510(k) Report

Devices descending from K982732

749 later devices reach Synthes (Usa) Distal Radius Plate System (DRPS) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K160553DePuy Synthes 4.0 mm and 5.0 mm Locking Screws – MR Conditional, DePuy Synthes Wrist…Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.20170—
+1K163361ANTHEM™ Fracture SystemGlobus Medical, Inc.201714—
+1K153716GPC BRAND Locking Bone Plates and Screws Osteosynthesis Plating System.Gpc Medical, Ltd.201615—
+1K142419Mini and Micro Fragments Reconstruction System-NEOFIXNeoortho Productos Orthopedicos S/A20148—
+1K142579Zimmer Periarticular Plating SystemZimmer, Inc.201402
+1K1026942.4MM VA-LCP Dorsal Distal Radius PlatesSynthes (Usa)2010503
+1K052150Volar Plate SystemDvo Extremity Solutions, LLC20050—
+1K040593Periarticular Locking Plates and Screws, 2358, 2359 SeriesZimmer, Inc.20041622
+1K023007Distal Radius Fracture Repair SystemHand Innovations, Inc.2002681—
+2K260390Super Upper Limbs Versalock Plating SystemGM Dos Reis Industria e Comercio Ltda.20261—
+2K251161ANTHEM® Fracture SystemGlobus Medical, Inc.20250—
+2K242939ARTFX Trauma Bone Plate and Screw SystemArtfx Medical20242—
+2K243308Bonebridge Osteosynthesis Plating System (SALGINA 2.5mm Distal Radius System, CASCELLA…Bonebridge AG20241—
+2K242596Versalock Mini and Micro Plating SystemGM Dos Reis Industria e Comercio Ltda.20242—
+2K202496ANTHEM Fracture SystemGlobus Medical, Inc.20208—
+2K182718Mini and Micro Fragments Reconstruction System – GMReisGm Dos Reis Industria E Comerico Ltda.20194—
+2K190391TDM Plate and Screw SystemsTdm Co., Ltd.20191—
+2K182650Arzzt Distal Radius and Ulna SystemTruemed Group, LLC20191—
+2K180554ANTHEM Fracture SystemGlobus Medical, Inc.201810—
+2K171320ARMAR / ARTIS Small Fragment and Calcaneal Plates & MBOSS / FIXION Screws, ARMAR/ ARTIS…Meril Healthcare Pvt., Ltd.20182—
+2K173746Activmotion RangeNewclip Technics20181—
+2K173166ANTHEM Fracture SystemGlobus Medical, Inc.201711—
+2K170705ARIX Wrist SystemJeil Medical Corporation20172—
+2K170843Alians Fragment SpecificNewclip Technics20171—
+2K163046DePuy Synthes 2.4/2.7mm VA LCP Two-Column Volar Distal Radius Plate, Extra-LongDePuy Synthes20175—
+2K161058Cannulated ScrewMiami Device Solutions, LLC20161—
+2K153034aap LOQTEQ VA Radius Set 2.5Aap Implantate AG20160—
+2K152242G3¿ Active Plate® Large Fragment SystemGenesis Fracture Care, Inc.20151—
+2K142938G3 Active Plate Large Fragment SystemGenesis Fracture Care, Inc.20143—
+2K133246Zimmer Distal Radius Plating SystemZimmer, Inc.20132—
+2K130774Universal Distal Radius SystemNewclip Technics20135—
+2K121601Synthes 2.7/3.5MM Variable Angle LCP Ankle Trauma System-Anterolateral Distal Tibia PlateSynthes USA20126—
+2K111039Zimmer Periarticular Locking Plate SystemZimmer, Inc.201134
+2K1101252.4 MM VA-LCP Volar Rim Distal Radius SystemSynthes USA20115—
+2K100271Vari AX Distal Radius Line Extensions of XXL PlatesHowmedica Osteonics Corp.201080—
+2K080184Distal Humeral Plates with Angular StabilityI.T.S. Implantat-Technologie-Systeme GmbH2008151
+2K063672Fibula Plate Prolock with Angular StabilityI.T.S. Implantat-Technologie-Systeme GmbH2007251
+2K060969Polyax Locked Plating SystemDePuy Orthopaedics, Inc.20061010
+2K052294Shoulder Nail PlateHand Innovations, LLC20050—
+2K052248Dorsal Nail Plate, AnatomicalHand Innovations, LLC200535
+2K051567Aptus Titanium Osteosynthesis SystemMedartis, Inc.20051571
+2K051098Periarticular Locking Plates and Screws, Model 2358 SeriesZimmer, Inc.200513—
+2K043560Periarticular Locking Plates and Screws, Series 2358 and 2359Zimmer, Inc.200513—
+2K043227Periarticular Locking Plates, 2358 SeriesZimmer, Inc.200413—
+2K042598Periarticular Locking Plates and Screws, 2357 and 2359 SeriesZimmer, Inc.2004311
+2K030198Hand Innovations, Inc. Distal Radius Fracture Repair SystemHand Innovations, Inc.2003678—
