management process. The following is a brief description of the key points detailed 
in this plan.
8.3.1 Data Review and Quality Assurance 
Data will be transcribed from the data source to an electronic Case Report Form (eCRF). All data 
requested on the eCRFs are considered required. Data points not collected and/or recorded will be 
considered deviations unless otherwise specified. 
Data collection is the responsibility of the clinical trial staff at the site under the supervision of the 
Principal Investigator. The Principal Investigator is responsible for ensuring the accuracy, 
completeness, legibility, and timeliness of the data reported. The Principal Investigator must provide 

 
Clinical Protocol  
Study Number: FAST-FIX 
FLEX.2020.09 
A Prospective, Multi-center Clinical Study to Evaluate the Safety 
and Performance of the FAST-FIX FLEX System for Meniscal Repairs 
(MR) and Meniscal Allograft Transplantations (MAT) 
Version: 3.0, 05/May/2023 
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his/her electronic signature on the appropriate eCRFs to be documented in compliance with local 
regulations. Changes to data previously submitted to the sponsor will require a new signature by the 
Investigator to acknowledge/approve the changes.  
Visual and computer data review will be performed in line with Smith and Nephew procedures to 
identify possible data discrepancies. Manual and automatic queries will be created within the 
electronic data capture system, and will be issued by Smith and Nephew to the site for appropriate 
response. Site staff are responsible for resolving all queries in the electronic data capture system.  
8.3.2 Retention Period 
All eCRFs will be archived once the study is completed and will be kept for a period of no less than 
five years after the later of the following dates: the date of which the study is terminated or completed 
or the date that the records are no longer required for supporting marketing applications. 
8.4 Study Endpoints 
8.4.1 Primary Endpoint 
The primary endpoint of this study is defined as the rate of reoperation due to meniscal repair failure 
at 12 months post-operative. Failure is defined as a revision at the primary site of tear.  
 
8.4.2 Secondary Endpoints 
The secondary endpoints of this study are:  
Rate of reoperation due to meniscal repair failure at 6 months post-operative;  
Rate of reoperation due to meniscal allograft transplantation failure at 6 months & 12 months 
post-operative. Failure is defined as a revision of the transplantation and/or removal of 
transplant; 
MRI to assess meniscal healing for both clinical indications at 6 months and 12 months; 
Patient-Reported Outcome (PRO) data will be collected at baseline, 6 months & 12 months: 
International Knee Documentation Committee (IKDC) scores, Lysholm scores, & EQ-5D-5L. 

 
Clinical Protocol  
Study Number: FAST-FIX 
FLEX.2020.09 
A Prospective, Multi-center Clinical Study to Evaluate the Safety 
and Performance of the FAST-FIX FLEX System for Meniscal Repairs 
(MR) and Meniscal Allograft Transplantations (MAT) 
Version: 3.0, 05/May/2023 
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The secondary endpoints provide more context on whether the meniscal repair or meniscal 
transplantation was a success at earlier time points and whether it is durable for 12 months. MRI will 
allow surgeons to assess meniscal healing and help determine whether a reoperation is required or 
not. PROs provide meaningful quality of life measurements to assess improvement, which is 
ultimately the clinical goal of any successful meniscal repair. IKDC, EQ-5D-5L, and Lysholm scores 
are standard validated tools to measure patient symptoms associated with meniscal function. 
8.4.3 Other Endpoints 
Other study endpoints are:  
Analysis of reoperation rate and PROs by meniscal repair procedure (i.e. MR alone vs MR with 
ACL repair), location of the repair (posterior horn, body, anterior horn) and type of tear (bucket 
handle, longitudinal, horizontal, radial, complex).  
Healing status at 6 months & 12 months by repair procedure, location of tear and tear type;  
Surgical technique details (curvature of the distal needle: bender tool used vs bender tool not 
used); 
Procedural details for MR (S+N instruments used with FAST-FIX FLEX) and MAT (hybrid vs 
non-hybrid approach and types of devices used with FAST-FIX FLEX); 
Analysis of the change in extrusion and joint space narrowing for meniscal allograft 
transplantations on MRI at baseline, 6 months and 12 months; 
Rate of mechanical symptoms as defined by PROs (Lysholm: section 3 & 4 and IKDC scores: 
question 6) and radiological evidence of repair failure at 6 months and 12 months.  
8.4.4 Safety Endpoints  
Safety endpoints include the collection of the following events: 
Device-related re-intervention; 
All adverse events (AEs) occurring from the time of surgery until revision or study 
completion; 
Device related AEs (ADEs) and serious adverse events (SAEs); 
Device deficiencies (DDs). 

 
Clinical Protocol  
Study Number: FAST-FIX 
FLEX.2020.09 
A Prospective, Multi-center Clinical Study to Evaluate the Safety 
and Performance of the FAST-FIX FLEX System for Meniscal Repairs 
(MR) and Meniscal Allograft Transplantations (MAT) 
Version: 3.0, 05/May/2023 
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8.5 Methods Used to Minimize Bias and Maximize Validity 
8.5.1 Balanced Covariates 
The inclusion/exclusion criteria will be generalizable and applicable to the widest possible subset of 
the population needing meniscal repair procedures. These criteria will be uniformly applied to enroll 
a cohort of subjects with similar symptoms and clinical requirements. This should maximise the 
applicability to as many subjects with similar baseline characteristics and help to bolster external 
validity.  
8.5.2 Subject Attrition 
Subject attrition due to a reduction in sample size required for precision analysis has been accounted 
for in the sample size calculation so that the estimate of the confidence interval (CI) to be obtained 
will still be valid through the most efficient use of available subjects. 
8.5.3 Pre-specification of Statistical Analysis 
The primary outcome measure has been pre-specified as well as the type of statistical analysis to be 
performed to evaluate repair failure rate to minimize reporting bias. The precision analysis planned 
for the study includes construction of confidence intervals for the outcome summaries and a pre-
defined range in which the 95% CI for the primary outcome is expected to fall within are designed 
to maximize the validity of the study results. 
More detailed information on analyses to be carried out will be incorporated in the Statistical Analysis 
Plan (SAP) so as to minimize any threats to external validity in order to yield clinically relevant 
estimates of effects and precision. 

 
Clinical Protocol  
Study Number: FAST-FIX 
FLEX.2020.09 
A Prospective, Multi-center Clinical Study to Evaluate the Safety 
and Performance of the FAST-FIX FLEX System for Meniscal Repairs 
(MR) and Meniscal Allograft Transplantations (MAT) 
Version: 3.0, 05/May/2023 
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9 STUDY PROCEDURES 
9.1 Visits and Examinations 
9.1.1 Summary 
For a summary of the required procedures by visit, refer to the Study Schematic Table 9.1-1: 
Study Procedures by Visit. 
Table 9.1-1 Study Procedures by Visit
Schedule of Events 
Visit 1 - 
Screening  
< 8 weeks 
pre-op 
Visit 2 - 
Procedure
Visit 3   
2 weeks  
(± 5 days)
Visit 4 -     
3 Months 
(+ 30 
days) 
Visit 5 -     
6 Months 
(± 45days)
Visit 6 -      
12 Months 
(± 75 days) 
Unscheduled 
Visit  
Informed Consent 
X 
  
 
  
  
  
Screening 
Inclusion/Exclusion  
X1 
  
 
  
  
  
Demographics/ 
Medical History/  
X 
  
 
  
  
  
Details of Surgery 
Procedure CRF 
 
X 
 
 
 
 
 
Details of Pathology 
CRF
 
X 
 
 
 
 
 
Post-op Surgery 
Failure 
  
  
X 
X 
X 
X 
X 
MRI assessment 
X2 
 
 
 
X3 
X3 
X 
PRO: IKDC subjective 
X 
  
 
 
X 
X 
X 
PRO: Lysholm  
X 
  
 
 
X 
X 
X 
EQ-5D-5L CRF 
X 
 
 
X 
X 
X 
Concomitant 
Medication/ Therapy  
X 
X 
X 
X 
X 
X 
X 
Safety Assessment 
(AE/SAE/ADE/DevD) 
 
X 
X 
X 
X 
X 
X 
End of Study/Exit   
X4 
X4 
X4 
X4 
X4 
X4 
X4 
1 Inclusion/exclusion confirmation will be performed at the time of screening and study procedure to confirm subject 
meets eligibility criteria.  
2MRI to confirm eligibility criteria must be within 6 months of surgery 
3MRI 1.5 T or greater, no contrast preferred, to be reviewed by independent radiologist appointed 
4As applicable 

 
Clinical Protocol  
Study Number: FAST-FIX 
FLEX.2020.09 
A Prospective, Multi-center Clinical Study to Evaluate the Safety 
and Performance of the FAST-FIX FLEX System for Meniscal Repairs 
(MR) and Meniscal Allograft Transplantations (MAT) 
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9.1.2 Visit 1: Screening/Preoperative Visit (Baseline, <8 weeks prior 
to procedure) 
NOTE: Any subject who signs an informed consent/assent but fails to meet the required entry criteria 
is considered to be a Screen Failure. For screen Failure subjects, their demographic information must 
be captured in the appropriate CRF with the reason for screen failure specified. 
1.
Obtain written informed consent from the subject as detailed in Section 7.7 
----- Do not proceed until consent has been obtained ----- 
2.
Obtain demographic information and medical history, including information on all concomitant 
medications/therapies.  
3.
Obtain baseline MRI and confirm eligibility. 
4.
Screen the subject for protocol inclusion/exclusion criteria. 
5.
Assign the subject a study number and instruct the subject on treatment procedures. 
6.
Have the subject complete the IKDC Subjective Questionnaire  
7.
Have the subject complete the Lysholm Questionnaire 
8.
Have the subject complete the EQ-5D-5L Questionnaire 
9.
Subjects will be instructed to return for the Operation Visit (Procedure) as scheduled by the site. 
 
 
 

 
Clinical Protocol  
Study Number: FAST-FIX 
FLEX.2020.09 
A Prospective, Multi-center Clinical Study to Evaluate the Safety 
and Performance of the FAST-FIX FLEX System for Meniscal Repairs 
(MR) and Meniscal Allograft Transplantations (MAT) 
Version: 3.0, 05/May/2023 
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9.1.3 Visit 2: Operation Visit (Procedure) 
 
1.
Query subject regarding any changes in general health and the use of concomitant 
medications. 
2.
Commence procedure. 
3.
If any adverse device effects or device deficiencies are observed or reported, they must be 
recorded as instructed in Section 12, adverse events and device deficiencies. 
4.
Instruct the subject on proper postoperative care/procedures, including any contraindicated 
treatments/medication(s). 
5.
Complete Details of Surgery Procedure CRF. 
6.
Complete Details of Pathology CRF. 
7.
Complete End of Study/exit information (if appropriate). 
8.
Instruct the subject on follow-up procedures, including returning to the site for follow-up (FU) 
Visit 3 in 14 (±5) days. 
 
 
 

 
Clinical Protocol  
Study Number: FAST-FIX 
FLEX.2020.09 
A Prospective, Multi-center Clinical Study to Evaluate the Safety 
and Performance of the FAST-FIX FLEX System for Meniscal Repairs 
(MR) and Meniscal Allograft Transplantations (MAT) 
Version: 3.0, 05/May/2023 
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9.1.4 Visit 3: Follow-up visit at 2 weeks (14 days after procedure +/- 
5 days) 
 
1.
Query subject regarding any changes in general health and the use of concomitant 
medications. 
2.
If any adverse device effects or device deficiencies are observed or reported, they must be 
recorded as instructed in Section 12, adverse events and device deficiencies. 
3.
If any Reoperation occurred complete Post-operative Surgery Failure CRF. 
4.
Complete End of Study/exit information (if appropriate). 
5.
Instruct the subject on follow-up procedures, including returning to the site for a FU visit at 3 
months. 
 
9.1.5 Visit 4: Follow-up visit at 3 months (90 days after procedure + 
30 days) 
1.
Query subject regarding any changes in general health and the use of concomitant 
medications/concomitant therapies. 
2.
If any adverse events, adverse device effects or device deficiencies are observed or reported, 
they must be recorded as instructed in Section 12, adverse events and device deficiencies. 
3.
If any Reoperation occurred complete Post-operative Surgery Failure CRF. 
4.
Complete End of Study/exit information (if appropriate). 
5.
Instruct the subject on follow-up procedures, including returning to the site for FU visit at 6 
months. 
 

 
Clinical Protocol  
Study Number: FAST-FIX 
FLEX.2020.09 
A Prospective, Multi-center Clinical Study to Evaluate the Safety 
and Performance of the FAST-FIX FLEX System for Meniscal Repairs 
(MR) and Meniscal Allograft Transplantations (MAT) 
Version: 3.0, 05/May/2023 
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9.1.6 Visit 5: Follow-up visit at 6 months (180 days after procedure 
+/- 45 days) 
1.
Query subject regarding any changes in general health and the use of concomitant 
medications/concomitant therapies. 
2.
If any adverse events, adverse device effects or device deficiencies are observed or reported, 
they must be recorded as instructed in Section 12, adverse events and device deficiencies. 
3.
If any Reoperation occurred complete Post-operative Surgery Failure CRF. 
4.
Obtain 6-month MRI. 
5.
Have the subject complete the IKDC Subjective Questionnaire.  
6.
Have the subject complete the Lysholm Questionnaire. 
7.
Have the subject complete the EQ-5D-5L Questionnaire. 
8.
Complete End of Study/exit information (if appropriate). 
9.
Instruct the subject on follow-up procedures, including returning to the site for FU visit at 12 
months. 
 
 

 
Clinical Protocol  
Study Number: FAST-FIX 
FLEX.2020.09 
A Prospective, Multi-center Clinical Study to Evaluate the Safety 
and Performance of the FAST-FIX FLEX System for Meniscal Repairs 
(MR) and Meniscal Allograft Transplantations (MAT) 
Version: 3.0, 05/May/2023 
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9.1.7 Exit Visit (Visit 6: Follow-up visit at 12 months (365 days after 
procedure +/- 75 days)) 
1.
Query subject regarding any changes in general health and the use of concomitant 
medications/concomitant therapies. 
2.
If any adverse events, adverse device effects or device deficiencies are observed or reported, 
they must be recorded as instructed in Section 12, adverse events and device deficiencies. 
3.
If any Reoperation occurred complete Post-operative Repair Failure CRF. 
4.
Obtain a 12-month MRI. 
5.
Have the subject complete the IKDC Subjective Questionnaire  
6.
Have the subject complete the Lysholm Questionnaire 
7.
Have the subject complete the EQ-5D-5L Questionnaire 
8.
Complete Exit Visit CRF and inform the subject of End of Study. 
9.1.8 Reoperations  
Any reoperations will be captured in the source documents and on the Post-operative Surgery Failure 
CRF. Details of the reoperation will be captured, including the reason for the reoperation. At the 
reoperation, the use of any concomitant medications, concomitant therapies, adverse events, and 
device deficiencies will be collected.  
9.1.9 Unscheduled Visits 
All information obtained during an unscheduled visit should be recorded in the source documents and 
on the appropriate CRF. If any adverse events or device deficiencies are observed or reported, they 
must be recorded as instructed in Section 12 - Adverse Events and Device Deficiencies. The subject 
should be scheduled to return for the next scheduled study visit within the acceptable time window. 

 
Clinical Protocol  
Study Number: FAST-FIX 
FLEX.2020.09 
A Prospective, Multi-center Clinical Study to Evaluate the Safety 
and Performance of the FAST-FIX FLEX System for Meniscal Repairs 
(MR) and Meniscal Allograft Transplantations (MAT) 
Version: 3.0, 05/May/2023 
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9.1.10 Concomitant Medications and Therapies 
Concomitant medications and concomitant therapies (e.g., physical therapy, TENS Unit, massage) 
 
Concomitant Medications 
Excluded Concomitant Medications 
Any individual who is on immunosuppressive therapy at screening is ineligible for the study.  If a 
subject starts immunosuppressive therapy during the study, they will be withdrawn from the study. 
There are no other medication restrictions for this study. 
Recording Concomitant Medications in CRF 
All medications that the subject is on will be recorded in the CRF. The CRF Completion Guidelines will 
stipulate how medications should be recorded in the CRF. 
Concomitant Therapies 
Therapies Prohibited During the Study 
No restrictions on concomitant therapies. 
Recording Concomitant Therapies in the CRF 
Concomitant therapies should be recorded on the designated CRF. Reference the CRF Completion 
Guidelines for how concomitant therapies are recorded. 
9.1.11 Discontinued Subjects 
Discontinued subjects are those who voluntarily discontinue participation, who are withdrawn for 
reasons of safety or use of prohibited concomitant medications, who are lost to follow-up, or who 

 
Clinical Protocol  
Study Number: FAST-FIX 
FLEX.2020.09 
A Prospective, Multi-center Clinical Study to Evaluate the Safety 
and Performance of the FAST-FIX FLEX System for Meniscal Repairs 
(MR) and Meniscal Allograft Transplantations (MAT) 
Version: 3.0, 05/May/2023 
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have missed 2 consecutive follow-up visits, or fail to complete the procedure at baseline so are 
ineligible for further participation; refer to section 6.8 for further details. Where possible, a full Exit 
Visit should be completed for all subjects who discontinue the study early. Where consent is 
withdrawn, the date and any reason given for discontinuation should be captured, at a minimum (see 
Section 6.8.2). 
 
Finally, if appropriate, the Investigator will also advise the subject of subsequent therapy and/or 
procedures necessary for their medical condition. Medical care will not be provided to the subject 
after the clinical investigation is completed, other than the standard care provided by the site, which 
is not considered a study visit(s). 
9.1.12 Subject Pregnancy 
Women of child-bearing potential are not excluded from the study. If a woman becomes pregnant 
during the study, S+N must be contacted immediately once the investigator is made aware of the 
pregnancy and a decision will be made regarding the continuation in the study of the pregnant 
woman. Pregnancy is not an adverse event; however, complications related to the pregnancy may 
be reportable as determined on a case-by-case basis. Pregnancy-related information will be collected 
until the end of the pregnancy or the end of the study. 
9.2 Study Methods and Measurements 
The following methods and measurements will be used for this study: 
Magnetic Resonance Imaging (MRI) 
IKDC Subjective PRO  
Lysholm PRO 
EQ-5D-5L PRO 

 
Clinical Protocol  
Study Number: FAST-FIX 
FLEX.2020.09 
A Prospective, Multi-center Clinical Study to Evaluate the Safety 
and Performance of the FAST-FIX FLEX System for Meniscal Repairs 
(MR) and Meniscal Allograft Transplantations (MAT) 
Version: 3.0, 05/May/2023 
Page: 59 of 151   
 
 
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9.2.1 Magnetic Resonance Imaging (MRI) 
Magnetic Resonance Imaging (MRI) is a medical imaging technique that uses magnetic field and 
computer-generated radio waves to create detailed images of an organ or tissue in the body.43 For 
this study, MRIs will be obtained at baseline, 6 months and 1 year post-treatment to assess structural 
integrity and healing. Sites will make arrangements for MRIs per standard procedures and provide 
the images/results to the Sponsor. All MRI assessments are detailed in the Image Review Charter. 
MRI to confirm eligibility criteria must be within 6 months of surgery. 
 
The specific imaging evaluation requirements will be provided in a separate document to radiologists. 
 
9.2.2 International Knee Documentation Committee (IKDC) Subjective
The International Knee Documentation Committee (IKDC) Subjective score was developed to detect 
improvement or deterioration in symptoms, function, and sports activities due to knee impairment, 
including patients with meniscal injuries. The original IKDC form was published in 1993, and there 
were several revisions up to the current version published in 2001. This is a validated questionnaire 
if it is completed by the patient; it takes the patient about 10 minutes to complete.43  
 
There are three domains: 1) symptoms, including pain, stiffness, swelling, locking/catching, and 
giving way (7 items), 2) sports and daily activities (10 items), and 3) current knee function and knee 
function prior to a knee injury (1 item, not included in the score). Responses vary for each item. The 
possible score ranges from 0-100, where 100 = no limitation with daily or sporting activities and the 
absence of symptoms. The normative data for the score are available for the general US population, 
stratified for age, gender, and current/prior knee problems.43 
9.2.3 Lysholm 
The Lysholm scale was first introduced into the medical community in 1982, modified in 1985, and 
is a validated patient or physician administered instrument to measure symptoms and function in 

 
Clinical Protocol  
Study Number: FAST-FIX 
FLEX.2020.09 
A Prospective, Multi-center Clinical Study to Evaluate the Safety 
and Performance of the FAST-FIX FLEX System for Meniscal Repairs 
(MR) and Meniscal Allograft Transplantations (MAT) 
Version: 3.0, 05/May/2023 
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patients with a variety of knee injuries. This tool measures the domains of symptoms and complaints 
and the functioning of daily activities. The scale consists of 8 items and is scaled from 0 to 100, with 
a higher score indicating fewer symptoms and a higher level of functioning.45,46   
 
9.2.4 EQ-5D-5L 
EQ-5D-5L will be used to derive general health-related QoL scores at baseline, 6 months and 1 year. 
The EQ-5D-5L descriptive system comprises the following dimensions: Mobility, Self-Care, Usual Pain 
/ Discomfort and Anxiety/ Depression. Each dimension has 5 levels: no problems, slight problems, 
moderate problems, severe problems, and extreme problems. The tool is widely used in cost-
effectiveness analysis and is available in a variety of languages.47 
 
9.3 Health Economics/Quality of Life 
There are no health economics procedures in this study. EQ-5D-5L will be used to derive general 
health-related QoL scores at baseline, 6 months and 1 year. Please refer to section 9.2.4 for further 
details. 
10 STATISTICAL DESIGN 
A Statistical Analysis Plan (SAP) will be written and finalized prior to database lock. The following is 
a brief description of the analyses to be described in this plan.  
10.1 General 
tistical analysis for this 
study. Unless otherwise stated, all significance tests will be two-sided, performed at the 5% 
significance level. The resulting p-values will be quoted. Point estimates and their corresponding 95% 
two-sided confidence intervals will be generated where appropriate. Where data summaries are 
specified, categorical or ordinal variables will be summarized with frequencies and percentages. 
Continuous variables will be summarized with the following summary statistics: number of 

 
Clinical Protocol  
Study Number: FAST-FIX 
FLEX.2020.09 
A Prospective, Multi-center Clinical Study to Evaluate the Safety 
and Performance of the FAST-FIX FLEX System for Meniscal Repairs 
(MR) and Meniscal Allograft Transplantations (MAT) 
Version: 3.0, 05/May/2023 
Page: 61 of 151   
 
 
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observations, mean, median, standard deviation, minimum and maximum values. All analyses will 
be performed in SAS 9.4 (or later). 
10.2 Analysis Populations 
The following analysis populations will be used for this study: 
 
Full Analysis Set (FAS), following Intention to Treat principle including all subjects who were 
recruited into the study and attended at least one post-surgery assessment.  
 
Safety Population (SAF), including all subjects who have received the study device. 
 
Per-Protocol Population (PP), including all subjects in the full analysis set who have no 
significant protocol deviations and met the inclusion/exclusion criteria. 
Statistical analysis will be performed using each of the patient populations as follows: analysis of 
primary and secondary reoperation rate endpoints will be performed on the SAF population; PROs 
will be presented separately using both the FAS and PP populations. All safety analyses will utilize 
the SAF population. 
10.3 Baseline Data 
Data to be summarized at baseline includes, but is not limited to, all collected demographic variables 
such as age, gender, BMI, primary diagnosis and medical history. The baseline variables will be used 
to describe the outcome data where necessary. 
10.4 Efficacy Analysis 
10.4.1 Analysis of Primary Endpoint 
A binary variable will be defined for whether each patient had reoperation due to meniscal repair 
failure for all treatment visits. This variable will be used to present the proportion of reoperations 
due to meniscal repair failure at 12 months, together with a percentage and 95% confidence interval 
for a single proportion (calculated using the Clopper-Pearson method)40.  
 

 
Clinical Protocol  
Study Number: FAST-FIX 
FLEX.2020.09 
A Prospective, Multi-center Clinical Study to Evaluate the Safety 
and Performance of the FAST-FIX FLEX System for Meniscal Repairs 
(MR) and Meniscal Allograft Transplantations (MAT) 
Version: 3.0, 05/May/2023 
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As a further analysis of the primary endpoint, if the data allows, the time taken for reoperation to 
occur will be assessed as a survival endpoint for both indications in order to assess the trend of 
incidence of reoperation over time.  
 
Analysis will be carried out using the SAF population as the primary analysis population. 
10.4.2 Analysis of Secondary Endpoints 
The following secondary endpoints will be analysed for this study: 
 
Rate of reoperations due to meniscal repair failure at 6 months post-operative will be 
summarized using frequency and percentage. A 95% exact confidence interval for the 
percentage will also be presented using the Clopper-Pearson method.  
 
Rate of reoperations due to meniscal allograft transplantation failure at 6 months & 12 months 
post-operative will be summarized using frequency and percentage. A 95% exact confidence 
interval for the percentage will also be presented using the Clopper-Pearson method. 
 
Analysis of meniscal healing as assessed by MRI at baseline, 6 months and 12 months will be 
conducted separately by an imaging vendor. 
 
IKDC, Lysholm and EQ-5D-5L PRO scores will be calculated and summarized for each visit 
appropriately for categorical or continuous variables. Change from baseline score to each 
post-operative visit (6 and 12 months) score will be presented. For Lysholm and IKDC, the 
numbers and proportions of subjects, together with a 95% confidence interval, meeting the 
minimal clinically important differences (MCID) from baseline to appropriate post-operative 
visit (those which have MCID thresholds available in published literature) will be presented. 
10.4.3 Analysis of Other Endpoint 
The following other endpoints will be analysed for this study: 
Reoperation rate and change from baseline PROs at 6 and 12 months will be presented 
separately by meniscal repair procedure (i.e. MR alone vs MR with ACL repair), location of the 

 
Clinical Protocol  
Study Number: FAST-FIX 
FLEX.2020.09 
A Prospective, Multi-center Clinical Study to Evaluate the Safety 
and Performance of the FAST-FIX FLEX System for Meniscal Repairs 
(MR) and Meniscal Allograft Transplantations (MAT) 
Version: 3.0, 05/May/2023 
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repair (posterior horn, body, anterior horn) and type of tear (bucket handle, longitudinal, 
horizontal, radial, complex); 
Healing status at 6 months & 12 months by repair procedure, location of tear and tear type;  
Surgical technique details (curvature of the distal needle: bender tool used vs bender tool not 
used);  
Procedural details for MR (S+N instruments used with FAST-FIX FLEX) and MAT (hybrid vs 
non-hybrid approach and types of devices used with FAST-FIX FLEX); 
Analysis of the change in extrusion and joint space narrowing for meniscal allograft 
transplantations on MRI at baseline, 6 months and 12 months; 
Rate of mechanical symptoms as defined by PROs (Lysholm: section 3 & 4 and IKDC scores: 
question 6) and radiological evidence of repair failure at 6 months and 12 months. 
10.5 Safety Analyses 
All safety endpoints will be summarized using the safety population. 
 
Adverse Events 
The number of events and the number of subjects reporting events will be summarized by the 
following: adverse events, serious adverse events, adverse device effects, serious adverse device 
effects, unanticipated adverse events, and serious unanticipated adverse events. In addition, for each 
adverse event, the following will be summarized: severity, the relationship to the investigational 
device, outcome and duration of the resolved adverse events and the duration of the adverse events 
at trial discontinuation. 
 
 
 

 
Clinical Protocol  
Study Number: FAST-FIX 
FLEX.2020.09 
A Prospective, Multi-center Clinical Study to Evaluate the Safety 
and Performance of the FAST-FIX FLEX System for Meniscal Repairs 
(MR) and Meniscal Allograft Transplantations (MAT) 
Version: 3.0, 05/May/2023 
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Device deficiencies 
The number of device deficiencies and the number of patients reporting a device deficiency will be 
summarized. 
 
