Suture, Nonabsorbable, Synthetic, Polyethylene

FDA product code GAT · 165 cleared devices

Class 2 General, Plastic Surgery

Regulation: 21 CFR 878.5000
Review panel: SU
Implant: Yes
Life sustaining: No
Third party review: No
GMP exempt: No
Clearance span: 1993-12-13 – 2026-08-22

GAT 2026-08-22

Stitch - Suture Wires and Tapes

Applicant GM Dos Reis Industria e Comercio Ltda.

K number K253910

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GAT 2026-07-01

EasyWhip Family

Applicant Winter Innovations, Inc.

K number K261021

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GAT 2026-05-06

Polyethylene;Polyethylene Fusion;Polyethylene OrthoTape™

Applicant Teleflex Medical, LLC

K number K260775

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GAT 2026-03-23

HyperSuture All Green Extension Line

Applicant Threadstone, LLC

K number K254275

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GAT 2026-02-19

Meniscus Versaflex

Applicant GM Dos Reis Industria e Comercio Ltda.

K number K254188

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GAT 2025-10-22

Pre-Sutured Tendon

Applicant Rti Surgical, Inc.

K number K253145

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GAT 2025-10-16

ProZip Knotless Implant

Applicant Riverpoint Medical

K number K253024

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GAT 2025-09-12

PowerKnot High Strength Sutures

Applicant Medacta International S.A.

K number K252225

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GAT 2025-08-13

HS Fiber

Applicant Riverpoint Medical

K number K252201

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GAT 2025-03-27

HyperSuture White/Green Extension Line

Applicant Threadstone, LLC

K number K242201

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GAT 2024-08-09

HyperSuture All Blue Extension Line

Applicant Threadstone, LLC

K number K241376

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GAT 2024-05-10

HyperSuture Extension Line

Applicant Threadstone, LLC

K number K234079

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GAT 2024-01-05

HS Fiber Sutures

Applicant Riverpoint Medical

K number K231163

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GAT 2023-11-24

HyperSuture

Applicant Threadstone, LLC

K number K230311

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GAT 2023-08-25

Non absorbable Surgical Polyester Suture

Applicant Shandong Haidike Medical Products Co., Ltd.

K number K231183

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GAT 2023-08-10

SuperBall Meniscal Repair System

Applicant Arcuro Medical , Ltd.

K number K223500

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GAT 2023-08-03

MENIX®; MENIX® DUO

Applicant S.B.M. Sas (Science & Bio Materials)

K number K223122

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GAT 2023-07-06

MyEllevate

Applicant Cynosure, LLC

K number K230510

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GAT 2023-06-27

AceConnex Pre-Sutured Fascia

Applicant Allosource

K number K213046

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GAT 2023-06-23

Pre-Sutured Tendon (4561SC / Single Strand); Pre-Sutured Tendon (4564SC / Quadruple Strand )

Applicant Rti Surgical, Inc.

K number K230036

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GAT 2023-06-02

ACTIVBRAID™

Applicant Embody, Inc.

K number K223822

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GAT 2022-10-27

Arthrex BioSuture

Applicant Arthrex, Inc.

K number K220880

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GAT 2022-09-14

Arthrex SoftStitch

Applicant Arthrex, Inc.

K number K222078

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GAT 2022-09-09

Arthrex SutureTape

Applicant Arthrex, Inc.

K number K221354

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GAT 2022-05-13

Zone Specific AIM

Applicant Conmed Corporation

K number K220186

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GAT 2022-04-26

PERMALOOP Suture, PERMATAPE Suture

Applicant Medos International SARL

K number K220219

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GAT 2021-10-25

Arthrex LoopLoc Knotless Suture

Applicant Arthrex, Inc.

K number K212146

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GAT 2021-05-03

EasyWhip

Applicant Winter Innovations, Inc.

