510(k) Report

Devices descending from K031666

161 later devices reach Arthrex Fiberwire Button Repair Kit, Model AR-8920DS/AR-8921DS through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K123341Arthrex Pec Repair Button, Arthrex Large Pec Button, Arthrex Biceps Button, Arthrex…Arthrex, Inc.201252—
+1K100652Acl TightropeArthrex, Inc.201065—
+1K090107Mini TightropeArthrex, Inc.200921—
+1K062747Arthrex Retrobutton, 15MM, 60MM, Retrobutton, Long, 15MM, 60MMArthrex, Inc.2006143—
+1K052901Arthrex TensionlokArthrex, Inc.20050—
+2K241995HyperFlex™ Bunion Correction SystemFootbridge Medical20241—
+2K242311EXPERT - Flexible Joint Fixation SystemGM Dos Reis Industria e Comercio Ltda.20240—
+2K213644Arthrex Knotless Mini TightRopesArthrex, Inc.20211—
+2K211049Tigon Medical Button SystemTigon Medical20210—
+2K202444Knotless TensionTight Button Implant SystemArthrex, Inc.20201—
+2K200332EXPERT - Joint Fixation SystemGM Dos Reis Industria e Comercio Ltda.20201—
+2K191426FiberTak ButtonArthrex, Inc.20190—
+2K190288Arthrex Tenodesis ButtonArthrex, Inc.20194—
+2K190774RIGIDLOOP Titanium Button , RIGIDLOOP Cortical Fixation System XL ImplantMedos International SARL20191—
+2K181086Cortical Fixation SystemsCousin Biotech Sas20190—
+2K171703PUMA SystemPanther Orthopedics, Inc.20180—
+2K170388ANCHORMAN Tibial Ligament Fixation DeviceSummit Medical, Ltd.20170—
+2K150768JuggerKnot Soft AnchorsBiomet Manufacturing Corp201540—
+2K133835Arthrosurface Kissloc Knotless Suture SystemArthrosurface, Inc.20142—
+2K133275Mini TightropeArthrex, Inc.201411—
+2K122374Arthrex Suture (Uhmwpe)Arthrex, Inc.201213—
+2K112990Acl Tightrope,Acl Tightrope Duuble BundleArthrex, Inc.201149—
+2K111032CMC Cable FixInstratek, Inc.20112—
+2K070780Conmed Linvatec XO ButtonConmed Linvatec200738—
+3K253065Aevumed SUPERCYNCH™ Button SystemAevumed, Inc.20260—
+3K253910Stitch - Suture Wires and TapesGM Dos Reis Industria e Comercio Ltda.20260—
+3K260018Arthrex FiberButtonArthrex, Inc.20260—
+3K260405FiberTape ButtonArthrex, Inc.20260—
+3K252997HyperFlex® Bunion Correction SystemHyperflex Medical20250—
+3K243480SuturePatch Tissue ReinforcementArthrex, Inc.20250—
+3K250424Arthrex TightRope Soft Button, RTArthrex, Inc.20250—
+3K240947TENSOR® Suture Button SystemGlobus Medical, Inc.20240—
+3K232941Megaloop Button SystemSuzhou Endophix Co., Ltd.20240—
+3K232886INFILOOP® Fixed Loop UHMWPE Suture Titanium ButtonHealthium Medtech Limited20230—
+3K221128Arthrex ACL TightRope®, PCL TightRope®, and TightRope® IIArthrex, Inc.20226—
+3K220906Secure-LockXiros, Ltd.20220—
+3K212146Arthrex LoopLoc Knotless SutureArthrex, Inc.20210—
+3K203259FairFix Adjustable Button SystemMedacta International S.A.20213—
+3K203740JuggerKnot Soft AnchorRiverpoint Medical20215—
+3K203485SnugFit All-Suture AnchorMedacta International S.A.20212—
+3K202581Arthrex TightRope IIArthrex, Inc.20209—
+3K193461MectaLock All-Suture AnchorsMedacta International S.A.20203—
+3K192750AcTiFlip Naked, AcTiFlip Cinch, AcTiFlip WHIP, GFS Ultimate HipParcus Medical, LLC20203—
+3K191319Dunamis Fixation Button SystemDunamis, LLC20191—
+3K190777DemeTECH DemeFORCE Nonabsorbable Surgical SutureDemetech Corporation20190—
+3K191204Infinity Fixation SystemConmed Corporation20190—
+3K190728Arthrex SwiveLock AnchorsArthrex, Inc.20192—
+3K180768Arthrex SwiveLock AnchorsArthrex, Inc.201828—
+3K171296SutureTapeArthrex, Inc.20173—
+3K170440KISSloc Suture SystemArthrosurface, Inc.20171—
+3K160854MaxBraid BroadBand Suture and Expressbraid BroadBand Graft Manipulation SutureBiomet Manafacturing Corp.20160—
+3K153558Ventix Suture AnchorBiomet Manufacturing Corp20160—
