Atlas FDA

GAT

175 FDA 510(k) clearances · Product code

90 daysmedian time to decision
280 days90th percentile
175clearances measured

FDA profile

Official device name
Suture, Nonabsorbable, Synthetic, Polyethylene
Device class
Class II (moderate risk)
Regulation
21 CFR 878.5000
Medical specialty
General, Plastic Surgery
Flags
Implant
Adverse events (MAUDE)
2021: 1,643 · 2022: 1,419 · 2023: 2,038 · 2024: 2,597 · 2025: 3,001 · 2026: 2,046
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Sort:Newest firstOldest first

Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
EasyWhip Family (K261021)Winter Innovations, Inc.2026-07-01
Polyethylene;Polyethylene Fusion;Polyethylene OrthoTape™ (K260775)Teleflex Medical, LLC2026-05-06
HyperSuture All Green Extension Line (K254275)Threadstone, LLC2026-03-23
Meniscus Versaflex (K254188)GM Dos Reis Industria e Comercio Ltda.2026-02-19
Pre-Sutured Tendon (K253145)Rti Surgical, Inc.2025-10-22
ProZip Knotless Implant (K253024)Riverpoint Medical2025-10-16
PowerKnot High Strength Sutures (K252225)Medacta International S.A.2025-09-12
HS Fiber (K252201)Riverpoint Medical2025-08-13
HyperSuture White/Green Extension Line (K242201)Threadstone, LLC2025-03-27
HyperSuture All Blue Extension Line (K241376)Threadstone, LLC2024-08-09
HyperSuture Extension Line (K234079)Threadstone, LLC2024-05-10
HS Fiber Sutures (K231163)Riverpoint Medical2024-01-05
HyperSuture (K230311)Threadstone, LLC2023-11-24
Non absorbable Surgical Polyester Suture (K231183)Shandong Haidike Medical Products Co., Ltd.2023-08-25
SuperBall Meniscal Repair System (K223500)Arcuro Medical , Ltd.2023-08-10
MENIX®; MENIX® DUO (K223122)S.B.M. Sas (Science & Bio Materials)2023-08-03
MyEllevate (K230510)Cynosure, LLC2023-07-06
AceConnex Pre-Sutured Fascia (K213046)Allosource2023-06-27
Pre-Sutured Tendon (4561SC / Single Strand); Pre-Sutured Tendon (4564SC / Quadruple Strand ) (K230036)Rti Surgical, Inc.2023-06-23
ACTIVBRAID™ (K223822)Embody, Inc.2023-06-02
Arthrex BioSuture (K220880)Arthrex, Inc.2022-10-27
Arthrex SoftStitch (K222078)Arthrex, Inc.2022-09-14
Arthrex SutureTape (K221354)Arthrex, Inc.2022-09-09
Zone Specific AIM (K220186)Conmed Corporation2022-05-13
PERMALOOP Suture, PERMATAPE Suture (K220219)Medos International SARL2022-04-26
Arthrex LoopLoc Knotless Suture (K212146)Arthrex, Inc.2021-10-25
EasyWhip (K210675)Winter Innovations, Inc.2021-05-03
DYNATAPE Suture (K203186)Medos International SARL2021-03-18
FAST-FIX FLEX (K203393)Smith & Nephew, Inc.2021-02-01
Arthrex SoftStitch (K190707)Arthrex, Inc.2020-10-02
HS Fiber (K202242)Riverpoint Medical, LLC2020-09-10
Arthrex SutureTape (K193575)Arthrex, Inc.2020-07-24
Tevdek II, Silky II Polydek, 'Cottony' II, NextStitch (K192490)Teleflex Medical2020-03-30
High Strength Suture (K192637)Yunyi (Beijing) Medical Device Co., Ltd.2020-03-02
