510(k) Report

Devices descending from K990120

221 later devices reach Modification of Depuy Ace Timax Medial Pilon Plate through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K111663Trauma Internal Fixation SystemsDePuy Orthopaedics, Inc.2012117
+1K072832Anterolateral and Medial Locking Plating SystemDePuy Orthopaedics, Inc.2007582
+1K031666Arthrex Fiberwire Button Repair Kit, Model AR-8920DS/AR-8921DSArthrex, Inc.20031611
+2K243761A.L.P.S. Small Fragment Plating SystemBiomet Orthopedics20250—
+2K123341Arthrex Pec Repair Button, Arthrex Large Pec Button, Arthrex Biceps Button, Arthrex…Arthrex, Inc.201252—
+2K100652Acl TightropeArthrex, Inc.201065—
+2K092812Synthes (Usa) 2.7MM/ 3.5MM LCP Anterolateral Distal Tibia PlatesSynthes (Usa)201055—
+2K090107Mini TightropeArthrex, Inc.200921—
+2K062747Arthrex Retrobutton, 15MM, 60MM, Retrobutton, Long, 15MM, 60MMArthrex, Inc.2006143—
+2K052901Arthrex TensionlokArthrex, Inc.20050—
+3K242988Genostis Osteosynthesis SystemGenostis AF20250—
+3K241995HyperFlex™ Bunion Correction SystemFootbridge Medical20241—
+3K242311EXPERT - Flexible Joint Fixation SystemGM Dos Reis Industria e Comercio Ltda.20240—
+3K232394Internal Locking Plate and Screw Fixation SystemChangzhou Geasure Medical Apparatus and Instruments Co., Ltd.20230—
+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—
+3K193633APTUS® Ankle Trauma System 2.8/3.5Medartis AG202011—
+3K191793Nebula Brand Locking Bone Plates and Screws Osteosynthesis Plating System, Nebula Brand…Nebula Surgical Private Limited20193—
+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—
+3K162674BioPro Foot Plating SystemsBiopro, Inc.201719—
+3K163383GREENS BRAND Locking Bone Plates and Screws Osteosynthesis Plating System, GREENS BRAND…Greens Surgicals Pvt., Ltd.20173—
+3K161747LOQTEQ® VA Distal Tibia Plate System: LOQTEQ® VA Distal Medial Tibia Plate 3.5; LOQTEQ®…Aap Implantate AG20160—
+3K153716GPC BRAND Locking Bone Plates and Screws Osteosynthesis Plating System.Gpc Medical, Ltd.201615—
+3K150768JuggerKnot Soft AnchorsBiomet Manufacturing Corp201540—
+3K141680AUXEIN BRAND OF Bone Plates and Bone Screws & AUXEIN Brand of DCS Plate System AUXEIN…Auxein Medical20151—
+3K133835Arthrosurface Kissloc Knotless Suture SystemArthrosurface, Inc.20142—
+3K133275Mini TightropeArthrex, Inc.201411—
+3K133675Aap Loqteq Distal Anterolateral Tibia Plate 3.5Aap Implantate AG20140—
+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—
+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—
+4K240613APTUS Elbow Dorsal Olecranon PlatesMedartis AG20244—
+4K240947TENSOR® Suture Button SystemGlobus Medical, Inc.20240—
+4K232941Megaloop Button SystemSuzhou Endophix Co., Ltd.20240—
+4K232105APTUS Foot System 2.8-3.5Medartis AG20240—
+4K232886INFILOOP® Fixed Loop UHMWPE Suture Titanium ButtonHealthium Medtech Limited20230—
+4K230971APTUS® 3.5 TriLock Straight PlatesMedartis AG20232—
+4K223853Medartis APTUS® Ulna PlatesMedartis AG20235—
+4K221128Arthrex ACL TightRope®, PCL TightRope®, and TightRope® IIArthrex, Inc.20226—
+4K220906Secure-LockXiros, Ltd.20220—
+4K201510Traufix osteosynthesis, osteotomy, and arthrodesis devicesFixier S.A. DE C.V.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—
+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—
+4K183011Additive Orthopaedics Patient Specific 3D Locking Lattice PlatesAdditive Orthopaedics20195—
+4K180768Arthrex SwiveLock AnchorsArthrex, Inc.201828—
+4K171296SutureTapeArthrex, Inc.20173—
+4K170440KISSloc Suture SystemArthrosurface, Inc.20171—
+4K163361ANTHEM™ Fracture SystemGlobus Medical, Inc.201714—
+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—
+5K261830FRAXION 3.5 Plate System (Various - See Catalog);FRAXION 4.5 Plate System (Various - See…Ortler Global Tibbi Gerecler Anonim Sirketi20260—
+5K260277Mikron Trauma Bone Plate& Screw SystemMikron Makina San. ve Tic. Ltd. Sti.20260—
+5K261145Avanti Distal Elbow ORIF SystemAvanti Orthopaedics, LLC20260—
+5K252081SportLinc Syndesmosis DeviceLincotek Medical20260—
+5K253693Strut Suture; No-Tie ButtonRiverpoint Medical, LLC20260—
+5K251161ANTHEM® Fracture SystemGlobus Medical, Inc.20250—
+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—
+5K243610APTUS Hand System; APTUS Elbow Dorsal OlecranonMedartis AG20252—
+5K243624Acu-Sinch Knotless MiniAcumed, LLC20250—