510(k) Report

Devices descending from K961522

439 later devices reach Kirschner Wire (K-Wire) and Steinmann Pin through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K150359Tensyn PlugDallen Medical, Inc.20150—
+4K142776Flow-ScrewFlow-Fx, LLC20151—
+4K143049LYNC intramedullary implantNovastep20150—
+4K133835Arthrosurface Kissloc Knotless Suture SystemArthrosurface, Inc.20142—
+4K132244N-Force Fixation SystemInnovision, Inc.20143—
+4K133858Tensyn BandDallen Medical, Inc.20143—
+4K133691Extrimilock Ankle Plating SystemOsteomed LP201410—
+4K133275Mini TightropeArthrex, Inc.201411—
+4K132733Orthohelix Syndesmosis Fixation DevicesOrthohelix Surgical Designs, Inc.20143—
+4K131850Tensyn BandDallen Medical, Inc.20135—
+4K131061Restore Bunion Correction SystemNextremity Solutions201315—
+4K130627Swing-Off ScrewAdvanced Interventional Technology, LLC20130—
+4K122374Arthrex Suture (Uhmwpe)Arthrex, Inc.201213—
+4K120360Ortho Solutions Trauma Plates for OsteosysnthesisOrtho Solutions Limited20122—
+4K121004Apex Kirschner Wires and Steinmann PinsApex Tools & Orthopedics Co.20122—
+4K111971Synde-Lock Syndesmosis Repair KitTarsus Medical, Inc.20120—
+4K112437Arthrex Fracture SystemArthrex, Inc.201191—
+4K112990Acl Tightrope,Acl Tightrope Duuble BundleArthrex, Inc.201149—
+4K111032CMC Cable FixInstratek, Inc.20112—
+4K091156Trimed Sterile ProductTriMed, Inc.20090—
+4K083070Toggleloc SystemBiomet Sports Medicine2008946
+4K082095Ultraslide Acromioclavicular and Syndesmotic Repair DeviceSmith & Nephew Endoscopy, Inc.200859—
+4K070780Conmed Linvatec XO ButtonConmed Linvatec200738—
+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—
+5K261830FRAXION 3.5 Plate System (Various - See Catalog);FRAXION 4.5 Plate System (Various - See…Ortler Global Tibbi Gerecler Anonim Sirketi20260—
+5K253910Stitch - Suture Wires and TapesGM Dos Reis Industria e Comercio Ltda.20260—
+5K260277Mikron Trauma Bone Plate& Screw SystemMikron Makina San. ve Tic. Ltd. Sti.20260—
+5K261406Versalock Proximal Tibial Plating SystemGM Dos Reis Industria e Comercio Ltda.20261—
+5K261632Thunderbolt SystemResponsive Arthroscopy, Inc.20260—
+5K260018Arthrex FiberButtonArthrex, Inc.20260—
+5K260900DYNEX® External Fixation SystemsVilex, LLC20260—
+5K260405FiberTape ButtonArthrex, Inc.20260—
+5K252196Arthrex FibuLock Nail SystemArthrex, Inc.20260—
+5K252997HyperFlex® Bunion Correction SystemHyperflex Medical20250—
+5K251643Synchfix EVTWright Medical Technology, Inc. (Stryker Corporation)20250—
+5K250867Dunamis Screw and Suture Locking SystemDunamis Medical, LLC20250—
+5K243480SuturePatch Tissue ReinforcementArthrex, Inc.20250—
+5K250424Arthrex TightRope Soft Button, RTArthrex, Inc.20250—
+5K243798Orthex External Fixation SystemOrthoPediatrics Corp.20251—
+5K242415TMC Compression Implant SystemTreace Medical Concepts20243—
+5K240035TACTIX Vector Syndesmosis SystemVilex, LLC20241—
+5K241262Baby Gorilla/Gorilla Plating System; Monster Screw SystemParagon 28, Inc.20240—
+5K240947TENSOR® Suture Button SystemGlobus Medical, Inc.20240—
+5K233089NeoSpan® Compression Implant SystemIn2bones USA, LLC20240—
+5K232780CC-Clip® Implant SystemCc-Instruments, Inc.20230—
+5K232886INFILOOP® Fixed Loop UHMWPE Suture Titanium ButtonHealthium Medtech Limited20230—
+5K230118Bony Trauma Extremity System (BTES) Screw Range, NX NailField Orthopaedics Pty, Ltd.20230—
