510(k) Report

Devices descending from K982347

262 later devices reach Depuy Ace Timax Pilon Plate through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K052011Pilonplate with Angular StabilityI.T.S. Implantat-Technologie-Systeme GmbH200511
+1K033639Acumed Lower Extremity Congruent Plate SystemAcumed, LLC20049810
+1K031666Arthrex Fiberwire Button Repair Kit, Model AR-8920DS/AR-8921DSArthrex, Inc.20031611
+2K260958I.T.S. Clavicle Plates with Angular Stability; I.T.S. Volar Radius Plate with Angular…I.T.S. GmbH20260—
+2K242973CanMINI Hand and Foot SystemCanwell Medical Co., Ltd.20250—
+2K123341Arthrex Pec Repair Button, Arthrex Large Pec Button, Arthrex Biceps Button, Arthrex…Arthrex, Inc.201252—
+2K100652Acl TightropeArthrex, Inc.201065—
+2K090107Mini TightropeArthrex, Inc.200921—
+2K073375Newdeal Tibiaxys SystemNewdeal Sas2008732
+2K063831Basal Dorsal PlatesNewdeal Sas20070—
+2K063672Fibula Plate Prolock with Angular StabilityI.T.S. Implantat-Technologie-Systeme GmbH2007251
+2K062747Arthrex Retrobutton, 15MM, 60MM, Retrobutton, Long, 15MM, 60MMArthrex, Inc.2006143—
+2K060474Lisfranc PlateNew Deal, S.A.20061—
+2K060476Lapidus PlateNew Deal, S.A.20061—
+2K052901Arthrex TensionlokArthrex, Inc.20050—
+3K241995HyperFlex™ Bunion Correction SystemFootbridge Medical20241—
+3K242311EXPERT - Flexible Joint Fixation SystemGM Dos Reis Industria e Comercio Ltda.20240—
+3K213644Arthrex Knotless Mini TightRopesArthrex, Inc.20211—
+3K202803Activmotion S DTONewclip Technics20210—
+3K211049Tigon Medical Button SystemTigon Medical20210—
+3K210016Integra DigiFuse Cannulated Intramedullary Fusion System,Integra Total Foot…Integra LifeSciences Corporation20210—
+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—
+3K173121Ankle Fusion Plating SystemIn2bones Sas20172—
+3K170388ANCHORMAN Tibial Ligament Fixation DeviceSummit Medical, Ltd.20170—
+3K162674BioPro Foot Plating SystemsBiopro, Inc.201719—
+3K161894SurgTech Trauma SystemSurgtech, Inc.20173—
+3K150768JuggerKnot Soft AnchorsBiomet Manufacturing Corp201540—
+3K133835Arthrosurface Kissloc Knotless Suture SystemArthrosurface, Inc.20142—
+3K133275Mini TightropeArthrex, Inc.201411—
+3K121425Ortholoc 3DI Ankle Fusion Plating SystemWrightmedicaltechnologyinc201253—
+3K122374Arthrex Suture (Uhmwpe)Arthrex, Inc.201213—
+3K112990Acl Tightrope,Acl Tightrope Duuble BundleArthrex, Inc.201149—
+3K111032CMC Cable FixInstratek, Inc.20112—
+3K110670VLP Foot Talus Plates, VLP Percutaneous Calcaneus Plates and Misc VLP Bone Screws…Smith & Nephew, Inc.201169—
+3K100176Ascension Ankle Fusion Plate SystemAscension Orthopedics, Inc.201056—
+3K070780Conmed Linvatec XO ButtonConmed Linvatec200738—
+3K063820Lisfranc PlateNew Deal, S.A.20070—
+3K070241Modification to Lapidus PlateNew Deal, S.A.200701
+4K253065Aevumed SUPERCYNCH™ Button SystemAevumed, Inc.20260—
+4K253910Stitch - Suture Wires and TapesGM Dos Reis Industria e Comercio Ltda.20260—
+4K260018Arthrex FiberButtonArthrex, Inc.20260—
+4K260274Airlock® Ankle Plating SystemNovastep SAS20260—
+4K260405FiberTape ButtonArthrex, Inc.20260—
+4K252997HyperFlex® Bunion Correction SystemHyperflex Medical20250—
+4K251892MAXXOS P.A.C.E. Foot & Ankle Plating SystemMaxxos Medical GmbH20250—
