510(k) Report

Devices descending from K003590

281 later devices reach Grams Polyester Nonabsorbable Suture through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K160454AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove ClipAtriCure, Inc.201602
+4K153746Dunamis Force DFX Tensile TapeDunamis, LLC20160—
+4K153307HS SutureTapeRiverpoint Medical20167—
+4K153500AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove PRO V ClipAtriCure, Inc.201610—
+4K143582Mopylen, Resopren, Silk, Polyester, Nylon, Resolon, Polyamide Pseudo, SteelResorba Medical GmbH20150—
+4K152795RiverLon (Nylon) SutureRiverpoint Medical20150—
+4K150768JuggerKnot Soft AnchorsBiomet Manufacturing Corp201540—
+4K150584Stryker Suture TapeStryker20152—
+4K143473Short SureLock All-Suture Anchor, 1.4mm with (1) size 0 UHMWPE suture with needles…Cayenne Medical, Inc.20150—
+4K141264Tensyn Band, Tensyn Fracture PlatesDallen Medical, Inc.20142—
+4K133835Arthrosurface Kissloc Knotless Suture SystemArthrosurface, Inc.20142—
+4K133275Mini TightropeArthrex, Inc.201411—
+4K132867Surelock All-Suture Anchor with Inserter, 1.4MM, Surelock All-Suture Anchor with…Cayenne Medical, Inc.20137—
+4K132513Q-Fix Suture Anchor,1.8MM and 2.8MM / Drill, Drill Guide and Obturator,1.8MM and 2.8MM…ArthroCare Corporation20136—
+4K131325Quattro GL Suture AnchorCayenne Medical, Inc.20130—
+4K1208243.9MM Reelx STT Suture Anchor SystemStryker Corp.20121—
+4K112814CuffinkCayenne Medical, Inc.20120—
+4K112960Labralink Suture Anchor with Inserter, 2.9MM Per-Loaded with One (1) and (2) #2 Uhmwpe…Cayenne Medical, Inc.20121—
+4K112990Acl Tightrope,Acl Tightrope Duuble BundleArthrex, Inc.201149—
+4K111032CMC Cable FixInstratek, Inc.20112—
+4K070780Conmed Linvatec XO ButtonConmed Linvatec200738—
+5K253065Aevumed SUPERCYNCH™ Button SystemAevumed, Inc.20260—
+5K261021EasyWhip FamilyWinter Innovations, Inc.20260—
+5K254275HyperSuture All Green Extension LineThreadstone, LLC20260—
+5K252997HyperFlex® Bunion Correction SystemHyperflex Medical20250—
+5K253024ProZip Knotless ImplantRiverpoint Medical20250—
+5K242201HyperSuture White/Green Extension LineThreadstone, LLC20251—
+5K250424Arthrex TightRope Soft Button, RTArthrex, Inc.20250—
+5K241376HyperSuture All Blue Extension LineThreadstone, LLC20240—
+5K240947TENSOR® Suture Button SystemGlobus Medical, Inc.20240—
+5K234079HyperSuture Extension LineThreadstone, LLC20240—
+5K232941Megaloop Button SystemSuzhou Endophix Co., Ltd.20240—
+5K231163HS Fiber SuturesRiverpoint Medical20243—
+5K232886INFILOOP® Fixed Loop UHMWPE Suture Titanium ButtonHealthium Medtech Limited20230—
+5K221128Arthrex ACL TightRope®, PCL TightRope®, and TightRope® IIArthrex, Inc.20226—
+5K220906Secure-LockXiros, Ltd.20220—
+5K203259FairFix Adjustable Button SystemMedacta International S.A.20213—
+5K203834Arthrex Patella SuturePlatesArthrex, Inc.20211—
+5K203740JuggerKnot Soft AnchorRiverpoint Medical20215—
+5K203485SnugFit All-Suture AnchorMedacta International S.A.20212—
+5K202581Arthrex TightRope IIArthrex, Inc.20209—
+5K192637High Strength SutureYunyi (Beijing) Medical Device Co., Ltd.20200—
+5K193461MectaLock All-Suture AnchorsMedacta International S.A.20203—
+5K192750AcTiFlip Naked, AcTiFlip Cinch, AcTiFlip WHIP, GFS Ultimate HipParcus Medical, LLC20203—
+5K191319Dunamis Fixation Button SystemDunamis, LLC20191—
+5K191204Infinity Fixation SystemConmed Corporation20190—
+5K190728Arthrex SwiveLock AnchorsArthrex, Inc.20192—
+5K180768Arthrex SwiveLock AnchorsArthrex, Inc.201828—
+5K180759SECULOK™ Suture AnchorU&I Corporation20180—
+5K181772NovoStitch Pro Meniscal Repair System, CTX-A004 (size 0)Ceterix Orthopaedics, Inc.20180—
