510(k) Report

Devices descending from K021434

259 later devices reach Arthrex Fiberwire in Usp Sizes through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K112960Labralink Suture Anchor with Inserter, 2.9MM Per-Loaded with One (1) and (2) #2 Uhmwpe…Cayenne Medical, Inc.20121—
+3K112990Acl Tightrope,Acl Tightrope Duuble BundleArthrex, Inc.201149—
+3K111032CMC Cable FixInstratek, Inc.20112—
+3K070780Conmed Linvatec XO ButtonConmed Linvatec200738—
+4K253065Aevumed SUPERCYNCH™ Button SystemAevumed, Inc.20260—
+4K261021EasyWhip FamilyWinter Innovations, Inc.20260—
+4K260921Tigon Medical Static Javelin All-Suture Anchors & Javelin All-Suture Anchor LineTigon Medical20260—
+4K254275HyperSuture All Green Extension LineThreadstone, LLC20260—
+4K252997HyperFlex® Bunion Correction SystemHyperflex Medical20250—
+4K253145Pre-Sutured TendonRti Surgical, Inc.20250—
+4K253024ProZip Knotless ImplantRiverpoint Medical20250—
+4K242201HyperSuture White/Green Extension LineThreadstone, LLC20251—
+4K250424Arthrex TightRope Soft Button, RTArthrex, Inc.20250—
+4K241376HyperSuture All Blue Extension LineThreadstone, LLC20240—
+4K240947TENSOR® Suture Button SystemGlobus Medical, Inc.20240—
+4K234079HyperSuture Extension LineThreadstone, LLC20240—
+4K232941Megaloop Button SystemSuzhou Endophix Co., Ltd.20240—
+4K231163HS Fiber SuturesRiverpoint Medical20243—
+4K232886INFILOOP® Fixed Loop UHMWPE Suture Titanium ButtonHealthium Medtech Limited20230—
+4K221128Arthrex ACL TightRope®, PCL TightRope®, and TightRope® IIArthrex, Inc.20226—
+4K221354Arthrex SutureTapeArthrex, Inc.20220—
+4K220906Secure-LockXiros, Ltd.20220—
+4K203259FairFix Adjustable Button SystemMedacta International S.A.20213—
+4K203834Arthrex Patella SuturePlatesArthrex, Inc.20211—
+4K203740JuggerKnot Soft AnchorRiverpoint Medical20215—
+4K203485SnugFit All-Suture AnchorMedacta International S.A.20212—
+4K202581Arthrex TightRope IIArthrex, Inc.20209—
+4K193575Arthrex SutureTapeArthrex, Inc.20201—
+4K192637High Strength SutureYunyi (Beijing) Medical Device Co., Ltd.20200—
+4K193461MectaLock All-Suture AnchorsMedacta International S.A.20203—
+4K192750AcTiFlip Naked, AcTiFlip Cinch, AcTiFlip WHIP, GFS Ultimate HipParcus Medical, LLC20203—
+4K191319Dunamis Fixation Button SystemDunamis, LLC20191—
+4K191204Infinity Fixation SystemConmed Corporation20190—
+4K190728Arthrex SwiveLock AnchorsArthrex, Inc.20192—
+4K180768Arthrex SwiveLock AnchorsArthrex, Inc.201828—
+4K180759SECULOK™ Suture AnchorU&I Corporation20180—
+4K181772NovoStitch Pro Meniscal Repair System, CTX-A004 (size 0)Ceterix Orthopaedics, Inc.20180—
+4K170440KISSloc Suture SystemArthrosurface, Inc.20171—
+4K163651ExpressBraid Graft ManipulationBiomet Manufacturing Corp20170—
+4K162310XBraid TT Suture TapeStryker20161—
+4K153558Ventix Suture AnchorBiomet Manufacturing Corp20160—
+4K151004PULLUP® Adjustable Juxtacortical Fixation DeviceSbm Sciences For Bio Materials20152—
+4K151068SureLock W Suture AnchorCayenne Medical, Inc.20156—
+4K151037GraftMax Button, ALB with Cradle, GraftMax Button, BTB with CradleConmed Corporation20155—
+4K150416ProCinch Adjustable Loop DeviceStryker Endoscopy20151—
+4K143092Tensyn PlugDallen Medical, Inc.20151—
+4K141219Juggerloc Bone to Bone Implants/ Bone Instruments/ Bone Implant and Instrument KitsBiomet Manufacturing Corp20141—
+4K140328CMC Mini TightropeArthrex, Inc.20146—
+4K133727Q-Fix Suture Anchor, 1.8MM; Q-Fix Suture Anchor, 2.8MM; Drill, Drill Guide and…ArthroCare Corporation20145—
+4K130033Toggleloc Xtender; Toggleloc XL; Implant Kit Toggleloc; Implant Kit Toggleloc BTB…Biomet Manufacturing Corp2013353
+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—
+5K252201HS FiberRiverpoint Medical20250—
+5K251310OTS 25-L (100-5)Ots Medical, Ltd.20250—
+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—
+5K240487EVOS Patella PlatesSmith & Nephew20240—
+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—
+5K230544SnugFit All-Suture Anchor extensionMedacta International S.A.20231—
+5K222574Simparo Anchor Line Fixation SystemSimparo, Inc.20230—
+5K223795FairFix QT Adjustable ButtonMedacta International S.A.20230—
+5K222169FairFix Adjustable Button SystemMedacta International S.A.20220—
+5K221389FairFix AM Adjustable Button FairFix PSP Adjustable ButtonMedacta 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—
+5K200028Coronet Soft Tissue Fixation SystemConextions Medical20202—
+5K193165MectaFix CL Fixation Button with Continuous LoopMedacta International S.A.20200—
+5K192441Arthrex SwiveLock AnchorsArthrex, Inc.20192—
+5K190516MicroLink All-Suture Button Fixation System (Radiolucent)Conmed Corporation20190—
+5K190582MicroLink All-Suture Button Fixation System (Radiopaque)Conmed Corporation20190—
+5K191226Arthrex SwiveLock Suture AnchorArthrex, Inc.201921—
+5K173278ToggleLoc SystemBiomet, Inc.20183—
+5K172620SyndesMetrics Syndesmosis Repair SystemMortise Medical, LLC20170—
+5K172186BioWick X Implant with DriverCayenne Medical, Inc.20174—
+5K172165Q-Fix Suture AnchorArthroCare Corporation20174—
+5K162198GFS UltimateParcus Medical, LLC20168—
+5K153186Adjustable Fixation DeviceArthrocare Corp.20161—
+5K150359Tensyn PlugDallen Medical, Inc.20150—
+5K143172ACL SMART SystemSmith & Nephew, Inc.20150—
+5K141263Toggleloc and Juggerloc Implants/Instruments/KitsBiomet Manufacturing Corp201402
+5K142653G-Lok and G-Lok XL ExtenderT.A.G. Medical Products Corporation, Ltd.20140—