K number K210675

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GAT 2021-03-18

DYNATAPE Suture

Applicant Medos International SARL

K number K203186

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GAT 2021-02-01

FAST-FIX FLEX

Applicant Smith & Nephew, Inc.

K number K203393

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GAT 2020-10-02

Arthrex SoftStitch

Applicant Arthrex, Inc.

K number K190707

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GAT 2020-09-10

HS Fiber

Applicant Riverpoint Medical, LLC

K number K202242

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GAT 2020-07-24

Arthrex SutureTape

Applicant Arthrex, Inc.

K number K193575

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GAT 2020-03-30

Tevdek II, Silky II Polydek, 'Cottony' II, NextStitch

Applicant Teleflex Medical

K number K192490

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GAT 2020-03-02

High Strength Suture

Applicant Yunyi (Beijing) Medical Device Co., Ltd.

K number K192637

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GAT 2019-07-31

DemeTECH DemeFORCE Nonabsorbable Surgical Suture

Applicant Demetech Corporation

K number K190777

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GAT 2019-06-11

Force Fiber Suture

Applicant Teleflex Medical Incorporated

K number K191268

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GAT 2019-05-01

HS Fiber

Applicant Riverpoint Medical

K number K190817

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GAT 2019-03-15

MTF Pre-Sutured Tendon

Applicant Musculoskeletal Transplant Foundation

K number K181633

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GAT 2018-10-10

Force Fiber White and White/Blue, White/Black, Blue, and White/Green sutures; Force Fiber OrthoTape suture; Bondek suture and Bondek Plus suture; Monodek suture; Polyglytone*6211 suture

Applicant Teleflex Medical Incorporated

K number K181774

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GAT 2018-08-02

DYNACORD Suture

Applicant Medos International SARL

K number K181182

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GAT 2018-08-01

NovoStitch Pro Meniscal Repair System, CTX-A004 (size 0)

Applicant Ceterix Orthopaedics, Inc.

K number K181772

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GAT 2018-06-05

SuperBall Meniscal Repair System

Applicant Arcuro Medical , Ltd.

K number K180191

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GAT 2018-03-29

NovoStitch Pro Meniscal Repair System

Applicant Ceterix Orthopaedics, Inc.

K number K180531

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GAT 2018-03-20

ReConnex Pre-Sutured Tendon

Applicant Allosource

K number K170957

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GAT 2017-10-03

Force Fiber Fusion Suture

Applicant Teleflex Medical Incorporated

K number K172016

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GAT 2017-08-22

GRAVITY™ Soft Tissue Repair System

Applicant Wrightmedicaltechnologyinc

K number K170642

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GAT 2017-06-30

Infinity-Lock 3, Infinity-Lock 5

Applicant Xiros, Ltd.

K number K171680

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GAT 2017-05-26

SutureTape

Applicant Arthrex, Inc.

K number K171296

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GAT 2017-02-17

ExpressBraid Graft Manipulation

Applicant Biomet Manufacturing Corp

K number K163651

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GAT 2017-01-06

SpeedStitch Suture Passer; SpeedStitch Suture Cartridges, White Suture, Blue Cobraid, Black Cobraid, Mixed Pack; SpeedStitch Needle Loader and Unloader

Applicant ArthroCare Corporation

K number K163142

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GAT 2016-12-19

MaxBraid BroadBand Suture and Expressbraid BroadBand Graft Manipulation Suture

Applicant Biomet Manafacturing Corp.

K number K160854

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GAT 2016-12-15

PERMATAPE

Applicant Medos International SARL

K number K162247

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GAT 2016-11-10

XBraid TT Suture Tape

Applicant Stryker

K number K162310

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GAT 2016-11-07

SPEEDTRAP Graft Preparation System

Applicant Medos International SARL

K number K161638

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GAT 2016-08-12

'cottony' II TAPE, PLEDGETS

Applicant Teleflexmedical, Inc.

