510(k) Report

Devices descending from K022853

165 later devices reach Endotack through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K171640M-ARS ACL: Anatomic Ribbon Surgery SystemMedacta International S.A.20175—
+1K031666Arthrex Fiberwire Button Repair Kit, Model AR-8920DS/AR-8921DSArthrex, Inc.20031611
+2K221389FairFix AM Adjustable Button FairFix PSP Adjustable ButtonMedacta International S.A.20220—
+2K191300MectaLock Ti Suture AnchorMedacta International S.A.20193—
+2K123341Arthrex Pec Repair Button, Arthrex Large Pec Button, Arthrex Biceps Button, Arthrex…Arthrex, Inc.201252—
+2K100652Acl TightropeArthrex, Inc.201065—
+2K090107Mini TightropeArthrex, Inc.200921—
+2K062747Arthrex Retrobutton, 15MM, 60MM, Retrobutton, Long, 15MM, 60MMArthrex, Inc.2006143—
+2K052901Arthrex TensionlokArthrex, Inc.20050—
+3K241995HyperFlex™ Bunion Correction SystemFootbridge Medical20241—
+3K242311EXPERT - Flexible Joint Fixation SystemGM Dos Reis Industria e Comercio Ltda.20240—
+3K223582MectaLock TI Triple Loaded Suture AnchorMedacta International S.A.20232—
+3K213644Arthrex Knotless Mini TightRopesArthrex, Inc.20211—
+3K211049Tigon Medical Button SystemTigon Medical20210—
+3K202444Knotless TensionTight Button Implant SystemArthrex, Inc.20201—
+3K200332EXPERT - Joint Fixation SystemGM Dos Reis Industria e Comercio Ltda.20201—
+3K191426FiberTak ButtonArthrex, Inc.20190—
+3K190288Arthrex Tenodesis ButtonArthrex, Inc.20194—
+3K190774RIGIDLOOP Titanium Button , RIGIDLOOP Cortical Fixation System XL ImplantMedos International SARL20191—
+3K181086Cortical Fixation SystemsCousin Biotech Sas20190—
+3K171703PUMA SystemPanther Orthopedics, Inc.20180—
+3K170388ANCHORMAN Tibial Ligament Fixation DeviceSummit Medical, Ltd.20170—
+3K150768JuggerKnot Soft AnchorsBiomet Manufacturing Corp201540—
+3K133835Arthrosurface Kissloc Knotless Suture SystemArthrosurface, Inc.20142—
+3K133275Mini TightropeArthrex, Inc.201411—
+3K122374Arthrex Suture (Uhmwpe)Arthrex, Inc.201213—
+3K112990Acl Tightrope,Acl Tightrope Duuble BundleArthrex, Inc.201149—
+3K111032CMC Cable FixInstratek, Inc.20112—
+3K070780Conmed Linvatec XO ButtonConmed Linvatec200738—
+4K253065Aevumed SUPERCYNCH™ Button SystemAevumed, Inc.20260—
+4K253910Stitch - Suture Wires and TapesGM Dos Reis Industria e Comercio Ltda.20260—
+4K260018Arthrex FiberButtonArthrex, Inc.20260—
+4K260405FiberTape ButtonArthrex, Inc.20260—
+4K252997HyperFlex® Bunion Correction SystemHyperflex Medical20250—
+4K243480SuturePatch Tissue ReinforcementArthrex, Inc.20250—
+4K250424Arthrex TightRope Soft Button, RTArthrex, Inc.20250—
+4K240947TENSOR® Suture Button SystemGlobus Medical, Inc.20240—
+4K232941Megaloop Button SystemSuzhou Endophix Co., Ltd.20240—
+4K232886INFILOOP® Fixed Loop UHMWPE Suture Titanium ButtonHealthium Medtech Limited20230—
+4K230544SnugFit All-Suture Anchor extensionMedacta International S.A.20231—
+4K221128Arthrex ACL TightRope®, PCL TightRope®, and TightRope® IIArthrex, Inc.20226—
+4K220906Secure-LockXiros, Ltd.20220—
+4K212146Arthrex LoopLoc Knotless SutureArthrex, Inc.20210—
+4K203259FairFix Adjustable Button SystemMedacta International S.A.20213—
+4K203740JuggerKnot Soft AnchorRiverpoint Medical20215—
+4K203485SnugFit All-Suture AnchorMedacta International S.A.20212—
+4K202581Arthrex TightRope IIArthrex, Inc.20209—
+4K193461MectaLock All-Suture AnchorsMedacta International S.A.20203—
+4K192750AcTiFlip Naked, AcTiFlip Cinch, AcTiFlip WHIP, GFS Ultimate HipParcus Medical, LLC20203—
+4K191319Dunamis Fixation Button SystemDunamis, LLC20191—
+4K190777DemeTECH DemeFORCE Nonabsorbable Surgical SutureDemetech Corporation20190—
