510(k) Report

Devices descending from K922559

349 later devices reach Acufex Endofix Button through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K070167Endobutton DirectSmith & Nephew Inc., Endoscopy Division20072—
+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
+2K101616The Grapplr and Grapplr ExtenderTag Medical Corp.20111—
+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—
+2K033838Titanium Toggle Button (S)Biomet Manufacturing, Inc.2004971
+2K031666Arthrex Fiberwire Button Repair Kit, Model AR-8920DS/AR-8921DSArthrex, Inc.20031611
+2K984550Pre-Threaded EndobuttonSmith & Nephew, Inc.1999310—
+3K232886INFILOOP® Fixed Loop UHMWPE Suture Titanium ButtonHealthium Medtech Limited20230—
+3K212197WasherCap Fixation SystemAbanza Tecnomed S.L20223—
+3K202291Button LoopYunyi (Beijing) Medical Device Co., Ltd.20210—
+3K191053Xtreme-LoopXiros, Ltd.20190—
+3K191204Infinity Fixation SystemConmed Corporation20190—
+3K162198GFS UltimateParcus Medical, LLC20168—
+3K151037GraftMax Button, ALB with Cradle, GraftMax Button, BTB with CradleConmed Corporation20155—
+3K142653G-Lok and G-Lok XL ExtenderT.A.G. Medical Products Corporation, Ltd.20140—
+3K133757GFS II Standard, GFS II Large, GFS MimiParcus Medical, LLC201416—
+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—
+3K113591Cols PeekFournitures Hospitalieres Industrie20110—
+3K100652Acl TightropeArthrex, Inc.201065—
+3K090107Mini TightropeArthrex, Inc.200921—
+3K083070Toggleloc SystemBiomet Sports Medicine2008946
+3K081098Endobutton Continuous Loop (CL)Smith & Nephew Inc., Endoscopy Division200831—
+3K062747Arthrex Retrobutton, 15MM, 60MM, Retrobutton, Long, 15MM, 60MMArthrex, Inc.2006143—
+3K053461Ezloc Femoral Fixation DeviceArthrotek, Inc.20060—
+3K052901Arthrex TensionlokArthrex, Inc.20050—
+3K043248Tightrope Syndesmosis Repair Kit, Titanium, Model AR-8920DS; Stainless Steel. Model…Arthrex, Inc.2005306—
+3K041261Femoral HookArthrotek, Inc.200412
+4K252081SportLinc Syndesmosis DeviceLincotek Medical20260—
+4K253727Syndesmosis TightRope PROArthrex, Inc.20250—
+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—
+4K233531OIC FLEX-FIX™ SystemOrthopaedic Implant Company20240—
+4K231857Arthrex TightRope IIArthrex, Inc.20234—
+4K220650TriMed Ripcord DeviceTriMed, Inc.202211
+4K220260Hercules Syndesmosis Implant SystemIn2bones USA, LLC20220—
+4K212990Acumed Ankle Syndesmosis Repair SystemAcumed, LLC20220—
+4K211770R3ACT Stabilization SystemParagon 28, Inc.20213—
+4K213644Arthrex Knotless Mini TightRopesArthrex, Inc.20211—
+4K211049Tigon Medical Button SystemTigon Medical20210—
+4K203121Responsive Arthroscopy Thunderbolt SystemResponsive Arthroscopy, LLC20211—
+4K203259FairFix Adjustable Button SystemMedacta International S.A.20213—
+4K202444Knotless TensionTight Button Implant SystemArthrex, Inc.20201—
+4K200332EXPERT - Joint Fixation SystemGM Dos Reis Industria e Comercio Ltda.20201—
+4K202259Parcus GFS II and GFS Mini, GFS Naked, GFS Ultimate, GFS BTB, ATLAS, Synd-EZ Ti…Parcus Medical, LLC20202—
+4K201522Arthrex Syndesmosis TightRope XP Buttress Plate Implant SystemArthrex, Inc.20207—
+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—
+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—
+4K183331Parcus GFS BTBParcus Medical, LLC20193—
+4K173910Impress SFS SystemCable Fix Medical, LLC20180—
+4K171703PUMA SystemPanther Orthopedics, Inc.20180—
+4K173278ToggleLoc SystemBiomet, Inc.20183—
+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—
+4K170440KISSloc Suture SystemArthrosurface, Inc.20171—
+4K162805Akros Fibulink Syndesmosis Repair KitAkros Medical20175—
+4K160655OrthoButton CLRiverpoint Medical20169—
+4K153186Adjustable Fixation DeviceArthrocare Corp.20161—
+4K152711Parcus GFS NakedParcus Medical, LLC20154—
+4K151004PULLUP® Adjustable Juxtacortical Fixation DeviceSbm Sciences For Bio Materials20152—
+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—
+4K133579Multifilament Stainless Steel Sutures with CrimpsPontis Orthopaedics, LLC20140—
+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—
+4K122374Arthrex Suture (Uhmwpe)Arthrex, Inc.201213—
+4K111971Synde-Lock Syndesmosis Repair KitTarsus Medical, Inc.20120—
+4K112437Arthrex Fracture SystemArthrex, Inc.201191—