+3K152868ExpressBraid Graft ManipulationBiomet Manufacturing Corp20162—
+3K151004PULLUP® Adjustable Juxtacortical Fixation DeviceSbm Sciences For Bio Materials20152—
+3K151037GraftMax Button, ALB with Cradle, GraftMax Button, BTB with CradleConmed Corporation20155—
+3K150416ProCinch Adjustable Loop DeviceStryker Endoscopy20151—
+3K141219Juggerloc Bone to Bone Implants/ Bone Instruments/ Bone Implant and Instrument KitsBiomet Manufacturing Corp20141—
+3K140328CMC Mini TightropeArthrex, Inc.20146—
+3K130033Toggleloc Xtender; Toggleloc XL; Implant Kit Toggleloc; Implant Kit Toggleloc BTB…Biomet Manufacturing Corp2013353
+3K123668OrthocordDepuy Mitek, Inc., A Johnson and Johnson Company20130—
+3K101616The Grapplr and Grapplr ExtenderTag Medical Corp.20111—
+3K090923Parcus Graft Fixation SystemParcus Medical, LLC200921—
+3K081098Endobutton Continuous Loop (CL)Smith & Nephew Inc., Endoscopy Division200831—
+4K252081SportLinc Syndesmosis DeviceLincotek Medical20260—
+4K253693Strut Suture; No-Tie ButtonRiverpoint Medical, LLC20260—
+4K250867Dunamis Screw and Suture Locking SystemDunamis Medical, LLC20250—
+4K251134RipCordTriMed, Inc.20250—
+4K251933SnugFit ASA ExtensionMedacta International S.A.20250—
+4K250844PULLUP®; PULLUP® CLIP; BT LOOP®; PULLUP® TEX CLIP; RIGIDLOOP™ T; RIGIDLOOP™ Clip…Science & Bio Materials (S.B.M.) Sas20250—
+4K243624Acu-Sinch Knotless MiniAcumed, LLC20250—
+4K242091Bolo Button SystemFusion Orthopedics20240—
+4K242494OsseoFit Interfacing Anchor; OsseoFit Bone Tunnel ConstructRiverpoint Medical, LLC20240—
+4K233531OIC FLEX-FIX™ SystemOrthopaedic Implant Company20240—
+4K232973Arthrex Knee FiberTak® Button Suture AnchorArthrex, Inc.20234—
+4K232411JuggerKnot Soft Anchor OCRiverpoint Medical, LLC20232—
+4K231857Arthrex TightRope IIArthrex, Inc.20234—
+4K231404T-Button® A Adjustable Loop UHMWPE Suture PEEK Button, Close Button, T-Button® S…Healthium Medtech Limited20230—
+4K231128JuggerKnot Soft AnchorRiverpoint Medical, LLC20230—
+4K230544SnugFit All-Suture Anchor extensionMedacta International S.A.20231—
+4K222574Simparo Anchor Line Fixation SystemSimparo, Inc.20230—
+4K223795FairFix QT Adjustable ButtonMedacta International S.A.20230—
+4K221354Arthrex SutureTapeArthrex, Inc.20220—
+4K222169FairFix Adjustable Button SystemMedacta International S.A.20220—
+4K221389FairFix AM Adjustable Button FairFix PSP Adjustable ButtonMedacta International S.A.20220—
+4K220650TriMed Ripcord DeviceTriMed, Inc.202211
+4K220260Hercules Syndesmosis Implant SystemIn2bones USA, LLC20220—
+4K211770R3ACT Stabilization SystemParagon 28, Inc.20213—
+4K212381VersaTap, VersaLat, DueLock, VersaTi, MiniTiOrtho-Design (Pty), Ltd.20211—
+4K212739ActiFlipParcus Medical, LLC20210—
+4K203121Responsive Arthroscopy Thunderbolt SystemResponsive Arthroscopy, LLC20211—
+4K210078Stryker ProCinch Adjustable Loop DeviceStryker Endoscopy20210—
+4K202259Parcus GFS II and GFS Mini, GFS Naked, GFS Ultimate, GFS BTB, ATLAS, Synd-EZ Ti…Parcus Medical, LLC20202—
+4K202193PULLUP BTB Adjustable Fixation System for Ligament Reconstruction, PULLUP CLIP…S.B.M. Sas (Science & Bio Materials)20201—
+4K193575Arthrex SutureTapeArthrex, Inc.20201—
+4K200028Coronet Soft Tissue Fixation SystemConextions Medical20202—
+4K193165MectaFix CL Fixation Button with Continuous LoopMedacta International S.A.20200—
+4K192441Arthrex SwiveLock AnchorsArthrex, Inc.20192—
+4K190516MicroLink All-Suture Button Fixation System (Radiolucent)Conmed Corporation20190—
+4K190582MicroLink All-Suture Button Fixation System (Radiopaque)Conmed Corporation20190—
+4K191226Arthrex SwiveLock Suture AnchorArthrex, Inc.201921—