510(k) Report

Devices descending from K952535

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K170388ANCHORMAN Tibial Ligament Fixation DeviceSummit Medical, Ltd.20170—
+4K162996INVISIKNOT Ankle Syndesmosis Repair KitSmith & Nephew, Inc.20172—
+4K170440KISSloc Suture SystemArthrosurface, Inc.20171—
+4K163361ANTHEM™ Fracture SystemGlobus Medical, Inc.201714—
+4K160655OrthoButton CLRiverpoint Medical20169—
+4K153211M-Fix Acromioclavicular DeviceCoracoid Solutions, Inc.20160—
+4K153186Adjustable Fixation DeviceArthrocare Corp.20161—
+4K152711Parcus GFS NakedParcus Medical, LLC20154—
+4K151004PULLUP® Adjustable Juxtacortical Fixation DeviceSbm Sciences For Bio Materials20152—
+4K150768JuggerKnot Soft AnchorsBiomet Manufacturing Corp201540—
+4K143092Tensyn PlugDallen Medical, Inc.20151—
+4K143139Arthrex Fracture SystemArthrex, Inc.20151—
+4K141420FastforwardMedShape, Inc.20145—
+4K141263Toggleloc and Juggerloc Implants/Instruments/KitsBiomet Manufacturing Corp201402
+4K142653G-Lok and G-Lok XL ExtenderT.A.G. Medical Products Corporation, Ltd.20140—
+4K141264Tensyn Band, Tensyn Fracture PlatesDallen Medical, Inc.20142—
+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—
+4K133275Mini TightropeArthrex, Inc.201411—
+4K123241Arthrex Fracture PlatesArthrex, Inc.201371—
+4K122374Arthrex Suture (Uhmwpe)Arthrex, Inc.201213—
+4K112990Acl Tightrope,Acl Tightrope Duuble BundleArthrex, Inc.201149—
+4K112111Acu-Sinch Repair System and Acumed Suture AnchorAcumed, LLC201149—
+4K111032CMC Cable FixInstratek, Inc.20112—
+4K091207Surgicraft Lockdown Acromioclavicular (AC) DeviceSurgicraft, Ltd.20113—
+4K091763Michelangelo Bunion System - Mabs, Model: MA6000Instratek, Inc.20094—
+4K082384Hav-Lok Bunion Correction SystemInstratek, Inc.20085—
+4K071978Mini Tightrope FT Repair KitArthrex, Inc.200722—
+5K253065Aevumed SUPERCYNCH™ Button SystemAevumed, Inc.20260—
+5K253910Stitch - Suture Wires and TapesGM Dos Reis Industria e Comercio Ltda.20260—
+5K262537Versalock Sterile Plating SystemGM Dos Reis Industria e Comercio Ltda.20260—
+5K260018Arthrex FiberButtonArthrex, Inc.20260—
+5K253115Lars AcjMovmedix S.A.S.20260—
+5K260390Super Upper Limbs Versalock Plating SystemGM Dos Reis Industria e Comercio Ltda.20261—
+5K260405FiberTape ButtonArthrex, Inc.20260—
+5K253713Arthrex Variable Angle (VA) Proximal Tibia Plating SystemArthrex, Inc.20260—
+5K253618QuadLock™ Fixation SystemAbanza Tecnomed S.L20260—
+5K252997HyperFlex® Bunion Correction SystemHyperflex Medical20250—
+5K251161ANTHEM® Fracture SystemGlobus Medical, Inc.20250—
+5K243368Montblanc Plate SystemMedifield Medical Co., Ltd.20250—
+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—
+5K243740Versalock Upper Limb Plating SystemGM Dos Reis Industria e Comercio Ltda.20251—
+5K243408TACTIX Vector Syndesmosis SystemVilex, LLC20240—
+5K242998GMReis Ankle Plating SystemGM Dos Reis Industria e Comercio Ltda.20241—
+5K230546SignexOsteonic Co., Ltd.20242—