Additional summaries of safety endpoints, if applicable, will be described in the SAP. 
10.6 Interim Analyses 
There are no formal interim analyses planned for this study. 
11 SAMPLE SIZE JUSTIFICATION 
The sample size for this study is precision-based, and not based on statistical power considerations, 
thus no formal statistical hypothesis is formulated.  .  
The primary endpoint for the study upon which sample size is determined is meniscal repair success 
rate in the study device at 12 months. The publication upon which this is based, is the systematic 
literature 
Clinical performance of FAST-FIX family
Paul Souter (2022)39 
the repair success rate was reported to be 90% for all-inside meniscal repair. This recent systematic 
literature review provides sufficient evidence to increase the success rate from 85% (as defined in 
previous protocol version) to 90% for all-inside meniscal repair. For the full report please refer to 
appendix 22.10. 
Assuming an overall success rate of at least 90%, 45 subjects are sufficient to obtain at least 80% 
probability of estimating the two-sided 95% confidence interval around the success rate to within 
10%.  
Assuming a 15% drop out rate at the end of the 12 months, 53 subjects will be enrolled.  
Additionally, secondary endpoints in this study assess the success rate, meniscus healing and clinical 
performance of PROs for meniscal allograft transplantation (MAT). To have sufficient evidence to 

 
Clinical Protocol  
Study Number: FAST-FIX 
FLEX.2020.09 
A Prospective, Multi-center Clinical Study to Evaluate the Safety 
and Performance of the FAST-FIX FLEX System for Meniscal Repairs 
(MR) and Meniscal Allograft Transplantations (MAT) 
Version: 3.0, 05/May/2023 
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support European Medical Device Regulation (EU MDR) requirements, a minimum of 9 and maximum 
of 15 subjects will be recruited to provide sufficient evidence on this indication. Furthermore, internal 
evidence generated by the Smith+Nephew Research and Development (R&D) provides evidence that 
the procedural technique, device use, and resulting suture placement is identical for meniscus MR 
and MAT (see Appendix 22.11). It will be at the discretion of the Sponsor when enrolment to the MAT 
indication is completed (between 9 and 15 subjects). 
12 ADVERSE EVENTS AND DEVICE DEFICIENCIES 
12.1 Definitions (ISO 14155) 
The categories of adverse events are shown in table 12.1-1. The definitions for each of these 
categories are given in the subsequent sections. 
Table 12.1-1 Categories of Adverse Event 
NOT DEVICE-
RELATED 
DEVICE- OR PROCEDURE- RELATED 
Non-Serious  Adverse Event (AE) 
Adverse Device Effect (ADE) 
Serious 
Serious Adverse 
Event (SAE) 
Serious Adverse Device Effect 
(SADE) (See 12.1.3) 
Anticipated 
Unanticipated 
Anticipated Serious 
Adverse Device Effect 
(ASADE) 
Unanticipated Serious 
Adverse Device Effect 
(USADE) 

 
Clinical Protocol  
Study Number: FAST-FIX 
FLEX.2020.09 
A Prospective, Multi-center Clinical Study to Evaluate the Safety 
and Performance of the FAST-FIX FLEX System for Meniscal Repairs 
(MR) and Meniscal Allograft Transplantations (MAT) 
Version: 3.0, 05/May/2023 
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12.1.1 Adverse Event 
An Adverse Event (AE) is any untoward medical occurrence, unintended disease or injury or untoward 
clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or 
not related to the investigational medical device and whether anticipated or unanticipated.   
Note 1: This definition includes events related to the investigational medical device or the 
comparator.  
Note 2: This definition includes events related to the procedures involved.  
Note 3: For users or other persons, this definition is restricted to events related to the use of 
investigational medical devices. 
AE is used both to refer to AE which do not meet the definitions of Adverse Device Effects or Serious 
Adverse Events and as an umbrella term referring to adverse events of all classifications.  
An AE can be any unfavorable and unintended sign (for example, an abnormal laboratory finding), 
symptom, or disease. For reporting purposes, emphasis is placed first and foremost on whether or 
not the event constitutes an untoward medical occurrence. 
12.1.2 Adverse Device Effect 
An Adverse Device Effect (ADE) is an adverse event related to the use of an investigational medical 
device.  
Note 1: This definition includes adverse events resulting from insufficient or inadequate instructions 
for use, deployment, implantation, installation or operation, or any malfunction of the investigational 
medical device.  

 
Clinical Protocol  
Study Number: FAST-FIX 
FLEX.2020.09 
A Prospective, Multi-center Clinical Study to Evaluate the Safety 
and Performance of the FAST-FIX FLEX System for Meniscal Repairs 
(MR) and Meniscal Allograft Transplantations (MAT) 
Version: 3.0, 05/May/2023 
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Note 2: This definition includes any event resulting from use error or from intentional misuse of the 
investigational medical device.  
Note 3: This includes "comparator" if the comparator is a medical device. 
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 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, or DEFINITE relationship between the AE and the use of the IP or the procedure. 
An ADE is further categorized depending on whether the criteria in section 12.1.3 and 12.1.4 are 
met.
12.1.3 Related Serious Adverse Events and Serious Adverse Device 
Effects 
An AE or ADE is considered a Serious Adverse Event (SAE) or Serious Adverse Device Effects (SADE) 
if, it led to any of the following: 
a) death, 
b) serious deterioration in the health of the subject, users or other persons as defined by one or 
more of the following:  
1) a life-threatening illness or injury, or 
2) a permanent impairment of a body structure or a body function including chronic 
diseases, or 
3) in-patient or prolonged hospitalization, or 
4) medical or surgical intervention to prevent life-threatening illness or injury or permanent 
impairment to a body structure or a body function, 

 
Clinical Protocol  
Study Number: FAST-FIX 
FLEX.2020.09 
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c) foetal distress, foetal death or a congenital abnormality or birth defect including physical or 
mental impairment 
Note 1: Planned hospitalization for a pre-existing condition, or a procedure required by the study 
protocol, without serious deterioration in health, is not considered a serious adverse event. 
12.1.4 Anticipated/Unanticipated Serious Adverse Device Effect 
An Unanticipated Serious Adverse Device Effect (USADE) is a serious ADE which by its nature, 
incidence, severity or outcome has not been identified in the current version of the risk assessment. 
Note 1: Anticipated serious adverse device effect (ASADE) is an effect which by its nature, incidence, 
severity or outcome has been identified in the risk assessment (see Section 4.4 for details). 
12.1.5 Severity 
The severity of every AE will be assessed by the PI or medically qualified site staff to whom the 
responsibility has been delegated and documented on the delegation of authority log. AE should be 
classified as mild, moderate, or severe, regardless of whether or not the AE is 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 
 
Severe -  
inability to work or engage in their usual activities. 

 
Clinical Protocol  
Study Number: FAST-FIX 
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(MR) and Meniscal Allograft Transplantations (MAT) 
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12.1.6 Device Deficiency 
A Device Deficiency (DD) is an inadequacy of a medical device with respect to its identity, quality, 
durability, reliability, safety or performance. DD includes malfunctions, use errors and inadequate 
labeling.  
Note 1: DD includes malfunctions, use errors and inadequacy in the information supplied by the 
manufacturer including labelling.  
Note 2: This definition includes device deficiencies related to the investigational medical device or 
the comparator. 
Device deficiencies that did not lead to an adverse event but could have led to a medical occurrence 
a) if either suitable action had not been taken,  
b) if intervention had not been made, or  
c) if circumstances had been less fortunate,  
are considered Device Deficiencies with potential to cause SADE and shall be reported as specified in 
section 12.3. 
12.2 AE Coding Dictionary 
Coding for this study will be done per International Medical Device Regulators Forum (IMDRF) AE 
Terminology Annex E  Clinical signs, symptoms and conditions. 
12.3 Reporting procedures 
AE of any kind and DD will be recorded in the applicable CRF and source notes to include the date of 
occurrence, treatment and the details resolution. The Investigator will evaluate all AE for relationship 
to the device and procedure, seriousness, and severity (if applicable). DD will be evaluated for 

 
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potential to cause SADE.  The following timescales should be followed for the AE/DD information to 
be submitted/entered into the CRF and reported to the Sponsor or designee (see figure 12.2-1): 
ADE and DD  without unreasonable delay 
SAE, SADE and DD with potential to cause SADE  immediately (i.e. within 24 hours of the 
investigator being informed about the event) 
All other events  according to usual timescales 
In addition to inputting SAE and SADE information within 24 hours of being aware of the event, the 
investigator should email Clinical.safety@Smith-nephew.com to alert the safety representative of the 
events existence and to clarify details if necessary. 
For ADE and DD, date of occurrence, and 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 S+N unless it is contaminated. Updates to submitted information will be 
recorded in the CRF according to the timescales above. 
All adverse events 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 regulatory agency and IRB/IEC of adverse events as per the 
requirements listed below: -  
Unanticipated 
authorities within 10 working days. 
All other events will be reported on a periodic/annual basis. 
Depending on the nature of the adverse event, S+N 
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 S+N and should be forwarded as soon as it becomes available. In 

 
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certain cases, S+N also may request a letter from the Investigator that summarizes the events 
related to the case. Refer to the ISF Sponsor Contact Information Sheet to report SAE, 
unanticipated SADE, anticipated SADE, and DD. 
 
Figure 12.3-1: Evaluation and Reporting of AE
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
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 
IMMEDIATELY  
Record 
information in 
patient CRF 
according to 
usual 
timescales.
Complete CRF 
and alert S+N 
without 
unreasonable 
delay. 
Record 
details in 
subject s 
medical 
records
 
Figure 12.3-2: Evaluation and Reporting of Device Deficiencies 

 
Clinical Protocol  
Study Number: FAST-FIX 
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12.4 Unblinding of Investigational Product 
Not applicable.  
12.5 Follow-up of Subjects with Adverse Events 
For subjects who are experiencing 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 to determine the outcome of the event.  
Any additional data must be documented and available to the Sponsor who will determine whether 
the data need to be documented in the CRF/Clinical Study Report. 

 
Clinical Protocol  
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12.5.1 Ongoing Adverse Events at Study Discontinuation 
Adverse events which are related to a study procedure or S+N IP and are ongoing at the end of 
Adverse events which are not related to a study procedure or S+N IP and are ongoing at the end 
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. 
13 INVESTIGATOR OBLIGATIONS 
The Principal Investigator will comply with the commitments outlined in the in the Statement of 
Investigator, provided by the Sponsor, and with Good Clinical Practice (GCP), and all applicable 
regulatory requirements as outlined in Appendix 22.8 of this protocol. Sub-Investigators, who are 
individual member of the investigation site team designated and supervised by the Principal 
Investigator at an investigation site to perform clinical investigation-related procedures or to make 
important clinical investigation-related and medical treatment decisions, may have responsibilities 
delegated to them by the Principal Investigator. However, the Principal Investigator retains overall 
responsibility for the clinical investigation at the site. 
In addition, the PI will ensure that the Financial Disclosure Statements will be completed by the PI 
and the Sub-Investigator upon entry into the study and as any changes that affect their financial 
disclosure status occur during the course of the study and up to one year after study completion. 
The Coordinating Investigator appointed by the Sponsor will assist in coordinating the work in the 
multicentre clinical investigation. 

 
Clinical Protocol  
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14 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 
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 and 
amendment(s), if applicable, with GCP regulations, and with applicable regulatory requirements. 
Detailed monitoring requirements will be documented in the Clinical Monitoring Plan for this study.  
14.1 Site Qualification Visit 
A site qualification visit may be performed 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. 
14.2 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 CTA and documented IRB/IEC approval.  
14.3 Interim Monitoring Visit 
Regular interim monitoring visits will be performed by the Sponsor or qualified person designated by 
the Sponsor. 

 
Clinical Protocol  
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14.4 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.   
14.5 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.  When no subjects have been included, a remote 
close-out visit may be conducted.  
15 PROTOCOL DEVIATIONS 
An Investigator must not make any changes or deviate from this protocol, except to protect the life 
and physical well-being of a subject in an emergency. Protocol deviations reported by the Investigator 
or discovered during monitoring visits will be compiled in a Protocol / GCP Deviation Log (FRM-402046 
Protocol/GCP Deviation Log). Significant and/or recurrent protocol/GCP deviations will be 
documented on a protocol deviation form (FRM-400347 Protocol/GCP Deviation) including identified 
root cause and, as necessary, appropriate corrective and preventive actions will be put in place and 
signed off by the study personnel. If it is deemed necessary full clinical Corrective and Preventive 
Action (CAPA) will be initiated. 
It is not allowed to use waivers to allow planned deviation of the study protocol.  

 
Clinical Protocol  
Study Number: FAST-FIX 
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An investigator may be early terminated from the study upon identification of serious protocol 
deviations whereby there are concerns for patient safety or data quality (especially those not reported 
to the sponsor by the site). Early termination may also occur if there are repeated protocol deviations 
which have previously been addressed via corrective and preventative actions thereby suggesting an 
issue with site compliance. 
Protocol deviations requiring reporting to the IRB/IEC should be done so in the timeframe stipulated 
by the IRB/IEC. 
16 PROTOCOL AMENDMENTS 
Amendments should be made only in necessary cases once the study has started. Protocol 
amendments must be approved by the protocol signatories prior to submission to the IRB/IEC. 
Protocol amendments need to be approved by the IRB/IEC and Regulatory Authority(ies), according 
to the applicable requirements prior to implementation at the site. 
17 CONFIDENTIALITY OF THE STUDY 
The confidentiality of this study and associated documents is governed by the terms of the Clinical 
Trial Agreement (CTA). 
18 STATEMENTS OF COMPLIANCE 
This clinical study will be performed in compliance with the ethical principles of the Declaration of 
Helsinki; and ISO 14155: Clinical investigation of medical devices  Good Clinical Practice. 
This clinical study will not commence until the required approval/favorable opinion from the IRB/IEC 
or regulatory authority has been obtained. Any additional requirements imposed by the IRB/IEC or 
regulatory authority will be followed.  

 
Clinical Protocol  
Study Number: FAST-FIX 
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(MR) and Meniscal Allograft Transplantations (MAT) 
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Public/Products Liability Insurance has been purchased by Smith & Nephew plc. Worldwide and 
incorporates coverage for personal injury in respect of clinical studies. The Sponsor agrees to operate 
in good faith and in accordance with ABHI (Association of British Healthcare Industries) guidelines 
regarding compensation for injury arising in the course of clinical studies. 
The clinical study is financed by the sponsor. All financial arrangements between the sponsor and 
investigation sites/investigators are documented separate clinical trial agreements. 
19 END OF STUDY 
The end of study is defined as last subject last visit. 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 SOPs of the Sponsor. 
The requirement for subject follow up in these instances will be considered as part of these processes. 
This study may be temporarily suspended or prematurely terminated if there is sufficient reasonable 
cause. Written notification, documenting the reason for study suspension or termination, will be 
provided by the suspending or terminating party to other parties (Investigator, IRB/IEC, Sponsor 
and regulatory authorities). If the study is prematurely terminated or suspended, the Investigator 
will promptly inform the IRB/IEC and the study sites, and will provide the reason(s) for the 
termination or suspension. Circumstances that may warrant termination or suspension include, but 
are not limited to: 
Determination of unexpected, significant or unacceptable risk to participants 
Demonstration of efficacy that would warrant stopping 
Insufficient compliance with study protocol requirements 
Data that are not sufficiently complete and/or evaluable 
Determination of futility 

 
Clinical Protocol  
Study Number: FAST-FIX 
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The study may resume once concerns about safety, study protocol compliance, and data quality are 
addressed and satisfy the Sponsor and IRB/IEC. 
A specific study site in this multi-center study may also warrant termination under the following 
conditions: 
Non-compliance to GCP or protocol 
Failure to enroll subjects 
Major protocol deviations 
Inaccurate or incomplete data 
Unsafe or unethical practices 
Safety or performance considerations 
Investigator involuntarily discontinues participation in study 
20 PUBLICATION POLICY 
20.1 Publication of Study Data 
The study will be registered in a publicly accessible database and the results will be made available 
within that database. 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. 
20.2 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 

 
Clinical Protocol  
Study Number: FAST-FIX 
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A Prospective, Multi-center Clinical Study to Evaluate the Safety 
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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 begin nine 
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 datasharing.gcs@smith-nephew.com. 
To gain access, data requestors will need to sign a data access agreement. 
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Study Number: FAST-FIX 
FLEX.2020.09 
A Prospective, Multi-center Clinical Study to Evaluate the Safety 
and Performance of the FAST-FIX FLEX System for Meniscal Repairs 
(MR) and Meniscal Allograft Transplantations (MAT) 
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27.Kalliakmanis A, Zourntos S, Bousgas D, Nikolaou P. Comparison of arthroscopic meniscal 
repair results using 3 different meniscal repair devices in anterior cruciate ligament 
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28.Haas AL, Schepsis AA, Hornstein J, Edgar CM. Meniscal repair using the FasT-Fix all-inside 
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31.Kamimura T, Kimura M. Meniscal Repair of Degenerative Horizontal Cleavage Tears Using 
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32.Furumatsu T, Miyazawa S, Tanaka T, Okada Y, Fujii M, Ozaki T. Postoperative change in medial 
meniscal length in concurrent all-inside meniscus repair with anterior cruciate ligament 
reconstruction. Int Orthop. 2014;38(7):1393-1399. 
33.Terai S, Hashimoto Y, Yamasaki S, Takahashi S, Shimada N, Nakamura H. Prevalence, 
development, and factors associated with cyst formation after meniscal repair with the all-
inside suture device. Arch Orthop Trauma Surg. 2019;139(9):1261-1268. 
34.Hirtler L, Unger J, Weninger P. Acute and chronic menisco-capsular separation in the young 
athlete: diagnosis, treatment and results in thirty seven consecutive patients. Int Orthop. 
2015;39(5):967-974. 
35.Laurendon L, Neri T, Farizon F, Philippot R. Prognostic factors for all-inside meniscal repair. A 
87-case series. Orthopaedics & traumatology, surgery & research : OTSR. 2017;103(7):1017-
1020. 
36.Gelber PE, Petrica AM, Isart A, Mari-Molina R, Monllau JC. The magnetic resonance aspect of 
a polyurethane meniscal scaffold is worse in advanced cartilage defects without deterioration 
of clinical outcomes after a minimum two-year follow-up. Knee. 2015. 

 
Clinical Protocol  
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37.Gelber PE, Isart A, Erquicia JI, Pelfort X, Tey-Pons M, Monllau JC. Partial meniscus substitution 
with a polyurethane scaffold does not improve outcome after an open-wedge high tibial 
osteotomy. Knee surgery, sports traumatology, arthroscopy : official journal of the ESSKA. 
2014. 
38. Alentorn-Geli E, Seijas Vazquez R, Garcia Balletbo M, et al. Arthroscopic meniscal allograft 
transplantation without bone plugs. Knee surgery, sports traumatology, arthroscopy : official 
journal of the ESSKA. 2011;19(2):174-182. 
39.Souter, P. Clinical performance of FAST-FIX family. 2022 p. 1-24. 
40.Clopper, CJ, Pearson ES. In: Biometrika. The use of confidence or fiducial limits illustrated in 
the case of the binomial. 1934, 26 p. 404 413. 
41.McCormick F, Harris JD, Abrams GD, Hussey KE, Wilson H, Frank R, Gupta AK, Bach BR Jr, 
Cole BJ. Survival and reoperation rates after meniscal allograft transplantation: analysis of 
failures for 172 consecutive transplants at a minimum 2-year follow-up. Am J Sports Med. 
2014 Apr;42(4):892-7. doi: 10.1177/0363546513520115. Epub 2014 Feb 14. PMID: 
24532597. 
42.Taichman, DB, et al. Data Sharing Statements for Clinical Trials: A Requirement of the 
International Committee of Medical Journal Editors. Ann Intern Med. 2017. 6th June. 
doi:10.7326/M17-1028 
43.MRI [Internet]. Mayo Clinic [updated 2019 Aug 3, cited 2020 Feb 6] Available from: 
https://www.mayoclinic.org/tests-procedures/mri/about/pac-20384768 
44.
[Internet]. Arthritis Care Res; 
2011 Nov [cited 2020 Feb 6] Available from: 
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4336550/ 
45.Van Meer BL, Reijman M, et al. [Internet]. In: The Anterior Cruciate Ligament (Second 
Edition). A Comparison of the Standardized Rating Forms for Evaluation of Anterior Cruciate 
Ligament Injured or Reconstructed Patients. 2018. [updated 2020, cited 2020 Feb 6]. 
Available from: https://www.sciencedirect.com/book/9780323389624/the-anterior-cruciate-
ligament 
46.Barber-Westin SD, Noyes FR. [Internet]. In: 
Clinical Outcomes (Second Edition). Rating of Athletic and Daily Functional Activities. 2017. 
[updated 
2020, 
cited 
2020 
Feb 
6]. 
Available 
from: 
https://www.sciencedirect.com/book/9780323329033/noyes-knee-disorders-surgery-
rehabilitation-clinical-outcomes 
47.EQ-5D-5L / About [Internet]. EuroQol [updated 2020, cited 2020 February 26] Available from: 
https://euroqol.org/eq-5d-instruments/eq-5d-5l-about/ 
 

 
Clinical Protocol  
Study Number: FAST-FIX 
FLEX.2020.09 
A Prospective, Multi-center Clinical Study to Evaluate the Safety 
and Performance of the FAST-FIX FLEX System for Meniscal Repairs 
(MR) and Meniscal Allograft Transplantations (MAT) 
Version: 3.0, 05/May/2023 
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22 APPENDICES 
22.1 Protocol Amendment 1 
22.1.1 General Purpose 
This protocol amendment has been completed to document the following changes:  
1. Clarification and update to the Inclusion/Exclusion criteria for the MAT indication. 
2. Removal of the date of ISO 14155 throughout the document. 
3. Additional text specifying the FAST-FIX FLEX device registration approvals to fulfil the request 
made by the Australian Ethics Committee. 
22.1.2 Rationale 
Rationale 1: The majority of patients who require a meniscal allograft transplantation should have 
previously had a meniscectomy prior to the procedure. Therefore, minor clarifications were made to 
the specific MAT inclusion criteria and to number 9 of the exclusion criteria to allow prior knee surgery 
for the MAT indication. The changes were made before recruiting any patients for this clinical 
indication. 
 
Rationale 2: Reference to date of ISO 14155 removed throughout the text to align with the latest 
revision of the protocol template, D.1. 
 
Rationale 3: Additional text specifying the FAST-FIX FLEX device registration approvals was added 
to the product section to address the request from the Australian Ethics Committee.    
22.1.3 Effect on Study Status 
Not applicable; this amendment is to be in effect and implemented prior to subject enrollment to 
the MAT indication.  
 

 
Clinical Protocol  
Study Number: FAST-FIX 
FLEX.2020.09 
A Prospective, Multi-center Clinical Study to Evaluate the Safety 
and Performance of the FAST-FIX FLEX System for Meniscal Repairs 
(MR) and Meniscal Allograft Transplantations (MAT) 
Version: 3.0, 05/May/2023 
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22.1.4 Details 
Section 
Current Text 28/Apr/2021 
Version 1 
Revised Text 23/Nov/2021  
Version 2 
Footer  
TMP-CD-05-01 Clinical Protocol - 
Device  Revision D; SOP-CD-05 
Clinical Protocol 
TMP-CD-05-01 Clinical Protocol - 
Device  Revision D.1; SOP-CD-05 
Clinical Protocol 
2 Synopsis 
 
Inclusion Criteria 
(rationale 1) 
Subject requires a MAT for 
symptomatic meniscal 
insufficiency (load-related pain 
and swelling in the compartment 
undergoing meniscectomy) for 
which conservative treatment has 
failed. 
Subject requires a MAT for 
symptomatic meniscal insufficiency 
(load-related pain and swelling in the 
compartment post meniscectomy) for 
which conservative treatment has 
failed. 
2 Synopsis 
Exclusion Criteria 
(rationale 1) 
9. History of ipsilateral knee 
surgery, septic joint, or 
fracture. 
9. History of ipsilateral knee surgery, 
septic joint, or fracture (excluding 
MAT indication). 
Throughout the 
protocol 
(rationale 2) 
 
ISO/DIS 14155:2011  
 
14155:2020 
DIS and date removed.  
6.3.1 Labelling of 
Investigational Product
(rationale 3) 
The FAST-FIX FLEX Meniscal 
Repair System has received 
510(k) clearance in the United 
States. 
The FAST-FIX FLEX Meniscal Repair 
System has received 510(k) clearance 
in the United States, CE marking in 
Europe, Australian Register of 
Therapeutic Goods (ARTG) approval in 
Australia and is commercially available 
on the market. 
7.2 Inclusion Criteria 
(rationale 1) 
7. Subject requires a MAT for 
symptomatic meniscal 
insufficiency (load-related pain 
and swelling in the 
compartment undergoing 
meniscectomy) for which 
conservative treatment has 
failed. 
7. Subject requires a MAT for 
symptomatic meniscal insufficiency 
(load-related pain and swelling in 
the compartment post 
meniscectomy) for which 
conservative treatment has failed. 
7.3 Exclusion Criteria 
(rationale 1) 
9. Subjects with a history of 
ipsilateral knee surgery, septic 
joint, or fracture. 
9. Subjects with a history of ipsilateral 
knee surgery, septic joint, or 
fracture (excluding MAT indication). 

 
Clinical Protocol  
Study Number: FAST-FIX 
FLEX.2020.09 
A Prospective, Multi-center Clinical Study to Evaluate the Safety 
and Performance of the FAST-FIX FLEX System for Meniscal Repairs 
(MR) and Meniscal Allograft Transplantations (MAT) 
Version: 3.0, 05/May/2023 
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TMP-800052 Clinical Protocol - Device  Revision 4; PRO-201725 Clinical Protocols 
 
 
22.1.5 Approval/Notification 
The changes and recruitment of subjects to the MAT indication will only be implemented following 
IRB/IEC approval. 
22.2  Protocol Amendment 2 
22.2.1 General Purpose 
This protocol amendment has been completed to document the following changes:  
1. Refinement of the Inclusion/Exclusion criteria for the MR and MAT indications.  
2. Addition of the FAST-FIX FLEX slim packs (SKUs: 72205676 and 72205677).  
3. Removed accountability procedures for the Investigational Product which was included in error. 
4. Updated the 3 months follow-up visit window to 3 months +30 days rather than +/- 14 days.
5. Reduction of the MR and MAT sample size.  
6. Addition of the informed consent / assent and screening process for minors 
7. General correction of typographical and formatting errors, administrative changes 
8. Added new sections and information required in S+N protocols 
9. Remove Germany as a participating country 
10. Increased study duration and enrollment timelines 
11.Updated the 6 months follow-up visit window to 6 months +/- 45 days rather than +/- 30 
days. 
12.Updated the 12 months follow-up visit window to 12 months +/- 75 days rather than +/- 60 
days. 
22.2.2 Rationale 
Rationale 1: Closer alignment of the Inclusion/Exclusion criteria for the MR and MAT indications with 
the IFU and improve generalizability. Site PIs also provided feedback and recommendations on this 

 
Clinical Protocol  
Study Number: FAST-FIX 
FLEX.2020.09 
A Prospective, Multi-center Clinical Study to Evaluate the Safety 
and Performance of the FAST-FIX FLEX System for Meniscal Repairs 
(MR) and Meniscal Allograft Transplantations (MAT) 
Version: 3.0, 05/May/2023 
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TMP-800052 Clinical Protocol - Device  Revision 4; PRO-201725 Clinical Protocols 
refinement based on screen fail information and their patient population. The MR and MAT 
Inclusion/Exclusion criteria has been separated for ease of reading following site feedback. 
Rationale 2: The slim packs may also be used by investigators in this study. These are a more 
environmentally friendly version of the FAST-FIX FLEX Meniscal Repair System. 
 
Rationale 3: No accountability procedures are required for this post-market clinical follow-up study 
(as per S+N SOPs). 
 
Rationale 4: The lifetime of the device is 12 weeks (i.e. 3 months) and therefore the 3 months 
follow-up visit window has been adjusted to ensure that data is captured at a minimum of 3 
months. There is greater flexibility beyond 3 months (+30 days) to remove the possibility of data 
being captured prior to 3 months (+/- 14 days). 
 
Rationale 5: A new systematic literature review has provided evidence that the device has a 
greater success rate than originally included in the protocol, therefore the sample size calculation 
has been adjusted for the MR indication, thus reducing the sample size. The MAT indication had no 
formal sample size calculation and S+N are engaging in additional retrospective clinical activities to 
provide evidence for the MAT indication outside of this PMCF study. S+N Research and 
Development have also confirmed that data collected for the MR indication can be used to support 
use of the device in the niche MAT indication, given that the device
performance does not differ by indication (see Appendix 22.11). Therefore, the sample size for the 
MAT indication has been reduced and the study will aim to recruit a minimum of 9 and maximum of 
15 MAT subjects. 
 
Rationale 6: To provide guidance regarding the informed consent / assent and screening 
procedures for subjects aged 16 and 17 years of age given this addition to the Inclusion criteria, 
and ensure compliance with the relevant regulations. 
 

 
Clinical Protocol  
Study Number: FAST-FIX 
FLEX.2020.09 
A Prospective, Multi-center Clinical Study to Evaluate the Safety 
and Performance of the FAST-FIX FLEX System for Meniscal Repairs 
(MR) and Meniscal Allograft Transplantations (MAT) 
Version: 3.0, 05/May/2023 
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TMP-800052 Clinical Protocol - Device  Revision 4; PRO-201725 Clinical Protocols 
Rationale 7: Improve readability and understanding of the protocol, remove inconsistencies and 
ambiguity, changes in staff, update version numbers and dates based on new document version. 
 
Rationale 8: A new version of the S+N template protocol has been released, therefore some minor 
changes have been made to ensure compliance with the latest protocol template (TMP-800052, 
Revision 4). 
 
Rationale 9: Germany can no longer participate due to competent authority requirements and 
consideration for the estimated study end date. 
 
Rationale 10: Recruitment has been slower than anticipated, particularly due to the restricted 
Inclusion/Exclusion criteria. As such, an additional 12 months for study enrollment and overall 
duration of the study has been included.  
 
