510(k) Report

Devices descending from K922559

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K112990Acl Tightrope,Acl Tightrope Duuble BundleArthrex, Inc.201149—
+4K111032CMC Cable FixInstratek, Inc.20112—
+4K082095Ultraslide Acromioclavicular and Syndesmotic Repair DeviceSmith & Nephew Endoscopy, Inc.200859—
+4K061925Mini Tightrope Repair Kit, Model AR-8911DSArthrex, Inc.200633—
+4K052776Tightrope Acromioclavicular (AC) Device, Titanium, Stainless Steel , Models AR-2257…Arthrex, Inc.2005217—
+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—
+5K260405FiberTape ButtonArthrex, Inc.20260—
+5K252196Arthrex FibuLock Nail SystemArthrex, Inc.20260—
+5K253618QuadLock™ Fixation SystemAbanza Tecnomed S.L20260—
+5K252997HyperFlex® Bunion Correction SystemHyperflex Medical20250—
+5K251643Synchfix EVTWright Medical Technology, Inc. (Stryker Corporation)20250—
+5K250867Dunamis Screw and Suture Locking SystemDunamis Medical, LLC20250—
+5K250844PULLUP®; PULLUP® CLIP; BT LOOP®; PULLUP® TEX CLIP; RIGIDLOOP™ T; RIGIDLOOP™ Clip…Science & Bio Materials (S.B.M.) Sas20250—
+5K243480SuturePatch Tissue ReinforcementArthrex, Inc.20250—
+5K250424Arthrex TightRope Soft Button, RTArthrex, Inc.20250—
+5K240035TACTIX Vector Syndesmosis SystemVilex, LLC20241—
+5K240947TENSOR® Suture Button SystemGlobus Medical, Inc.20240—
+5K241235Arthrex TightRope IIArthrex, Inc.20243—
+5K232780CC-Clip® Implant SystemCc-Instruments, Inc.20230—
+5K220966SinefixBAAT Medical Products B.V.20231—
+5K223589Grappler Suture Anchor R3FLEX IOL SystemParagon 28, Inc.20232—
+5K222971ULTRABUTTON QUAD Adjustable Fixation Device; ULTRABUTTON BB Adjustable Fixation Device…Smith & Nephew, Inc.20230—
+5K223795FairFix QT Adjustable ButtonMedacta International S.A.20230—
+5K213018Auxilock GFS Mini, GFS II Large, and GFS UltimateAuxein Medical Private Limited20220—
+5K221128Arthrex ACL TightRope®, PCL TightRope®, and TightRope® IIArthrex, Inc.20226—
+5K222169FairFix Adjustable Button SystemMedacta International S.A.20220—
+5K221502Parcus Synd-EZ SSParcus Medical, LLC20220—
+5K220906Secure-LockXiros, Ltd.20220—
+5K221389FairFix AM Adjustable Button FairFix PSP Adjustable ButtonMedacta International S.A.20220—
+5K220947Arthrex Knotless AC Repair DevicesArthrex, Inc.20223—
+5K212146Arthrex LoopLoc Knotless SutureArthrex, Inc.20210—
+5K212739ActiFlipParcus Medical, LLC20210—
+5K203740JuggerKnot Soft AnchorRiverpoint Medical20215—
+5K203485SnugFit All-Suture AnchorMedacta International S.A.20212—
+5K203239Arthrex Low Profile ScrewsArthrex, Inc.20200—
+5K202581Arthrex TightRope IIArthrex, Inc.20209—
+5K202193PULLUP BTB Adjustable Fixation System for Ligament Reconstruction, PULLUP CLIP…S.B.M. Sas (Science & Bio Materials)20201—
+5K200361Akros Scruture Anchor LisFranc Repair KitAkros Medical20200—
+5K193461MectaLock All-Suture AnchorsMedacta International S.A.20203—
+5K192964Parcus Synd-EZ SSParcus Medical, LLC20191—
+5K190777DemeTECH DemeFORCE Nonabsorbable Surgical SutureDemetech Corporation20190—
+5K190728Arthrex SwiveLock AnchorsArthrex, Inc.20192—
+5K183232Double ENDOBUTTON Fixation DeviceSmith and Nephew, Inc.20196—
+5K180768Arthrex SwiveLock AnchorsArthrex, Inc.201828—
+5K180243Infinity-Lock Button SystemXiros, Ltd.20180—
+5K172383Arthrosurface Bone ScrewsArthrosurface, Inc.20171—