+5K173031AtriClip LAA Exclusion System with Preloaded PRO·V ClipAtriCure, Inc.20179—
+5K170440KISSloc Suture SystemArthrosurface, Inc.20171—
+5K162310XBraid TT Suture TapeStryker20161—
+5K153558Ventix Suture AnchorBiomet Manufacturing Corp20160—
+5K151004PULLUP® Adjustable Juxtacortical Fixation DeviceSbm Sciences For Bio Materials20152—
+5K151068SureLock W Suture AnchorCayenne Medical, Inc.20156—
+5K151037GraftMax Button, ALB with Cradle, GraftMax Button, BTB with CradleConmed Corporation20155—
+5K150416ProCinch Adjustable Loop DeviceStryker Endoscopy20151—
+5K143092Tensyn PlugDallen Medical, Inc.20151—
+5K141219Juggerloc Bone to Bone Implants/ Bone Instruments/ Bone Implant and Instrument KitsBiomet Manufacturing Corp20141—
+5K140328CMC Mini TightropeArthrex, Inc.20146—
+5K133727Q-Fix Suture Anchor, 1.8MM; Q-Fix Suture Anchor, 2.8MM; Drill, Drill Guide and…ArthroCare Corporation20145—
+5K130033Toggleloc Xtender; Toggleloc XL; Implant Kit Toggleloc; Implant Kit Toggleloc BTB…Biomet Manufacturing Corp2013353
+5K101616The Grapplr and Grapplr ExtenderTag Medical Corp.20111—
+5K090923Parcus Graft Fixation SystemParcus Medical, LLC200921—
+5K081098Endobutton Continuous Loop (CL)Smith & Nephew Inc., Endoscopy Division200831—
+6K252081SportLinc Syndesmosis DeviceLincotek Medical20260—
+6K253693Strut Suture; No-Tie ButtonRiverpoint Medical, LLC20260—
+6K252201HS FiberRiverpoint Medical20250—
+6K251310OTS 25-L (100-5)Ots Medical, Ltd.20250—
+6K251134RipCordTriMed, Inc.20250—
+6K251933SnugFit ASA ExtensionMedacta International S.A.20250—
+6K250844PULLUP®; PULLUP® CLIP; BT LOOP®; PULLUP® TEX CLIP; RIGIDLOOP™ T; RIGIDLOOP™ Clip…Science & Bio Materials (S.B.M.) Sas20250—
+6K243624Acu-Sinch Knotless MiniAcumed, LLC20250—
+6K242091Bolo Button SystemFusion Orthopedics20240—
+6K242494OsseoFit Interfacing Anchor; OsseoFit Bone Tunnel ConstructRiverpoint Medical, LLC20240—
+6K240487EVOS Patella PlatesSmith & Nephew20240—
+6K233531OIC FLEX-FIX™ SystemOrthopaedic Implant Company20240—
+6K232973Arthrex Knee FiberTak® Button Suture AnchorArthrex, Inc.20234—
+6K232411JuggerKnot Soft Anchor OCRiverpoint Medical, LLC20232—
+6K231857Arthrex TightRope IIArthrex, Inc.20234—
+6K231404T-Button® A Adjustable Loop UHMWPE Suture PEEK Button, Close Button, T-Button® S…Healthium Medtech Limited20230—
+6K231128JuggerKnot Soft AnchorRiverpoint Medical, LLC20230—
+6K230544SnugFit All-Suture Anchor extensionMedacta International S.A.20231—
+6K222574Simparo Anchor Line Fixation SystemSimparo, Inc.20230—
+6K223795FairFix QT Adjustable ButtonMedacta International S.A.20230—
+6K222169FairFix Adjustable Button SystemMedacta International S.A.20220—
+6K221389FairFix AM Adjustable Button FairFix PSP Adjustable ButtonMedacta International S.A.20220—
+6K220650TriMed Ripcord DeviceTriMed, Inc.202211
+6K220260Hercules Syndesmosis Implant SystemIn2bones USA, LLC20220—
+6K211770R3ACT Stabilization SystemParagon 28, Inc.20213—
+6K212381VersaTap, VersaLat, DueLock, VersaTi, MiniTiOrtho-Design (Pty), Ltd.20211—
+6K212739ActiFlipParcus Medical, LLC20210—
+6K203121Responsive Arthroscopy Thunderbolt SystemResponsive Arthroscopy, LLC20211—
+6K210078Stryker ProCinch Adjustable Loop DeviceStryker Endoscopy20210—
+6K202259Parcus GFS II and GFS Mini, GFS Naked, GFS Ultimate, GFS BTB, ATLAS, Synd-EZ Ti…Parcus Medical, LLC20202—
+6K202193PULLUP BTB Adjustable Fixation System for Ligament Reconstruction, PULLUP CLIP…S.B.M. Sas (Science & Bio Materials)20201—
+6K200028Coronet Soft Tissue Fixation SystemConextions Medical20202—
+6K193165MectaFix CL Fixation Button with Continuous LoopMedacta International S.A.20200—
+6K192441Arthrex SwiveLock AnchorsArthrex, Inc.20192—