Rationale 11 and 12: To improve follow-up visit window compliance and completion of these visits. 
22.2.3 Effect on Study Status 
There is no anticipated impact on the data already collected from subjects enrolled in this 
study prior to this amendment, including how their data will be analyzed. 
The reconsent of enrolled subjects (who have not completed the study) will be considered 
and obtained where deemed appropriate, however it is not anticipated that reconsent will be 
required based on this amendment.  
Any previously enrolled subjects that are due to attend the 3-month, 6-month or 12-month 
follow-up visits will attend as per the updated visit windows, following implementation of this 
amendment. 
The Case Report Form (CRF) will be updated for new subjects enrolled in the study following 
implementation of and in accordance with this protocol amendment. For previously enrolled 
subjects, data collected following implementation of this protocol amendment will be 

 
Clinical Protocol  
Study Number: FAST-FIX 
FLEX.2020.09 
A Prospective, Multi-center Clinical Study to Evaluate the Safety 
and Performance of the FAST-FIX FLEX System for Meniscal Repairs 
(MR) and Meniscal Allograft Transplantations (MAT) 
Version: 3.0, 05/May/2023 
Page: 88 of 151   
 
 
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TMP-800052 Clinical Protocol - Device  Revision 4; PRO-201725 Clinical Protocols 
captured using the updated CRF and data already collected will remain on the superseded 
CRF version.  
At the time of this amendment, the approximate number of active subjects is 35, 3 subjects 
are withdrawn and the number of completed subjects is 5.  
 
 

 
 
Clinical Protocol  
Study Number: FAST-FIX 
FLEX.2020.09 
A Prospective, Multi-center Clinical Study to Evaluate the Safety 
and Performance of the FAST-FIX FLEX System for Meniscal Repairs 
(MR) and Meniscal Allograft Transplantations (MAT) 
Version: 3.0, 05/May/2023 
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22.2.4 Details 
Section 
 
Current Text 23/Nov/2021 Version 2 
Revised Text 05/May/2023 Version 3 
Header 
(Rationale 7)
A Prospective, Multi-center Clinical Study to Evaluate 
the Safety and Performance of the FAST-FIX FLEX 
System for Meniscal Repairs 
(MR) and Meniscal Allograft Transplantations (MAT) 
Study Number: FAST-FIX 
FLEX.2020.09 
Version: 1.0, 28/Apr/2021 
A Prospective, Multi-center Clinical Study to Evaluate the 
Safety and Performance of the FAST-FIX FLEX System for 
Meniscal Repairs 
(MR) and Meniscal Allograft Transplantations (MAT) 
Study Number: FAST-FIX 
FLEX.2020.09 
Version: 3.0, 05/May/2023 
Footer 
(Rationale 7)
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 
D; SOP-CD-05 Clinical Protocols 
CONFIDENTIAL AND PROPRIETARY 
TMP-800052 Clinical Protocol - Device  Revision 4; PRO-
201725 Clinical Protocols 

 
 
Clinical Protocol  
Study Number: FAST-FIX 
FLEX.2020.09 
A Prospective, Multi-center Clinical Study to Evaluate the Safety 
and Performance of the FAST-FIX FLEX System for Meniscal Repairs 
(MR) and Meniscal Allograft Transplantations (MAT) 
Version: 3.0, 05/May/2023 
Page: 90 of 151   
 
 
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TMP-800052 Clinical Protocol - Device  Revision 4; PRO-201725 Clinical Protocols 
Front Page 
(Rationale 8)
N/A 
Summary of Revision History 
 
Version 2.0, 23 Nov 2021 
Version 1.0, 28 Apr 2021 
1.1 
(Rationale 7)
2.0, dated 23/Nov/2021 
Section 22.7 
 
3.0, dated 05/May/2023 
Section 22.8 
1.2 
(Rationale 7)
2.0, dated 23/Nov/2021 
A Prospective, Multi-center Clinical Study
 
3.0, dated 05/May/2023 
A Prospective, Multi-center Clinical Study
 
1.3 
(Rationale 7)
Stephan Mangin  
Director of GCS Sports 
Medicine and ENT  
Head of Global Clinical Strategy 
 
Alan Rossington 
Senior Director, Global Data Analytics  
(Head of Global Data Analytics) 
 
Lori Fontaine  
VP, Global Clinical Strategy - Orthopaedics, Sports Med & 
ENT 
(Global Clinical Strategy Franchise Head or Representative) 
 
Jay Jantz 
Senior Director, Global Data Analytics  
(Head of Global Data Analytics) 
 
Sam Timson 
Senior Clinical Compliance and Training Specialist 
(Clinical Compliance and Training/Clinical Quality Assurance) 
2  
(Rationale 8)
N/A 
Sponsor and Funding Source 
Smith & Nephew Inc, 1450 E. Brooks Road, Memphis, 
Tennessee 38116, USA   
2  
(Rationale 5)
Sample Size: A total of 130 subjects will be enrolled 
into the study: 
 
97 MR subjects 
Sample Size: A minimum of 62 and maximum of 68 subjects 
will be enrolled into the study:  
 
53 MR subjects 

 
 
Clinical Protocol  
Study Number: FAST-FIX 
FLEX.2020.09 
A Prospective, Multi-center Clinical Study to Evaluate the Safety 
and Performance of the FAST-FIX FLEX System for Meniscal Repairs 
(MR) and Meniscal Allograft Transplantations (MAT) 
Version: 3.0, 05/May/2023 
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TMP-800052 Clinical Protocol - Device  Revision 4; PRO-201725 Clinical Protocols 
 
33 MAT subjects 
The sample size for this study is precision-based and 
not based on 
statistical power considerations. Thus, no formal 
statistical hypothesis is 
formulated. The sample size for this study is 
determined based on the feasibility of recruitment, 
enrolment and follow-up considerations.  
is determined is 
meniscal repair success rate in the study device at 12 
months. The publication upon which this is based, is 
the systematic review entitled: 
-inside meniscal repair. An 
87-
 authored by Laurendon et al. (2017) 
the repair success rate was reported 
to be 85% for all-inside meniscal repair. 
Assuming an overall success rate of at least 85%, 82 
subjects are 
sufficient to obtain at least 99% probability of 
estimating the two-sided 95% confidence interval 
around the success rate to within 10%. 
Additionally, secondary endpoints in this study assess 
success rate, 
meniscus healing and clinical performance of PROs for 
meniscal allograft transplantation (MAT). To satisfy 
European Medical Device Regulation (EU MDR) 
requirements, 30 subjects will be recruited to provide 
sufficient evidence on this indication. 
 
A minimum of 9 and maximum of 15 MAT subjects 
The sample size for this study is precision-based and not 
based on statistical power considerations. Thus, no formal 
statistical hypothesis is formulated.  The sample size for this 
study is determined based on the feasibility of recruitment, 
enrolment and follow-up considerations.  
determined is meniscal repair success rate in the study 
device at 12 months. The publication upon which this is 
performance of FAST-
(2022) the repair success rate was reported to be 90% for 
all-inside meniscal repair. This recent systematic literature 
review provides sufficient evidence to increase the success 
rate from 85% (as defined in previous protocol version) to 
90% for all-inside meniscal repair. For the full report please 
refer to appendix 22.10. 
Assuming an overall success rate of at least 90%, 45 
subjects are sufficient to obtain at least 80% probability of 
estimating the two-sided 95% confidence interval around the 
success rate to within 10%.  
Assuming a 15% drop out rate at the end of the 12 months, 
53 MR subjects will be enrolled.    
Additionally, secondary endpoints in this study assess 
success rate, meniscus healing and clinical performance of 
PROs for meniscal allograft transplantation (MAT). To have 
sufficient evidence to support European Medical Device 
Regulation (EU MDR) requirements, a minimum of 9 and 
maximum of 15 subjects will be recruited to provide 

 
 
Clinical Protocol  
Study Number: FAST-FIX 
FLEX.2020.09 
A Prospective, Multi-center Clinical Study to Evaluate the Safety 
and Performance of the FAST-FIX FLEX System for Meniscal Repairs 
(MR) and Meniscal Allograft Transplantations (MAT) 
Version: 3.0, 05/May/2023 
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TMP-800052 Clinical Protocol - Device  Revision 4; PRO-201725 Clinical Protocols 
Assuming a 15% drop-out rate at the end of 12 
months, 130 subjects will be enrolled in order to 
complete 82 evaluable subjects for MR and 30 
evaluable subjects for MAT. 
sufficient evidence on this indication.  Furthermore, internal 
evidence generated by the Smith+Nephew Research and 
Development (R&D) provides evidence that the procedural 
technique, device use, and resulting suture placement is 
identical for meniscus MR and MAT (see Appendix 22.11). It 
will be at the discretion of the Sponsor when enrolment to 
the MAT indication is completed (between 9 and 15 
subjects). 
 
2  
(Rationale 9)
Number of Study Sites: Up to 6 sites 
Number of Study Sites: Up to 5 sites 
2  
(Rationale 9)
Targeted Global Regions: United States, United 
Kingdom, Germany, France and Australia 
Targeted Global Regions: United States, United Kingdom, 
France and Australia 
2  
(Rationale 1 
and 7) 
Inclusion Criteria: 
1. Subject provides written informed consent for study 
participation using an independent ethical committee 
(IEC) / institutional review 
board (IRB) approved consent form; 
2. Subject is between eighteen (18) and seventy (70) 
years of age, inclusive at the time of screening; 
3. Subject is willing and able to participate in required 
follow-up visits and is able to complete study 
activities; 
4. Subject requires a meniscal repair or meniscal 
allograft 
transplantation; 
Meniscal Repair Inclusion Criteria:  
1. Subject provides written informed consent for study 
participation using an independent ethical committee 
(IEC) / institutional review board (IRB) approved consent 
form; 
2. Subject is between sixteen (16) and seventy (70) 
years of age, inclusive at the time of screening; 
3. Subject is willing and able to participate in required 
follow-up visits and is able to complete study activities; 
4. Subject requires a meniscal repair;  
5. Subject is suitable to participate in the study in the 
opinion of the Investigator. 
6. Subject requires a meniscus repair concerning the red-
red or red-white zones for acute or chronic 1-, 2- or 3-

 
 
Clinical Protocol  
Study Number: FAST-FIX 
FLEX.2020.09 
A Prospective, Multi-center Clinical Study to Evaluate the Safety 
and Performance of the FAST-FIX FLEX System for Meniscal Repairs 
(MR) and Meniscal Allograft Transplantations (MAT) 
Version: 3.0, 05/May/2023 
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TMP-800052 Clinical Protocol - Device  Revision 4; PRO-201725 Clinical Protocols 
5. Subject is suitable to participate in the study in the 
opinion of the Investigator. 
Meniscal Repair ONLY: 
1. Subject requires a meniscus repair concerning the 
red-red or red-white zones for acute or chronic 1-, 2- 
or 3-segment lesions, with or without associated 
anterior cruciate ligament (ACL) reconstruction. 
 
Meniscal Allograft Transplantation ONLY: 
1. Subject requires a MAT for symptomatic meniscal 
insufficiency (load-related 
pain and swelling in the compartment post 
meniscectomy) for 
which conservative treatment has failed. 
segment lesions, with or without associated anterior 
cruciate ligament (ACL) reconstruction. 
 
Meniscal Allograft Transplantation Inclusion Criteria: 
1. Subject provides written informed consent for study 
participation using an independent ethical committee 
(IEC) / institutional review board (IRB) approved consent 
form; 
2. Subject is between sixteen (16) and seventy (70) 
years of age, inclusive at the time of screening; 
3. Subject is willing and able to participate in required 
follow-up visits and is able to complete study activities; 
4. Subject requires a meniscal allograft transplantation;  
5. Subject is suitable to participate in the study in the 
opinion of the Investigator. 
6. Subject requires a MAT for symptomatic meniscal 
insufficiency (load-related pain and swelling in the 
compartment post meniscectomy) for which conservative 
treatment has failed, with or without cartilage repair or 
restoration (including ACL reconstruction or repair). 
2  
(Rationale 1,
7 and 8) 
Exclusion Criteria: 
1. Contraindications (per the FAST-FIX FLEX IFU) or 
hypersensitivity to the use of the FAST-FIX FLEX 
implant material. Where material sensitivity is 
suspected, appropriate tests should be made and 
sensitivity ruled out prior to implantation; 
Meniscal Repair Exclusion Criteria: 
1. Contraindications (per the FAST-FIX FLEX IFU) or 
hypersensitivity to the use of the FAST-FIX FLEX implant 
material. Where material sensitivity is suspected, 
appropriate tests should be made and sensitivity ruled out 
prior to implantation; 

 
 
Clinical Protocol  
Study Number: FAST-FIX 
FLEX.2020.09 
A Prospective, Multi-center Clinical Study to Evaluate the Safety 
and Performance of the FAST-FIX FLEX System for Meniscal Repairs 
(MR) and Meniscal Allograft Transplantations (MAT) 
Version: 3.0, 05/May/2023 
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TMP-800052 Clinical Protocol - Device  Revision 4; PRO-201725 Clinical Protocols 
2. Participation in the treatment period of another 
clinical trial within thirty (30) days of operative visit, 
or during the study; 
3. Women who are pregnant, nursing, or of child-
bearing potential whoare not utilizing highly effective 
birth control measures; 
4. Any subject that meets the definition of a 
Vulnerable Subject per ISO 14155 Section 3.44; 
5. Subjects with a history of poor compliance with 
medical treatment, physical therapy 
(PT)/rehabilitation, or clinical study participation; 
6. Patients with irreparable meniscal tears (i.e. grade 
3 outerbridge osteoarthritis or greater, serious 
defects, multiple tears); 
7. Patients with multi-ligament tears (i.e. ACL tear is 
not associated with lateral collateral ligament (LCL) or 
medial collateral ligament (MCL) tears); 
8. Performance of a significant concomitant 
procedure, specifically a cartilage repair or restoration 
(excluding ACL reconstruction or repair) intended as a 
therapeutic intervention on the study knee; 
9. History of ipsilateral knee surgery, septic joint, or 
fracture (excluding MAT indication); 
10.Pathological conditions in the soft tissue that would 
prevent secure fixation of the device; 
11.Physical conditions which would eliminate, or tend 
to eliminate, adequate anchor support or retard 
healing; 
2. Enrolled in the treatment period of another clinical trial 
within thirty (30) days of operative visit, or during the 
study; 
3. Women who are pregnant or nursing; 
4. Any subject that meets the definition of a Vulnerable 
Subject per ISO 14155 Section 3.55 (except for subjects 
aged sixteen (16) or seventeen (17) years of age with 
consent from their legally authorized representative); 
5. Subjects with a history of poor compliance with 
medical treatment, physical therapy (PT)/rehabilitation, 
or clinical study participation; 
6. Patients with irreparable meniscal tears (i.e. multiple 
tears);  
7. Subjects with full thickness cartilage defects greater 
than 10mm in diameter and/or serious defects;   
8. Patients with concomitant ligament injuries that do not 
require surgical repair (i.e. ACL with Grade 3 lateral 
collateral ligament (LCL) injury or medial collateral 
ligament (MCL) injury); 
9. Performance of a significant concomitant procedure, 
specifically a cartilage repair or restoration (excluding ACL 
reconstruction or repair, lateral extra-articular tenodesis, 
anterolateral ligament (ALL) reconstruction) intended as a 
therapeutic intervention on the study knee; 
10. History of ipsilateral knee surgery, septic joint, or 
fracture;  
11. Pathological conditions in the soft tissue that would 
prevent secure fixation of the device; 

 
 
Clinical Protocol  
Study Number: FAST-FIX 
FLEX.2020.09 
A Prospective, Multi-center Clinical Study to Evaluate the Safety 
and Performance of the FAST-FIX FLEX System for Meniscal Repairs 
(MR) and Meniscal Allograft Transplantations (MAT) 
Version: 3.0, 05/May/2023 
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12.The presence of infection; 13.Conditions which 
 
restrict activities or follow directions during the 
healing period; 
14.Malalignment: genu varus and genu valgus angles 
greater than 5° with respect to the normal axis to 
indicate malalignment; 
15.Patients who had an Ahlback grade greater than 
II; 
16.Patients with a body mass index larger than 30; 
12. Physical conditions which would eliminate, or tend to 
eliminate, adequate anchor support or retard healing; 
13. The presence of infection; 
14. 
willingness to restrict activities or follow directions during 
the healing period; 
15. Malalignment: genu varus and genu valgus angles 
greater than 5° 
per their standard of care;  
16. Patients who have an Ahlback grade greater than II;  
17. Patients with a body mass index larger than 35; 
18. Subjects with a medical or physical condition that, in 
the opinion of the Investigator, would preclude safe 
subject participation in the study. 
 
Meniscal Allograft Transplantation Exclusion Criteria: 
1. Contraindications (per the FAST-FIX FLEX IFU) or 
hypersensitivity to the use of the FAST-FIX FLEX implant 
material. Where material sensitivity is suspected, 
appropriate tests should be made and sensitivity ruled out 
prior to implantation; 
2. Enrolled in the treatment period of another clinical trial 
within thirty (30) days of operative visit, or during the 
study; 
3. Women who are pregnant or nursing; 
4. Any subject that meets the definition of a Vulnerable 
Subject per ISO 14155 Section 3.55 (except for subjects 
aged sixteen (16) or seventeen (17) years of age with 
consent from their legally authorized representative); 

 
 
Clinical Protocol  
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5. Subjects with a history of poor compliance with 
medical treatment, physical therapy (PT)/rehabilitation, 
or clinical study participation; 
6. Patients with concomitant ligament injuries that do not 
require surgical repair (i.e. ACL with Grade 3 lateral 
collateral ligament (LCL) injury or medial collateral 
ligament (MCL) injury); 
7. Performance of a significant concomitant procedure 
(excluding ACL reconstruction or repair, lateral extra-
articular tenodesis, anterolateral ligament (ALL) 
reconstruction) intended as a therapeutic intervention on 
the study knee; 
8. History of ipsilateral knee surgery, septic joint, or 
fracture (excluding MAT indication);  
9. Pathological conditions in the soft tissue that would 
prevent secure fixation of the device; 
10. Physical conditions which would eliminate, or tend to 
eliminate, adequate anchor support or retard healing; 
11. The presence of infection; 
12. 
willingness to restrict activities or follow directions during 
the healing period; 
13. Malalignment: genu varus and genu valgus angles 
greater than 5° 
per their standard of care;  
14. Patients who have an Ahlback grade greater than II;  
15. Patients with a body mass index larger than 35; 

 
 
Clinical Protocol  
Study Number: FAST-FIX 
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16. Subjects with a medical or physical condition that, in 
the opinion of the Investigator, would preclude safe 
subject participation in the study. 
2  
(Rationale 
10) 
Study Duration: It is anticipated to take 30 months 
(16 months for subject enrolment and 
14 months follow-up period). 
Study Duration: It is anticipated to take 39 months (21 
months for subject enrolment and 14 months follow-up 
period). 
2  
(Rationale 4, 
11, 12) 
Study Schedule: 
Visit 4 - 3 Months 
(± 14 days) 
Visit 5 - 6 Months 
(± 30 days) 
Visit 6 - 12 Months 
(± 60 days) 
 
Study Schedule: 
Visit 4 - 3 Months 
(+ 30 days)   
Visit 5 - 6 Months 
(± 45 days)  
Visit 6 - 12 Months 
(± 75 days) 
 
3.4 
(Rationale 8)
List of Abbreviations and Definitions 
List of Abbreviations/Acronyms and Definitions 
3.4 
(Rationale 7)
ACL Anterior Cruciate Ligament 
ADE Adverse Device Effect(s) 
AE Adverse Event(s) 
BMI Body Mass Index 
BSI British Standards Institute 
CE Conformité Européene  
CER Clinical Evaluation Report 
CoCr Cobalt Chrome 
 
CRF Case Report Form(s) 
CRO Contract Research Organization 
CV Curriculum Vitae 
ACL Anterior Cruciate Ligament 
ADE Adverse Device Effect(s) 
AE Adverse Event(s) 
ALL Anterolateral Ligament 
BMI Body Mass Index 
CE Conformité Européene  
CRF Case Report Form(s) 
CV Curriculum Vitae 
DD Device Deficiency(ies) 
EQ-5D-5L EuroQol 5 Dimension 5 Level 
FAS Full Analysis Set Population 

 
 
Clinical Protocol  
Study Number: FAST-FIX 
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DD Device Deficiency(ies) 
EQ-5D-5L EuroQol 5 Dimension 5 Level 
FAS Full Analysis Set Population 
FDA Food and Drug Administration 
FU Follow-Up 
GCP Good Clinical Practice 
HIPAA Health Information Portability Accountability Act
IB 
 
ICH International Conference on Harmonisation  
IEC Independent Ethics Committee 
IFU Instructions for Use 
IKDC International Knee and Documentation 
Committee  
Interventional study 
A type of clinical study in 
which participants are assigned to groups that receive 
one or more intervention/treatment so that 
researchers can evaluate the effects of the 
interventions on biomedical or health-related 
outcomes. 
IP Investigational Product  
IRB Institutional Review Board 
ISF Investigator Site File 
ITT Intention to Treat population 
LCL Lateral Collateral Ligament 
LOCF Last Observation Carried Forward 
MCL Medial Collateral Ligament 
MedDRA Medical Dictionary for Regulatory Activities  
MAT Meniscal Allograft Transplantation 
MR Meniscal Repair 
FDA Food and Drug Administration 
FU Follow-Up 
GCP Good Clinical Practice 
HIPAA Health Information Portability Accountability Act 
ICH International Conference on Harmonisation  
IEC Independent Ethics Committee 
IFU Instructions for Use 
IKDC International Knee and Documentation Committee  
Interventional study A type of clinical study in which 
participants are assigned to groups that receive one or 
more intervention/treatment so that researchers can 
evaluate the effects of the interventions on biomedical or 
health-related outcomes. 
IP Investigational Product  
IRB Institutional Review Board 
ISF Investigator Site File 
ITT Intention to Treat population 
LCL Lateral Collateral Ligament 
MAT Meniscal Allograft Transplantation 
MCL Medial Collateral Ligament 
MedDRA Medical Dictionary for Regulatory Activities  
MR Meniscal Repair 
NA or N/A Not Applicable 
N (or n) Total Sample Size (or subgroup sample size) 
PEEK Polyether Ether Ketone 
PRO Patient-reported Outcome  
PI Principal Investigator 
PP Per-protocol Population 
S+N Smith & Nephew Inc. 

 
 
Clinical Protocol  
Study Number: FAST-FIX 
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NA or N/A Not Applicable 
N (or n) Total Sample Size (or subgroup sample size) 
NHS National Health Service  
Non-interventional study A clinical study in which the 
investigational medical device of interest is used in 
accordance with the approved instructions for use. 
Assigning a subject/patient to a particular therapeutic 
arm is not decided in advance by a protocol but falls 
within current practice; use of the device is clearly 
separated from the decision to include the patient in 
the study. No additional diagnostic or monitoring 
procedures are used, and epidemiological methods are 
used to analyze the collected data. 
PEEK Polyether Ether Ketone 
PRO Patient-reported Outcome  
PI Principal Investigator 
PMA Pre-Market Authorization 
PP Per-protocol Population 
RCT Randomized Controlled Trial 
S+N Smith & Nephew Inc. 
SADE Serious Adverse Device Effect(s) 
SAE Serious Adverse Event(s) 
SAF Safety population 
SAP Statistical Analysis Plan 
TGA Therapeutic Goods Administration 
TKA Total Knee Arthroplasty 
TÜV Technischer Überwachungsverein/ Technical 
Inspection Association 
Tx Treatment 
SADE Serious Adverse Device Effect(s) 
SAE Serious Adverse Event(s) 
SAF Safety population 
SAP Statistical Analysis Plan 
TGA Therapeutic Goods Administration 
USADE Unanticipated Serious Adverse Device Effect(s) 

 
 
Clinical Protocol  
Study Number: FAST-FIX 
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USADE Unanticipated Serious Adverse Device Effect(s)
4.1 
(Rationale 8)
Each knee has a pair of semi-lunar wedge-shaped 
menisci consisting of fibrocartilage, located both 
laterally and medially between the tibial plateaus and 
the femoral condyles.1,2 Because of their location, 
menisci are highly susceptible to injury, the medial 
meniscus being two to three times more likely to be 
injured than the lateral meniscus.2,3 The most 
common mechanism of injury is trauma during sports 
activity and often occurs in combination with anterior 
cruciate ligament (ACL) injury.4-6 Degenerative injury 
is also possible and may signify the onset of 
osteoarthritis (OA).7 Traumatic knee injuries more 
associated with radial and vertical tears, whereas 
degenerative tears are more associated with horizontal 
and complex tears.3 
Tears along the outer edge of the meniscus (red zone) 
have superior healing potential as blood supply is 
more available in that area than in the inner two-thirds 
of the meniscus (red-white and white zones).2,8 Tears 
can be described as horizontal, vertical, or bucket 
handle. Horizontal cleavage tears are primarily 
degenerative in nature, but can result from trauma.9 
The tear itself extends from the inner free margin of 
the meniscus into the intra-meniscal substance and is 
typically treated with partial meniscectomy.10 These 
tears typically extend into the avascular zone, 
vascularity is poor which can affect their ability to 
Each knee has a pair of semi-lunar wedge-shaped menisci 
consisting of fibrocartilage, located both laterally and 
medially between the tibial plateaus and the femoral 
condyles.1,2 Because of their location, menisci are highly 
susceptible to injury, the medial meniscus being two to 
three times more likely to be injured than the lateral 
meniscus.2,3 The most common mechanism of injury is 
trauma during sports activity and often occurs in 
combination with anterior cruciate ligament (ACL) 
injury.4-6 Degenerative injury is also possible and may 
signify the onset of osteoarthritis (OA).7 Traumatic knee 
injuries more associated with radial and vertical tears, 
whereas degenerative tears are more associated with 
horizontal and complex tears.3 
Tears along the outer edge of the meniscus (red zone) 
have superior healing potential as blood supply is more 
available in that area than in the inner two-thirds of the 
meniscus (red-white and white zones).2,8 Tears can be 
described as horizontal, vertical, or bucket handle. 
Horizontal cleavage tears are primarily degenerative in 
nature, but can result from trauma.9 The tear itself 
extends from the inner free margin of the meniscus into 
the intra-meniscal substance and is typically treated with 
partial meniscectomy.10 These tears typically extend into 
the avascular zone, vascularity is poor which can affect 
their ability to heal, and have been historically treated 
with partial meniscectomy.10 

 
 
Clinical Protocol  
Study Number: FAST-FIX 
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heal, and have been historically treated with partial 
meniscectomy.10 
Historically, the removal of the meniscus, known as a 
total meniscectomy, was the approach for managing 
tears of the meniscus.11,12 However, a direct 
relationship between total meniscectomy and the 
worse clinical outcomes such as the development of 
early osteoarthritis, degenerative knee changes, and 
increased pressure loads compared to modern 
techniques, was observed, causing this treatment 
method to be largely abandoned.11,13-16 In a multi-
center study cited by Beaufils et al.,17, 10-year 
osteoarthritis rates were 31% in patients treated with 
meniscectomy and 11% in patients treated with a 
meniscal repair or non-surgical treatment. At 20 years, 
the rates increased to 46% and 17%, respectively.17 
Meniscal repair attempts to suture the meniscus back 
together, achieve meniscal healing, and avoid the 
effects of meniscectomy. This technique was 
introduced to preserve knee function and limit the 
accelerated degenerative changes associated with 
surgical techniques mentioned above.18,19 The most 
recently developed technique is the all-inside repair 
technique. The all-inside technique is typically used 
within the meniscal body and for posterior horn 
tears.20 In this approach, the surgeon uses posterior 
accessory portals and suture hooks to shuttle sutures 
through meniscal tears of the posterior horn that were 
not easily repairable using the other approaches. This 
Historically, the removal of the meniscus, known as a 
total meniscectomy, was the approach for managing tears 
of the meniscus.11,12 However, a direct relationship 
between total meniscectomy and the worse clinical 
outcomes such as the development of early osteoarthritis, 
degenerative knee changes, and increased pressure loads 
compared to modern techniques, was observed, causing 
this treatment method to be largely abandoned.11,13-16 
In a multi-center study cited by Beaufils et al.,17, 10-
year osteoarthritis rates were 31% in patients treated 
with meniscectomy and 11% in patients treated with a 
meniscal repair or non-surgical treatment. At 20 years, 
the rates increased to 46% and 17%, respectively.17 
Meniscal repair attempts to suture the meniscus back 
together, achieve meniscal healing, and avoid the effects 
of meniscectomy. This technique was introduced to 
preserve knee function and limit the accelerated 
degenerative changes associated with surgical techniques 
mentioned above.18,19 The most recently developed 
technique is the all-inside repair technique. The all-inside 
technique is typically used within the meniscal body and 
for posterior horn tears.20 In this approach, the surgeon 
uses posterior accessory portals and suture hooks to 
shuttle sutures through meniscal tears of the posterior 
horn that were not easily repairable using the other 
approaches. This approach can reduce surgical time,21 
speed up patient recovery,11 does not require an open 
incision, and can prevent complications seen with external 
approaches.11, 22 

