510(k) Report

Devices descending from K964532

394 later devices reach Multitak SS Suture System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K990156Multitak SS ButtonsBonutti Research1999336—
+1K973015Multitak SS Suture SystemBonutti Research1997393—
+2K101063Sleeve with Ziploop Fixation DevicesBiomet Sports Medicine201031
+2K080088Biomet Sports Medicine Anchor Devices and Ziploop ConstructsBiomet Manufacturing, Inc.200868
+2K071704Sleeve and Button Soft Tissue DevicesBiomet Sports Medicine, Inc.2007142—
+2K033717Transet Fracture Fixation SystemBonutti Research, Inc.2004309—
+2K031666Arthrex Fiberwire Button Repair Kit, Model AR-8920DS/AR-8921DSArthrex, Inc.20031611
+2K993115Multitak SSBonutti Research, Inc.19994—
+3K193402ALLthread PEEK Suture AnchorBiomet, Inc.20200—
+3K192942ALLthread Titanium Suture AnchorBiomet, Inc.20200—
+3K162429ZipE Knotless Tissue Repair and Attachment DevicesZiptek, LLC20175—
+3K123485Juggerknotless Soft Anchors, Juggerknotless M Soft Anchors, Juggerknotless Soft Anchors…Biomet Sports Medicine201302
+3K123341Arthrex Pec Repair Button, Arthrex Large Pec Button, Arthrex Biceps Button, Arthrex…Arthrex, Inc.201252—
+3K110473Nanotack Suture Anchor 1.4MMPivot Medical20112—
+3K110145Biomet Sports Medicine Juggerknot Soft AnchorBiomet, Inc.2011833
+3K100652Acl TightropeArthrex, Inc.201065—
+3K090107Mini TightropeArthrex, Inc.200921—
+3K083070Toggleloc SystemBiomet Sports Medicine2008946
+3K081348Tenodesis Cross Screw, Interference Screw, Suture BeadTriMed, Inc.20081—
+3K062747Arthrex Retrobutton, 15MM, 60MM, Retrobutton, Long, 15MM, 60MMArthrex, Inc.2006143—
+3K052901Arthrex TensionlokArthrex, Inc.20050—
+3K043248Tightrope Syndesmosis Repair Kit, Titanium, Model AR-8920DS; Stainless Steel. Model…Arthrex, Inc.2005306—
+3K011985Smith & Nephew Phoenix 5.0 Allograft Anchor KitSmith & Nephew, Inc.20013—
+4K252081SportLinc Syndesmosis DeviceLincotek Medical20260—
+4K253727Syndesmosis TightRope PROArthrex, Inc.20250—
+4K241995HyperFlex™ Bunion Correction SystemFootbridge Medical20241—
+4K242311EXPERT - Flexible Joint Fixation SystemGM Dos Reis Industria e Comercio Ltda.20240—
+4K232941Megaloop Button SystemSuzhou Endophix Co., Ltd.20240—
+4K233429OTS 25 (100-1)Ots Medical, Ltd.20232—
+4K220260Hercules Syndesmosis Implant SystemIn2bones USA, LLC20220—
+4K212990Acumed Ankle Syndesmosis Repair SystemAcumed, LLC20220—
+4K213644Arthrex Knotless Mini TightRopesArthrex, Inc.20211—
+4K211049Tigon Medical Button SystemTigon Medical20210—
+4K203121Responsive Arthroscopy Thunderbolt SystemResponsive Arthroscopy, LLC20211—
+4K202444Knotless TensionTight Button Implant SystemArthrex, Inc.20201—
+4K200332EXPERT - Joint Fixation SystemGM Dos Reis Industria e Comercio Ltda.20201—
+4K201522Arthrex Syndesmosis TightRope XP Buttress Plate Implant SystemArthrex, Inc.20207—
+4K200028Coronet Soft Tissue Fixation SystemConextions Medical20202—
+4K191227Paratrooper Plantar Plate Repair SystemParagon 28, Inc.20201—
+4K191426FiberTak ButtonArthrex, Inc.20190—
+4K191783Parcus Synd-EZ TiParcus Medical, LLC20195—
+4K190288Arthrex Tenodesis ButtonArthrex, Inc.20194—
+4K191319Dunamis Fixation Button SystemDunamis, LLC20191—
+4K190774RIGIDLOOP Titanium Button , RIGIDLOOP Cortical Fixation System XL ImplantMedos International SARL20191—
+4K182898TenoTac Soft Tissue Fixation SystemParagon 28, Inc.20191—
+4K181086Cortical Fixation SystemsCousin Biotech Sas20190—
+4K173910Impress SFS SystemCable Fix Medical, LLC20180—
+4K171703PUMA SystemPanther Orthopedics, Inc.20180—
+4K173550Akros FibuLink™ Syndesmosis Repair KitAkros Medical20174—
+4K172620SyndesMetrics Syndesmosis Repair SystemMortise Medical, LLC20170—
