510(k) Report

Devices descending from K990156

336 later devices reach Multitak SS Buttons through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K033717Transet Fracture Fixation SystemBonutti Research, Inc.2004309—
+1K031666Arthrex Fiberwire Button Repair Kit, Model AR-8920DS/AR-8921DSArthrex, Inc.20031611
+2K123341Arthrex Pec Repair Button, Arthrex Large Pec Button, Arthrex Biceps Button, Arthrex…Arthrex, Inc.201252—
+2K100652Acl TightropeArthrex, Inc.201065—
+2K090107Mini TightropeArthrex, Inc.200921—
+2K081348Tenodesis Cross Screw, Interference Screw, Suture BeadTriMed, Inc.20081—
+2K062747Arthrex Retrobutton, 15MM, 60MM, Retrobutton, Long, 15MM, 60MMArthrex, Inc.2006143—
+2K052901Arthrex TensionlokArthrex, Inc.20050—
+2K043248Tightrope Syndesmosis Repair Kit, Titanium, Model AR-8920DS; Stainless Steel. Model…Arthrex, Inc.2005306—
+3K252081SportLinc Syndesmosis DeviceLincotek Medical20260—
+3K253727Syndesmosis TightRope PROArthrex, Inc.20250—
+3K241995HyperFlex™ Bunion Correction SystemFootbridge Medical20241—
+3K242311EXPERT - Flexible Joint Fixation SystemGM Dos Reis Industria e Comercio Ltda.20240—
+3K232941Megaloop Button SystemSuzhou Endophix Co., Ltd.20240—
+3K220260Hercules Syndesmosis Implant SystemIn2bones USA, LLC20220—
+3K212990Acumed Ankle Syndesmosis Repair SystemAcumed, LLC20220—
+3K213644Arthrex Knotless Mini TightRopesArthrex, Inc.20211—
+3K211049Tigon Medical Button SystemTigon Medical20210—
+3K203121Responsive Arthroscopy Thunderbolt SystemResponsive Arthroscopy, LLC20211—
+3K202444Knotless TensionTight Button Implant SystemArthrex, Inc.20201—
+3K200332EXPERT - Joint Fixation SystemGM Dos Reis Industria e Comercio Ltda.20201—
+3K201522Arthrex Syndesmosis TightRope XP Buttress Plate Implant SystemArthrex, Inc.20207—
+3K191426FiberTak ButtonArthrex, Inc.20190—
+3K191783Parcus Synd-EZ TiParcus Medical, LLC20195—
+3K190288Arthrex Tenodesis ButtonArthrex, Inc.20194—
+3K191319Dunamis Fixation Button SystemDunamis, LLC20191—
+3K190774RIGIDLOOP Titanium Button , RIGIDLOOP Cortical Fixation System XL ImplantMedos International SARL20191—
+3K181086Cortical Fixation SystemsCousin Biotech Sas20190—
+3K173910Impress SFS SystemCable Fix Medical, LLC20180—
+3K171703PUMA SystemPanther Orthopedics, Inc.20180—
+3K173550Akros FibuLink™ Syndesmosis Repair KitAkros Medical20174—
+3K172620SyndesMetrics Syndesmosis Repair SystemMortise Medical, LLC20170—
+3K170388ANCHORMAN Tibial Ligament Fixation DeviceSummit Medical, Ltd.20170—
+3K170249GRAVITY™ Syndesmosis LPWrightmedicaltechnologyinc20172—
+3K162805Akros Fibulink Syndesmosis Repair KitAkros Medical20175—
+3K150768JuggerKnot Soft AnchorsBiomet Manufacturing Corp201540—
+3K150359Tensyn PlugDallen Medical, Inc.20150—
+3K133835Arthrosurface Kissloc Knotless Suture SystemArthrosurface, Inc.20142—
+3K133858Tensyn BandDallen Medical, Inc.20143—
+3K133275Mini TightropeArthrex, Inc.201411—
+3K132733Orthohelix Syndesmosis Fixation DevicesOrthohelix Surgical Designs, Inc.20143—
+3K131850Tensyn BandDallen Medical, Inc.20135—
+3K122374Arthrex Suture (Uhmwpe)Arthrex, Inc.201213—
+3K111971Synde-Lock Syndesmosis Repair KitTarsus Medical, Inc.20120—
+3K112437Arthrex Fracture SystemArthrex, Inc.201191—
+3K112990Acl Tightrope,Acl Tightrope Duuble BundleArthrex, Inc.201149—
+3K111032CMC Cable FixInstratek, Inc.20112—
+3K091156Trimed Sterile ProductTriMed, Inc.20090—
+3K083070Toggleloc SystemBiomet Sports Medicine2008946
