510(k) Report

Devices descending from K952535

348 later devices reach Acufex Endobutton Tape through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K984550Pre-Threaded EndobuttonSmith & Nephew, Inc.1999310—
+1K980155Endobutton Continuous LoopSmith & Nephew, Inc.1998347—
+2K232941Megaloop Button SystemSuzhou Endophix Co., Ltd.20240—
+2K181086Cortical Fixation SystemsCousin Biotech Sas20190—
+2K151601Secure-LoopXiros, Ltd.20151—
+2K143172ACL SMART SystemSmith & Nephew, Inc.20150—
+2K130814Rigidloop Fixation Device (15MM, 60MM, XL, 20MM, 25MM, 30MM, 35MM, 40MM, 45MM, 50MM, 55MMDepuy Mitek, A Johnson & Johnson Company20133—
+2K130217Orthopediatrics Acl Reconstructive SystemOrthoPediatrics Corp.201343
+2K102982Endobutton DirectSmith & Nephew Inc., Endoscopy Division201136—
+2K090923Parcus Graft Fixation SystemParcus Medical, LLC200921—
+2K080974TLS Fixation SystemFournitures Hospitalieres Industrie20082—
+2K070780Conmed Linvatec XO ButtonConmed Linvatec200738—
+2K052652Smith & Nephew Continuous Loop Fixation DeviceSmith & Nephew, Inc.20050—
+2K043248Tightrope Syndesmosis Repair Kit, Titanium, Model AR-8920DS; Stainless Steel. Model…Arthrex, Inc.2005306—
+2K033838Titanium Toggle Button (S)Biomet Manufacturing, Inc.2004971
+2K031666Arthrex Fiberwire Button Repair Kit, Model AR-8920DS/AR-8921DSArthrex, Inc.20031611
+3K252081SportLinc Syndesmosis DeviceLincotek Medical20260—
+3K253727Syndesmosis TightRope PROArthrex, Inc.20250—
+3K232886INFILOOP® Fixed Loop UHMWPE Suture Titanium ButtonHealthium Medtech Limited20230—
+3K212197WasherCap Fixation SystemAbanza Tecnomed S.L20223—
+3K220260Hercules Syndesmosis Implant SystemIn2bones USA, LLC20220—
+3K212990Acumed Ankle Syndesmosis Repair SystemAcumed, LLC20220—
+3K203121Responsive Arthroscopy Thunderbolt SystemResponsive Arthroscopy, LLC20211—
+3K202291Button LoopYunyi (Beijing) Medical Device Co., Ltd.20210—
+3K200332EXPERT - Joint Fixation SystemGM Dos Reis Industria e Comercio Ltda.20201—
+3K201522Arthrex Syndesmosis TightRope XP Buttress Plate Implant SystemArthrex, Inc.20207—
+3K191783Parcus Synd-EZ TiParcus Medical, LLC20195—
+3K191319Dunamis Fixation Button SystemDunamis, LLC20191—
+3K191053Xtreme-LoopXiros, Ltd.20190—
+3K191204Infinity Fixation SystemConmed Corporation20190—
+3K173910Impress SFS SystemCable Fix Medical, LLC20180—
+3K171703PUMA SystemPanther Orthopedics, Inc.20180—
+3K173550Akros FibuLink™ Syndesmosis Repair KitAkros Medical20174—
+3K172620SyndesMetrics Syndesmosis Repair SystemMortise Medical, LLC20170—
+3K170249GRAVITY™ Syndesmosis LPWrightmedicaltechnologyinc20172—
+3K162805Akros Fibulink Syndesmosis Repair KitAkros Medical20175—
+3K162198GFS UltimateParcus Medical, LLC20168—
+3K151037GraftMax Button, ALB with Cradle, GraftMax Button, BTB with CradleConmed Corporation20155—
+3K150359Tensyn PlugDallen Medical, Inc.20150—
+3K133858Tensyn BandDallen Medical, Inc.20143—
+3K133757GFS II Standard, GFS II Large, GFS MimiParcus Medical, LLC201416—
+3K132733Orthohelix Syndesmosis Fixation DevicesOrthohelix Surgical Designs, Inc.20143—
+3K131850Tensyn BandDallen Medical, Inc.20135—
+3K130033Toggleloc Xtender; Toggleloc XL; Implant Kit Toggleloc; Implant Kit Toggleloc BTB…Biomet Manufacturing Corp2013353
+3K120740Cols® Fixation SystemFournitures Hospitalieres Industrie20130—
+3K123341Arthrex Pec Repair Button, Arthrex Large Pec Button, Arthrex Biceps Button, Arthrex…Arthrex, Inc.201252—