 
 
Clinical Protocol  
Study Number: FAST-FIX 
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approach can reduce surgical time,21 speed up patient 
recovery,11 does not require an open incision, and can 
prevent complications seen with external 
approaches.11, 22 
In an attempt to optimize the healing capacity of the 
meniscus following meniscal repair, augmentation 
techniques have been developed and investigated to 
varying extents.23 Advances, such as the use of 
biologics such as platelet-rich plasma (PRP),24 
biomaterial augmentation,25 stem cell-based 
therapy,26 and allograft transplantation.22 Meniscal 
allograft transplantation (MAT) can be performed in 
patients who present with affected compartment-
specific pain and have pain and swelling secondary to 
chondral overload after a subtotal meniscectomy.22 
The ideal patient age for this treatment is younger 
than 40 years, however no specific upper age limits 
have been identified.22 Meniscal allografts are 
available in various forms which include, frozen, 
lyophilized, fresh and cryopreserved. Frozen allografts 
are most commonly used. Allografts need to be sized 
 
Currently, a plethora of devices for all-inside meniscal 
repair is being used. One highly coveted device is the 
FAST-FIX 360 Meniscal Repair System (Smith & 
Nephew, Andover, MA, U.S.A.); this device combines 
the advantages of the all-inside technique with strong 
biomechanical properties, 12, 13 and is a modification 
of the previous Smith & Nephew T-FIX device. This 
In an attempt to optimize the healing capacity of the 
meniscus following meniscal repair, augmentation 
techniques have been developed and investigated to 
varying extents.23 Advances, such as the use of biologics 
such as platelet-rich plasma (PRP),24 biomaterial 
augmentation,25 stem cell-based therapy,26 and allograft 
transplantation.22 Meniscal allograft transplantation 
(MAT) can be performed in patients who present with 
affected compartment-specific pain and have pain and 
swelling secondary to chondral overload after a subtotal 
meniscectomy.22 The ideal patient age for this treatment 
is younger than 40 years, however no specific upper age 
limits have been identified.22 Meniscal allografts are 
available in various forms which include, frozen, 
lyophilized, fresh and cryopreserved. Frozen allografts are 
most commonly used. Allografts need to be sized 
 
Currently, a plethora of devices for all-inside meniscal 
repair is being used. One highly coveted device is the 
FAST-FIX 360 Meniscal Repair System (Smith & Nephew, 
Andover, MA, U.S.A.); this device combines the 
advantages of the all-inside technique with strong 
biomechanical properties, 12, 13 and is a modification of 
the previous Smith & Nephew T-FIX device. This system 
can be used for vertical, horizontal, or oblique meniscal 
tears. FAST-
next-generation meniscal repair device that will improve 
on the FF-360 design and will encompass: 1) reliable 
deployment of implants, 2) minimal disruption to the 

 
 
Clinical Protocol  
Study Number: FAST-FIX 
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(MR) and Meniscal Allograft Transplantations (MAT) 
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system can be used for vertical, horizontal, or oblique 
meniscal tears. FAST-FIX FLEX Meniscal Repair System 
-generation meniscal repair device that 
will improve on the FF-360 design and will encompass: 
1) reliable deployment of implants, 2) minimal 
disruption to the meniscus (via a smaller needle tip) 
and 3) more accessibility to tear locations (ability to 
bend the shaft to access a variety of locations, 
particularly the body and anterior horn). This all-inside 
meniscal repair device is intended to be used by 
healthcare professionals to repair meniscal tears and 
by anchoring the allograft to the capsular rim during 
allograft transplant procedures. The proposed study 
aims to evaluate the safety and performance of 
arthroscopic meniscal repairs and meniscus allograft 
transplants using the FAST-FIX Flex System.  
 
meniscus (via a smaller needle tip) and 3) more 
accessibility to tear locations (ability to bend the shaft to 
access a variety of locations, particularly the body and 
anterior horn). This all-inside meniscal repair device is 
intended to be used by healthcare professionals to repair 
meniscal tears and by anchoring the allograft to the 
capsular rim during allograft transplant procedures. The 
proposed study aims to evaluate the safety and 
performance of arthroscopic meniscal repairs and 
meniscus allograft transplants using the FAST-FIX Flex 
System.  
 
A summary of known and potential risks and benefits to 
humans of the investigational product can be found in the 
Instructions For Use (IFU). 
4.2 
(Rationale 7)
 
Improvements in IKDC Subjective scores ranged from 
21.8 to 28.1 points, with postoperative scores ranging 
from 79.6 to 82.6 points.84 Hirtler et al.34 
Improvements in IKDC Subjective scores ranged from 
21.8 to 28.1 points, with postoperative scores ranging 
from 79.6 to 82.6 points, Hirtler et al.34 
5.4 
(Rationale 7)
Claims 
The proposed Marketing Claims for this study include, 
but are not limited to, the following: 
 
Meniscal tears repaired with FAST-FIX FLEX 
have a clinical success rate of 85% or higher 
(low re-op rate); 
 
Meniscal tears repaired with FAST-FIX FLEX lead 
to a significant improvement in patient 
Claims 
-FIX FLEX lead to an 
improvement in patient symptom scores (PROs). 
 The FAST-FIX FLEX Meniscal Repair System provides an 
increased access to tear location and increased zone of 
repair. 

 
 
Clinical Protocol  
Study Number: FAST-FIX 
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(MR) and Meniscal Allograft Transplantations (MAT) 
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symptom scores (PROs). 
 
The FAST-FIX FLEX Meniscal Repair System 
provides an increased access to tear location 
and increased zone of repair. 
6.1.1 
(Rationale 2)
Two device configurations having different distal 
needle curvature are being offered and are each 
packaged with a Bend Tool and Slotted Cannula. 
Four device configurations having different distal needle 
curvature are being offered. Two are with a Bend Tool 
and Slotted Cannula and two configurations are packaged 
without a Bend Tool and Slotted Cannula. 
6.1.1 
(Rationale 2)
The package contains the following:  
(1) Single-use delivery needle assembly preloaded 
with  
pre-tied with #2-0 non-absorbable suture made of 
uncoated ultrahigh-molecular-weight polyethylene 
fiber braided with polypropylene monofilament fiber 
(1) Single-use FAST-FIX FLEX Slotted Delivery Cannula
(1) Single-use Bend Tool 
SKUs 72205324 and 72205325 contain the following:  
(1) Single-use delivery needle assembly preloaded with  
-
tied with #2-0 non-absorbable suture made of uncoated 
ultrahigh-molecular-weight polyethylene fiber braided 
with polypropylene monofilament fiber 
(1) Single-use FAST-FIX FLEX Slotted Delivery Cannula 
(1) Single-use Bend Tool 
SKUs 72205676 and 72205677 contain the following:  
(1) Single-use delivery needle assembly preloaded with  
-
tied with #2-0 non-absorbable suture made of uncoated 
ultrahigh-molecular-weight polyethylene fiber braided 
with polypropylene monofilament fiber 
 
72205676 FAST-FIX FLEX CURVED INSERTER 
72205677 FAST-FIX FLEX REVERSE CURVED INSERTER 
Inserter: The device user interface includes a handle and 
deployment knob used to deploy two PEEK implants in the 
joint space. The handle and deployment knob are 

 
 
Clinical Protocol  
Study Number: FAST-FIX 
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(MR) and Meniscal Allograft Transplantations (MAT) 
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designed such that they are easy to hold/grip onto, allow 
for single-handed deployment, and provide tactile 
feedback for implant deployment 
 
6.2 
(Rationale 7)
The devices are provided sterile and fully assembled to 
the OR. 
The devices are provided sterile and fully assembled to 
the operating room. 
6.3.1 
(Rationale 7 
and 8) 
6.3.1 Labelling of Investigational Product 
The FAST-FIX FLEX Meniscal Repair System has 
received 510(k) clearance in the United States, CE 
marking in Europe, Australian Register of Therapeutic 
Goods (ARTG) approval in Australia and is 
commercially available on the market. All devices used 
in this study will be procured in standard commercial 
packaging, ordered via usual and customary Smith + 
Nephew procedures and managed per study site 
processes.  
Lot Number  
Catalogue Number 
Unique Device Identifier  
Package contents  
Use by Date  
Date of Manufacture  
Distributor information: Smith + Nephew, Inc.  
Manufacturer name and address  
Product name and cartridge size  
Customer service contact information  
Product sale restriction 
 
6.3.1 Labelling of Investigational Product 
The FAST-FIX FLEX Meniscal Repair System has received 
510(k) clearance in the United States, CE marking in 
Europe, Australian Register of Therapeutic Goods (ARTG) 
approval in Australia and is commercially available on the 
market. All devices used in this study will be procured in 
standard commercial packaging, ordered via usual and 
customary Smith + Nephew procedures and managed per 
study site processes. The labels on FAST-FIX FLEX 
Meniscal Repair system contain the following information:
Lot Number  
Catalogue Number 
Unique Device Identifier  
Package contents  
Use by Date  
Date of Manufacture  
Distributor information: Smith + Nephew, Inc.  
Manufacturer name and address  
Product name 
Customer service contact information  
Product sale restriction 
 

 
 
Clinical Protocol  
Study Number: FAST-FIX 
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A Prospective, Multi-center Clinical Study to Evaluate the Safety 
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(MR) and Meniscal Allograft Transplantations (MAT) 
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6.3.2 
(Rationale 8)
N/A 
6.3.2 Ancillary Products 
 
The labels on the ancillary products 
contain the following information: 
Lot Number  
Catalogue Number 
Unique Device Identifier  
Package contents  
Use by Date  
Date of Manufacture  
Distributor information: Smith + Nephew, Inc.  
Manufacturer name and address  
Product name 
Product sale restriction 
6.4 
(Rationale 3)
The investigational site will maintain an inventory of 
the Investigational Device. The Sponsor or its 
designee will provide a log(s) to facilitate 
Investigational Device inventory control. The log will 
contain 
details of receipt, use, returns etc. of Investigational 
Devices. All Investigational Device accountability logs 
must be retained in the Investigator Site File (ISF). 
These records must be available for inspection by the 
Sponsor, its designees, or by regulatory agencies at 
any time. The Sponsor will provide Investigational 
Device Management Instructions to the site detailing 
all additional forms that might need completion (e.g., 
confirmation of receipt) for Investigational Device 
control. 
All devices used in this study will be procured in standard 
commercial packaging, ordered via usual and customary 
Smith + Nephew procedures and managed per study site 
processes. Therefore, product accountability / inventory 
local processes and 
procedures. 

 
 
Clinical Protocol  
Study Number: FAST-FIX 
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(MR) and Meniscal Allograft Transplantations (MAT) 
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The study monitor will ensure that the procedures and 
records are in place for the appropriate 
reconciliation of all Investigational Devices. As part of 
monitoring, the study monitor will check that 
site personnel are following the proper procedures for 
accountability and completing all necessary 
documentation. 
6.5 
(Rationale 8)
Surgical Technique 
Surgical Technique/Medical Procedures 
6.5 
(Rationale 2)
All study-related procedures with the FAST-FIX FLEX 
Meniscal Repair System must be performed according 
to the recommended surgical technique described in 
the IFU (10601463). 
All study-related procedures with the FAST-FIX FLEX 
Meniscal Repair System must be performed according to 
the recommended surgical technique described in the IFU 
(10601463 / 10601589). 
7.1 
(Rationale 1, 
5 and 9) 
A total of 130 subjects between the ages of 18 and 70 
years of age will be enrolled into the study. The 
subjects will be recruited from up to 6 sites in the 
United States, United Kingdom, Germany, France and 
Australia. Sites failing to enroll may be replaced.  
 
 97 subjects will be enrolled for meniscal repair with 
the use of the FAST-FIX FLEX system 
 30 subjects will be enrolled for meniscal allograft 
transplantation with the use of the FAST-FIX FLEX 
system 
 
For the two subgroups, the clinician has decided the 
A minimum of 62 and maximum of 68 subjects between 
the ages of 16 and 70 years of age will be enrolled into 
the study. The subjects will be recruited from up to 5 
sites in the United States, United Kingdom, France and 
Australia. Sites failing to enroll may be replaced.  
 
 53 subjects will be enrolled for meniscal repair with the 
use of the FAST-FIX FLEX system 
 A minimum of 9 and maximum of 15 subjects will be 
enrolled for meniscal allograft transplantation with the 
use of the FAST-FIX FLEX system 
For the two subgroups, the clinician has decided the 
allograft transplantation facilitated with the FAST-FIX 

 
 
Clinical Protocol  
Study Number: FAST-FIX 
FLEX.2020.09 
A Prospective, Multi-center Clinical Study to Evaluate the Safety 
and Performance of the FAST-FIX FLEX System for Meniscal Repairs 
(MR) and Meniscal Allograft Transplantations (MAT) 
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TMP-800052 Clinical Protocol - Device  Revision 4; PRO-201725 Clinical Protocols 
meniscal allograft transplantation facilitated with the 
FAST-FIX FLEX system as routine medical care. This 
decision will be made irrespectively of study 
participation. 
FLEX system as routine medical care. This decision will be 
made irrespectively of study participation. 
7.1.1 
(Rationale 1 
and 7) 
N/A 
enrolled in this study. The rationale for inclusion of this 
age group is to better align with the Investigational 
group, and strengthen the evidence required for European 
Medical Device Regulation (EU MDR). Also, the study sites 
use the Investigational Product in this age group as per 
standard care and therefore should improve recruitment 
rates in this study. As this is a post-market clinical follow-
up (PMCF) study, any minors who are enrolled in this 
study may receive the Investigational Product regardless 
of their participation. 
7.2 
(Rationale 1 
and 7) 
Inclusion Criteria 
Subjects will be considered qualified for enrollment if 
they meet the following criteria: 
1. Subject provides written informed consent for study 
participation using an independent ethical committee 
(IEC) / institutional review board (IRB) approved 
consent form. 
Subject is between eighteen (18) and seventy (70) 
years of age, inclusive at the time of 
screening. 
3. Subject is willing and able to participate in required 
follow-up visits and is able to complete 
Inclusion Criteria  Meniscal Repair ONLY 
Subjects will be considered qualified for enrollment in the 
MR arm if they meet the following criteria: 
1. Subject provides written informed consent for study 
participation using an independent ethical committee 
(IEC) / institutional review board (IRB) approved consent 
form. 
2. Subject is between sixteen (16) and seventy (70) 
years of age, inclusive at the time of screening. 
3. Subject is willing and able to participate in required 
follow-up visits and is able to complete study activities. 
4. Subject requires a meniscal repair. 

 
 
Clinical Protocol  
Study Number: FAST-FIX 
FLEX.2020.09 
A Prospective, Multi-center Clinical Study to Evaluate the Safety 
and Performance of the FAST-FIX FLEX System for Meniscal Repairs 
(MR) and Meniscal Allograft Transplantations (MAT) 
Version: 3.0, 05/May/2023 
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TMP-800052 Clinical Protocol - Device  Revision 4; PRO-201725 Clinical Protocols 
study activities. 
4. Subject requires a meniscal repair or meniscal 
allograft transplantation. 
5. Subject is suitable to participate in the study in the 
opinion of the Investigator. 
6. Meniscal Repair ONLY: 
Subject requires a meniscus repair concerning the red-
red or red-white zones for acute or 
chronic 1-, 2- or 3-segment lesions, with or without 
associated anterior cruciate ligament (ACL) 
reconstruction. 
7. Meniscal Allograft Transplantation ONLY: 
Subject requires a MAT for symptomatic meniscal 
insufficiency (load-related pain and swelling in the 
compartment post meniscectomy) for which 
conservative treatment has failed. 
5. Subject is suitable to participate in the study in the 
opinion of the Investigator. 
6.  Subject requires a meniscus repair concerning the red-
red or red-white zones for acute or chronic 1-, 2- or 3-
segment lesions, with or without associated anterior 
cruciate ligament (ACL) reconstruction. 
7.3 
(Rationale 1, 
7 and 8) 
Exclusion Criteria 
Any one (1) of the following criteria will disqualify a 
potential subject from participation in the study: 
1. Contraindications (per the FAST-FIX FLEX IFU) or 
hypersensitivity to the use of the FAST-FIX FLEX 
implant material. Where material sensitivity is 
suspected, appropriate tests should be made and 
sensitivity ruled out prior to implantation. 
2. Participation in the treatment period of another 
clinical trial within thirty (30) days of the 
operative visit, or during the study. 
Exclusion Criteria  Meniscal Repair ONLY 
Any one (1) of the following criteria will disqualify a 
potential subject from participation in the study: 
1. Contraindications (per the FAST-FIX FLEX IFU) or 
hypersensitivity to the use of the FAST-FIX FLEX implant 
material. Where material sensitivity is suspected, 
appropriate tests should be made and sensitivity ruled out 
prior to implantation. 
2. Enrolled in the treatment period of another clinical trial 
within thirty (30) days of the operative visit, or during the 
study. 
3. Women who are pregnant or nursing. 

 
 
Clinical Protocol  
Study Number: FAST-FIX 
FLEX.2020.09 
A Prospective, Multi-center Clinical Study to Evaluate the Safety 
and Performance of the FAST-FIX FLEX System for Meniscal Repairs 
(MR) and Meniscal Allograft Transplantations (MAT) 
Version: 3.0, 05/May/2023 
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3. Women who are pregnant, nursing, or of child-
bearing potential who are not utilizing highly effective 
birth control measures. 
4. Any subject that meets the definition of a 
Vulnerable Subject per ISO 14155 Section 3.44.1 
5. Subjects with a history of poor compliance with 
medical treatment, physical therapy 
(PT)/rehabilitation, or clinical study participation. 
6. Patients with irreparable meniscal tears (i.e. grade 
3 outerbridge osteoarthritis or greater, serious defects, 
multiple tears). 
7. Patients with multi-ligament tears (i.e. ACL tear is 
not associated with lateral collateral 
ligament (LCL) or medial collateral ligament (MCL) 
tears). 
8. Performance of a significant concomitant procedure, 
specifically a cartilage repair or 
restoration (excluding ACL reconstruction or repair) 
intended as a therapeutic intervention on the study 
knee. 
9. Subjects with a history of ipsilateral knee surgery, 
septic joint, or fracture (excluding MAT 
indication). 
10. Subjects with pathological conditions in the soft 
tissue that would prevent secure fixation of the device.
11. Physical conditions that would eliminate, or tend to 
eliminate, adequate anchor support or retard healing. 
12. The presence of infection. 
4. Any subject that meets the definition of a Vulnerable 
Subject per ISO 14155 Section 3.55 (except for subjects 
aged sixteen (16) or seventeen (17) years of age with 
consent from their legally authorized representative).   
5. Subjects with a history of poor compliance with 
medical treatment, physical therapy (PT)/rehabilitation, 
or clinical study participation. 
6. Patients with irreparable meniscal tears (i.e. multiple 
tears). 
7. Subjects with full thickness cartilage defects greater 
than 10mm in diameter and/or serious defects;   
8. Patients with concomitant ligament injuries that do not 
require surgical repair (i.e. ACL with Grade 3 lateral 
collateral ligament (LCL) injury or medial collateral 
ligament (MCL) injury). 
9. Performance of a significant concomitant procedure, 
specifically a cartilage repair or restoration (excluding ACL 
reconstruction or repair, lateral extra-articular tenodesis, 
anterolateral ligament (ALL) reconstruction) intended as a 
therapeutic intervention on the study knee. 
10. Subjects with a history of ipsilateral knee surgery, 
septic joint, or fracture. 
11. Subjects with pathological conditions in the soft tissue 
that would prevent secure fixation of the device. 
12. Physical conditions that would eliminate, or tend to 
eliminate, adequate anchor support or retard healing. 
13. The presence of infection. 

 
 
Clinical Protocol  
Study Number: FAST-FIX 
FLEX.2020.09 
A Prospective, Multi-center Clinical Study to Evaluate the Safety 
and Performance of the FAST-FIX FLEX System for Meniscal Repairs 
(MR) and Meniscal Allograft Transplantations (MAT) 
Version: 3.0, 05/May/2023 
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willingness to restrict activities or follow directions 
during the healing period. 
14. Malalignment: genu varus and genu valgus angles 
greater than 5° with respect to the normal axis to 
indicate malalignment. 
15. Patients who had an Ahlback grade greater than II
16. Patients with a body mass index larger than 30 
17. Subjects with a medical or physical condition that, 
in the opinion of the Investigator, would 
preclude safe subject participation in the study. 
 
1. ISO 14155 Section 3.44 States: Vulnerable subject  individual 
whose willingness to volunteer in a clinical investigation could be 
unduly influenced by the expectation, whether justified or not, of 
benefits associated with participation or of retaliatory response 
from senior members of a hierarchy in case of refusal to 
participate.  EXAMPLE: Individuals with a lack of or loss of 
autonomy due to immaturity or through mental disability, persons 
in nursing homes, children, impoverished persons, subjects in 
emergency situations, ethnic minority groups, homeless persons, 
nomads, refugees, and those incapable of giving informed consent.  
Other vulnerable subjects include, for example, members of a 
subordinate hospital and laboratory personnel, employees of the 
sponsor, members of the armed forces and persons kept in 
detention.
14. Con
willingness to restrict activities or follow directions during 
the healing period. 
15. Malalignment: genu varus and genu valgus angles 
greater than 5° 
per their standard of care. 
16. Patients who have an Ahlback grade greater than II. 
17. Patients with a body mass index larger than 35. 
18. Subjects with a medical or physical condition that, in 
the opinion of the Investigator, would  
preclude safe subject participation in the study. 
 
1. ISO 14155 Section 3.55 States: Vulnerable subject  individuals 
who are unable to fully understand all aspects of the investigation that 
are relevant to the decision to participate, or who could be 
manipulated or unduly influenced as a result of a compromised 
position, expectation of benefits or fear of retaliatory response 
7.4 
(Rationale 1 
and 7) 
N/A  section was screening and is covered below. 
Inclusion Criteria  Meniscal Allograft Transplantation 
ONLY 
Subjects will be considered qualified for enrollment in the 
MAT arm if they meet the following criteria: 

 
 
Clinical Protocol  
Study Number: FAST-FIX 
FLEX.2020.09 
A Prospective, Multi-center Clinical Study to Evaluate the Safety 
and Performance of the FAST-FIX FLEX System for Meniscal Repairs 
(MR) and Meniscal Allograft Transplantations (MAT) 
Version: 3.0, 05/May/2023 
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TMP-800052 Clinical Protocol - Device  Revision 4; PRO-201725 Clinical Protocols 
1. Subject provides written informed consent for study 
participation using an independent ethical committee 
(IEC) / institutional review board (IRB) approved consent 
form. 
2. Subject is between sixteen (16) and seventy (70) 
years of age, inclusive at the time of screening. 
3. Subject is willing and able to participate in required 
follow-up visits and is able to complete study activities. 
4. Subject requires a meniscal allograft transplantation. 
5. Subject is suitable to participate in the study in the 
opinion of the Investigator. 
6. Subject requires a MAT for symptomatic meniscal 
insufficiency (load-related pain and swelling in the 
compartment post meniscectomy) for which conservative 
treatment has failed, with or without cartilage repair or 
restoration (including ACL reconstruction or repair). 
7.5 
(Rationale 1 
and 7) 
N/A  section was informed and is covered below. 
Exclusion Criteria  Meniscal Allograft Transplantation 
ONLY 
Any one (1) of the following criteria will disqualify a 
potential subject from participation in the study: 
1. Contraindications (per the FAST-FIX FLEX IFU) or 
hypersensitivity to the use of the FAST-FIX FLEX implant 
material. Where material sensitivity is suspected, 
appropriate tests should be made and sensitivity ruled out 
prior to implantation. 
2. Enrolled in the treatment period of another clinical trial 
within thirty (30) days of the operative visit, or during the
study. 

 
 
Clinical Protocol  
Study Number: FAST-FIX 
FLEX.2020.09 
A Prospective, Multi-center Clinical Study to Evaluate the Safety 
and Performance of the FAST-FIX FLEX System for Meniscal Repairs 
(MR) and Meniscal Allograft Transplantations (MAT) 
Version: 3.0, 05/May/2023 
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TMP-800052 Clinical Protocol - Device  Revision 4; PRO-201725 Clinical Protocols 
3. Women who are pregnant or nursing. 
4. Any subject that meets the definition of a Vulnerable 
Subject per ISO 14155 Section 3.55 (except for subjects 
aged sixteen (16) or seventeen (17) years of age with 
consent from their legally authorized representative).   
5. Subjects with a history of poor compliance with 
medical treatment, physical therapy (PT)/rehabilitation, 
or clinical study participation. 
6. Patients with concomitant ligament injuries that do not 
require surgical repair (i.e. ACL with Grade 3 lateral 
collateral ligament (LCL) injury or medial collateral 
ligament (MCL) injury. 
7. Performance of a significant concomitant procedure 
(excluding ACL reconstruction or repair, lateral extra-
articular tenodesis, anterolateral ligament (ALL) 
reconstruction) intended as a therapeutic intervention on 
the study knee. 
8. Subjects with a history of ipsilateral knee surgery, 
septic joint, or fracture (excluding MAT indication). 
9. Subjects with pathological conditions in the soft tissue 
that would prevent secure fixation of the device. 
10. Physical conditions that would eliminate, or tend to 
eliminate, adequate anchor support or retard healing. 
11. The presence of infection. 
12. Conditions which would limit t
willingness to restrict activities or follow directions during 
the healing period. 