K number K153089

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GAT 2016-07-14

IvyAIR Meniscus System, Curved, IvyAIR Meniscus System, Straight, IvyAIR Meniscus System, Reverse Curved

Applicant Ivy Sports Medicine, LLC

K number K153087

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GAT 2016-06-16

silky II POLYDEK, cottony II, TEVDEK II, NextStitch, DEKLENE II, DEKLENE MAXX Gabbay-Frater, NYLON, SILK, STAINLESS STEEL

Applicant Teleflexmedical, Inc.

K number K153076

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GAT 2016-03-03

Dunamis Force DFX Tensile Tape

Applicant Dunamis, LLC

K number K153746

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GAT 2016-02-12

HS SutureTape

Applicant Riverpoint Medical

K number K153307

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GAT 2016-02-08

ExpressBraid Graft Manipulation

Applicant Biomet Manufacturing Corp

K number K152868

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GAT 2013-12-05

TFCC FAST-FIX KIT

Applicant Smith & Nephew, Inc.

K number K132079

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GAT 2013-10-30

SMITH & NEPHEW ULTRATAPE

Applicant Smith & Nephew, Inc.

K number K132357

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GAT 2013-07-31

ARTHREX SPEEDCINCH

Applicant Arthrex, Inc.

K number K132043

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GAT 2013-05-21

SORIN VASCULOOP TWO TIE ENDOSCOPIC LIGATION SYSTEM MODEL DTTS2

Applicant Sorin Group USA, Inc.

K number K122735

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GAT 2012-11-07

SMARTSTITCH PERFECTPASSER SYSTEM

Applicant Arthocare Corporation

K number K123268

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GAT 2012-10-18

SMITH & NEPHEW ULTRA FAST-FIX MENISCAL REPAIR SYSTEM, SMITH & NEPHEW ULTRA FAST-FIX AB MENISCAL REPAIR SYSTEM, SMITH & N

Applicant Smith & Nephew, Inc.

K number K121861

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GAT 2012-09-25

ARTHREX SUTURE (UHMWPE)

Applicant Arthrex, Inc.

K number K122374

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GAT 2012-07-12

SMARTSTITCH M-CONNECTOR ULTRA SMARTSTITCH SUTURE DEVICE HANDLE SMARTSTITCH SUTURE DEVICE HANDLE

Applicant Arthocare Corporation

K number K121306

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GAT 2012-06-04

CROSSFIX II MEMISCAL REPAIR DEVICE

Applicant Cayenne Medical, Inc.

K number K121413

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GAT 2012-04-06

ARTHREX BIO-SUTURE

Applicant Arthrex, Inc.

K number K112899

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GAT 2011-04-08

SMITH & NEWPHEW ULTRABRAID II SUTURE

Applicant Smith & Newphew, Inc.

K number K101377

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GAT 2010-11-23

CONMED LINVATEC SEQUENT MENISCAL REPAIR DEVICE

Applicant Conmed Linvatec

K number K102339

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GAT 2010-11-10

V-LOC(TM) NONABSORBABLE WOUND CLOSURE DEVICE

Applicant Covidien, LLC

K number K103052

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GAT 2010-10-20

G-CATH TISSUE ANCHOR DELIVERY CATHETER

Applicant Usgi Medical

K number K102916

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GAT 2010-08-04

NEOTRACT ANCHOR SYSTEM MODEL TAS400

Applicant Neotract, Inc.

K number K102028

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GAT 2010-07-15

NEOTRACT ANCHOR SYSTEM MODEL: REF 11208

Applicant Neotract, Inc.

K number K101252

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GAT 2010-05-10

HS FIBER (POLYBLEND), RIVER BOND, RIVERSILK (SILK), RIVERPRO (POLYPROPYLENE), RIVERLON (NYLON) MODEL VERIES BY SIZE/NEED

Applicant Riverpoint Medical

K number K100006

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GAT 2010-03-18

CP-FIBER (ORTHOFIBER)

Applicant Cp Medical

K number K094028

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GAT 2010-03-17

VERSACLOSE, MODEL VC-200-01

Applicant Anulex Technologies, Inc.