+3K111971Synde-Lock Syndesmosis Repair KitTarsus Medical, Inc.20120—
+3K113591Cols PeekFournitures Hospitalieres Industrie20110—
+3K112437Arthrex Fracture SystemArthrex, Inc.201191—
+3K101616The Grapplr and Grapplr ExtenderTag Medical Corp.20111—
+3K100652Acl TightropeArthrex, Inc.201065—
+3K090107Mini TightropeArthrex, Inc.200921—
+3K083070Toggleloc SystemBiomet Sports Medicine2008946
+3K082095Ultraslide Acromioclavicular and Syndesmotic Repair DeviceSmith & Nephew Endoscopy, Inc.200859—
+3K081098Endobutton Continuous Loop (CL)Smith & Nephew Inc., Endoscopy Division200831—
+3K061925Mini Tightrope Repair Kit, Model AR-8911DSArthrex, Inc.200633—
+3K062747Arthrex Retrobutton, 15MM, 60MM, Retrobutton, Long, 15MM, 60MMArthrex, Inc.2006143—
+3K053461Ezloc Femoral Fixation DeviceArthrotek, Inc.20060—
+3K052776Tightrope Acromioclavicular (AC) Device, Titanium, Stainless Steel , Models AR-2257…Arthrex, Inc.2005217—
+3K052901Arthrex TensionlokArthrex, Inc.20050—
+3K041261Femoral HookArthrotek, Inc.200412
+4K261406Versalock Proximal Tibial Plating SystemGM Dos Reis Industria e Comercio Ltda.20261—
+4K261632Thunderbolt SystemResponsive Arthroscopy, Inc.20260—
+4K252196Arthrex FibuLock Nail SystemArthrex, Inc.20260—
+4K251643Synchfix EVTWright Medical Technology, Inc. (Stryker Corporation)20250—
+4K250867Dunamis Screw and Suture Locking SystemDunamis Medical, LLC20250—
+4K251134RipCordTriMed, Inc.20250—
+4K250238WasherCap™ Fixation SystemAbanza Tecnomed S.L20250—
+4K243712WasherCap™ Mini Fixation System (Model 45)Abanza Tecnomed S.L20251—
+4K242091Bolo Button SystemFusion Orthopedics20240—
+4K241995HyperFlex™ Bunion Correction SystemFootbridge Medical20241—
+4K242311EXPERT - Flexible Joint Fixation SystemGM Dos Reis Industria e Comercio Ltda.20240—
+4K240035TACTIX Vector Syndesmosis SystemVilex, LLC20241—
+4K240947TENSOR® Suture Button SystemGlobus Medical, Inc.20240—
+4K233531OIC FLEX-FIX™ SystemOrthopaedic Implant Company20240—
+4K232780CC-Clip® Implant SystemCc-Instruments, Inc.20230—
+4K231857Arthrex TightRope IIArthrex, Inc.20234—
+4K221502Parcus Synd-EZ SSParcus Medical, LLC20220—
+4K220947Arthrex Knotless AC Repair DevicesArthrex, Inc.20223—
+4K220650TriMed Ripcord DeviceTriMed, Inc.202211
+4K211770R3ACT Stabilization SystemParagon 28, Inc.20213—
+4K213644Arthrex Knotless Mini TightRopesArthrex, Inc.20211—
+4K211049Tigon Medical Button SystemTigon Medical20210—
+4K203259FairFix Adjustable Button SystemMedacta International S.A.20213—
+4K203239Arthrex Low Profile ScrewsArthrex, Inc.20200—
+4K202444Knotless TensionTight Button Implant SystemArthrex, Inc.20201—
+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—
+4K200028Coronet Soft Tissue Fixation SystemConextions Medical20202—
+4K193165MectaFix CL Fixation Button with Continuous LoopMedacta International S.A.20200—
+4K192750AcTiFlip Naked, AcTiFlip Cinch, AcTiFlip WHIP, GFS Ultimate HipParcus Medical, LLC20203—
+4K191426FiberTak ButtonArthrex, Inc.20190—
+4K192964Parcus Synd-EZ SSParcus Medical, LLC20191—
+4K190288Arthrex Tenodesis ButtonArthrex, Inc.20194—
+4K190774RIGIDLOOP Titanium Button , RIGIDLOOP Cortical Fixation System XL ImplantMedos International SARL20191—
+4K183232Double ENDOBUTTON Fixation DeviceSmith and Nephew, Inc.20196—
+4K183331Parcus GFS BTBParcus Medical, LLC20193—
+4K180243Infinity-Lock Button SystemXiros, Ltd.20180—
+4K173278ToggleLoc SystemBiomet, Inc.20183—
+4K172383Arthrosurface Bone ScrewsArthrosurface, Inc.20171—