 
 
Clinical Protocol  
Study Number: FAST-FIX 
FLEX.2020.09 
A Prospective, Multi-center Clinical Study to Evaluate the Safety 
and Performance of the FAST-FIX FLEX System for Meniscal Repairs 
(MR) and Meniscal Allograft Transplantations (MAT) 
Version: 3.0, 05/May/2023 
Page: 114 of 151   
 
 
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TMP-800052 Clinical Protocol - Device  Revision 4; PRO-201725 Clinical Protocols 
13. Malalignment: genu varus and genu valgus angles 
greater than 5° 
per their standard of care. 
14. Patients who have an Ahlback grade greater than II. 
15. Patients with a body mass index larger than 35. 
16. Subjects with a medical or physical condition that, in 
the opinion of the Investigator, would preclude safe 
subject participation in the study. 
7.6 
(Rationale 1, 
5, 6 and 7) 
Section 7.4 Screening 
The Investigators will continuously screen subjects 
during recruitment, which will continue until a total of 
130 subjects (97 enrolled for MR and 33 enrolled for 
MAT) are recruited. It remains the 
decision of the Sponsor to increase or decrease 
enrollment, as necessary. 
Once a subject has completed the informed consent 
procedure and signed the Informed Consent 
Form (IFU), the Principal Investigator (PI), or 
delegated study research staff, can complete the 
screening process to determine whether they meet all 
inclusion and none of the exclusion criteria. 
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 recorded in the subject's 
source documents and noted on the Screening and 
Enrollment Log. All screening activities that occur prior 
to consent shall be referred to as pre-screening. 
Section 7.6 Screening 
The Investigators will continuously screen subjects during 
recruitment, which will continue until a minimum of 62 
and maximum of 68 subjects (53 enrolled for MR and a 
minimum of 9 and maximum of 15 enrolled for MAT) are 
recruited. It remains the decision of the Sponsor to 
increase or decrease enrollment, as necessary. 
Subjects aged 18 years and over: Once a subject has 
completed the informed consent procedure and signed 
the Informed Consent Form (ICF), the Principal 
Investigator (PI), or delegated study research staff, can 
complete the screening process to determine whether 
they meet all inclusion and none of the exclusion criteria. 
Subjects aged 16 and 17 years: Once a subject has 
completed the informed consent procedure (assent), the 
zed representative (parent or 
legal guardian) has completed the informed consent 
procedure and signed the relevant ICFs, the Principal 
Investigator (PI), or delegated study research staff, can 

 
 
Clinical Protocol  
Study Number: FAST-FIX 
FLEX.2020.09 
A Prospective, Multi-center Clinical Study to Evaluate the Safety 
and Performance of the FAST-FIX FLEX System for Meniscal Repairs 
(MR) and Meniscal Allograft Transplantations (MAT) 
Version: 3.0, 05/May/2023 
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Part of the screening process will include 
the woman is not of childbearing potential this should 
be documented in the medical history (e.g., surgically 
postmenopausal, postmenopausal [i.e., at least one 
year without menses]). For women of 
childbearing potential, their method of birth control 
should be documented in the source. Acceptable birth 
control methods include abstinence, condoms, birth 
control pills, IUDs, and other hormonal or physical 
methods. 
complete the screening process to determine whether 
they meet all inclusion and none of the exclusion criteria. 
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 recorded in the subject's source 
documents and noted on the Screening and Enrollment 
Log. All screening activities that occur prior to consent 
shall be referred to as pre-screening. 
7.7 
(Rationale 6, 
7 and 8) 
7.5 Informed Consent 
Before conducting any study procedures or 
examinations, the purpose and nature of the study 
should be explained to the subject in their native 
language. 
The subject, or their legally authorized representative, 
will then read, sign, and personally date the IRB/IEC-
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 document will be 
provided to the subject, and a copy will be placed in 
the ISF. 
7.7 Informed Consent 
Before conducting any study procedures or examinations, 
the purpose and nature of the study should be explained 
to the subject in their native language. Subjects will have 
the opportunity to ask any questions. 
The subject, or their legally authorized representative, 
will then read, sign, and personally date the IRB/IEC-
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 document will be provided to the 
record, with the original filed in the ISF. 
If the subject is unable to read, the informed consent 
document and associated study information may be read 

 
 
Clinical Protocol  
Study Number: FAST-FIX 
FLEX.2020.09 
A Prospective, Multi-center Clinical Study to Evaluate the Safety 
and Performance of the FAST-FIX FLEX System for Meniscal Repairs 
(MR) and Meniscal Allograft Transplantations (MAT) 
Version: 3.0, 05/May/2023 
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If the subject is unable to read, the informed consent 
document and associated study information may be 
read aloud to the subject in the presence of an 
impartial witness. If possible, the subject 
shall sign and personally date the Informed Consent 
Form (ICF). Where this is not possible, due to 
difficulties in writing, the subject shall provide verbal 
consent to participate in the study. The witness shall 
then personally sign and date the informed consent 
form, attesting that the information was 
accurately explained and that the informed consent 
was freely given. 
ICFs will comply with Health Information Portability 
Accountability Act (HIPAA) regulations the EU Global 
Data Protection Regulation (GDPR), The Privacy Act 
1988 in Australia and the New Zealand Privacy Act 
1993 and or applicable national regulations and laws. 
 
aloud to the subject in the presence of an impartial 
witness. If possible, the subject shall sign and personally 
date the ICF. Where this is not possible, due to difficulties 
in writing, the subject shall provide verbal consent to 
participate in the study. The witness shall then personally 
sign and date the informed consent form, attesting that 
the information was accurately explained and that the 
informed consent was freely given. 
In the case of vulnerable subjects (minors), the ICF must 
be understood 
authorized representative (parent or legal guardian). 
Assent to participate in the study should be obtained for 
subjects 16 years of age and 17 years of age if allowed by 
local regulations. If the legally authorized representative 
is unable to read/write, a witness signature is required as 
described previously. 
The minor shall participate in the informed consent 
process in a way suitable for their age and mental 
maturity. Minors will receive the study information in a 
way adapted to their age and mental maturity from 
investigators or members of the investigating team who 
are trained or experienced in working with children. If 
minors express a wish or an opinion with regards to study 
participation this needs to be respected by the 
Investigator. If during the study, the minor reaches the 
age of 18 years (legal competence), the informed consent 
shall be obtained again, before the subject can continue 
to participate in the clinical investigation. ICFs will comply 
with Health Information Portability Accountability Act 

 
 
Clinical Protocol  
Study Number: FAST-FIX 
FLEX.2020.09 
A Prospective, Multi-center Clinical Study to Evaluate the Safety 
and Performance of the FAST-FIX FLEX System for Meniscal Repairs 
(MR) and Meniscal Allograft Transplantations (MAT) 
Version: 3.0, 05/May/2023 
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(HIPAA) regulations the EU Global Data Protection 
Regulation (GDPR), The Privacy Act 1988 in Australia and 
the New Zealand Privacy Act 1993 and or applicable 
national regulations and laws. 
 
If new information becomes available during the course of 
health and medical care, Smith + Nephew will ensure that 
information shall be provided to the subject(s) affected in 
written form and if relevant, all affected subjects shall be 
asked to confirm their continuing consent in writing. 
7.8 
(Rationale 7)
7.6 Enrollment 
7.8 Enrollment 
7.9 
(Rationale 7)
7.7 Lost to Follow-up 
7.9 Lost to Follow-up 
7.10 
(Rationale 7)
7.8 Withdrawal 
7.10 Withdrawal 
7.10.1 
(Rationale 7 
and 8) 
7.8.1 Withdrawal from Treatment 
Subjects may be withdrawn from having the related 
procedures with the FAST-FIX FLEX Meniscal Repair 
System at a date close to surgery or during surgery 
for the following reasons: 
At the discretion of the Investigator due to: 
oA change in treatment is clinically warranted 
oAn adverse event 
oAny other significant reason identified by the 
Investigator 
7.10.1 Withdrawal from Treatment 
Subjects may be withdrawn from having the related 
procedures with the FAST-FIX FLEX Meniscal Repair 
System at a date close to surgery or during surgery for 
the following reasons: 
At the discretion of the Investigator due to: 
oA change in treatment is clinically warranted 
oAn adverse event 
oAny other significant reason identified by the 
Investigator 

 
 
Clinical Protocol  
Study Number: FAST-FIX 
FLEX.2020.09 
A Prospective, Multi-center Clinical Study to Evaluate the Safety 
and Performance of the FAST-FIX FLEX System for Meniscal Repairs 
(MR) and Meniscal Allograft Transplantations (MAT) 
Version: 3.0, 05/May/2023 
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Any subjects who have provided consent but do not 
receive treatment or withdraw consent prior to surgery 
will be considered a screen failure. 
7.10.2 
(Rationale 7)
7.8.2 Withdrawal from Study 
7.10.2 Withdrawal from Study 
7.10.3 
(Rationale 7) Study 
Study 
7.10.4 
(Rationale 7)
7.8.4 Use of Data Following Withdrawal 
7.10.4 Use of Data Following Withdrawal 
8.1 
(Rationale 8)
N/A 
Figure 8-1 8 2: Study Stages 
8.1 
(Rationale 5, 
7, 10, 11 
and 12) 
This is a prospective, multi-center, non-randomized 
clinical study intended to evaluate the safety and 
performance of the FAST-FIX FLEX Meniscal Repair 
system for meniscal repairs and meniscal allograft 
transplantations. Up to 5 sites will participate within 
United States, United Kingdom, Germany, Spain, 
and Australia. 
Subjects will be enrolled in one of two (2) groups 
based on medical indication and general practice at 
the site, as shown in Table 8.1-1. 
 
Table 8.1 1  Overview of Study Groups 
 
Group Surgical Technique  Number of Subjects 
This is a prospective, multi-center, non-randomized 
clinical study intended to evaluate the safety and 
performance of the FAST-FIX FLEX Meniscal Repair 
system for meniscal repairs and meniscal allograft 
transplantations. Up to 5 sites will participate within 
United States, United Kingdom, France, and Australia.  
Subjects will be enrolled in one of two (2) groups based 
on medical indication and general practice at the site, as 
shown in Table 8.1-1. 
 
Table 8.1 1  Overview of Study Groups 
 
Group Surgical Technique  Number of Subjects 
Meniscal Repair Smith+Nephew FAST-FIX FLEX System 
53 

 
 
Clinical Protocol  
Study Number: FAST-FIX 
FLEX.2020.09 
A Prospective, Multi-center Clinical Study to Evaluate the Safety 
and Performance of the FAST-FIX FLEX System for Meniscal Repairs 
(MR) and Meniscal Allograft Transplantations (MAT) 
Version: 3.0, 05/May/2023 
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Meniscal Repair Smith+Nephew FAST-FIX FLEX 
System 97 
 
Meniscal Allograft Transplantations 
Smith+Nephew FAST-FIX FLEX System 33 
 
The study is expected to be 30 months in duration, but 
this will depend on the enrollment rate. These include:
16 months for enrollment 
14 months for follow-up 
o The final visit is 12 months post-surgery and 
includes a +/-2-month window period. 
The study's treatment will occur once, in the form of 
surgery to repair the torn portion of the meniscus or 
provide allograft transplantation to replace the 
irreparable meniscus or for patients who have had a 
meniscectomy. 
The primary outcome measures that will be examined 
include whether the repair success rate at 12 months 
will be similar or less than historical rates (85% for all-
inside meniscal repair).35; whether the FAST-FIX FLEX 
system increases access to tear location and zone of 
repair; whether a significant 
proportion of the subjects will show meniscus healing 
at 6 months; and whether Patient-Reported Outcomes 
(PROs) will be improved up to 12 months following the 
procedure. 
 
Meniscal Allograft Transplantations 
Smith+Nephew FAST-FIX FLEX System 
A minimum of 9 and maximum of 15 
The study is expected to be 39 months in duration, but 
this will depend on the enrollment rate. These include: 
 21 months for enrollment 
 14 months for follow-up 
O The final visit is 12 months post-surgery and includes a 
+/- 75 day window period. 
 
The study's treatment will occur once, in the form of 
surgery to repair the torn portion of the meniscus or 
provide allograft transplantation to replace the irreparable 
meniscus or for patients who have had a meniscectomy. 
 
The primary outcome measures that will be examined 
include whether the repair success rate at 12 months will 
be similar or less than historical rates (90% for all-inside 
meniscal repair)39; whether the FAST-FIX FLEX system 
increases access to tear location and zone of repair; 
whether a significant proportion of the subjects will show 
meniscus healing at 6 months; and whether Patient-
Reported Outcomes (PROs) will be improved up to 12 
months following the procedure. 

 
 
Clinical Protocol  
Study Number: FAST-FIX 
FLEX.2020.09 
A Prospective, Multi-center Clinical Study to Evaluate the Safety 
and Performance of the FAST-FIX FLEX System for Meniscal Repairs 
(MR) and Meniscal Allograft Transplantations (MAT) 
Version: 3.0, 05/May/2023 
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8.3.2 
(Rationale 7)
All eCRFs will be archived once the study is completed 
and will be kept for a period of no less than five years 
after the later of the following dates: the date of which 
the study is terminated or completed or; the date that 
the records are no longer required supporting 
marketing applications. 
All eCRFs will be archived once the study is completed 
and will be kept for a period of no less than five years 
after the later of the following dates: the date of which 
the study is terminated or completed or the date that the 
records are no longer required for supporting marketing 
applications. 
8.4.4 
(Rationale 7)
 
(SAEs); 
9.1.1 
(Rationale 4, 
11 and 12) 
Table 9.1 1 Study Procedures by Visit 
 
Visit 4 - 3 Months 
(± 14days) 
 
Visit 5  6 months (± 30 days) 
Visit 6  12 months (± 60 days) 
 
Table 9.1 1 Study Procedures by Visit 
 
Visit 4 - 3 Months 
(+ 30 days) 
Visit 5  6 months (± 45 days) 
Visit 6  12 months (± 75 days) 
9.1.2 
(Rationale 7)
Screen Failure subjects should not be assigned 
randomization 
numbers, but their demographic information must be 
captured in the appropriate CRF with the reason for 
screen failure specified. 
1. Obtain written informed consent from the subject as 
detailed in Section 7.5 
----- Do not proceed until consent has been obtained -
---- 
2. Obtain demographic information and medical 
history, including information on all concomitant 
For screen Failure subjects, their demographic 
information must be captured in the appropriate CRF with 
the reason for screen failure specified. 
1. Obtain written informed consent from the subject as 
detailed in Section 7.7 
----- Do not proceed until consent has been obtained -----
2. Obtain demographic information and medical history, 
including information on all concomitant 
medications/therapies.  
3Obtain baseline MRI and confirm eligibility. 

 
 
Clinical Protocol  
Study Number: FAST-FIX 
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medications/therapies. 
3 Obtain baseline MRI and confirm eligibility. 
4. Screen the subject for protocol inclusion/exclusion 
criteria. 
5. Assign the subject a study number and instruct the 
subject on treatment procedures. 
6. Have the subject complete the IKDC Questionnaire 
7 Have the subject complete the Lysholm 
Questionnaire 
8 Have the subject complete the EQ-5D-5L 
Questionnaire 
9. Subjects will be instructed to return for the 
Operation Visit (Procedure) as scheduled by the site. 
4. Screen the subject for protocol inclusion/exclusion 
criteria. 
5. Assign the subject a study number and instruct the 
subject on treatment procedures. 
6. Have the subject complete the IKDC Subjective 
Questionnaire  
7. Have the subject complete the Lysholm Questionnaire 
8. Have the subject complete the EQ-5D-5L Questionnaire
9. Subjects will be instructed to return for the Operation 
Visit (Procedure) as scheduled by the site.   
9.1.5 
(Rationale 4)
Visit 4: Follow-up visit at 3 months (90 days after 
procedure +/- 14 days) 
Visit 4: Follow-up visit at 3 months (90 days after 
procedure + 30 days) 
9.1.6 
(Rationale 7 
and 11) 
9.1.6 Visit 5: Follow-up visit at 6 months (180 days 
after procedure +/- 30 days) 
 
Have the subject complete the IKDC Questionnaire. 
9.1.6 Visit 5: Follow-up visit at 6 months (180 days after 
procedure +/- 45 days) 
 
Have the subject complete the IKDC Subjective 
Questionnaire. 
9.1.7 
(Rationale 8 
and 12) 
9.1.7 Visit 6: Follow-up visit at 12 months (365 days 
after procedure +/- 60 days) 
9.1.7 Exit Visit (Visit 6: Follow-up visit at 12 months (365 
days after procedure +/- 75 days)) 
9.1.7 
(Rationale 7)
Have the subject complete the IKDC Questionnaire. 
Have the subject complete the IKDC Subjective 
Questionnaire. 

 
 
Clinical Protocol  
Study Number: FAST-FIX 
FLEX.2020.09 
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and Performance of the FAST-FIX FLEX System for Meniscal Repairs 
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9.1.12 
(Rationale 1)
Women of child-bearing potential are not excluded 
from the study as long as adequate birth control 
methods are being used by the subject as outlined in 
becomes pregnant during the study, S+N must be 
contacted immediately once the investigator is made 
aware of the pregnancy and a decision will be made 
regarding the continuation in the study of the 
pregnant woman. 
Women of child-bearing potential are not excluded from 
the study. If a woman becomes pregnant during the 
study, S+N must be contacted immediately once the 
investigator is made aware of the pregnancy and a 
decision will be made regarding the continuation in the 
study of the pregnant woman. 
9.2 
(Rationale 7)
The following methods and measurements will be used 
for this study: 
 Magnetic Resonance Imaging (MRI) 
 IKDC Subjective PRO  
 Lysholm PRO 
 EQ-5D-5L 
The following methods and measurements will be used for 
this study: 
 Magnetic Resonance Imaging (MRI) 
 IKDC Subjective PRO  
 Lysholm PRO 
 EQ-5D-5L PRO 
9.2.1 
(Rationale 7)
Magnetic Resonance Imaging (MRI) is a medical 
imaging technique that uses magnetic field and 
computer-generated radio waves to create detailed 
images of an organ or tissue in the body.42 For this 
study, MRIs will be obtained at baseline, 6 months and 
1 years post-treatment to assess structural integrity 
and healing. Sites will make arrangements for MRIs 
per standard procedures and provide the 
images/results to the Sponsor. All MRI assessments 
are detailed in the Image Review Charter. 
Magnetic Resonance Imaging (MRI) is a medical imaging 
technique that uses magnetic field and computer-
generated radio waves to create detailed images of an 
organ or tissue in the body.43 For this study, MRIs will be 
obtained at baseline, 6 months and 1 year post-treatment 
to assess structural integrity and healing. Sites will make 
arrangements for MRIs per standard procedures and 
provide the images/results to the Sponsor. All MRI 
assessments are detailed in the Image Review Charter. 
MRI to confirm eligibility criteria must be within 6 months 
of surgery. 

 
 
Clinical Protocol  
Study Number: FAST-FIX 
FLEX.2020.09 
A Prospective, Multi-center Clinical Study to Evaluate the Safety 
and Performance of the FAST-FIX FLEX System for Meniscal Repairs 
(MR) and Meniscal Allograft Transplantations (MAT) 
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9.2.3 
(Rationale 7)
The Lysholm scale was first introduced into the 
medical community in 1982, modified in 1985, and is a 
validated patient or physician administered instrument 
to measure symptoms and function in patients in 
patients with a variety of knee injuries. This tool 
measures the domains of symptoms and complaints 
and the functioning of daily activities. The scale 
consists of 8 items and is scaled from 0 to 100, with a 
higher score indicating fewer symptoms and a higher 
level of functioning.44,45   
The Lysholm scale was first introduced into the medical 
community in 1982, modified in 1985, and is a validated 
patient or physician administered instrument to measure 
symptoms and function in patients with a variety of knee 
injuries. This tool measures the domains of symptoms 
and complaints and the functioning of daily activities. The 
scale consists of 8 items and is scaled from 0 to 100, with 
a higher score indicating fewer symptoms and a higher 
level of functioning.45,46   
9.2.4 
(Rationale 7)
The tool is widely used in cost-effectivess analysis and 
is available in a variety of languages.46 
The tool is widely used in cost-effectiveness analysis and 
is available in a variety of languages.47 
10.2 
(Rationale 7)
Statistical analysis will be performed using each of the 
patient populations as follows: analysis of primary and 
secondary endpoints will be performed separately 
using both the FAS and PP populations.  
Statistical analysis will be performed using each of the 
patient populations as follows: analysis of primary and 
secondary reoperation rate endpoints will be performed 
on the SAF population; PROs will be presented separately 
using both the FAS and PP populations. 
10.4.1 
(Rationale 5 
and 7) 
A binary variable will be defined for whether each 
patient had reoperation due to meniscal repair failure 
for all treatment visits. This variable will be used to 
present the proportion of reoperations due to meniscal 
repair failure at 12 months, together with a 
percentage and 95% confidence interval 
for a single proportion (calculated using the Clopper-
Pearson method)39. 
The following hypotheses will be tested to establish 
that the rate of reoperations of the Fast-Fix Flex is 
A binary variable will be defined for whether each patient 
had reoperation due to meniscal repair failure for all 
treatment visits. This variable will be used to present the 
proportion of reoperations due to meniscal repair failure 
at 12 months, together with a percentage and 95% 
confidence interval for a single proportion (calculated 
using the Clopper-Pearson method)40.  
 
As a further analysis of the primary endpoint, if the data 
allows, the time taken for reoperation to occur will be 

 
 
Clinical Protocol  
Study Number: FAST-FIX 
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strictly no worse (lower) than the literature derived 
value: 
H0 - 0 < 0 
Ha - 0 0 
reoperations for the Fast-
 
represents the literature derived value (85%)35. A t-
test with alpha = 0.05 will be used to evaluate the 
hypothesis and the corresponding 95% CIs will also be 
presented. 
As a further analysis of the primary endpoint, the time 
taken for reoperation to occur will be assessed as a 
survival endpoint for both indications in order to 
assess the trend of incidence of reoperation 
over time. 
Analysis will be carried out using the FAS population 
as the primary analysis population with the PP 
population used for sensitivity analysis. 
assessed as a survival endpoint for both indications in 
order to assess the trend of incidence of reoperation over 
time.  
 
Analysis will be carried out using the SAF population as 
the primary analysis population. 
10.4.2 
(Rationale 5 
and 7) 
For Lysholm and IKDC, the numbers and proportions 
of subjects, together with a 95% confidence interval 
(calculated using the Clopper-Pearson Exact method), 
meeting the minimal clinically important differences 
(MCID) from baseline to appropriate post-operative 
visit (those which have MCID thresholds available in 
published literature) will be presented. 
For Lysholm and IKDC, the numbers and proportions of 
subjects, together with a 95% confidence interval, 
meeting the minimal clinically important differences 
(MCID) from baseline to appropriate post-operative visit 
(those which have MCID thresholds available in published 
literature) will be presented. 
10.4.3 
(Rationale 7)
The following other endpoints will be analysed for this 
study. 
The following other endpoints will be analysed for this 
study: 

 
 
Clinical Protocol  
Study Number: FAST-FIX 
FLEX.2020.09 
A Prospective, Multi-center Clinical Study to Evaluate the Safety 
and Performance of the FAST-FIX FLEX System for Meniscal Repairs 
(MR) and Meniscal Allograft Transplantations (MAT) 
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11 
(Rationale 5 
and 7) 
The sample size for this study is precision-based, and 
not based on statistical power considerations, thus no 
formal statistical hypothesis is formulated. The sample 
size for this study is determined based on the 
feasibility of recruitment, enrolment and follow-up 
considerations. 
The primary endpoint for the study upon which sample 
size is determined is meniscal repair success rate in 
the study device at 12 months. This is based on the 
 
factors for all-inside meniscal repair. An 87-case 
 
the repair success rate was reported to be 85% for all-
inside meniscal repair. 
Assuming an overall success rate of at least 85%, 82 
subjects are sufficient to obtain at least 99% 
probability of estimating the two-sided 95% 
confidence interval around the success rate to within 
10%. 
Additionally, secondary endpoints in this study assess 
the success rate, meniscus healing and clinical 
performance of PROs for meniscal allograft 
transplantation (MAT). To satisfy European Medical 
Device 
Regulation (EU MDR) requirements, 30 subjects will be 
recruited to provide sufficient evidence on this 
indication. Assuming a 15% drop-out rate at the end 
of 12 months, 130 subjects (97 MR and 33 MAT) will 
The sample size for this study is precision-based, and not 
based on statistical power considerations, thus no formal 
statistical hypothesis is formulated.   
The primary endpoint for the study upon which sample 
size is determined is meniscal repair success rate in the 
study device at 12 months. The publication upon which 
this is based, is the systematic literature review entitled: 
-
Paul Souter (2022)39 the repair success rate was 
reported to be 90% for all-inside meniscal repair. This 
recent systematic literature review provides sufficient 
evidence to increase the success rate from 85% (as 
defined in previous protocol version) to 90% for all-inside 
meniscal repair. For the full report please refer to 
appendix 22.10. 
Assuming an overall success rate of at least 90%, 45 
subjects are sufficient to obtain at least 80% probability 
of estimating the two-sided 95% confidence interval 
around the success rate to within 10%.  
Assuming a 15% drop out rate at the end of the 12 
months, 53 subjects will be enrolled.  
Additionally, secondary endpoints in this study assess the 
success rate, meniscus healing and clinical performance 
of PROs for meniscal allograft transplantation (MAT). To 
have sufficient evidence to support European Medical 
Device Regulation (EU MDR) requirements, a minimum of 
9 and maximum of 15 subjects will be recruited to 
provide sufficient evidence on this indication.  
Furthermore, internal evidence by the Smith+Nephew 

 
 
Clinical Protocol  
Study Number: FAST-FIX 
FLEX.2020.09 
A Prospective, Multi-center Clinical Study to Evaluate the Safety 
and Performance of the FAST-FIX FLEX System for Meniscal Repairs 
(MR) and Meniscal Allograft Transplantations (MAT) 
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be enrolled in order to complete 82 evaluable subjects 
for MR and 30 evaluable subjects for MAT. 
Research and Development (R&D) provides evidence that 
the procedural technique, device use, and resulting suture 
placement is identical for meniscus MR and MAT (see 
Appendix 22.11). It will be at the discretion of the 
Sponsor when enrolment to the MAT indication is 
completed (between 9 and 15 subjects). 
13 
(Rationale 7 
and 8) 
The Principal Investigator will comply with the 
commitments outlined in the in the Statement of 
Investigator, provided by the Sponsor, and with Good 
Clinical Practice (GCP), and all applicable regulatory 
requirements as outlined in Appendix 23.7 of this 
protocol.  
In addition, the PI will ensure that the Financial 
Disclosure  Statements will be completed by the PI 
and the Sub-Investigator upon entry into the study 
and as any changes that affect their financial 
disclosure status occur during the course of the study 
and up to one year after study completion. 
 
The Principal Investigator will comply with the 
commitments outlined in the in the Statement of 
Investigator, provided by the Sponsor, and with Good 
Clinical Practice (GCP), and all applicable regulatory 
requirements as outlined in Appendix 22.8 of this 
protocol. Sub-Investigators, who are individual member 
of the investigation site team designated and supervised 
by the Principal Investigator at an investigation site to 
perform clinical investigation-related procedures or to 
make important clinical investigation-related and medical 
treatment decisions, may have responsibilities delegated 
to them by the Principal Investigator. However, the 
Principal Investigator retains overall responsibility for the 
clinical investigation at the site. 
In addition, the PI will ensure that the Financial 
Disclosure Statements will be completed by the PI and 
the Sub-Investigator upon entry into the study and as 
any changes that affect their financial disclosure status 
occur during the course of the study and up to one year 
after study completion. 

 
 
Clinical Protocol  
Study Number: FAST-FIX 
FLEX.2020.09 
A Prospective, Multi-center Clinical Study to Evaluate the Safety 
and Performance of the FAST-FIX FLEX System for Meniscal Repairs 
(MR) and Meniscal Allograft Transplantations (MAT) 
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The Coordinating Investigator appointed by the Sponsor 
will assist in coordinating the work in the multicentre 
clinical investigation. 
15 
(Rationale 7 
and 8) 
An Investigator must not make any changes or deviate 
from this protocol, except to protect the life and 
physical well-being of a subject in an emergency. 
Protocol deviations reported by the Investigator or 
discovered during monitoring visits will be compiled in 
a Protocol / GCP Deviation Log (TMP-CD-31-02 
Protocol/GCP Deviation Log). Significant and/or 
recurrent protocol/GCP deviations will be documented 
on a protocol deviation form (TMP-CD-31-01 
Protocol/GCP Deviation) including identified root cause 
and, as necessary, appropriate corrective and 
preventive actions will be put in place and signed off 
by the study personnel. If it is deemed necessary full 
clinical CAPA will be initiated. 
It is not allowed to use waivers to allow planned 
deviation of the study protocol.  
An investigator may be early terminated from the 
study upon identification of serious protocol deviations 
whereby there are concerns for patient safety or data 
quality (especially those not reported to the sponsor 
by the site). Early termination may also occur if there 
are repeated protocol deviations which have previously 
been addressed via corrective and preventative actions 
thereby suggesting an issue with site compliance. 
An Investigator must not make any changes or deviate 
from this protocol, except to protect the life and physical 
well-being of a subject in an emergency. Protocol 
deviations reported by the Investigator or discovered 
during monitoring visits will be compiled in a Protocol / 
GCP Deviation Log (FRM-402046 Protocol/GCP Deviation 
Log). Significant and/or recurrent protocol/GCP deviations 
will be documented on a protocol deviation form (FRM-
400347 Protocol/GCP Deviation) including identified root 
cause and, as necessary, appropriate corrective and 
preventive actions will be put in place and signed off by 
the study personnel. If it is deemed necessary full clinical 
Corrective and Preventive Action (CAPA) will be initiated. 
It is not allowed to use waivers to allow planned deviation 
of the study protocol.  
An investigator may be early terminated from the study 
upon identification of serious protocol deviations whereby 
there are concerns for patient safety or data quality 
(especially those not reported to the sponsor by the site). 
Early termination may also occur if there are repeated 
protocol deviations which have previously been addressed 
via corrective and preventative actions thereby 
suggesting an issue with site compliance. 