DemeTECH DemeFORCE Nonabsorbable Surgical Suture (K190777)Demetech Corporation2019-07-31
Force Fiber Suture (K191268)Teleflex Medical Incorporated2019-06-11
HS Fiber (K190817)Riverpoint Medical2019-05-01
MTF Pre-Sutured Tendon (K181633)Musculoskeletal Transplant Foundation2019-03-15
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 (K181774)Teleflex Medical Incorporated2018-10-10
DYNACORD Suture (K181182)Medos International SARL2018-08-02
NovoStitch Pro Meniscal Repair System, CTX-A004 (size 0) (K181772)Ceterix Orthopaedics, Inc.2018-08-01
SuperBall Meniscal Repair System (K180191)Arcuro Medical , Ltd.2018-06-05
NovoStitch Pro Meniscal Repair System (K180531)Ceterix Orthopaedics, Inc.2018-03-29
ReConnex Pre-Sutured Tendon (K170957)Allosource2018-03-20
Force Fiber Fusion Suture (K172016)Teleflex Medical Incorporated2017-10-03
GRAVITY™ Soft Tissue Repair System (K170642)Wrightmedicaltechnologyinc2017-08-22
Infinity-Lock 3, Infinity-Lock 5 (K171680)Xiros, Ltd.2017-06-30
SutureTape (K171296)Arthrex, Inc.2017-05-26
ExpressBraid Graft Manipulation (K163651)Biomet Manufacturing Corp2017-02-17
SpeedStitch Suture Passer; SpeedStitch Suture Cartridges, White Suture, Blue Cobraid, Black Cobraid, Mixed Pack; SpeedStitch Needle Loader and Unloader (K163142)ArthroCare Corporation2017-01-06
MaxBraid BroadBand Suture and Expressbraid BroadBand Graft Manipulation Suture (K160854)Biomet Manafacturing Corp.2016-12-19
PERMATAPE (K162247)Medos International SARL2016-12-15
XBraid TT Suture Tape (K162310)Stryker2016-11-10
SPEEDTRAP Graft Preparation System (K161638)Medos International SARL2016-11-07
'cottony' II TAPE, PLEDGETS (K153089)Teleflexmedical, Inc.2016-08-12
IvyAIR Meniscus System, Curved, IvyAIR Meniscus System, Straight, IvyAIR Meniscus System, Reverse Curved (K153087)Ivy Sports Medicine, LLC2016-07-14
silky II POLYDEK, cottony II, TEVDEK II, NextStitch, DEKLENE II, DEKLENE MAXX Gabbay-Frater, NYLON, SILK, STAINLESS STEEL (K153076)Teleflexmedical, Inc.2016-06-16
Dunamis Force DFX Tensile Tape (K153746)Dunamis, LLC2016-03-03
HS SutureTape (K153307)Riverpoint Medical2016-02-12
ExpressBraid Graft Manipulation (K152868)Biomet Manufacturing Corp2016-02-08
LARIAT RS Suture Delivery Device (K153096)Sentreheart, Inc.2015-11-25
ALAR Nasal Valve Stent (K151758)Medtronic Xomed, Inc.2015-10-29
Nexus Suture (K151009)Baylis Medical Company, Inc.2015-08-18
Stryker Suture Tape (K150584)Stryker2015-08-13
NovoStitch Plus Meniscal Repair System (K143356)Ceterix Orthopaedics, Inc.2015-07-21
Dunamis Force DFX Suture, Size 5, Dunamis Force DFX Suture Size 2 (K150327)Dunamis, LLC2015-06-29
Force Fiber OrthoTape suture (K150438)Teleflexmedical, Inc.2015-04-02
LARIAT sulture Delivery Device (K142241)Sentreheart, Inc.2014-09-12
SUPOLENE (K141072)Resorba Medical GmbH2014-06-23
A.I.M. KNOTLESS MENISCAL REPAIR DEVICE (K133770)Anchor Innovation Medical (A.I.M.)2014-06-10