+4K243480SuturePatch Tissue ReinforcementArthrex, Inc.20250—
+4K250424Arthrex TightRope Soft Button, RTArthrex, Inc.20250—
+4K242939ARTFX Trauma Bone Plate and Screw SystemArtfx Medical20242—
+4K241387CoLink NeoFuse MIS Plating System (see attached parts list)In2bones USA20240—
+4K240947TENSOR® Suture Button SystemGlobus Medical, Inc.20240—
+4K232941Megaloop Button SystemSuzhou Endophix Co., Ltd.20240—
+4K232886INFILOOP® Fixed Loop UHMWPE Suture Titanium ButtonHealthium Medtech Limited20230—
+4K222665Medline UNITE® Ankle Fusion Plating SystemMedline Industries, Inc.20230—
+4K221128Arthrex ACL TightRope®, PCL TightRope®, and TightRope® IIArthrex, Inc.20226—
+4K213126Smith & Nephew, Inc. Plates and Screws Systems: EVOS, Peri-Loc, D-Rad, TC-100, VLP…Smith & Nephew, Inc.202221
+4K220906Secure-LockXiros, Ltd.20220—
+4K213069CoLink NeoFuse Plating SystemIn2bones USA, LLC20211—
+4K212146Arthrex LoopLoc Knotless SutureArthrex, Inc.20210—
+4K210837Smith & Nephew Plates and ScrewsSmith & Nephew, Inc.202171
+4K203259FairFix Adjustable Button SystemMedacta International S.A.20213—
+4K203740JuggerKnot Soft AnchorRiverpoint Medical20215—
+4K203485SnugFit All-Suture AnchorMedacta International S.A.20212—
+4K202307Activ FuseNewclip Technics20200—
+4K202581Arthrex TightRope IIArthrex, Inc.20209—
+4K193461MectaLock All-Suture AnchorsMedacta International S.A.20203—
+4K193222Tyber Medical Anatomical Plating SystemTyber Medical, LLC202011—
+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—
+4K182991EPIC Extremity Fusion Plate SystemEpic Extremity, LLC20190—
+4K183011Additive Orthopaedics Patient Specific 3D Locking Lattice PlatesAdditive Orthopaedics20195—
+4K180768Arthrex SwiveLock AnchorsArthrex, Inc.201828—
+4K182148SILVERBACK Gorilla Plating SystemParagon 28, Inc.20183—
+4K171296SutureTapeArthrex, Inc.20173—
+4K170440KISSloc Suture SystemArthrosurface, Inc.20171—
+4K163650ORTHOLOC® 3Di Ankle Fusion Plating System Line ExtensionWrightmedicaltechnologyinc201712—
+4K160854MaxBraid BroadBand Suture and Expressbraid BroadBand Graft Manipulation SutureBiomet Manafacturing Corp.20160—
+4K153558Ventix Suture AnchorBiomet Manufacturing Corp20160—
+4K160191Align Anterior Ankle Fusion PlateExtremity Medical, LLC20165—
+4K152868ExpressBraid Graft ManipulationBiomet Manufacturing Corp20162—
+4K151004PULLUP® Adjustable Juxtacortical Fixation DeviceSbm Sciences For Bio Materials20152—
+4K152976VLP Mini-Mod Talus PlatesSmith & Nephew, Inc.20158—
+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—
+4K140792Salvation 3DI Plating SystemWrightmedicaltechnologyinc201421
+4K140408Salvation Osteopenic ScrewWrightmedicaltechnologyinc20141—
+4K140397Paralock Plating System / Tuffnek ScrewParagon 28201431—
+4K133930Flower Rear Foot Plating Set, Flower Calcaneus Planting Set, Flower Rearfoot Plating SetFlower Orthopedics Corporation201406
+4K140328CMC Mini TightropeArthrex, Inc.20146—
+4K123347Normed Ankle Fix System 4.0 and Normed Ankle Fix Plus System 4.0Normed Medizin-Technik GmbH201322
+4K130033Toggleloc Xtender; Toggleloc XL; Implant Kit Toggleloc; Implant Kit Toggleloc BTB…Biomet Manufacturing Corp2013353