 
 
Clinical Protocol  
Study Number: FAST-FIX 
FLEX.2020.09 
A Prospective, Multi-center Clinical Study to Evaluate the Safety 
and Performance of the FAST-FIX FLEX System for Meniscal Repairs 
(MR) and Meniscal Allograft Transplantations (MAT) 
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Give notification requirements and timeframes here for 
site staff and monitor to report to S+N and PI to 
report to IRB/IEC (which may be conducted by CSM). 
Protocol deviations requiring reporting to the IRB/IEC 
should be done so in the timeframe stipulated by the 
IRB/IEC. 
18 
(Rationale 7 
and 8) 
This clinical study will be performed in compliance with 
the ethical principles of the Declaration of Helsinki; 
and ISO 14155: Clinical investigation of medical 
devices  Good Clinical Practice. 
This clinical study will not commence until the required 
approval/favorable opinion from the IRB/IEC or 
regulatory authority has been obtained. Any additional 
requirements imposed by the IRB/IEC or regulatory 
authority will be followed.  
Public/Products Liability Insurance has been purchased 
by Smith & Nephew plc. Worldwide and incorporates 
coverage for personal injury in respect of clinical 
studies. The Sponsor agrees to operate in good faith 
and in accordance with ABHI (Association of British 
Healthcare Industries) guidelines regarding 
compensation for injury arising in the course of clinical
studies. 
This clinical study will be performed in compliance with 
the ethical principles of the Declaration of Helsinki; and 
ISO 14155: Clinical investigation of medical devices  
Good Clinical Practice. 
This clinical study will not commence until the required 
approval/favorable opinion from the IRB/IEC or regulatory 
authority has been obtained. Any additional requirements 
imposed by the IRB/IEC or regulatory authority will be 
followed.  
Public/Products Liability Insurance has been purchased by 
Smith & Nephew plc. Worldwide and incorporates 
coverage for personal injury in respect of clinical studies. 
The Sponsor agrees to operate in good faith and in 
accordance with ABHI (Association of British Healthcare 
Industries) guidelines regarding compensation for injury 
arising in the course of clinical studies. 
The clinical study is financed by the sponsor. All financial 
arrangements between the sponsor and investigation 
sites/investigators are documented separate clinical trial 
agreements. 
19 
(Rationale 7 
and 8) 
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-
The end of study is defined as last subject last visit. 
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., 

 
 
Clinical Protocol  
Study Number: FAST-FIX 
FLEX.2020.09 
A Prospective, Multi-center Clinical Study to Evaluate the Safety 
and Performance of the FAST-FIX FLEX System for Meniscal Repairs 
(MR) and Meniscal Allograft Transplantations (MAT) 
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compliance), then this will be undertaken according to 
the SOPs of the Sponsor. 
departure of Investigator, non-compliance), then this will 
be undertaken according to the SOPs of the Sponsor. 
20.1 
(Rationale 8)
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. 
The study will be registered in a publicly accessible 
database and the results will be made available within 
that database. 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. 
21 
(Rationale 5 
and 7) 
39.Clopper, CJ, Pearson ES. In: Biometrika. The use of 
confidence or fiducial limits illustrated in 
the case of the binomial. 1934, 26 p. 404 413. 
40.McCormick F, Harris JD, Abrams GD, Hussey KE, 
Wilson H, Frank R, Gupta AK, Bach BR Jr, 
Cole BJ. Survival and reoperation rates after meniscal 
allograft transplantation: analysis of 
failures for 172 consecutive transplants at a minimum 
2-year follow-up. Am J Sports Med. 
2014 Apr;42(4):892-7. doi: 
10.1177/0363546513520115. Epub 2014 Feb 14. 
PMID: 
24532597. 
41.Taichman, DB, et al. Data Sharing Statements for 
Clinical Trials: A Requirement of the 
39. Souter, P. Clinical performance of FAST-FIX family. 
2022 p. 1-24. 
40. Clopper, CJ, Pearson ES. In: Biometrika. The use of 
confidence or fiducial limits illustrated in the case of the 
binomial. 1934, 26 p. 404 413. 
41. McCormick F, Harris JD, Abrams GD, Hussey KE, 
Wilson H, Frank R, Gupta AK, Bach BR Jr, Cole BJ. 
Survival and reoperation rates after meniscal allograft 
transplantation: analysis of failures for 172 consecutive 
transplants at a minimum 2-year follow-up. Am J Sports 
Med. 2014 Apr;42(4):892-7. doi: 
10.1177/0363546513520115. Epub 2014 Feb 14. PMID: 
24532597. 
42. Taichman, DB, et al. Data Sharing Statements for 
Clinical Trials: A Requirement of the International 

 
 
Clinical Protocol  
Study Number: FAST-FIX 
FLEX.2020.09 
A Prospective, Multi-center Clinical Study to Evaluate the Safety 
and Performance of the FAST-FIX FLEX System for Meniscal Repairs 
(MR) and Meniscal Allograft Transplantations (MAT) 
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International Committee of Medical Journal Editors. 
Ann Intern Med. 2017. 6th June. 
doi:10.7326/M17-1028 
42.MRI [Internet]. Mayo Clinic [updated 2019 Aug 3, 
cited 2020 Feb 6] Available from: 
https://www.mayoclinic.org/tests-
procedures/mri/about/pac-20384768 
43.Collins NJ, Misra D, Felson DT, Crossley KM, Roos 
 
[Internet]. Arthritis Care Res; 2011 Nov [cited 2020 
Feb 6] Available from: 
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC43365
50/ 
44.Van Meer BL, Reijman M, et al. [Internet]. In: The 
Anterior Cruciate Ligament (Second 
Edition). A Comparison of the Standardized Rating 
Forms for Evaluation of Anterior Cruciate 
Ligament Injured or Reconstructed Patients. 2018. 
[updated 2020, cited 2020 Feb 6]. Available from: 
https://www.sciencedirect.com/book/9780323389624/
the-anterior-cruciateligament 
45.Barber-
Knee Disorders: Surgery, Rehabilitation, Clinical 
Outcomes (Second Edition). Rating of Athletic and 
Daily Functional Activities. 2017. 
[updated 2020, cited 2020 Feb 6]. Available from: 
https://www.sciencedirect.com/book/9780323329033/
noyes-knee-disorders-surgeryrehabilitation- 
clinical-outcomes 
Committee of Medical Journal Editors. Ann Intern Med. 
2017. 6th June. doi:10.7326/M17-1028 
43. MRI [Internet]. Mayo Clinic [updated 2019 Aug 3, 
cited 2020 Feb 6] Available from: 
https://www.mayoclinic.org/tests-
procedures/mri/about/pac-20384768 
44. Collins NJ, Misra D, Felson DT, Crossley KM, Roos EW. 
Res; 2011 Nov [cited 2020 Feb 6] Available from: 
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4336550/
45. Van Meer BL, Reijman M, et al. [Internet]. In: The 
Anterior Cruciate Ligament (Second Edition). A 
Comparison of the Standardized Rating Forms for 
Evaluation of Anterior Cruciate Ligament Injured or 
Reconstructed Patients. 2018. [updated 2020, cited 2020 
Feb 6]. Available from: 
https://www.sciencedirect.com/book/9780323389624/the
-anterior-cruciate-ligament 
46. Barber-
Knee Disorders: Surgery, Rehabilitation, Clinical 
Outcomes (Second Edition). Rating of Athletic and Daily 
Functional Activities. 2017. [updated 2020, cited 2020 
Feb 6]. Available from: 
https://www.sciencedirect.com/book/9780323329033/no
yes-knee-disorders-surgery-rehabilitation-clinical-
outcomes 
47. EQ-5D-5L / About [Internet]. EuroQol [updated 2020, 
cited 2020 February 26] Available from: 
https://euroqol.org/eq-5d-instruments/eq-5d-5l-about/ 

 
 
Clinical Protocol  
Study Number: FAST-FIX 
FLEX.2020.09 
A Prospective, Multi-center Clinical Study to Evaluate the Safety 
and Performance of the FAST-FIX FLEX System for Meniscal Repairs 
(MR) and Meniscal Allograft Transplantations (MAT) 
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46.EQ-5D-5L / About [Internet]. EuroQol [updated 
2020, cited 2020 February 26] Available from: 
https://euroqol.org/eq-5d-instruments/eq-5d-5l-
about/ 
22.1 
(Rationale 7)
Protocol Amendment 
Protocol Amendment 1 
22.4 
(Rationale 2)
22.3 Instructions for Use 
 
Smith+Nephew. FAST-FIX FLEX Meniscal Repair 
System IFU (Document ID: 10601463) 
 
22.4 Instructions for Use 
 Smith+Nephew. FAST-FIX FLEX Meniscal Repair System 
IFU (Document ID: 10601463) 
 Smith+Nephew. FAST-FIX FLEX Meniscal Repair System 
IFU slim pack (Document ID: 10601589) 
22.8 
(Rationale 7 
and 8) 
22.7 Principal Investigator Obligations (ISO 14155) 
1. 
General:  
a. The role of the PI is to implement and manage the 
day-to-day conduct of the clinical investigation as well 
as ensure data integrity and the rights, safety, and 
well-being of the subjects involved in the clinical 
investigation. 
22.8 Principal Investigator Obligations (ISO 14155) 
1. General:  
a. The role of the PI is to implement and manage the day-
to-day conduct of the clinical investigation as well as 
ensure data integrity and the rights, safety, and well-
being of the subjects involved in the clinical investigation.
b. The PI is responsible for ensuring adequate training 
and qualification of the investigation site team and for 
maintaining oversight of their activities. The principal 
investigator may delegate tasks to qualified members of 
the investigation site team but retains responsibility for 
the clinical investigation (see also 7.6). This also applies 
when activities are outsourced to an external organization 
by the principal investigator in which case he/she shall 
implement procedures to ensure the integrity of all tasks 

 
 
Clinical Protocol  
Study Number: FAST-FIX 
FLEX.2020.09 
A Prospective, Multi-center Clinical Study to Evaluate the Safety 
and Performance of the FAST-FIX FLEX System for Meniscal Repairs 
(MR) and Meniscal Allograft Transplantations (MAT) 
Version: 3.0, 05/May/2023 
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performed and any data generated by this external 
organization. 
22.8 
(Rationale 7 
and 8) 
22.7 Principal Investigator Obligations (ISO 14155) 
3. Qualification of investigation site. The PI shall be 
able to demonstrate that the proposed 
investigation site: 
a. has the required number of eligible subjects needed 
within the agreed recruitment period, 
and; 
b. has one or more qualified investigators, a qualified 
investigation site team and adequate 
facilities for the foreseen duration of the clinical 
investigation. 
22.8 Principal Investigator Obligations (ISO 14155) 
3. Qualification of investigation site. The PI shall be able 
to demonstrate that the proposed investigation site: 
a. has the required number of eligible subjects needed 
within the agreed recruitment period, and; 
b. has an investigation site team that is: qualified by 
education, training, and experience to assume 
responsibility for the proper conduct of the clinical 
investigation in accordance with this document; evidence 
of such qualifications for members of the investigation 
site team shall be documented through up-to-date CVs or 
other relevant documentation; 
c. has adequate facilities. 
22.8 
(Rationale 7 
and 8) 
22.7 Principal Investigator Obligations (ISO 14155) 
6. Compliance with the protocol. The Principal 
Investigator shall: 
a. indicate his/her acceptance of the protocol in 
writing, 
b. conduct the clinical investigation in compliance with 
the protocol, 
c. create and maintain source documents throughout 
the clinical investigation and make them available as 
requested during monitoring visits or audits, 
d. ensure that the investigational device is used solely 
by authorized users as specified in 6.2, and in 
accordance with the protocol and instructions for use, 
22.8 Principal Investigator Obligations (ISO 14155) 
6. Compliance with the protocol. The Principal 
Investigator shall: 
a. indicate his/her acceptance of the protocol in writing, 
b. conduct the clinical investigation in compliance with the 
protocol, 
c. create and maintain source documents throughout the 
clinical investigation and make them available as 
requested during monitoring visits or audits, 
d. ensure that the investigational device is used solely by 
authorized users as specified in 6.2, and in accordance 
with the protocol and instructions for use, 

 
 
Clinical Protocol  
Study Number: FAST-FIX 
FLEX.2020.09 
A Prospective, Multi-center Clinical Study to Evaluate the Safety 
and Performance of the FAST-FIX FLEX System for Meniscal Repairs 
(MR) and Meniscal Allograft Transplantations (MAT) 
Version: 3.0, 05/May/2023 
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TMP-800052 Clinical Protocol - Device  Revision 4; PRO-201725 Clinical Protocols 
e. propose to the Sponsor any appropriate 
modification(s) of the protocol or investigational 
device or of the use of the investigational device, 
f. refrain from implementing any modifications to the 
protocol without agreement from the 
Sponsor, IEC and regulatory authorities, if required, 
g. document and explain any deviation from the 
approved protocol that occurred during the 
course of the clinical investigation,  
h. ensure that an adequate investigation site team 
and facilities exist and are maintained and 
documented during the clinical investigation, 
i. ensure that maintenance and calibration of the 
equipment relevant for the assessment of the clinical 
investigation is appropriately performed and 
documented, where applicable, 
j. ensure the accuracy, completeness, legibility, and 
timeliness of the data reported to the Sponsor in the 
CRF and in all required reports, 
k. maintain the device accountability records, 
l. allow and support the Sponsor to perform 
monitoring and auditing activities, 
m. be accessible to the monitor and respond to 
questions during monitoring visits, 
n. allow and support regulatory authorities and the 
IEC when performing auditing activities, 
o. ensure that all clinical-investigation-related records 
are retained as required taking measures to prevent 
accidental or premature destruction, and 
e. propose to the Sponsor any appropriate modification(s) 
of the protocol or investigational device or of the use of 
the investigational device, 
f. refrain from implementing any modifications to the 
protocol without agreement from the Sponsor, IEC and 
regulatory authorities, if required, 
g. document and explain any deviation from the approved 
protocol that occurred during the course of the clinical 
investigation, 
h. ensure that an adequate investigation site team and 
facilities exist and are maintained and documented during 
the clinical investigation, 
i. ensure that maintenance and calibration of the 
equipment relevant for the assessment of the clinical 
investigation is appropriately performed and documented, 
where applicable, 
j. ensure the accuracy, completeness, legibility, and 
timeliness of the data reported to the Sponsor in the CRF 
and in all required reports, 
k. maintain the device accountability records, 
l. Comply with the procedure for the safe return of 
investigational devices including potentially hazardous 
devices and, in the case of reported device deficiencies, 
collaborate with the sponsor to provide the necessary 
information allowing an accurate analysis where 
appropriate. requirements and provide any information 
need to analyze device deficiencies, if applicable. 
m. allow and support the Sponsor to perform monitoring 
and auditing activities, 

 
 
Clinical Protocol  
Study Number: FAST-FIX 
FLEX.2020.09 
A Prospective, Multi-center Clinical Study to Evaluate the Safety 
and Performance of the FAST-FIX FLEX System for Meniscal Repairs 
(MR) and Meniscal Allograft Transplantations (MAT) 
Version: 3.0, 05/May/2023 
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p. review and sign the clinical investigation report, as 
applicable. 
n. be accessible to the monitor and respond to questions 
during monitoring visits, 
o. determine the cause and implement appropriate 
corrective and preventative actions to address significant 
noncompliance 
p. allow and support regulatory authorities and the IEC 
when performing auditing activities, 
q.ensure that all clinical-investigation-related records are 
retained as required taking measures to prevent 
accidental or premature destruction, and 
r. review and sign the clinical investigation report, as 
applicable. 
22.8 
(Rationale 7 
and 8) 
8. Safety reporting. The Principal Investigator shall: 
a. record every adverse event and observed device 
deficiency, together with an assessment, 
b. report to the Sponsor, without unjustified delay, all 
serious adverse events and device 
deficiencies that could have led to a serious adverse 
device effect; this information shall be 
promptly followed by detailed written reports, as 
specified in the protocol, 
c. report to the IEC serious adverse events and device 
deficiencies that could have led to a serious adverse 
device effect, if required by the national regulations or 
protocol or by the 
IEC, 
d. report to regulatory authorities, serious adverse 
events and device deficiencies that could have led to a 
8. Safety reporting. The Principal Investigator shall: 
a. record every adverse event and observed device 
deficiency, together with an assessment, 
b. report to the Sponsor, without unjustified delay, all 
serious adverse events and device deficiencies that could 
have led to a serious adverse device effect; this 
information shall be promptly followed by detailed written 
reports, as specified in the protocol, 
c. report to the IEC serious adverse events and device 
deficiencies that could have led to a serious adverse 
device effect, if required by the national regulations or 
protocol or by the IEC,  
d. report to regulatory authorities, serious adverse events 
and device deficiencies that could have led to a serious 
adverse device effect, as required by the national 
regulations, and 

 
 
Clinical Protocol  
Study Number: FAST-FIX 
FLEX.2020.09 
A Prospective, Multi-center Clinical Study to Evaluate the Safety 
and Performance of the FAST-FIX FLEX System for Meniscal Repairs 
(MR) and Meniscal Allograft Transplantations (MAT) 
Version: 3.0, 05/May/2023 
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TMP-800052 Clinical Protocol - Device  Revision 4; PRO-201725 Clinical Protocols 
serious adverse device effect, as required by the 
national regulations, and 
e. supply the Sponsor, upon Sponsor's request, with 
any additional information related to the safety 
reporting of a particular event. 
Note, for studies conducted under 21 CFR Part 812 
Investigational Device Exemption Regulations, an 
investigator shall prepare and submit the following 
complete, accurate, and timely reports: 
(1)Unanticipated Adverse Device Effects An 
investigator shall submit to the sponsor and to 
the reviewing IRB a report of any unanticipated 
adverse device effect occurring during 
an investigation as soon as possible, but in no event 
later than 10 working days after the 
investigator first learns of the effect. 
(2)Withdrawal of IRB approval. An investigator shall 
report to the sponsor, within 5 working 
days, a withdrawal of approval by the reviewing IRB 
of the investigator's part of an 
investigation. 
(3)Progress. An investigator shall submit progress 
reports on the investigation to the 
sponsor, the monitor, and the reviewing IRB at 
regular intervals, but in no event less 
often than yearly. 
(4)Deviations from the investigational plan. An 
investigator shall notify the sponsor and the 
e. supply the Sponsor, upon Sponsor's request, with any 
additional information related to the safety reporting of a 
particular event. 
Note, for studies conducted under 21 CFR Part 812 
Investigational Device Exemption Regulations, an 
investigator shall prepare and submit the following 
complete, accurate, and timely reports: 
(1) Unanticipated Adverse Device Effects An investigator 
shall submit to the sponsor and to the reviewing IRB a 
report of any unanticipated adverse device effect 
occurring during an investigation as soon as possible, but 
in no event later than 10 working days after the 
investigator first learns of the effect. 
(2) Withdrawal of IRB approval. An investigator shall 
report to the sponsor, within 5 working days, a 
withdrawal of approval by the reviewing IRB of the 
investigator's part of an investigation. 
(3) Progress. An investigator shall submit progress 
reports on the investigation to the sponsor, the monitor, 
and the reviewing IRB at regular intervals, but in no 
event less often than yearly. 
(4) Deviations from the investigational plan. An 
investigator shall notify the sponsor and the reviewing 
IRB of any deviation from the investigational plan to 
protect the life or physical well-being of a subject in an 
emergency. Such notice shall be given as soon as 
possible, but in no event later than 5 working days after 
the emergency occurred. Except in such an emergency, 
prior approval by the sponsor is required for changes in or 

 
 
Clinical Protocol  
Study Number: FAST-FIX 
FLEX.2020.09 
A Prospective, Multi-center Clinical Study to Evaluate the Safety 
and Performance of the FAST-FIX FLEX System for Meniscal Repairs 
(MR) and Meniscal Allograft Transplantations (MAT) 
Version: 3.0, 05/May/2023 
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TMP-800052 Clinical Protocol - Device  Revision 4; PRO-201725 Clinical Protocols 
reviewing IRB of any deviation from the 
investigational plan to protect the life or physical 
well-being of a subject in an emergency. Such notice 
shall be given as soon as possible, 
but in no event later than 5 working days after the 
emergency occurred. Except in such an emergency, 
prior approval by the sponsor is required for changes 
in or deviations from 
a plan, and if these changes or deviations may affect 
the scientific soundness of the plan 
or the rights, safety, or welfare of human subjects, 
FDA and IRB also is required. 
(5)Informed consent. If an investigator uses a device 
without obtaining informed consent, the investigator 
shall report such use to the sponsor and the reviewing 
IRB within 5 
working days after the use occurs. 
deviations from a plan, and if these changes or deviations 
may affect the scientific soundness of the plan or the 
rights, safety, or welfare of human subjects, FDA and IRB 
also is required. 
(5) Informed consent. If an investigator uses a device 
without obtaining informed consent, the investigator shall 
report such use to the sponsor and the reviewing IRB 
within 5 working days after the use occurs. 
(6) Final report. An investigator shall, within 3 months 
after termination or completion of the investigation or the 
investigator's part of the investigation, submit a final 
report to the sponsor and the reviewing IRB. 
(7) Other. An investigator shall, upon request by a 
reviewing IRB or FDA, provide accurate, complete, and 
current information about any aspect of the investigation.
22.9 
(Rationale 8)
N/A  new section 
22.9 Clinical Study Sites 
Smith + Nephew will maintain a list of the name and 
address of involved sites in the Trial Master File. This list 
is available upon request. 
22.10 
(Rationale 8)
N/A  new section 
22.10 Evidence Analysis Report 
The full Evidence Analysis Report, authored by Paul 
performance of FAST-
39 is appended below. 
22.11 
(Rationale 5)
N/A  new section 
22.11 R&D internal evidence generated for MAT Indication 

 
 
Clinical Protocol  
Study Number: FAST-FIX 
FLEX.2020.09 
A Prospective, Multi-center Clinical Study to Evaluate the Safety 
and Performance of the FAST-FIX FLEX System for Meniscal Repairs 
(MR) and Meniscal Allograft Transplantations (MAT) 
Version: 3.0, 05/May/2023 
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TMP-800052 Clinical Protocol - Device  Revision 4; PRO-201725 Clinical Protocols 
 
The full R&D internal evidence, dated 03/Apr/2023, for 
the MAT indication is appended below. 

 
Clinical Protocol - Device 
Study Number: FAST-FIX 
FLEX.2020.09 
A Prospective, Multi-center Clinical Study to Evaluate the Safety 
and Performance of the FAST-FIX FLEX System for Meniscal Repairs 
(MR) and Meniscal Allograft Transplantations (MAT) 
Version: 3.0, 05/May/2023 
Page: 138 of 151   
 
 
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 D; SOP-CD-05 Clinical Protocols 
22.2.5 Approval/Notification 
The changes outlined for this amendment will only be implemented following IRB/IEC approval. 
22.3 Sponsor Details 
Smith & Nephew Inc.  
1450 E. Brooks Road  
Memphis, TN 38116  
USA  
22.4 Instructions for Use 
Smith+Nephew. FAST-FIX FLEX Meniscal Repair System IFU (Document ID: 10601463) 
Smith+Nephew. FAST-FIX FLEX Meniscal Repair System IFU slim pack (Document ID: 
10601589)  
 
22.5 Equipment and Special Instructions 
Not applicable. 
22.6 Health Economic Outcome Measures/Quality of Life 
measures 
Not applicable. 
22.7 Additional Information 
Not applicable. 

 
Clinical Protocol - Device 
Study Number: FAST-FIX 
FLEX.2020.09 
A Prospective, Multi-center Clinical Study to Evaluate the Safety 
and Performance of the FAST-FIX FLEX System for Meniscal Repairs 
(MR) and Meniscal Allograft Transplantations (MAT) 
Version: 3.0, 05/May/2023 
Page: 139 of 151   
 
 
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 D; SOP-CD-05 Clinical Protocols 
22.8 Principal Investigator Obligations (ISO 14155) 
1. General:  
a.
The role of the PI is to implement and manage the day-to-day conduct of the clinical 
investigation as well as ensure data integrity and the rights, safety, and well-being of the 
subjects involved in the clinical investigation. 
b. The PI is responsible for ensuring adequate training and qualification of the investigation site 
team and for maintaining oversight of their activities. The principal investigator may delegate 
tasks to qualified members of the investigation site team but retains responsibility for the 
clinical investigation (see also 7.6). This also applies when activities are outsourced to an 
external organization by the principal investigator in which case he/she shall implement 
procedures to ensure the integrity of all tasks performed and any data generated by this 
external organization. 
2. Qualification of the PI. The PI shall: 
a.
be qualified by education, training, and experience to assume responsibility for the proper 
conduct of the clinical investigation in accordance with this International Standard; evidence 
of such qualifications of the PI and key members of the investigation site team shall be 
provided to the Sponsor through up-to-date Curriculum Vitae (CV) or other relevant 
documentation, 
b. be experienced in the field of application and trained in the use of the investigational device 
under consideration, 
c.
disclose potential conflicts of interest, including financial, that interfere with the conduct of 
the clinical investigation or interpretation of results, and 
d. be knowledgeable with the method of obtaining informed consent. 
3. Qualification of investigation site. The PI shall be able to demonstrate that the proposed 
investigation site: 
a.
has the required number of eligible subjects needed within the agreed recruitment period, 
and; 

 
Clinical Protocol - Device 
Study Number: FAST-FIX 
FLEX.2020.09 
A Prospective, Multi-center Clinical Study to Evaluate the Safety 
and Performance of the FAST-FIX FLEX System for Meniscal Repairs 
(MR) and Meniscal Allograft Transplantations (MAT) 
Version: 3.0, 05/May/2023 
Page: 140 of 151   
 
 
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 D; SOP-CD-05 Clinical Protocols 
b. has an investigation site team that is: qualified by education, training, and experience to 
assume responsibility for the proper conduct of the clinical investigation in accordance with 
this document; evidence of such qualifications for members of the investigation site team 
shall be documented through up-to-date CVs or other relevant documentation; 
c.
has adequate facilities. 
4. Communication with the IEC. The PI shall:  
a.
provide the Sponsor with copies of any clinical-investigation-related communications between 
the PI and the IEC, 
b. comply with the requirements described in 4.5 of ISO 14155. 
i. 
Submit to the IEC the following information, any amendments and any additional 
documentation required by the IEC: The Protocol; IB or equivalent; informed consent 
form and any other written information provided to subjects; procedures for recruiting 
subjects and advertising materials, if any; a copy of the CV of the PI(s) for with the IEC 
has oversight. 
ii. 
Provide documentation of the IECs approval/favorable opinion, identifying the 
documents and amendments on which the opinion was based, to the Sponsor, prior to 
commencing the clinical investigation.  
iii. 
Submit the following to the IEC if required by national regulations, the protocol or IEC, 
whichever is more stringent: 
1. SAEs 
2. 
rights, safety, and well-being, or the scientific integrity of the clinical investigation. 
Document and report to the Sponsor and IEC a report of deviations made to protect 
the rights, safety, and well-being of human subjects under emergency 
circumstances.  
3. Progress reports, including safety summary and deviations 
4. Amendments to any documents already approved by the IEC.  

 
Clinical Protocol - Device 
Study Number: FAST-FIX 
FLEX.2020.09 
A Prospective, Multi-center Clinical Study to Evaluate the Safety 
and Performance of the FAST-FIX FLEX System for Meniscal Repairs 
(MR) and Meniscal Allograft Transplantations (MAT) 
Version: 3.0, 05/May/2023 
Page: 141 of 151   
 
 
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 D; SOP-CD-05 Clinical Protocols 
5. If applicable, notifications of suspension or premature termination 
6. If applicable, justification and request for resuming the clinical investigation after 
suspension.  
7. Clinical investigation report or summary. 
iv. 
As a minimum, during the clinical investigation, the following information shall be 
obtained in writing from the IEC prior to implementation: 
1. Approval/favorable opinion of amendments 
2. 
and well-being or scientific integrity of the clinical investigation 
3. Approval for resumption of a suspended clinical investigation if applicable.  
c.
obtain the written and dated approval/favorable opinion of the IEC for the clinical 
investigation before recruiting subjects and implementing all subsequent amendments, if 
required, 
d. promptly report any deviations from the protocol that affect the rights, safety or well-being 
of the subject or the scientific integrity of the clinical investigation, including those which 
occur under emergency circumstances, if required by the IEC, protocol or national 
regulations. In particular circumstances, the communication with the IEC can be performed 
by the Sponsor, partly or in full, in which case the Sponsor shall keep the Principal 
Investigator informed. 
5. Informed consent process. The PI shall: 
a.
General: 
i. 
Informed consent shall be obtained in writing from the subject and the process shall be 
documented before any procedure specific to the clinical investigation is applied to the 
subject; except when special circumstances for emergency treatments apply (see below) 
b. Process of obtaining informed consent. The general process for obtaining informed consent 
shall be documented in the protocol and shall comply with the following. These requirements 

 
Clinical Protocol - Device 
Study Number: FAST-FIX 
FLEX.2020.09 
A Prospective, Multi-center Clinical Study to Evaluate the Safety 
and Performance of the FAST-FIX FLEX System for Meniscal Repairs 
(MR) and Meniscal Allograft Transplantations (MAT) 
Version: 3.0, 05/May/2023 
Page: 142 of 151   
 
 
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 D; SOP-CD-05 Clinical Protocols 
also a
representative:  
i. 
Ensure that the PI or his/her authorized designee conducts the informed consent process 
ii. 
Include all aspects of the clinical investigation that are relevant 
to participate throughout the clinical investigation 
iii. 
Avoid any coercion or undue improper influence on, or inducement of, the subject to 
participate 
iv. 
 
v. 
Use native non-technical language that is understandable to the subject 
vi. 
Provide ample time for the subject to read and understand the informed consent form 
and to consider participation in the clinical investigation 
vii. 
Include personally dated signatures and the PI or an authorized designee responsible 
for conducting the informed consent process 
viii. 
Show how informed consent will be obtained in special circumstances (see below) where 
the subject is unable to provide him or herself, and  
ix. 
Ensure important new information is provided to new and existing subjects throughout 
the clinical investigation.  
c.
Special circumstances for informed consent (the following provisions are subject to national 
regulations): 
i. 
Subject needing legally authorized representatives:  informed consent may be given by 
the legally authorized representative only if a subject is unable to make the decision to 
participate in a clinical investigation (e.g., infant, child, or juvenile, seriously ill or 
unconscious subject, mentally ill person, mentally handicapped person). In such cases, 
the subject shall also be informed about the clinical investigation within his/her ability 
to understand.  
ii. 
Subject unable to read or write: informed consent shall be obtained through a 
supervised oral process if a subject or legally authorized representative is unable to read 
or write. An independent witness shall be present throughout the process. The written 

 
Clinical Protocol - Device 
Study Number: FAST-FIX 
FLEX.2020.09 
A Prospective, Multi-center Clinical Study to Evaluate the Safety 
and Performance of the FAST-FIX FLEX System for Meniscal Repairs 
(MR) and Meniscal Allograft Transplantations (MAT) 
Version: 3.0, 05/May/2023 
Page: 143 of 151   
 
 
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 D; SOP-CD-05 Clinical Protocols 
informed consent form and any other information shall be read aloud and explained to 
the prospective subject or his/her legally authorized representative and, whenever 
possible, either shall sign and personally date the informed consent form. The witness 
also signs and personally dates the informed consent for attesting that the information 
was accurately explained and that the informed consent was freely given.  
iii. 
Emergency treatments:  
1. For clinical investigations involving emergency treatments, when prior informed 
be requested.  
2. When it is not possible to obtain prior informed consent from the subject, and the 
enrolled if a specific process has been described in the protocol.  
3. Arrangements shall be made to inform the subject or legally authorized 
representative
investigation and about all aspects of the clinical investigation.  
4. The subject shall be asked to provide informed consent for continued participation 
as soon as his/her medical condition allows.  
d. The Principal Investigator may not enroll a subject without obtaining informed consent of the 
subject or his/her legally authorized representative only when the following conditions are 
fulfilled: the prospective subject fulfils the emergency conditions and is obviously in a life-
threatening situation; no sufficient clinical benefits are anticipated from the currently 
available treatment; there is a fair possibility that the life-threatening risk to the prospective 
subject can be avoided if the investigational device is used; anticipated risks are outweighed 
by the potential benefits of applying the investigational device ; the legally authorized 
representative cannot be promptly reached and informed.  