+4K170388ANCHORMAN Tibial Ligament Fixation DeviceSummit Medical, Ltd.20170—
+4K170249GRAVITY™ Syndesmosis LPWrightmedicaltechnologyinc20172—
+4K162996INVISIKNOT Ankle Syndesmosis Repair KitSmith & Nephew, Inc.20172—
+4K162805Akros Fibulink Syndesmosis Repair KitAkros Medical20175—
+4K153186Adjustable Fixation DeviceArthrocare Corp.20161—
+4K150768JuggerKnot Soft AnchorsBiomet Manufacturing Corp201540—
+4K150359Tensyn PlugDallen Medical, Inc.20150—
+4K143092Tensyn PlugDallen Medical, Inc.20151—
+4K141263Toggleloc and Juggerloc Implants/Instruments/KitsBiomet Manufacturing Corp201402
+4K141219Juggerloc Bone to Bone Implants/ Bone Instruments/ Bone Implant and Instrument KitsBiomet Manufacturing Corp20141—
+4K140324Rigidloop Adjustable Cortical Implant: Standard, Long and XLDepuy Mitek, A Johnson and Johnson Company20140—
+4K133835Arthrosurface Kissloc Knotless Suture SystemArthrosurface, Inc.20142—
+4K133606N8TIVE Acl Anatomic Reconstruction System, N8TIVE Acl Femoral Implant, N8TIVE Acl Tibial…ArthroCare Corporation20142—
+4K133858Tensyn BandDallen Medical, Inc.20143—
+4K133275Mini TightropeArthrex, Inc.201411—
+4K132733Orthohelix Syndesmosis Fixation DevicesOrthohelix Surgical Designs, Inc.20143—
+4K131850Tensyn BandDallen Medical, Inc.20135—
+4K130033Toggleloc Xtender; Toggleloc XL; Implant Kit Toggleloc; Implant Kit Toggleloc BTB…Biomet Manufacturing Corp2013353
+4K130458Knotless Fibertak Suture AnchorArthrex, Inc.20132—
+4K122059All-Suture Anchor Twist Drill for All-Suture Anchors Inline Drill Guide for All-Suture…Smith & Nephew, Inc.201316
+4K130351Nanotack Suture Anchor 1.4MM with Flex InserterPivot Medical, Inc.20130—
+4K123651Cinchlock Knotless Suture AnchorPivot Medical20130—
+4K122805Parcus Draw Tight 1.8MM Single-Loaded Suture AnchorParcus Medical, LLC20131—
+4K122374Arthrex Suture (Uhmwpe)Arthrex, Inc.201213—
+4K111971Synde-Lock Syndesmosis Repair KitTarsus Medical, Inc.20120—
+4K112437Arthrex Fracture SystemArthrex, Inc.201191—
+4K112990Acl Tightrope,Acl Tightrope Duuble BundleArthrex, Inc.201149—
+4K111032CMC Cable FixInstratek, Inc.20112—
+4K111779Y-Knot All-Suture Anchor Model HF13Conmed Linvatec201129—
+4K091156Trimed Sterile ProductTriMed, Inc.20090—
+4K082095Ultraslide Acromioclavicular and Syndesmotic Repair DeviceSmith & Nephew Endoscopy, Inc.200859—
+4K070780Conmed Linvatec XO ButtonConmed Linvatec200738—
+4K061925Mini Tightrope Repair Kit, Model AR-8911DSArthrex, Inc.200633—
+4K061498Allofix Anchor, 5.0 MM AnchorMusculoskeletal Transplant Foundation200601
+4K052776Tightrope Acromioclavicular (AC) Device, Titanium, Stainless Steel , Models AR-2257…Arthrex, Inc.2005217—
+4K042038MTF Allograft AnchorMusculoskeletal Transplant Foundation20041—
+5K253065Aevumed SUPERCYNCH™ Button SystemAevumed, Inc.20260—
+5K253910Stitch - Suture Wires and TapesGM Dos Reis Industria e Comercio Ltda.20260—
+5K261406Versalock Proximal Tibial Plating SystemGM Dos Reis Industria e Comercio Ltda.20261—
+5K261632Thunderbolt SystemResponsive Arthroscopy, Inc.20260—
+5K260018Arthrex FiberButtonArthrex, Inc.20260—
+5K261363Y-Knotless™ Flex AnchorsCONMED Corporation20260—
+5K260405FiberTape ButtonArthrex, Inc.20260—
+5K252196Arthrex FibuLock Nail SystemArthrex, Inc.20260—
+5K252997HyperFlex® Bunion Correction SystemHyperflex Medical20250—
+5K252596Tigon Medical Knotless and Dual Javelin All-Suture AnchorsTigon Medical20251—
+5K251643Synchfix EVTWright Medical Technology, Inc. (Stryker Corporation)20250—
+5K250867Dunamis Screw and Suture Locking SystemDunamis Medical, LLC20250—
+5K251134RipCordTriMed, Inc.20250—
+5K243480SuturePatch Tissue ReinforcementArthrex, Inc.20250—