+4K191204Infinity Fixation SystemConmed Corporation20190—
+4K190728Arthrex SwiveLock AnchorsArthrex, Inc.20192—
+4K180768Arthrex SwiveLock AnchorsArthrex, Inc.201828—
+4K171296SutureTapeArthrex, Inc.20173—
+4K170440KISSloc Suture SystemArthrosurface, Inc.20171—
+4K160854MaxBraid BroadBand Suture and Expressbraid BroadBand Graft Manipulation SutureBiomet Manafacturing Corp.20160—
+4K153558Ventix Suture AnchorBiomet Manufacturing Corp20160—
+4K152868ExpressBraid Graft ManipulationBiomet Manufacturing Corp20162—
+4K151004PULLUP® Adjustable Juxtacortical Fixation DeviceSbm Sciences For Bio Materials20152—
+4K151037GraftMax Button, ALB with Cradle, GraftMax Button, BTB with CradleConmed Corporation20155—
+4K150416ProCinch Adjustable Loop DeviceStryker Endoscopy20151—
+4K141219Juggerloc Bone to Bone Implants/ Bone Instruments/ Bone Implant and Instrument KitsBiomet Manufacturing Corp20141—
+4K140328CMC Mini TightropeArthrex, Inc.20146—
+4K130033Toggleloc Xtender; Toggleloc XL; Implant Kit Toggleloc; Implant Kit Toggleloc BTB…Biomet Manufacturing Corp2013353
+4K123668OrthocordDepuy Mitek, Inc., A Johnson and Johnson Company20130—
+4K101616The Grapplr and Grapplr ExtenderTag Medical Corp.20111—
+4K090923Parcus Graft Fixation SystemParcus Medical, LLC200921—
+4K081098Endobutton Continuous Loop (CL)Smith & Nephew Inc., Endoscopy Division200831—
+5K252081SportLinc Syndesmosis DeviceLincotek Medical20260—
+5K253693Strut Suture; No-Tie ButtonRiverpoint Medical, LLC20260—
+5K250867Dunamis Screw and Suture Locking SystemDunamis Medical, LLC20250—
+5K251134RipCordTriMed, Inc.20250—
+5K251933SnugFit ASA ExtensionMedacta International S.A.20250—
+5K250844PULLUP®; PULLUP® CLIP; BT LOOP®; PULLUP® TEX CLIP; RIGIDLOOP™ T; RIGIDLOOP™ Clip…Science & Bio Materials (S.B.M.) Sas20250—
+5K243624Acu-Sinch Knotless MiniAcumed, LLC20250—
+5K242091Bolo Button SystemFusion Orthopedics20240—
+5K242494OsseoFit Interfacing Anchor; OsseoFit Bone Tunnel ConstructRiverpoint Medical, LLC20240—
+5K233531OIC FLEX-FIX™ SystemOrthopaedic Implant Company20240—
+5K232973Arthrex Knee FiberTak® Button Suture AnchorArthrex, Inc.20234—
+5K232411JuggerKnot Soft Anchor OCRiverpoint Medical, LLC20232—
+5K231857Arthrex TightRope IIArthrex, Inc.20234—
+5K231404T-Button® A Adjustable Loop UHMWPE Suture PEEK Button, Close Button, T-Button® S…Healthium Medtech Limited20230—
+5K231128JuggerKnot Soft AnchorRiverpoint Medical, LLC20230—
+5K222574Simparo Anchor Line Fixation SystemSimparo, Inc.20230—
+5K223795FairFix QT Adjustable ButtonMedacta International S.A.20230—
+5K221354Arthrex SutureTapeArthrex, Inc.20220—
+5K222169FairFix Adjustable Button SystemMedacta International S.A.20220—
+5K220650TriMed Ripcord DeviceTriMed, Inc.202211
+5K220260Hercules Syndesmosis Implant SystemIn2bones USA, LLC20220—
+5K211770R3ACT Stabilization SystemParagon 28, Inc.20213—
+5K212381VersaTap, VersaLat, DueLock, VersaTi, MiniTiOrtho-Design (Pty), Ltd.20211—
+5K212739ActiFlipParcus Medical, LLC20210—
+5K203121Responsive Arthroscopy Thunderbolt SystemResponsive Arthroscopy, LLC20211—
+5K210078Stryker ProCinch Adjustable Loop DeviceStryker Endoscopy20210—
+5K202259Parcus GFS II and GFS Mini, GFS Naked, GFS Ultimate, GFS BTB, ATLAS, Synd-EZ Ti…Parcus Medical, LLC20202—
+5K202193PULLUP BTB Adjustable Fixation System for Ligament Reconstruction, PULLUP CLIP…S.B.M. Sas (Science & Bio Materials)20201—
+5K193575Arthrex SutureTapeArthrex, Inc.20201—
+5K200028Coronet Soft Tissue Fixation SystemConextions Medical20202—
+5K193165MectaFix CL Fixation Button with Continuous LoopMedacta International S.A.20200—