+5K241235Arthrex TightRope IIArthrex, Inc.20243—
+5K232755Arthrex FiberTape and TigerTape Cerclage SuturesArthrex, Inc.20232—
+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—
+5K222244Arthrex 3.5 mm Locking Compression PlatesArthrex, Inc.20221—
+5K221485Arthrex FiberTape and TigerTape Cerclage SuturesArthrex, Inc.20225—
+5K222169FairFix Adjustable Button SystemMedacta International S.A.20220—
+5K220906Secure-LockXiros, Ltd.20220—
+5K221389FairFix AM Adjustable Button FairFix PSP Adjustable ButtonMedacta International S.A.20220—
+5K213837Arthrx Fracture PlatesArthrex, Inc.20220—
+5K212146Arthrex LoopLoc Knotless SutureArthrex, Inc.20210—
+5K212739ActiFlipParcus Medical, LLC20210—
+5K210750Acumed Clavicle Hook Plating SystemAcumed, LLC20210—
+5K203740JuggerKnot Soft AnchorRiverpoint Medical20215—
+5K203485SnugFit All-Suture AnchorMedacta International S.A.20212—
+5K202581Arthrex TightRope IIArthrex, Inc.20209—
+5K202496ANTHEM Fracture SystemGlobus Medical, Inc.20208—
+5K202193PULLUP BTB Adjustable Fixation System for Ligament Reconstruction, PULLUP CLIP…S.B.M. Sas (Science & Bio Materials)20201—
+5K200226RetroFixRetrofix Screws, LLC20200—
+5K193461MectaLock All-Suture AnchorsMedacta International S.A.20203—
+5K192984APTUS Clavicle SystemMedartis AG20206—
+5K190143LARS AC Band DeviceCorin USA20191—
+5K190777DemeTECH DemeFORCE Nonabsorbable Surgical SutureDemetech Corporation20190—
+5K183094CyclaPlex Correction SystemCycla Orthopedics, Ltd.20190—
+5K190728Arthrex SwiveLock AnchorsArthrex, Inc.20192—
+5K180768Arthrex SwiveLock AnchorsArthrex, Inc.201828—
+5K180554ANTHEM Fracture SystemGlobus Medical, Inc.201810—
+5K180972ARIX Clavicle SystemJeil Medical Corporation20181—
+5K171808TDM Plate and Screw SystemTdm Co., Ltd.20186—
+5K173746Activmotion RangeNewclip Technics20181—
+5K173166ANTHEM Fracture SystemGlobus Medical, Inc.201711—
+5K170518In2Bones Fracture and Correction SystemIn2bones USA, LLC2017151
+5K171060OrthoButton ALRiverpoint Medical20178—
+5K171296SutureTapeArthrex, Inc.20173—
+5K160854MaxBraid BroadBand Suture and Expressbraid BroadBand Graft Manipulation SutureBiomet Manafacturing Corp.20160—
+5K160264Additive Orthopaedics Hammertoe Correction SystemAdditive Orthopaedics, LLC20164—
+5K153558Ventix Suture AnchorBiomet Manufacturing Corp20160—
+5K152868ExpressBraid Graft ManipulationBiomet Manufacturing Corp20162—
+5K151732Arthrex Fracture PlatesArthrex, Inc.201521—
+5K150416ProCinch Adjustable Loop DeviceStryker Endoscopy20151—
+5K141735Arthrex Ankle Fusion Plating SystemArthrex, Inc.2014381
+5K141478Arthrex Fracture Plates and ScrewsArthrex, Inc.2014231
+5K140328CMC Mini TightropeArthrex, Inc.20146—
+5K131620Jones-FX Fracture SystemInstratek, Inc.20131—
+5K123668OrthocordDepuy Mitek, Inc., A Johnson and Johnson Company20130—
+5K113760Variax Superior and Anterior, Lateral and Midshaft Clavicle Plates Variax Aiming Blocks…Howmedica Osteonics Corp., Dba Stryker Orthopaedics201240—