 
Clinical Protocol - Device 
Study Number: FAST-FIX 
FLEX.2020.09 
A Prospective, Multi-center Clinical Study to Evaluate the Safety 
and Performance of the FAST-FIX FLEX System for Meniscal Repairs 
(MR) and Meniscal Allograft Transplantations (MAT) 
Version: 3.0, 05/May/2023 
Page: 144 of 151   
 
 
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 D; SOP-CD-05 Clinical Protocols 
e.
Information provided to the subject. All information pertinent to the clinical investigation, 
including at least the following, shall be provided in writing and in native, non-technical 
language that is understandable to 
authorized 
representative): 
i. 
Description and purpose 
ii. 
Potential benefits 
iii. 
Risks and inconveniences or the subject and, when applicable, for any embryo, fetus or 
nursing infant 
iv. 
Alternative procedures 
v. 
Confidentiality 
vi. 
Compensation 
vii. 
Anticipated expenses, if any, to be borne by the subject for participating in the clinical 
investigation 
viii. 
 
ix. 
Contact persons 
x. 
Statement declaring that new findings or the reasons for any amendment to the protocol 
xi. 
articipation in the clinical investigation 
xii. 
Termination procedures 
f. 
Informed consent signature shall contain the following:  
i. 
The voluntary agreement to participate in the clinical investigation and follow the 
 
ii. 
A statement declaring that refusal of participation incurs no penalty for the subject 
iii. 
A statement declaring that discontinuation at any time incurs no penalty for the subject 
iv. 
A statement with regard to the possible consequences of withdrawal 
v. 
An acknowledgment of the i
questions were answered 

 
Clinical Protocol - Device 
Study Number: FAST-FIX 
FLEX.2020.09 
A Prospective, Multi-center Clinical Study to Evaluate the Safety 
and Performance of the FAST-FIX FLEX System for Meniscal Repairs 
(MR) and Meniscal Allograft Transplantations (MAT) 
Version: 3.0, 05/May/2023 
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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 D; SOP-CD-05 Clinical Protocols 
vi. 
A statement confirming that the subject or his/her legally authorized representative 
al 
investigation 
vii. 
A statement confirming that the subject or his/her legally authorized representative 
 
g. New 
future health and medical care, that information shall be provided to the subject(s) affected 
in written form. If relevant, all affected subjects shall be asked to confirm their continuing 
consent in writing.  
h. ensure compliance with the applicable regulatory requirements and ethical principles for the 
process of obtaining informed consent, and 
i. 
ensure and document appropriate training if an authorized designee is appointed to conduct 
the informed consent process. 
6. Compliance with the protocol. The Principal Investigator shall: 
a.
indicate his/her acceptance of the protocol in writing, 
b. conduct the clinical investigation in compliance with the protocol, 
c.
create and maintain source documents throughout the clinical investigation and make them 
available as requested during monitoring visits or audits, 
d. ensure that the investigational device is used solely by authorized users as specified in 6.2, 
and in accordance with the protocol and instructions for use, 
e.
propose to the Sponsor any appropriate modification(s) of the protocol or investigational 
device or of the use of the investigational device, 
f. 
refrain from implementing any modifications to the protocol without agreement from the 
Sponsor, IEC and regulatory authorities, if required, 
g. document and explain any deviation from the approved protocol that occurred during the 
course of the clinical investigation, 

 
Clinical Protocol - Device 
Study Number: FAST-FIX 
FLEX.2020.09 
A Prospective, Multi-center Clinical Study to Evaluate the Safety 
and Performance of the FAST-FIX FLEX System for Meniscal Repairs 
(MR) and Meniscal Allograft Transplantations (MAT) 
Version: 3.0, 05/May/2023 
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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 D; SOP-CD-05 Clinical Protocols 
h. ensure that an adequate investigation site team and facilities exist and are maintained and 
documented during the clinical investigation, 
i. 
ensure that maintenance and calibration of the equipment relevant for the assessment of the 
clinical investigation is appropriately performed and documented, where applicable, 
j. 
ensure the accuracy, completeness, legibility, and timeliness of the data reported to the 
Sponsor in the CRF and in all required reports, 
k.
maintain the device accountability records, 
l. 
Comply with the procedure for the safe return of investigational devices including 
potentially hazardous devices and, in the case of reported device deficiencies, collaborate 
with the sponsor to provide the necessary information allowing an accurate analysis where 
appropriate. requirements and provide any information need to analyze device deficiencies, 
if applicable. 
m. allow and support the Sponsor to perform monitoring and auditing activities, 
n. be accessible to the monitor and respond to questions during monitoring visits, 
o.
determine the cause and implement appropriate corrective and preventative actions to 
address significant noncompliance 
p. allow and support regulatory authorities and the IEC when performing auditing activities, 
q. ensure that all clinical-investigation-related records are retained as required taking measures 
to prevent accidental or premature destruction, and 
r. 
review and sign the clinical investigation report, as applicable. 
7. Medical care of subjects. The Principal Investigator shall 
a.
provide adequate medical care to a subject during and after a subject's participation in a 
clinical investigation in the case of adverse events,  
b. inform the subject of the nature and possible cause of any adverse events experienced, 
c.
provide the subject with the necessary instructions on proper use, handling, storage, and 
return of the investigational device, when it is used or operated by the subject, 
d. inform the subject of any new significant findings occurring during the clinical investigation, 
including the need for additional medical care that may be required, 

 
Clinical Protocol - Device 
Study Number: FAST-FIX 
FLEX.2020.09 
A Prospective, Multi-center Clinical Study to Evaluate the Safety 
and Performance of the FAST-FIX FLEX System for Meniscal Repairs 
(MR) and Meniscal Allograft Transplantations (MAT) 
Version: 3.0, 05/May/2023 
Page: 147 of 151   
 
 
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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 D; SOP-CD-05 Clinical Protocols 
e.
provide the subject with well-defined procedures for possible emergency situations related to 
the clinical investigation, and make the necessary arrangements for emergency treatment, 
including decoding procedures for blinded/masked clinical investigations, as needed, 
f. 
ensure that clinical records are clearly marked to indicate that the subject is enrolled in a 
particular clinical investigation, 
g. if appropriate, subjects enrolled in the clinical investigation shall be provided with some 
means of showing their participation in the clinical investigation, together with identification 
and compliance information for concomitant treatment measures (contact address and 
telephone numbers shall be provided), 
h. inform, with the subject's approval or when required by national regulations, the subject's 
personal physician about the subject's participation in the clinical investigation, and  
i. 
make all reasonable efforts to ascertain the reason(s) for a subject's premature withdrawal 
from the clinical investigation while fully respecting the subject's rights. 
8. Safety reporting. The Principal Investigator shall: 
a.
record every adverse event and observed device deficiency, together with an assessment, 
b. report to the Sponsor, without unjustified delay, all serious adverse events and device 
deficiencies that could have led to a serious adverse device effect; this information shall be 
promptly followed by detailed written reports, as specified in the protocol, 
c.
report to the IEC serious adverse events and device deficiencies that could have led to a 
serious adverse device effect, if required by the national regulations or protocol or by the 
IEC,  
d. report to regulatory authorities, serious adverse events and device deficiencies that could 
have led to a serious adverse device effect, as required by the national regulations, and 
e.
supply the Sponsor, upon Sponsor's request, with any additional information related to the 
safety reporting of a particular event. 
Note, for studies conducted under 21 CFR Part 812 Investigational Device Exemption Regulations, 
an investigator shall prepare and submit the following complete, accurate, and timely reports: 

 
Clinical Protocol - Device 
Study Number: FAST-FIX 
FLEX.2020.09 
A Prospective, Multi-center Clinical Study to Evaluate the Safety 
and Performance of the FAST-FIX FLEX System for Meniscal Repairs 
(MR) and Meniscal Allograft Transplantations (MAT) 
Version: 3.0, 05/May/2023 
Page: 148 of 151   
 
 
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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 D; SOP-CD-05 Clinical Protocols 
(1) Unanticipated Adverse Device Effects An investigator shall submit to the sponsor and to 
the reviewing IRB a report of any unanticipated adverse device effect occurring during 
an investigation as soon as possible, but in no event later than 10 working days after the 
investigator first learns of the effect. 
(2) Withdrawal of IRB approval. An investigator shall report to the sponsor, within 5 working 
days, a withdrawal of approval by the reviewing IRB of the investigator's part of an 
investigation. 
(3) Progress. An investigator shall submit progress reports on the investigation to the 
sponsor, the monitor, and the reviewing IRB at regular intervals, but in no event less 
often than yearly. 
(4) Deviations from the investigational plan. An investigator shall notify the sponsor and the 
reviewing IRB of any deviation from the investigational plan to protect the life or physical 
well-being of a subject in an emergency. Such notice shall be given as soon as possible, 
but in no event later than 5 working days after the emergency occurred. Except in such 
an emergency, prior approval by the sponsor is required for changes in or deviations from 
a plan, and if these changes or deviations may affect the scientific soundness of the plan 
or the rights, safety, or welfare of human subjects, FDA and IRB also is required. 
(5) Informed consent. If an investigator uses a device without obtaining informed consent, 
the investigator shall report such use to the sponsor and the reviewing IRB within 5 
working days after the use occurs. 
(6) Final report. An investigator shall, within 3 months after termination or completion of the 
investigation or the investigator's part of the investigation, submit a final report to the 
sponsor and the reviewing IRB. 
(7) Other. An investigator shall, upon request by a reviewing IRB or FDA, provide accurate, 
complete, and current information about any aspect of the investigation. 
 

 
Clinical Protocol - Device 
Study Number: FAST-FIX 
FLEX.2020.09 
A Prospective, Multi-center Clinical Study to Evaluate the Safety 
and Performance of the FAST-FIX FLEX System for Meniscal Repairs 
(MR) and Meniscal Allograft Transplantations (MAT) 
Version: 3.0, 05/May/2023 
Page: 149 of 151   
 
 
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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 D; SOP-CD-05 Clinical Protocols 
22.9 Clinical Study Sites 
Smith + Nephew will maintain a list of the name and address of involved sites in the Trial Master 
File. This list is available upon request. 
 
 

 
Clinical Protocol - Device 
Study Number: FAST-FIX 
FLEX.2020.09 
A Prospective, Multi-center Clinical Study to Evaluate the Safety 
and Performance of the FAST-FIX FLEX System for Meniscal Repairs 
(MR) and Meniscal Allograft Transplantations (MAT) 
Version: 3.0, 05/May/2023 
Page: 150 of 151   
 
 
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 D; SOP-CD-05 Clinical Protocols 
22.10 Evidence Analysis Report 
The full Evidence Analysis Report, authored by Paul Souter on 29th November 2022 and titled 
Clinical performance of FAST-FIX family 39 is appended below. 
 
 
 

 
 
 
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Smith+Nephew 
Global Clinical and Medical Affairs 
Evidence Analysis Report 
Title 
Clinical performance of FAST-FIX family 
Author 
Paul Souter (Clinical Evidence Specialist) 
Requestor
Hadi El Heneidi (Director, Global Marketing)
Franchise 
SPM 
Reviewer 
Matthew Sedgwick (Senior Clinical Evidence 
Specialist)
Issue date
29th Nov 2022 
Report Reference EA/SPM/FASTFIX/007/v3 
For further explanation about the use of this report or its findings, please 
contact the author or a member of Evidence Analysis. 

 
 
 
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Contents 
Abbreviations ................................................................................................................................................ 3 
1. 
Executive Summary ............................................................................................................................... 3 
1.1. 
Purpose ......................................................................................................................................... 3 
1.2. 
Key Findings .................................................................................................................................. 3 
2. 
Search Methodology ............................................................................................................................. 5 
3. 
Results ................................................................................................................................................... 7 
3.1 Meniscal repair success/failure .......................................................................................................... 9 
3.2 Re-operation ..................................................................................................................................... 12 
4.4 Patient reported outcome measures ................................................................................................ 15 
4. 
Discussion............................................................................................................................................ 20 
5. 
References .......................................................................................................................................... 21 
 
 
 
 

 
 
 
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Abbreviations 
ACLR  
Anterior cruciate ligament reconstruction 
IKDC  
International Knee Documentation Committee 
MRI 
 
Magnetic Resonance Imaging 
PROMs 
Patient-reported outcome measures 
sd 
 
Standard deviation 
 
1. Executive Summary 
1.1. Purpose 
 
To establish the success rate and patient reported outcomes (PROMs) following the 
repair of meniscal body tears using a device from the FAST-FIX family. 
This is an update to the previously completed systematic literature review and meta-
analyses 
performed 
in 
2019 
to 
determine 
the 
success 
rates 
(EO/SPM/FASTFIX/002/v2) 
and 
patient 
reported 
outcomes 
(PROMs) 
(EO/SPM/FASTFIX/003/v2) when FAST-FIX was utilised for meniscus repair. 
 
1.2. Key Findings 
 
The systematic literature review identified 38 studies reporting on the success rate 
of FAST-FIX devices in meniscal repair. Of these publications, 27 also reported 
patient-reported outcome measures (PROMs). 
 
Meniscal repair success/failure: Meta-analysis revealed 
successful 
meniscal repair, as defined by individual studies, in 88% (95% CI: 86-90) of 
cases at a mean follow-up of 34.4 months. Of those patients undergoing 
surgery for isolated meniscal repair or with concomitant anterior cruciate 
ligament reconstruction (ACLR), success was reported in 92% (95% CI: 89-
94) and 89% (95% CI: 87-91), respectively. 
 
 
Re-operation: Meta-analysis revealed a success rate of 90% (95% CI: 86-
93) success with 10% (95% CI: 7-14) requiring re-operation at a weighted 
mean follow-up of 39.7 months. Of those patients undergoing surgery for 

 
 
 
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Page 4 of 24 
isolated meniscal repair or with concomitant (ACLR), re-operation was 
reported in 6% (95% CI: 4-9) and 11% (95% CI: 9-14), respectively. 
 
 
PROM: Meta-analysis revealed a mean International Knee Documentation 
Committee (IKDC), Lysholm and Tegner activity scores of 86.34 (95% CI: 
83.89-88.79; weighted mean follow-up, 37.4 months), 89.43 (95% CI: 86.77-
92.09; weighted mean follow-up, 28.3 months) and 6.22 (95% CI: 5.81-6.62; 
weighted mean follow-up, 54.5 months), respectively. Post-operative scores 
were similar when only considering isolated meniscal repair and meniscal 
repair with concomitant ACLR. 
 
 

 
 
 
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2. Search Methodology 
 
A systematic literature review was performed using Embase and PubMed to identify 
clinical studies that detailed the use of a FAST-FIX family device.  The search terms 
utilised were: 
Embase: fastfix OR 'fast fix' 
PubMed: fast-fix or “fast fix” or “fastfix” 
These searches were initially performed on 5th April 2019 (Embase) and 8th April 2019 
(PubMed) as detailed in EO/SPM/FASTFIX/002/v2 and EO/SPM/FASTFIX/003/v2.  
These searches were then updated on 26th (PubMed) and 27th (Embase) June 2022 
with limits placed on publication date to only capture publications following the initial 
searches. 
Additional relevant publications were identified from reference lists. 
 
The following inclusion/exclusion criteria were applied to the resulting publications. 
Inclusion criteria: 
 
Patients of any age undergoing meniscal body repair 
 
Sole use of FAST-FIX devices (any variant) for meniscal repair 
 
 
 
Meniscal repair as either an isolated procedure or in conjunction with anterior 
cruciate ligament reconstruction (ACLR) 
 
Reporting an outcome of interest: Success rate (as defined by individual 
study), re-operation rate or PROMs (Lysholm, Tegner, International Knee 
Documentation Committee (IKDC)) 
 
Primary empirical clinical study 
 
Full-text publication or conference abstract 
 
English language 
Exclusion criteria: 
 
Meniscal root tear repair 
 
Meniscal ramp lesion repair 
 
Use of meniscal allograft 
 
Hybrid repairs (e.g. concurrent use of FASTFIX and inside-out repair 
techniques) 
 
Outcome data not specific to the FAST-FIX only (i.e. pooled with other 
procedures or devices) 

 
 
 
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Page 6 of 24 
 
Studies not in English 
 
<10 patients 
 
Studies performed on animals 
 
Cadaveric studies 
 
Laboratory-based studies 
 
Surgical technique description without clinical data 
 
Reviews, systematic literature reviews, editorials and meta-analyses 
 
Data extraction 
Data were extracted from included studies by one reviewer using a predefined data 
extraction form. Extracted data included procedure (meniscus repair or meniscus 
repair with ACLR), tear type, mean follow-up, definition of successful repair, sample 
sizes, number of successful meniscal repairs, number of re-operations, IKDC (mean, 
standard deviation), Lysholm score (mean, standard deviation) and Tegner activity 
score (mean, standard deviation). 
 
Statistical analyses: 
 
Meta-analyses were performed using R statistical programming software (version 
4.0.2). Proportional meta-analysis was utilised for dichotomous outcome data and 
continuous meta-analysis was utilised for continuous outcome data to provide a mean 
score representative of included studies. All procedures were initially analysed and 
partitioned by surgical procedure (meniscal repair or meniscal repair with 
concomitant ACLR). Heterogeneity of included studies was assessed using the I2
statistic. When I2 was less than 50% (indicating no substantial heterogeneity), a 
fixed-effect/common effect model was used; when I2 was over 50%, a random-
effects model was used. Weighted mean of follow-up (months) were calculated from 
those for which they were provided and was based on patient number.  
When a median was provided along with a range or interquartile range the mean and 
standard deviation was determined using the estimates presented by Wan et al1. 
Where no variation data were provided, the sd was calculated as the mean of those 
for which the sd was stated in the publication2. 
 
 
 

 
 
 
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3. Results 
Thirty-eight relevant studies3-40 were identified to meet the inclusion/exclusion 
criteria of this review (Figure 1). These publications totaled 2007 patients, detailing 
the outcomes across vertical, longitudinal, horizontal, bucket-handle, radial and 
complex tears, and across both the medial and lateral menisci. 
 

 
 
 
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Records identified through database searching (to April 2019) 
PubMed (n = 86) 
Embase (n =160) 
Additional references from reference lists (n=6) 
Records identified through database searching (2019-June 2022) 
PubMed (n = 28) 
Embase (n = 50) 
Additional references from reference lists (n=1) 
Total = 331 
Records after duplicates removed
(n = 222)
Records excluded 
(n = 65)
Full-text articles assessed 
for eligibility 
(n = 157)
Full-text articles excluded, with 
reasons (n = 119): 
Not original (n = 12) 
Non-clinical (n = 44) 
Not meniscal repair (n = 27) 
Low sample size (n = 17) 
Meniscal ramp/root tear (n = 11) 
Hybrid repair (n = 3) 
Use of an implant (n = 5) 
Studies included in 
quantitative synthesis 
(meta-analysis) 
(n = 38) 
Records excluded (duplicates) 
(n = 109) 
 
Figure 1 Study selection flow chart.  

 
 
 
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3.1 Meniscal repair success/failure 
 
Thirty-eight studies reported on meniscal repair success following meniscal repair 
with FAST-FIX3-40. Meniscal repair success/failure was determined through several 
methods 
including: 
second 
look 
arthroscopy6,12,23,27,29,35, 
re-
operation5,10,13,15,18,21,26,28,30,33,34,37-40, magnetic resonance imaging (MRI)9,16, clinical 
assessment (i.e. absence of effusion or pain on palpation at the height of the intra-
articular space and negative tests for meniscal injury)3,7,8,11,17,20,22,24,25,31,36, threshold 
score from PROMs14,32, or multiple factors (re-operation, clinical assessment, MRI, 
PROM)4,19. 
Across 2114 tears, meniscal repair with FAST-FIX was determined to be successful in 
88% (95% CI: 86-90) of cases (Figure 2) at a weighted mean follow-up of 34.4 
months. Choi et al9 and Song et al29 reported on the degree of healing (complete, 
partial, failed), success was considered as complete or partial healing and failure as 
failed healing. 
 

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Figure 2: Success of meniscal repairs using FAST-FIX.
Seventeen publications reported success rates for isolated meniscal repair 3-
8,13,14,18,20,24,25,28,30,32,38,39 and 23 publications for meniscal repair with concomitant 
ACLR4-6,8-10,12-14,17,20,23-25,27,29,31,32,35,36,38-40. Meta-analysis of the 365 isolated meniscal 
repairs reported a success rate of 92% (95% CI: 89-94) (Figure 3) at a weighted 
mean follow-up of 32.2 months. Meta-analysis of the 941 tears repaired alongside

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Page 11 of 24
ACLR reported a success rate of 89% (95% CI: 87-91) (Figure 4) at a weighted 
mean follow-up of 37.2 months. Ahn et al performed their isolated repairs with a 
‘marrow-stimulating’ technique via reaming of the intercondylar notch3. While this 
technique has potential similarities to ACLR+, this was also assigned to the isolated 
tear analysis since ligament function had not been compromised.
Figure 3: Success rate of isolated meniscal repairs using FAST-FIX.

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Page 12 of 24
Figure 4: Success rate of meniscal repair using FAST-FIX with concomitant ACLR.
3.2 Re-operation
Twenty-six publications reported on the requirement for re-operation
3-5,8,10,11,13-
15,17,18,20-23,25,26,28,30,32-34,37-40. Meta-analysis of the 1484 tears reported 90% (95% CI: 
86-93) success with 10% (95% CI: 7-14) requiring re-operation (Figure 5) at a 
weighted mean follow-up of 39.7 months.

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Page 13 of 24
Figure 5: Rate of meniscal repair success (defined as not requiring meniscal re-
operation) using FAST-FIX.
Fourteen studies reported reoperation rates for patients who underwent isolated 
meniscal repair3-5,8,13,14,18,25,26,30,32,38,39,41. Meta-analysis of 273 tears revealed 94% 
(95% CI: 91-96) success, with 6% (95% CI: 4-9) requiring re-operation (Figure 6)
at a mean weighted follow-up of 36.5 months. Meta-analysis of 562 tears from 13 
studies reporting
on re-operation rate following repair of meniscal tear with 
concomitant ACLR found 89% (95% CI: 86-91) success with 11% (95% CI: 9-14) 
requiring re-operation (Figure 7)
at a mean weighted follow-up of 42.9
months4,5,8,10,13,14,23,25,26,32,38-40.

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Figure 6: Rate of isolated meniscal repair success (defined as not requiring meniscus 
re-operation) using FAST-FIX.
Figure 7: Rate of meniscal repair using FAST-FIX with concomitant ACLR success 
(defined as not requiring meniscus re-operation).

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4.4 Patient reported outcome measures
The systematic literature review identified 27 publications reporting one or more of 
PROMs of interest: IKDC (nine studies)4,11,14,21,24,27,32,36,38, Lysholm (18 studies)3,4,6-
10,12,14,16,17,20,24,25,27,29,30,36 and Tegner activity scores (11 studies)3,5,6,8,9,18,20,25,28,29,37.
IKDC is an assessment tool that measures seven items related to patient symptoms, 
two related to function and two to sport activities. Scoring ranges from ‘0’ (lowest 
function, highest symptom), to 100 (highest function, lowest symptom)42. Analysis
of IKDC was performed from 9 studies, with data from Bogunovic et al38 and 
Tucciaraone et al32 provided as separate isolated tear and ACLR+ series. Two 
publications within the systematic literature review contained IKDC scores, however
had excluded those patients with failed healing26,39. Due to the bias this may have on 
outcomes, these two studies were excluded from analysis.
All other data were 
provided as a complete study population. Following meniscal repair, weighted mean 
IKDC was calculated as 86.34 (95% CI: 83.89-88.79) across 439 patients (Figure 
8) at a weighted mean follow-up of 37.4 months.
Figure 8: IKDC scores following meniscal repair using FAST-FIX.
Meta-analysis of 46 patients receiving repair of isolated meniscal repair reported a 
weighted mean IKDC of 84.60 (95% CI: 78.34-90.86) (Figure 9) at a weighted mean 
follow-up of 58.6 months32,38. Following meniscal repair with concomitant ACLR, 

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Page 16 of 24
weighted mean IKDC was calculated as 84.84 (95% CI: 81.70-87.98) across 186
patients (Figure 10) at a weighted mean follow-up of 41.1 months11,27,32,36,38.
Figure 9: IKDC scores of isolated meniscal repair using FAST-FIX.
Figure 10: IKDC scores of meniscal repair using FAST-FIX with concomitant ACLR.
Lysholm score consists of eight items (pain, instability, locking, swelling, limp, stair 
climbing, squatting, support), with a range of 0-100 (greater score indicating better 
function with few symptoms). An overall score of 95-100 is considered excellent, with 
84-94, good; 65-83, fair; and <65, poor42. As with IKDC, Lysholm score was reported 
as isolated and concomitant ACLR series from Hoffelner et al16, with the other 17 
publications providing full study cohort data. One publication within the systematic 
literature review contained mean Lysholm scores, however had separated the scores 
depending on success/failed healing40. Due to this split, these data were excluded 
from the analysis.  Weighted mean Lysholm score was calculated as 89.43 (95% CI: 
86.77-92.09) for 665 patients (Figure 11) at a weighted mean follow-up of 28.3 
months. From this analysis, Surucu et al30 reported a Lysholm score considerably 

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Page 17 of 24
lower (69.63 sd 8.49; 75 patients) than that of the remaining 17 publications (all 
>81.0). While all patients within this study were >40 years of age and received 
isolated repair, the authors did not discuss any defining factor could be attributed to 
this lower score and believed the outcome to be successful.
Figure 11: Lysholm scores following meniscal repair using FAST-FIX.
Meta-analysis of 151 patients receiving repair of isolated meniscal repair reported a 
weighted mean Lysholm of 85.64 (95% CI: 73.85-97.43) (Figure 12) at a weighted 
mean follow-up of 29.6 months3,8,16,20,30. Following meniscal repair with concomitant 
ACLR, weighted mean Lysholm was calculated as 90.78 (95% CI: 89.07-92.50) 
across 345 patients (Figure 13) at a weighted mean follow-up of 26.7 months7-
10,12,16,17,20,27,29,36.

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Page 18 of 24
Figure 12: Lysholm scores following isolated meniscal repair using FAST-FIX.
Figure 13:
Lysholm scores following meniscal repair using FAST-FIX with 
concomitant ACLR.
Tegner activity scale is a single-item list of activities (rated 0-10) from which a patient 
selects their activity level (0-sick leave, 10-competitive sports (national elite)). Its 
purpose is to provide a method of grading work and sporting activity that may not 
be assessed using Lysholm. Of the 11 publications reporting Tegner scores, two only 
reported details for their isolated and ACLR+ cohorts (Alvarez-Diaz et al5 and Chiang 
et al8) and have therefore been included as separate items. One publication within 
the systematic literature review contained mean Lysholm scores, however had 
separated the scores depending on success/failed healing40. Due to this split, these 
data were excluded from the analysis. Weighted mean Tegner score was calculated 

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Page 19 of 24
as 6.22 (95% CI: 5.81-6.62, Figure 14) across 355 patients at a weighted mean
follow-up of 54.5 months, equating to ‘Recreational sports - tennis and badminton, 
handball, racquetball, down-hill skiing, jogging at least 5 times per week’ on the 
Tegner activity scale43.
Figure 14: Tegner activity score following meniscal repair using FAST-FIX.
Meta-analysis of 136 patients receiving repair of isolated meniscal repair reported a 
weighted mean Tegner activity score of 6.15 (95% CI: 5.63-6.67) (Figure 15) at a 
weighted mean follow-up of 46.5 months3,5,8,18,20,28,37. Following meniscal repair with 
concomitant ACLR, weighted mean Tegner activity score was calculated as 6.07 (95% 
CI: 5.50-6.64) across 158 patients (Figure 16) at a weighted mean follow-up of 72.2
months5,8,9,20,29,37.