K number K100572

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GAT 2010-03-10

FORCE FIBER GREEN ULTRA HIGH MOLECULAR WEIGHT POLYETHYLENE NON ABSORBABLE SUTURES MODEL:X-5000FFK, X-5001FFK, X-5002FFK

Applicant Teleflex Medical

K number K100506

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GAT 2010-02-17

G-CATH TISSUE ANCHOR DELIVERY CATHETER, MODELS 205302, 205333

Applicant Usgi Medical

K number K100251

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GAT 2010-01-28

FAST-FIX 360 MENISCAL REPAIR SYSTEM, STRIAGHT, CURVED, REVERSE CURVED,FAST FIX 360 AB MENISCAL REPAIR SYSTEM, STRAIGHT,

Applicant Smith & Nephew, Inc.

K number K092508

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GAT 2009-11-13

IMPLICITGUIDE SURGICAL SUTURE SYSTEM

Applicant Implicitcare, LLC

K number K091061

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GAT 2009-10-09

SILK BLACK BRAIDED SURGICAL SUTURES, NYLON MONOFILAMENT BLUE AND BLACK SURGICAL SUTURES

Applicant Supplidores Unidos Internacionales, S.A.

K number K091574

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GAT 2009-10-07

G-PROX ENDOSCOPIC GRASPER, MODEL 205333

Applicant Usgi Medical

K number K093018

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GAT 2009-09-15

FORCE FIBER BLUE ULTRA HIGH MOLECULAR WEIGHT POLYETHYLENE NON ABSORBABLE SUTURES

Applicant Beere Precision Medical Instruments, Kmedic, Telef

K number K092533

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GAT 2009-06-12

XCLOSE TISSUE REPAIR SYSTEM, MODEL XC-200-01

Applicant Anulex Technologies, Inc.

K number K091432

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GAT 2009-05-06

LARIAT II SUTURE DELIVERY DEVICE

Applicant Sentreheart, Inc.

K number K090385

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GAT 2009-05-04

COVIDIEN SPORTS SURGERY AS MENISCAL REPAIR DEVICE WITH HIGH STRENGTH SUTURE

Applicant Surgical Devices, A Global Business Unit Covidien

K number K091016

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GAT 2009-03-19

TAC-TITE (TM)

Applicant Core Essence Orthopaedics, Inc.

K number K090128

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GAT 2009-01-16

DUAL NEEDLE SUTURE PASSER SYSTEM

Applicant Cayenne Medical, Inc.

K number K082518

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GAT 2008-12-01

COVIDIEN SPORTS SURGERY AS MENISCAL REPAIR DEVICE

Applicant Surgical Devices, A Global Business Unit Covidien

K number K082535

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GAT 2008-02-11

MENISCAL CINCH

Applicant Arthrex, Inc.

K number K073149

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GAT 2008-02-07

ANCHORAGE CLOSURE DEVICE

Applicant Epitek, Inc.

K number K073096

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GAT 2008-02-01

NEOTRACT ANCHOR SYSTEM

Applicant Neotract, Inc.

K number K073651

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GAT 2007-10-19

CAPSEW PLICATION SYSTEM

Applicant Cayenne Medical, Inc.

K number K071796

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GAT 2007-09-18

ULTRA FAST-FIX AND ULTRA FAST-FIX AB MENISCAL REPAIR SYSTEMS

Applicant Smith & Nephew, Inc.

K number K072322

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GAT 2007-07-11

AXYA SUTURE WELDING SYSTEM AND KIT

Applicant Axya Medical, Inc.

K number K070253

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GAT 2007-07-03

ARTHREX FIBERWIRE

Applicant Arthrex, Inc.

K number K071622

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