+5K171060OrthoButton ALRiverpoint Medical20178—
+5K171296SutureTapeArthrex, Inc.20173—
+5K163361ANTHEM™ Fracture SystemGlobus Medical, Inc.201714—
+5K160854MaxBraid BroadBand Suture and Expressbraid BroadBand Graft Manipulation SutureBiomet Manafacturing Corp.20160—
+5K153558Ventix Suture AnchorBiomet Manufacturing Corp20160—
+5K152868ExpressBraid Graft ManipulationBiomet Manufacturing Corp20162—
+5K153211M-Fix Acromioclavicular DeviceCoracoid Solutions, Inc.20160—
+5K150416ProCinch Adjustable Loop DeviceStryker Endoscopy20151—
+5K143139Arthrex Fracture SystemArthrex, Inc.20151—
+5K141420FastforwardMedShape, Inc.20145—
+5K141264Tensyn Band, Tensyn Fracture PlatesDallen Medical, Inc.20142—
+5K140328CMC Mini TightropeArthrex, Inc.20146—
+5K123241Arthrex Fracture PlatesArthrex, Inc.201371—
+5K123668OrthocordDepuy Mitek, Inc., A Johnson and Johnson Company20130—
+5K112111Acu-Sinch Repair System and Acumed Suture AnchorAcumed, LLC201149—
+5K091207Surgicraft Lockdown Acromioclavicular (AC) DeviceSurgicraft, Ltd.20113—
+5K091763Michelangelo Bunion System - Mabs, Model: MA6000Instratek, Inc.20094—
+5K082384Hav-Lok Bunion Correction SystemInstratek, Inc.20085—
+5K071978Mini Tightrope FT Repair KitArthrex, Inc.200722—
+6K262537Versalock Sterile Plating SystemGM Dos Reis Industria e Comercio Ltda.20260—
+6K253115Lars AcjMovmedix S.A.S.20260—
+6K260390Super Upper Limbs Versalock Plating SystemGM Dos Reis Industria e Comercio Ltda.20261—
+6K254176SinefixBAAT Medical Products B.V.20260—
+6K253693Strut Suture; No-Tie ButtonRiverpoint Medical, LLC20260—
+6K253713Arthrex Variable Angle (VA) Proximal Tibia Plating SystemArthrex, Inc.20260—
+6K251161ANTHEM® Fracture SystemGlobus Medical, Inc.20250—
+6K251933SnugFit ASA ExtensionMedacta International S.A.20250—
+6K243368Montblanc Plate SystemMedifield Medical Co., Ltd.20250—
+6K243740Versalock Upper Limb Plating SystemGM Dos Reis Industria e Comercio Ltda.20251—
+6K243624Acu-Sinch Knotless MiniAcumed, LLC20250—
+6K243408TACTIX Vector Syndesmosis SystemVilex, LLC20240—
+6K242494OsseoFit Interfacing Anchor; OsseoFit Bone Tunnel ConstructRiverpoint Medical, LLC20240—
+6K242998GMReis Ankle Plating SystemGM Dos Reis Industria e Comercio Ltda.20241—
+6K240835Suture Button Repair SystemSkeletal Dynamics, Inc.20241—
+6K230546SignexOsteonic Co., Ltd.20242—
+6K240594Grappler Suture Anchor R3FLEX IOL SystemParagon 28, Inc.20241—
+6K240194ProCinch, QuadCinchRiverpoint Medical20240—
+6K233552IDEAL ZiploopRiverpoint Medical20230—
+6K232973Arthrex Knee FiberTak® Button Suture AnchorArthrex, Inc.20234—
+6K232411JuggerKnot Soft Anchor OCRiverpoint Medical, LLC20232—
+6K232755Arthrex FiberTape and TigerTape Cerclage SuturesArthrex, Inc.20232—
+6K231404T-Button® A Adjustable Loop UHMWPE Suture PEEK Button, Close Button, T-Button® S…Healthium Medtech Limited20230—
+6K231128JuggerKnot Soft AnchorRiverpoint Medical, LLC20230—
+6K230544SnugFit All-Suture Anchor extensionMedacta International S.A.20231—
+6K230212OrthoButton ALRiverpoint Medical, LLC20232—
+6K222574Simparo Anchor Line Fixation SystemSimparo, Inc.20230—
+6K222244Arthrex 3.5 mm Locking Compression PlatesArthrex, Inc.20221—
+6K221354Arthrex SutureTapeArthrex, Inc.20220—
+6K221485Arthrex FiberTape and TigerTape Cerclage SuturesArthrex, Inc.20225—
+6K213837Arthrx Fracture PlatesArthrex, Inc.20220—