+5K221128Arthrex ACL TightRope®, PCL TightRope®, and TightRope® IIArthrex, Inc.20226—
+5K221502Parcus Synd-EZ SSParcus Medical, LLC20220—
+5K220906Secure-LockXiros, Ltd.20220—
+5K220947Arthrex Knotless AC Repair DevicesArthrex, Inc.20223—
+5K220650TriMed Ripcord DeviceTriMed, Inc.202211
+5K211770R3ACT Stabilization SystemParagon 28, Inc.20213—
+5K212146Arthrex LoopLoc Knotless SutureArthrex, Inc.20210—
+5K210658Volition Plating SystemOrtho Solutions UK, Ltd.20210—
+5K210456Ligament StapleMedacta International S.A.20210—
+5K203259FairFix Adjustable Button SystemMedacta International S.A.20213—
+5K203479ExtremiLOCK Lateral Ankle Fusion PlatesOsteomed20210—
+5K203740JuggerKnot Soft AnchorRiverpoint Medical20215—
+5K202858Flex-ThreadTM Distal Fibula Intramedullary Nail SystemConventus Orthopaedics, LLC202132
+5K203485SnugFit All-Suture AnchorMedacta International S.A.20212—
+5K203239Arthrex Low Profile ScrewsArthrex, Inc.20200—
+5K202764Ortho Solutions Plating SystemOrtho Solutions UK, Ltd.20201—
+5K202581Arthrex TightRope IIArthrex, Inc.20209—
+5K202259Parcus GFS II and GFS Mini, GFS Naked, GFS Ultimate, GFS BTB, ATLAS, Synd-EZ Ti…Parcus Medical, LLC20202—
+5K200361Akros Scruture Anchor LisFranc Repair KitAkros Medical20200—
+5K193461MectaLock All-Suture AnchorsMedacta International S.A.20203—
+5K192750AcTiFlip Naked, AcTiFlip Cinch, AcTiFlip WHIP, GFS Ultimate HipParcus Medical, LLC20203—
+5K192964Parcus Synd-EZ SSParcus Medical, LLC20191—
+5K190777DemeTECH DemeFORCE Nonabsorbable Surgical SutureDemetech Corporation20190—
+5K191204Infinity Fixation SystemConmed Corporation20190—
+5K190728Arthrex SwiveLock AnchorsArthrex, Inc.20192—
+5K183232Double ENDOBUTTON Fixation DeviceSmith and Nephew, Inc.20196—
+5K180768Arthrex SwiveLock AnchorsArthrex, Inc.201828—
+5K173556Injection ScrewBiedermann Medtech, Inc.20180—
+5K181067AlignX Ankle Fusion SystemExtremity Medical, LLC20184—
+5K180243Infinity-Lock Button SystemXiros, Ltd.20180—
+5K172383Arthrosurface Bone ScrewsArthrosurface, Inc.20171—
+5K173121Ankle Fusion Plating SystemIn2bones Sas20172—
+5K163593Additive Orthopaedics Bunion SystemAdditive Orthopaedics, LLC20170—
+5K162996INVISIKNOT Ankle Syndesmosis Repair KitSmith & Nephew, Inc.20172—
+5K171296SutureTapeArthrex, Inc.20173—
+5K170440KISSloc Suture SystemArthrosurface, Inc.20171—
+5K170214Additive Orthopaedics Locking Lattice PlateAdditive Orthopaedics, LLC20178—
+5K163361ANTHEM™ Fracture SystemGlobus Medical, Inc.201714—
+5K162032Arrowhead Mini-Rail FixatorArrowhead De, LLC20171—
+5K160854MaxBraid BroadBand Suture and Expressbraid BroadBand Graft Manipulation SutureBiomet Manafacturing Corp.20160—
+5K153558Ventix Suture AnchorBiomet Manufacturing Corp20160—
+5K160191Align Anterior Ankle Fusion PlateExtremity Medical, LLC20165—
+5K152868ExpressBraid Graft ManipulationBiomet Manufacturing Corp20162—
+5K153211M-Fix Acromioclavicular DeviceCoracoid Solutions, Inc.20160—
+5K153186Adjustable Fixation DeviceArthrocare Corp.20161—
+5K152548AXI+LINE Proximal Bunion Correction SystemNextremity Solutions, Inc.20150—
+5K151004PULLUP® Adjustable Juxtacortical Fixation DeviceSbm Sciences For Bio Materials20152—
+5K151037GraftMax Button, ALB with Cradle, GraftMax Button, BTB with CradleConmed Corporation20155—
+5K150416ProCinch Adjustable Loop DeviceStryker Endoscopy20151—
+5K143092Tensyn PlugDallen Medical, Inc.20151—
+5K143139Arthrex Fracture SystemArthrex, Inc.20151—