ARTHREX BIOSUTURE (K140019)Arthrex, Inc.2014-01-30
TFCC FAST-FIX KIT (K132079)Smith & Nephew, Inc.2013-12-05
SMITH & NEPHEW ULTRATAPE (K132357)Smith & Nephew, Inc.2013-10-30
ARTHREX SPEEDCINCH (K132043)Arthrex, Inc.2013-07-31
SORIN VASCULOOP TWO TIE ENDOSCOPIC LIGATION SYSTEM MODEL DTTS2 (K122735)Sorin Group USA, Inc.2013-05-21
SMARTSTITCH PERFECTPASSER SYSTEM (K123268)Arthocare Corporation2012-11-07
SMITH & NEPHEW ULTRA FAST-FIX MENISCAL REPAIR SYSTEM, SMITH & NEPHEW ULTRA FAST-FIX AB MENISCAL REPAIR SYSTEM, SMITH & N (K121861)Smith & Nephew, Inc.2012-10-18
ARTHREX SUTURE (UHMWPE) (K122374)Arthrex, Inc.2012-09-25
SMARTSTITCH M-CONNECTOR ULTRA SMARTSTITCH SUTURE DEVICE HANDLE SMARTSTITCH SUTURE DEVICE HANDLE (K121306)Arthocare Corporation2012-07-12
CROSSFIX II MEMISCAL REPAIR DEVICE (K121413)Cayenne Medical, Inc.2012-06-04
ARTHREX BIO-SUTURE (K112899)Arthrex, Inc.2012-04-06
SMITH & NEWPHEW ULTRABRAID II SUTURE (K101377)Smith & Newphew, Inc.2011-04-08
CONMED LINVATEC SEQUENT MENISCAL REPAIR DEVICE (K102339)Conmed Linvatec2010-11-23
V-LOC(TM) NONABSORBABLE WOUND CLOSURE DEVICE (K103052)Covidien, LLC2010-11-10
G-CATH TISSUE ANCHOR DELIVERY CATHETER (K102916)Usgi Medical2010-10-20
NEOTRACT ANCHOR SYSTEM MODEL TAS400 (K102028)Neotract, Inc.2010-08-04
NEOTRACT ANCHOR SYSTEM MODEL: REF 11208 (K101252)Neotract, Inc.2010-07-15
HS FIBER (POLYBLEND), RIVER BOND, RIVERSILK (SILK), RIVERPRO (POLYPROPYLENE), RIVERLON (NYLON) MODEL VERIES BY SIZE/NEED (K100006)Riverpoint Medical2010-05-10
CP-FIBER (ORTHOFIBER) (K094028)Cp Medical2010-03-18
VERSACLOSE, MODEL VC-200-01 (K100572)Anulex Technologies, Inc.2010-03-17
FORCE FIBER GREEN ULTRA HIGH MOLECULAR WEIGHT POLYETHYLENE NON ABSORBABLE SUTURES MODEL:X-5000FFK, X-5001FFK, X-5002FFK (K100506)Teleflex Medical2010-03-10
G-CATH TISSUE ANCHOR DELIVERY CATHETER, MODELS 205302, 205333 (K100251)Usgi Medical2010-02-17
FAST-FIX 360 MENISCAL REPAIR SYSTEM, STRIAGHT, CURVED, REVERSE CURVED,FAST FIX 360 AB MENISCAL REPAIR SYSTEM, STRAIGHT, (K092508)Smith & Nephew, Inc.2010-01-28
IMPLICITGUIDE SURGICAL SUTURE SYSTEM (K091061)Implicitcare, LLC2009-11-13
SILK BLACK BRAIDED SURGICAL SUTURES, NYLON MONOFILAMENT BLUE AND BLACK SURGICAL SUTURES (K091574)Supplidores Unidos Internacionales, S.A.2009-10-09
G-PROX ENDOSCOPIC GRASPER, MODEL 205333 (K093018)Usgi Medical2009-10-07
FORCE FIBER BLUE ULTRA HIGH MOLECULAR WEIGHT POLYETHYLENE NON ABSORBABLE SUTURES (K092533)Beere Precision Medical Instruments, Kmedic, Telef2009-09-15
XCLOSE TISSUE REPAIR SYSTEM, MODEL XC-200-01 (K091432)Anulex Technologies, Inc.2009-06-12
LARIAT II SUTURE DELIVERY DEVICE (K090385)Sentreheart, Inc.2009-05-06
COVIDIEN SPORTS SURGERY AS MENISCAL REPAIR DEVICE WITH HIGH STRENGTH SUTURE (K091016)Surgical Devices, A Global Business Unit Covidien2009-05-04
Next →

Track GAT automatically

Every clearance here is in the API, with alerts when new ones post.