+3K082095Ultraslide Acromioclavicular and Syndesmotic Repair DeviceSmith & Nephew Endoscopy, Inc.200859—
+3K070780Conmed Linvatec XO ButtonConmed Linvatec200738—
+3K061925Mini Tightrope Repair Kit, Model AR-8911DSArthrex, Inc.200633—
+3K052776Tightrope Acromioclavicular (AC) Device, Titanium, Stainless Steel , Models AR-2257…Arthrex, Inc.2005217—
+4K253065Aevumed SUPERCYNCH™ Button SystemAevumed, Inc.20260—
+4K253910Stitch - Suture Wires and TapesGM Dos Reis Industria e Comercio Ltda.20260—
+4K261406Versalock Proximal Tibial Plating SystemGM Dos Reis Industria e Comercio Ltda.20261—
+4K261632Thunderbolt SystemResponsive Arthroscopy, Inc.20260—
+4K260018Arthrex FiberButtonArthrex, Inc.20260—
+4K260405FiberTape ButtonArthrex, Inc.20260—
+4K252196Arthrex FibuLock Nail SystemArthrex, Inc.20260—
+4K252997HyperFlex® Bunion Correction SystemHyperflex Medical20250—
+4K251643Synchfix EVTWright Medical Technology, Inc. (Stryker Corporation)20250—
+4K250867Dunamis Screw and Suture Locking SystemDunamis Medical, LLC20250—
+4K243480SuturePatch Tissue ReinforcementArthrex, Inc.20250—
+4K250424Arthrex TightRope Soft Button, RTArthrex, Inc.20250—
+4K240035TACTIX Vector Syndesmosis SystemVilex, LLC20241—
+4K240947TENSOR® Suture Button SystemGlobus Medical, Inc.20240—
+4K232780CC-Clip® Implant SystemCc-Instruments, Inc.20230—
+4K232886INFILOOP® Fixed Loop UHMWPE Suture Titanium ButtonHealthium Medtech Limited20230—
+4K221128Arthrex ACL TightRope®, PCL TightRope®, and TightRope® IIArthrex, Inc.20226—
+4K221502Parcus Synd-EZ SSParcus Medical, LLC20220—
+4K220906Secure-LockXiros, Ltd.20220—
+4K220947Arthrex Knotless AC Repair DevicesArthrex, Inc.20223—
+4K220650TriMed Ripcord DeviceTriMed, Inc.202211
+4K211770R3ACT Stabilization SystemParagon 28, Inc.20213—
+4K212146Arthrex LoopLoc Knotless SutureArthrex, Inc.20210—
+4K203259FairFix Adjustable Button SystemMedacta International S.A.20213—
+4K203740JuggerKnot Soft AnchorRiverpoint Medical20215—
+4K203485SnugFit All-Suture AnchorMedacta International S.A.20212—
+4K203239Arthrex Low Profile ScrewsArthrex, Inc.20200—
+4K202581Arthrex TightRope IIArthrex, Inc.20209—
+4K202259Parcus GFS II and GFS Mini, GFS Naked, GFS Ultimate, GFS BTB, ATLAS, Synd-EZ Ti…Parcus Medical, LLC20202—
+4K200361Akros Scruture Anchor LisFranc Repair KitAkros Medical20200—
+4K193461MectaLock All-Suture AnchorsMedacta International S.A.20203—
+4K192750AcTiFlip Naked, AcTiFlip Cinch, AcTiFlip WHIP, GFS Ultimate HipParcus Medical, LLC20203—
+4K192964Parcus Synd-EZ SSParcus Medical, LLC20191—
+4K190777DemeTECH DemeFORCE Nonabsorbable Surgical SutureDemetech Corporation20190—
+4K191204Infinity Fixation SystemConmed Corporation20190—
+4K190728Arthrex SwiveLock AnchorsArthrex, Inc.20192—
+4K183232Double ENDOBUTTON Fixation DeviceSmith and Nephew, Inc.20196—
+4K180768Arthrex SwiveLock AnchorsArthrex, Inc.201828—
+4K180243Infinity-Lock Button SystemXiros, Ltd.20180—
+4K172383Arthrosurface Bone ScrewsArthrosurface, Inc.20171—
+4K162996INVISIKNOT Ankle Syndesmosis Repair KitSmith & Nephew, Inc.20172—
+4K171296SutureTapeArthrex, Inc.20173—
+4K170440KISSloc Suture SystemArthrosurface, Inc.20171—
+4K163361ANTHEM™ Fracture SystemGlobus Medical, Inc.201714—
+4K160854MaxBraid BroadBand Suture and Expressbraid BroadBand Graft Manipulation SutureBiomet Manafacturing Corp.20160—
+4K153558Ventix Suture AnchorBiomet Manufacturing Corp20160—
+4K152868ExpressBraid Graft ManipulationBiomet Manufacturing Corp20162—