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Page 20 of 24
Figure 15: Tegner activity score following isolated meniscal repair using FAST-FIX.
Figure 16: Tegner activity score following meniscal repair using FAST-FIX with 
concomitant ACLR.
4. Discussion
A volunteer cohort (n=488, 244 male, 244, female; >18 years, range: 18-85) who 
considered themselves to have normal knee function, without previous injury
reported a mean Lysholm score of 94 and Tegner score of 5.744. Categorising the 
Lysholm results according to the previously mentioned criteria, 66% were ‘excellent’, 
25% ‘good’, 9% ‘fair’ and <1 % ‘poor’. These normative scores are similar to the 
post-operative study cohort Lysholm and Tegner scores reported in this meta-

 
 
 
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Page 21 of 24 
analysis (89.43 (95% CI: 86.77-92.09) and 6.22 (95% CI: 5.81-6.62); respectively).  
In the present study the mean Lysholm score would be considered a good score. It 
should be noted that Tegner scores are likely to have a ceiling effect for each patient 
determined by their sporting involvement and level prior to injury. 
A similar healthy volunteer study of 2670 individuals was conducted to assess IKDC 
scores across eight age/gender categories45. The report identified a negative 
correlation between score and age, and a higher score for men (mean range: 95.5 
(18-24 years old), 88.4 (51-65 years old)) than women (mean range: 93.4 (18-24 
years old), 84.7 (51-65 years old). The mean IKDC for the population of patients 
reported in this systematic literature review (86.34; 95% CI: 83.89-88.79) is on 
average 4 points lower than the overall population normative data (91.67; 95% CI: 
89.65-93.68). 
 
5. References 
 
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Wan X, Wang W, Liu J, Tong T. Estimating the sample mean and standard deviation from the 
sample size, median, range and/or interquartile range. BMC Medical Research Methodology. 
2014;14(1):135. 
2. 
Ma J, Liu W, Hunter A, Zhang W. Performing meta-analysis with incomplete statistical 
information in clinical trials. BMC Medical Research Methodology. 2008;8(1):56. 
3. 
Ahn JH, Kwon OJ, Nam TS. Arthroscopic repair of horizontal meniscal cleavage tears with 
marrow-stimulating technique. Arthroscopy. 2015;31(1):92-98. 
4. 
Albertoni LJB, Schumacher FC, Ventura MHA, et al. Meniscal repair by all-inside technique with 
Fast-Fix device. Rev Bras Ortop. 2013;48(5):448-454. 
5. 
Alvarez-Diaz P, Alentorn-Geli E, Llobet F, Granados N, Steinbacher G, Cugat R. Return to play 
after all-inside meniscal repair in competitive football players: a minimum 5-year follow-up. 
Knee Surg Sports Traumatol Arthrosc. 2016;24(6):1997-2001. 
6. 
Barber FA, Schroeder FA, Oro FB, Beavis RC. FasT-Fix meniscal repair: mid-term results. 
Arthroscopy. 2008;24(12):1342-1348. 
7. 
Buchcic P, Domzalski M, Maslon A, Lebiedzinski R, Grzegorzewski A. Reliability of clinical 
evaluation of meniscus repair with the all-inside technique. Ortop Traumatol Rehabil. 
2013;15(2):131-137. 
8. 
Chiang C, Chang C, Cheng C, et al. Clinical Results of All-inside Meniscal Repair Using the FasT-Fix 
Meniscal Repair System. Chang Gung Med J 2011;34(3):298-304. 
9. 
Choi NH, Kim BY, Hwang Bo BH, Victoroff BN. Suture versus FasT-Fix all-inside meniscus repair at 
time of anterior cruciate ligament reconstruction. Arthroscopy. 2014;30(10):1280-1286. 
10.
DeHaan A, Rubinstein R, Baldwin J. Evaluation of Success of a Meniscus Repair Device for 
Vertical Unstable Medial Meniscus Tears in ACL-reconstructed Knees. Orthopaedics. 
2009;32(4):246-251. 
11. 
Fok A, Yau W. Early results of all-inside meniscal repairs using a pre-loaded suture anchor. Hong 
Kong Med J. 2013;19(2):124-128. 

 
 
 
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12. 
Furumatsu T, Miyazawa S, Tanaka T, Okada Y, Fujii M, Ozaki T. Postoperative change in medial 
meniscal length in concurrent all-inside meniscus repair with anterior cruciate ligament 
reconstruction. Int Orthop. 2014;38(7):1393-1399. 
13. 
Grossi S, Ipponi E, Bufalino E, et al. All-Inside Arthroscopic Repair For Longitudinal Meniscal 
Tears: Clinical and Functional Results. Surgical technology international. 2021;38:387-392. 
14. 
Haas AL, Schepsis AA, Hornstein J, Edgar CM. Meniscal repair using the FasT-Fix all-inside 
meniscal repair device. Arthroscopy. 2005;21(2):167-175. 
15. 
Hazaparu N, Jenny J-Y, Besse J. Meniscal Suture: Is Debridement Necessary? Arthroscopy: The 
Journal of Arthroscopic & Related Surgery. 2017;33(10). 
16. 
Hoffelner T, Resch H, Forstner R, Michael M, Minnich B, Tauber M. Arthroscopic all-inside 
meniscal repair--Does the meniscus heal? A clinical and radiological follow-up examination to 
verify meniscal healing using a 3-T MRI. Skeletal Radiol. 2011;40(2):181-187. 
17. 
Kalliakmanis A, Zourntos S, Bousgas D, Nikolaou P. Comparison of arthroscopic meniscal repair 
results using 3 different meniscal repair devices in anterior cruciate ligament reconstruction 
patients. Arthroscopy. 2008;24(7):810-816. 
18. 
Kise N, Drogset J, Ekeland A, Sivertsen E, Heir S. All-inside suture device is superior to meniscal 
arrows in meniscal repair: a prospective randomized multicenter clinical trial with 2-year follow-
up. Knee Surg Sports Traumatol Arthrosc. 2015;23(1):211-218. 
19. 
Konan S, Haddad FS. Outcomes of meniscal preservation using all-inside meniscus repair 
devices. Clin Orthop Relat Res. 2010;468(5):1209-1213. 
20. 
Kotsovolos E, Hantes M, Mastrokalos D, Lorbach O, Paessler H. Results of all-inside meniscal 
repair with the FasT-Fix meniscal repair system. Arthroscopy. 2006;22(1):3-9. 
21. 
Laurendon L, Neri T, Farizon F, Philippot R. Prognostic factors for all-inside meniscal repair. A 87-
case series. Orthop Traumatol Surg Res. 2017;103(7):1017-1020. 
22. 
Majeed H, Karuppiah S, Sigamoney KV, Geutjens G, Straw RG. All-inside meniscal repair surgery: 
factors affecting the outcome. J Orthop Traumatol. 2015;16(3):245-249. 
23. 
Miao Y, Yu J, Ao Y, Zheng Z, Gong X, Leung K. Diagnostic values of 3 methods for evaluating 
meniscal healing status after meniscal repair: comparison among second-look arthroscopy, 
clinical assessment, and magnetic resonance imaging. Am J Sports Med. 2011;39(4):735-742. 
24. 
Monllau J, Leal J, Voss C, Pelfort X, Tey M, Pavlovich R. Good outcome after meniscal repair 
using an all-inside suturing system in combination with high-frequency biostimulation. 
Orthopedics. 2010;33(6):407-412. 
25. 
Popescu D, Sastre S, Caballero M, et al. Meniscal repair using the FasT-Fix device in patients with 
chronic meniscal lesions. Knee Surg Sports Traumatol Arthrosc. 2010;18(4):546-550. 
26. 
Pujol N, Tardy N, Boisrenoult P, Beaufils P. Magnetic resonance imaging is not suitable for 
interpretation of meniscal status ten years after arthroscopic repair. Int Orthop. 
2013;37(12):2371-2376. 
27. 
Seo SS, Kim CW, Lee CR, et al. Second-look arthroscopic findings and clinical outcomes of 
meniscal repair with concomitant anterior cruciate ligament reconstruction: comparison of 
suture and meniscus fixation device. Archives of Orthopaedic and Trauma Surgery. 
2020;140(3):365-372. 
28. 
Sexton P, Moran C, Ferguson D, Shannon F. Using the fast-fix device in arthroscopic all-inside 
repair of meniscal tears. Paper presented at: XXXVIth Sir Peter Freyer Memorial Lecture and 
Surgical Symposium. September 2-3, 2011. ; Sep, 2011; Galway, Ireland. 
29. 
Song H, Bae T, Park B, Shim J, In Y. Repair of a radial tear in the posterior horn of the lateral 
meniscus. Knee. 2014;21(6):1185-1190. 

 
 
 
            Confidential document for internal use only                                                                           
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30. 
Surucu S, Kasman UO, Aydin M, Korkmaz O. Repair Results of Horizontal Meniscus Tears in 
Patients Over 40 Years of Age. International Journal of Academic Medicine and Pharmacy. 
2022;4(1):42-45. 
31. 
Tachibana Y, Sakaguchi K, Goto T, Oda H, Yamazaki K, Iida S. Repair integrity evaluated by 
second-look arthroscopy after arthroscopic meniscal repair with the FasT-Fix during anterior 
cruciate ligament reconstruction. Am J Sports Med. 2010;38(5):965-971. 
32. 
Tucciarone A, Godente L, Fabbrini R, Garro L, Salate Santone F, Chillemi C. Meniscal tear 
repaired with Fast-Fix sutures: clinical results in stable versus ACL-deficient knees. Arch Orthop 
Trauma Surg. 2012;132(3):349-356. 
33. 
Tuckman D, Bravman J, Lee S, Jeffrey A, Rosen E, Sherman O. Outcomes of Meniscal Repair: 
Minimum of 2-Year Follow-Up. Bulletin of the Hospital for Joint Diseases. 2006;63:100-104. 
34. 
Walter R, Dhadwal A, Schranz P, Mandalia V. The outcome of all-inside meniscal repair with 
relation to previous anterior cruciate ligament reconstruction. Knee. 2014;21(6):1156-1159. 
35. 
Yu J-K, Ao Y, Wang J, et al. Paper # 19: The Relationship Between the Different Femoral Tunnel 
Techniques and the Second-look Arthroscopy Results in Double-Bundle ACL Reconstructions. 
Arthroscopy: The Journal of Arthroscopic & Related Surgery. 2011;27(10):e83-e84. 
36. 
Zhang Z, Zhou Y, Luo H, et al. A novel surgical technique for arthroscopic repair of type II 
posterior lateral meniscal root tear. Knee. 2020;27(5):1560-1566. 
37. 
Zimmerer A, Sobau C, Nietschke R, Schneider M, Ellermann A. Long-term outcome after all 
inside meniscal repair using the FasT-Fix system. J Orthop. 2018;15(2):602-605. 
38. 
Bogunovic L, Kruse LM, Haas AK, Huston LJ, Wright RW. Outcome of All-Inside Second-
Generation Meniscal Repair: Minimum Five-Year Follow-up. J Bone Joint Surg Am. 
2014;96(15):1303-1307. 
39. 
Schmitt A, Batisse F, Bonnard C. Results with all-inside meniscal suture in pediatrics. Orthop 
Traumatol Surg Res. 2016;102(2):207-211. 
40. 
Shearman AD, Foster AJ, Wilson AJ, Risebury MJ, Yasen SK. Excellent medium-term survival of an 
all-inside tensionable knotted suture device justifies repair of most meniscal tears encountered 
during reconstructive knee ligament surgery. Knee Surgery, Sports Traumatology, Arthroscopy. 
2021;29(6):1714-1721. 
41. 
Sexton P, Moran C, Ferguson D, Waters P, Roche S, Shannon F. Arthroscopic meniscal repair 
using the fast- fix system. Paper presented at: Sylvester O’Halloran Meeting; Mar, 2011; 
Limerick, Ireland. 
42. 
Collins NJ, Misra D, Felson DT, Crossley KM, Roos EM. Measures of knee function: International 
Knee Documentation Committee (IKDC) Subjective Knee Evaluation Form, Knee Injury and 
Osteoarthritis Outcome Score (KOOS), Knee Injury and Osteoarthritis Outcome Score Physical 
Function Short Form (KOOS-PS), Knee Outcome Survey Activities of Daily Living Scale (KOS-ADL), 
Lysholm Knee Scoring Scale, Oxford Knee Score (OKS), Western Ontario and McMaster 
Universities Osteoarthritis Index (WOMAC), Activity Rating Scale (ARS), and Tegner Activity 
Score (TAS). Arthritis Care Res (Hoboken). 2011;63 Suppl 11:S208-228. 
43. 
Tegner Y, Lysholm J. Rating systems in the evaluation of knee ligament injuries. Clinical 
Orthopaedics and Related Research. 1985;198:42-49. 
44. 
Briggs KK, Steadman JR, Hay CJ, Hines SL. Lysholm score and Tegner activity level in individuals 
with normal knees. Am J Sports Med. 2009;37(5):898-901. 
45. 
Anderson AF, Irrgang JJ, Kocher MS, Mann BJ, Harrast JJ. The International Knee Documentation 
Committee Subjective Knee Evaluation Form:Normative Data. The American Journal of Sports 
Medicine. 2006;34(1):128-135. 
 
 

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Page 24 of 24
Author (Title)
Signature
Date
Paul Souter
(Clinical Evidence 
Specialist)
Reviewer (Title)
Signature
Date
Matthew Sedgwick
(Senior Clinical Evidence 
Specialist)
Version
Date issued
Reason for re-issue
V1
9th August 2022
Initial release
V2
7th October 2022
Update to include 
additional analyses of 
PROM and minor correction
of numerical errors
V3
29th Nov 2022
Correction to IKDC ACLR+
Zhang score

 
Clinical Protocol - Device 
Study Number: FAST-FIX 
FLEX.2020.09 
A Prospective, Multi-center Clinical Study to Evaluate the Safety 
and Performance of the FAST-FIX FLEX System for Meniscal Repairs 
(MR) and Meniscal Allograft Transplantations (MAT) 
Version: 3.0, 05/May/2023 
Page: 151 of 151   
 
 
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 D; SOP-CD-05 Clinical Protocols 
22.11 R&D Internal Evidence for MAT Indication 
The full R&D internal evidence, dated 03/Apr/2023, for the MAT indication is appended below. 
 
 

 
FAST-FIX  FLEX Memo 
 
 
FAST-FIX  FLEX 
 
Memo 
Product
FAST-FIX FLEX
Risk Management File Number
RM-M-16500559
 
 

 
FAST-FIX  FLEX Memo 
 
1. FAST-FIX FLEX KNEE INDICATIONS RATIONALE 
The FAST-FIX  family of All-Inside Meniscal Repair devices have been designed to meet all clinical needs 
when utilized to repair or reconstruct multiple types of tissue tears. This memo will describe the 
biomechanical requirements of the knee indications listed below and demonstrate the clinical value of 
the FAST-FIX FLEX family of devices.   
 
Catalog #
Name
72205324
FAST-
72205325
FAST-
REVERSE CURVED INSERTER, BENDER, CANNULA SET
72205676
FAST-
72205677
FAST-
REVERSE CURVED INSERTER
 
INDICATIONS per IFU 10601463 & 10601589 
The FAST-FIX FLEX Meniscal Repair System is indicated for use in meniscal repairs, allograft 
transplant procedures, and anchoring the allograft to the meniscal rim during allograft 
transplant procedures. 
 
BACKGROUND 
FAST-FIX  represents a family of meniscal repair devices that are designed to provide reliable tissue 
fixation in Meniscus Repair (MR). The devices are also used for Meniscal Allograft Transplantation 
(MAT), which is a surgical option to treat patients with symptomatic compartmental overload after total 
or subtotal meniscectomies. In clinical practice, meniscal allograft transplantation (MAT) is a well-
established surgical procedure that has demonstrated satisfactory results in terms of survival, clinical 
outcomes, return to sport, and efficacy in preventing or delaying osteoarthritic changes. Satisfactory 
clinical results for pain reduction and improved knee function have been demonstrated in more than 55 
studies and 1500 patients.[1] 
The purpose of this memo is to provide a rationale for pooling a singular patient population for both 
Meniscal Repair (MR) and Meniscal Allograft Transplantation (MAT) reconstruction procedures using the 
FAST-FIX family of Meniscal Devices. Multiple tear types are repaired using the All-Inside technique by 
using a combination of longitudinal and horizontal stitch patterns. The rationale explained in this Memo 
will consider (A) Similarities in tear configurations between longitudinal vertical tears and MAT 
approximation to the native tissue, (B) restoration of native Biomechanical kinematics post-MAT, and (C) 
clinical uses of all-inside meniscus fixation devices for MAT reconstruction. The common surgical 
technique used for both repair and the graft attachment method utilized across all indications will be 
highlighted. 
 
 
 

FAST-FIX
FLEX Memo
(A)
LONGITUDINAL VERTICAL MENISCUS TEAR PRESENTATION VS MAT
The meniscus is an important structure in load distribution, shock absorption, joint lubrication, stability, 
and proprioception. The dramatic consequences of total meniscectomy, together with advances in
surgical techniques, has resulted in a significant increase in meniscus preservation/repair procedures. 
Meniscal tissue is relatively avascular. The peripheral third of the meniscus, referred to as the red-red 
zone, is vascularized, supplied by the medial and lateral genicular arteries. The central transition zone, 
called the red-white zone, also has some nutrition from blood, while the remaining inner third of the 
meniscus, referred to as the white-white zone, must receive its nutrition through synovial fluid diffusion. 
Due to the avascular nature of the tissue, meniscectomy of the inner third is presently the standard of 
care.
Figure 1: Meniscus Zones
As shown above, the outer vascular meniscal tissue is tightly integrated with the surrounding capsule. 
Research has shown that the meniscus capsule, which circumferentially covers the meniscus, sustains
the hoop stress in part by showing about 4.2% to 30.0% circumferential tensile modulus of the 
corresponding adjacent meniscus. Also, the meniscus capsule is thick and circumferentially oriented,
showing morphological similarity with the meniscus itself that is presumed to effectively sustain the 
hoop stress. [2]
Longitudinal vertical tears present as a tear running parallel to the outer perimeter of the meniscus and 
extending vertically, either completely or partially, through the meniscus. Vertical tears are one of the 

 
FAST-FIX  FLEX Memo 
 
most common tear types, and, if left untreated, can progress into large bucket-handle tears. Repair is 
important to preserve the meniscus integrity and function. 
Figure 2: Longitudinal vertical meniscus tear. [3] 
 
The all-inside repair technique is often used to repair longitudinal vertical tears. This technique takes 
advantage of the load-sharing capabilities of the thick meniscus capsule to anchor the two PEEK 
implants. As shown below, both the curved and reverse curved FAST-FIX devices provide access 
necessary to place repair stitches in a vertical fashion on the superior (curved device) and inferior 
(reverse-curved device) surfaces. Small, partial thickness tears can be repaired using a single device, as 
shown in Figure 3A. For larger tears or tears extending completely through the meniscus, several 
stitches are used to complete the repair, as shown in Figure 3B. The repair suture pattern used is 
referred to as a vertical mattress suture. 
 
Figure 3: All-Inside Repair techniques for longitudinal vertical tears. (A) 
represents a single curved device used to position two PEEK anchors along 
the outer capsule, and (b) demonstrates a curved device used to place the 
upper suture combined with a reverse curve device used to place the lower 
suture. [3] 
 

 
FAST-FIX  FLEX Memo 
 
The MAT surgical technique includes a step to prepare the native meniscus to receive the allograft. The 
preparation step removes the avascular portion of the native meniscus, while preserving a portion of 
the vascular circular rim adjacent to the capsule, as shown in Figure 4. Comparing the longitudinal 
vertical tear above to the MAT tissue remnant, one can see the same vertical gap presentation as the 
longitudinal vertical tear. As such, the same all-inside repair techniques used for longitudinal vertical 
tears is also employed to re-approximate the allograft to the preserved native vascular tissue. All-inside 
devices have historically been used to attach the posterior region of the allograft. The added bend 
capabilities of the FAST-FIX FLEX device has extended All-Inside usage to the mid and anterior thirds of 
the meniscus as well. 
 
Figure 4: MAT native remnant preserved for attachment of allograft. 
 
The most significant advantages of the All-Inside meniscal repair technique include ease of use, reduced 
surgical times, and reduced risk to the neurovascular structures. Many tear types can be repaired using 
the FAST-FIX FLEX device, including longitudinal vertical, horizontal, radial, oblique, and complex tears. 
 
(B) BIOMECHANICAL FORCES POST-MAT PROCEDURE 
Real in-vivo compartment loads experienced by menisci have been studied using experimental cadaveric 
data under limited simulated loading conditions or numerical simulations data to give us rough estimation 
of forces experienced under dynamic loading conditions. These simulation data are highly dependent on 
types and accuracy of assumptions, simulation model, boundary conditions, etc. However, the similarities 
in the results from these studies combined with the clinical evidence of success provide valuable insight 
into the benefits of MAT. 
McDermott completed human cadaveric biomechanics study that simulated four different contact 
pressure testing conditions for each knee: 1. Intact 2. Meniscectomy 3. Graft with bone block plus sutures 
4. Graft with sutures only. A significant difference was not found between the peak contact pressure after 
the reconstructions and that of the intact knee when loaded in axial compression up to 700 N. [4] Brial 
conducted a similar joint contact mechanics study that assessed the contact area, peak contact stress, and 

 
FAST-FIX  FLEX Memo 
 
the distribution of stress across the tibial plateau at 14% and 45% of the gait cycle, at which axial forces 
are at their highest. Translation of the weighted center of contact stress throughout simulated gait was 
computed. The native intact meniscus and several MAT transplantation fixation techniques keyhole 
technique was not significantly different from the intact condition. [5] 
Macchiarola demonstrated strong improvement in several key biomechanical metrics using an in-vivo 
surgical navigation system on 10 consecutive patients undergoing lateral MAT.  The biomechanical effect 
of MAT restored knee functionality to clinically acceptable values. MAT improved knee kinematics of the 
ACL-intact knee. Several key metrics were significantly improved postoperatively. This is the first study to 
analyze the in vivo kinematics of MAT.[6] 
 
Figure 5: Pre- and postoperative in-vivo improvement in AP Displacement, Varus-Valgus Rotation, and 
dynamic laxity during Pivot Shift testing. 
 
It is important to note that during healing period, generally the graft does not reach the level of its normal 
physiological loadings. In rehabilitation period, only controlled exercises are recommended to patients and the 
intensity of loadings are increases gradually over a period of months to reach normal loadbearing scenarios.  
Additional studies corroborate the conclusions expressed above, including Spang [7] and Novaretti [8]. 
These biomechanical studies conclude that MAT procedures can restore intra-articular knee kinematics, 
resulting in a similar biomechanical environment to the native intact meniscus. 
(C) CLINICAL APPLICATION OF ALL-INSIDE DEVICES FOR MAT 
All-Inside Meniscal Repair devices, such as the Smith+Nephew FAST-FIX products, are commonly being 
used for MAT procedures. These fixation devices approximate the meniscal allograft to the preserved 
outer rim of the native meniscus. This interface presents as a vertical surface between the allograft and 
vascular tissue of the native meniscus. The FAST-FIX device utilizes a high strength non-absorbable 
suture and allows the repair to be performed with a vertical mattress suture. A literature search was 
completed to provide representative examples of the common surgical technique and graft fixation 
method used to complete MAT procedures using All-Inside Meniscal Repair devices. 

 
FAST-FIX  FLEX Memo 
 
1. Meniscal Allograft Transplantation surgical technique is described by Cole [9]. An All-Inside 
fixation technique is described to secure the posterior portion of the allograft to the preserved 
native meniscal remnant using vertical mattress sutures. Comparing to Figure 3, the same 
vertical mattress suture pattern is used for this MAT procedure. 
 
Figure 6: Example of All-Inside vertical mattress 
sutures used in a MAT procedure. 
 
2. Cugat also demonstrate a surgical technique using FAST-FIX devices to attach the posterior horn 
of the allograft to the vertical native meniscal rim preserved to provide vascular attachment. 
[10] Again, comparing to Figure 3, the same vertical mattress suture pattern is used for this MAT 
procedure to couple the posterior portion of the allograft.  
 
 
All-Inside vertical 
mattress sutures

 
FAST-FIX  FLEX Memo 
 
Figure 7: All-Inside reinforcement of the attachment of the posterior 
horn of the meniscal allograft to the posterior meniscal rim using a 
FAST-FIX 360 device.[10] 
 
In each of the MAT procedure scenarios listed above, the device is used to reapproximate two opposing 
vertical surfaces in a common manner using a vertical mattress stitch. The PEEK implants are placed 
along the outer surface of the capsule adjacent to the meniscus. Suture reduction follows to bring the 
tissue together with the desired tension.  
 
Post-operative protocols are similar to MR.  At 4-6 weeks, patients are allowed full weightbearing and 
unrestricted ROM. Stationary biking with low resistance and straight leg swimming are also started at 
that time. Progressive, low-impact strengthening is implemented when the gait pattern has returned to 
normal.  
 
Several important similarities have been highlighted in this memo. Firstly, All-Inside meniscus repair of 
longitudinal vertical tears using vertical mattress sutures is representative of the tissue re-
approximation method used in MAT procedures. Secondly, numerous studies have concluded that MAT 
procedures can restore intra-articular contact pressures and knee kinematics, resulting in a similar 
biomechanical environment to the native intact meniscus. Therefore, based on the anticipated clinical 
loading for the stated knee indications, the All-Inside implant performance requirements are the same 
for both MR and MAT environments. In general, the mechanical fixation demand is the highest during 
the healing period and does reduce by biological incorporation of the tissue. Thirdly, the same use steps 
and sequence are utilized to complete the repair/reconstruction. The procedural technique, device use, 
and resulting suture placement is identical for meniscus MR and MAT.  
Based on the above-mentioned factors, the benefit from efficacy pooling with the larger sample size 
provides increased coverage, despite the added heterogeneity, given the common method of assessing 
effectiveness, surgical technique, surgical instrumentation, and identical surgeon populations.  
 

 
FAST-FIX  FLEX Memo 
 
2. Bibliography 
[1] 
Rosso et al. Meniscal Allograft Transplantation. The American Journal of Sports Medicine, Vol. 43, 
No. 4 DOI: 10.1177/0363546514536021 
[2] 
Xiang Yun Yin, Jun Young Chung, Do Young Park, Hyung Keun Song, Byeong Kook Kim, Hee Won 
Bae , Ki Hoon Park, and Byoung-Hyun Min. The Perimeniscal Capsule: Potential Supporting 
Structure Surrounding Meniscus. Cartilage 2021, Vol. 13(Suppl 1) 208S 215S © The Author(s) 
2019 DOI: 10.1177/1947603519892316  
[3] 
Foissey et al., All-Inside Double-Sided Suture Repair for Longitudinal Meniscal 
Tears. Arthroscopy Techniques, Vol 10, No 8 (August), 2021: pp e2043-e2048J 
https://doi.org/10.1016/j.eats.2021.05.006 
[4] 
McDermott et al. The effects of lateral meniscus allograft transplantation techniques on tibio-
femoral contact pressures. Knee Surg Sports Traumatol Arthrosc (2008) 16:553 560 DOI 
10.1007/s00167-008-0503-4 
[5] 
Brial et al. Lateral Meniscal Graft Transplantation. Am J Sports Med. 2019 August ; 47(10): 2437
2443. doi:10.1177/0363546519860113. 
[6] 
Macchiarola et al. In Vivo Kinematic Analysis of Lateral Meniscal Allograft Transplantation With 
Soft Tissue Fixation. The Orthopaedic Journal of Sports Medicine, 9(5), 23259671211000459 
DOI: 10.1177/23259671211000459 
[7] 
Spang et al. The Effects of Medial Meniscectomy and Mensical Allograft Transplantation on Knee 
and Anterior Cruciate Ligament Biomechanics. Arthroscopy: The Journal of Arthroscopic and 
Related Surgery, Vol 26, No 2 (February), 2010: pp 192-201 
[8] 
Novaretti et al. Lateral Meniscus Allograft Transplantation With Bone Block and Suture-Only 
Techniques Partially Restores Knee Kinematics and Forces. The American Journal of Sports 
Medicine Volume 47, Issue 10, August 2019, Pages 2427-2436 © 2019 
https://doi.org/10.1177/0363546519858085 
[9] 
Cole et al. Medial Meniscus Transplantation and Bone-Tendon-Bone Anterior Cruciate Ligament 
Reconstruction. J Am Acad Orthop Surg 2022;30:104-110 DOI: 10.5435/JAAOS-D-20-00363 
[10] 
Cugat et al. All-Arthroscopic Meniscal Allograft Transplantation Technique with Bone Plugs and 
Preloaded Sutures. Arthroscopy Techniques, Vol 9, No 9 (September), 2020: pp e1357-e1362 
 
 
 
 

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