+3K261830FRAXION 3.5 Plate System (Various - See Catalog);FRAXION 4.5 Plate System (Various - See…Ortler Global Tibbi Gerecler Anonim Sirketi20260—
+3K262537Versalock Sterile Plating SystemGM Dos Reis Industria e Comercio Ltda.20260—
+3K260277Mikron Trauma Bone Plate& Screw SystemMikron Makina San. ve Tic. Ltd. Sti.20260—
+3K261351SALGINA 2.5mm Distal Radius SystemBonebridge AG20260—
+3K260958I.T.S. Clavicle Plates with Angular Stability; I.T.S. Volar Radius Plate with Angular…I.T.S. GmbH20260—
+3K253906Xpert HandNewclip Technics20260—
+3K243469SignexOsteonic Co., Ltd.20250—
+3K243610APTUS Hand System; APTUS Elbow Dorsal OlecranonMedartis AG20252—
+3K241599Signature Osteosynthesis Plate SystemSignature Orthopaedic Pty, Ltd.20250—
+3K241128TDM Plate and Screw SystemTdm Co., Ltd.20240—
+3K241539Activmotion SNewclip Technics20240—
+3K234059Forma Medical Optimal Plating SystemForma Medical, Inc.20240—
+3K231684Quick - Radius Disposable SetGM Dos Reis Industria e Comercio Ltda.20240—
+3K232144Sterile Products of the APTUS SystemMedartis AG20233—
+3K213864Bonebridge Osteosynthesis Plating SystemBonebridge AG20228—
+3K213591ANTHEM® Fracture SystemGlobus Medical, Inc.20225—
+3K210198GPC 2.4mm Variable Angle Locking Twon Column Volar Distal Radius Plates, 6 head Holes…Gpc Medical Limited20220—
+3K213214Xpert WristNewclip Technics20210—
+3K212433Anthem Fracture SystemGlobus Medical, Inc.20217—
+3K200575Truemed Hand, Foot and Ankle Plates SystemTruemed Group, LLC20210—
+3K200062Foot and Ankle SystemLeith Medical, LLC20210—
+3K200701Skeletal Dynamics Midshaft Humerus Plating SystemSkeletal Dynamics, Inc.20200—
+3K200043Field Orthopaedics Bony Trauma Extremity System (BTES) Plate Range and Plate Screws…Field Orthopaedics Pty, Ltd.20201—
+3K191972ARIX Wrist SystemJeil Medical Corporation20190—
+3K182810Distal Radius Plating SystemMiami Device Solutions, LLC20180—
+3K180310DePuy Synthes Trauma Orthopedic Plates and ScrewsSynthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.20184—
+3K180972ARIX Clavicle SystemJeil Medical Corporation20181—
+3K181009APTUS CMC-I Fusion Plate SystemMedartis AG20180—
+3K180348Field Orthopaedics Micro Screw SystemField Orthopaedics Pty, Ltd.20183—
+3K173556Injection ScrewBiedermann Medtech, Inc.20180—
+3K171624IXOS Radius Plate SystemStuckenbrock Medizintechnik GmbH20180—
+3K171808TDM Plate and Screw SystemTdm Co., Ltd.20186—
+3K172170APTUS (R) Wrist 2.5 SystemMedartis AG20178—
+3K162674BioPro Foot Plating SystemsBiopro, Inc.201719—
+3K161894SurgTech Trauma SystemSurgtech, Inc.20173—
+3K160633G3(TM) Active Plate (R) Small Fragment SystemGenesis Fracture Care, Inc.20160—
+3K142906APTUS Wrist 2.5 SystemMedartis AG201559—
+3K143496Piccolo Composite Plate SystemCarboFix Orthopedics, Ltd.20154—
+3K150649G3 Active Plate Large Fragment SystemGenesis Fracture Care, Inc.20152—
+3K142502Alians Ulna Locking Plating SystemNewclip Technics20142—
+3K141734Zimmer Periarticular Locking SystemZimmer, Inc.201403
+3K141232Aptus Ulna Shortening 2.5Medartis AG201451
+3K133974Variax Distal Radius Plating SystemStryker Leibinger GmbH201420—
+3K132945CFN-Cannulated Femur Nail, CTN-Cannulated Tibia Nail, CHN-Cannulated Humeral NailI.T.S. GmbH201410—
+3K132886Smith & Nephew Variable-Angle Locking Mini-Fragment Plating SystemSmith & Nephew, Inc.2014462
+3K132769Acumed Hand Plating SystemAcumed, LLC20147—
+3K133102Flower Ankle Plating SetFlower Orthopedics Corporation20130—
+3K132502Variax 2 SystemStryker Trauma AG201321—
+3K130810Zimmer Motionloc Screw for Periarticular Locking Plate SystemZimmer, Inc.20131—
+3K131474Arthrex Distal Radius Plate SystemArthrex, Inc.201320—
+3K120015Osteomed Wrist Plating SystemOsteomed LP20122—
+3K111663Trauma Internal Fixation SystemsDePuy Orthopaedics, Inc.2012117
+3K112169Aptus Wrist Arthrodesis PlatesMedartis AG20128—
+3K111447Zimmer Periarticular ScrewsZimmer, Inc.201114