510(k) Report

Devices descending from K962616

1,063 later devices reach Synthes Dorsal Distal Radius Plate (DDRP) System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K031334Texas T - PlateBiomet, Inc.20030—
+1K982732Synthes (Usa) Distal Radius Plate System (DRPS)Synthes1998749—
+1K974876Bionx Distal Radius ScrewBionx Implants, Inc.1998419—
+2K160553DePuy Synthes 4.0 mm and 5.0 mm Locking Screws – MR Conditional, DePuy Synthes Wrist…Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.20170—
+2K163361ANTHEM™ Fracture SystemGlobus Medical, Inc.201714—
+2K153716GPC BRAND Locking Bone Plates and Screws Osteosynthesis Plating System.Gpc Medical, Ltd.201615—
+2K142419Mini and Micro Fragments Reconstruction System-NEOFIXNeoortho Productos Orthopedicos S/A20148—
+2K142579Zimmer Periarticular Plating SystemZimmer, Inc.201402
+2K1026942.4MM VA-LCP Dorsal Distal Radius PlatesSynthes (Usa)2010503
+2K052150Volar Plate SystemDvo Extremity Solutions, LLC20050—
+2K050388Refix Internal Fracture Fixation ScrewsXtremi-T, LLC20050—
+2K032447Cannulated Nugen FX Screw Fully Threaded, Cannulated Nugen FX Screw Partially ThreadedLinvatec Biomaterials, Ltd.20041—
+2K040593Periarticular Locking Plates and Screws, 2358, 2359 SeriesZimmer, Inc.20041622
+2K023007Distal Radius Fracture Repair SystemHand Innovations, Inc.2002681—
+2K023022Nugen FX ScrewBionx Implants, Inc.20022—
+2K020222Wisorb Malleolar ScrewCambridge Scientific, Inc.20022—
+2K020819Distal Radius Plating SystemBiomet, Inc.20021—
+2K013057Biocuff,C, Models 236018, 236028, 236036Bionx Implants, Inc.200179—
+2K012001SmartscrewBionx Implants, Ltd.2001337—
+2K992947Cannulated Smartscrew Models 224540C, 224570CBionx Implants, Ltd.1999413—
+3K260390Super Upper Limbs Versalock Plating SystemGM Dos Reis Industria e Comercio Ltda.20261—
+3K251161ANTHEM® Fracture SystemGlobus Medical, Inc.20250—
+3K242939ARTFX Trauma Bone Plate and Screw SystemArtfx Medical20242—
+3K243308Bonebridge Osteosynthesis Plating System (SALGINA 2.5mm Distal Radius System, CASCELLA…Bonebridge AG20241—
+3K242596Versalock Mini and Micro Plating SystemGM Dos Reis Industria e Comercio Ltda.20242—
+3K202496ANTHEM Fracture SystemGlobus Medical, Inc.20208—
+3K182718Mini and Micro Fragments Reconstruction System – GMReisGm Dos Reis Industria E Comerico Ltda.20194—
+3K190391TDM Plate and Screw SystemsTdm Co., Ltd.20191—
+3K182650Arzzt Distal Radius and Ulna SystemTruemed Group, LLC20191—
+3K180554ANTHEM Fracture SystemGlobus Medical, Inc.201810—
+3K171320ARMAR / ARTIS Small Fragment and Calcaneal Plates & MBOSS / FIXION Screws, ARMAR/ ARTIS…Meril Healthcare Pvt., Ltd.20182—
+3K173746Activmotion RangeNewclip Technics20181—
+3K173166ANTHEM Fracture SystemGlobus Medical, Inc.201711—
+3K170705ARIX Wrist SystemJeil Medical Corporation20172—
+3K170843Alians Fragment SpecificNewclip Technics20171—
+3K163046DePuy Synthes 2.4/2.7mm VA LCP Two-Column Volar Distal Radius Plate, Extra-LongDePuy Synthes20175—
+3K161058Cannulated ScrewMiami Device Solutions, LLC20161—
+3K153034aap LOQTEQ VA Radius Set 2.5Aap Implantate AG20160—
+3K152242G3¿ Active Plate® Large Fragment SystemGenesis Fracture Care, Inc.20151—
+3K142938G3 Active Plate Large Fragment SystemGenesis Fracture Care, Inc.20143—
+3K133246Zimmer Distal Radius Plating SystemZimmer, Inc.20132—
+3K130774Universal Distal Radius SystemNewclip Technics20135—
+3K121601Synthes 2.7/3.5MM Variable Angle LCP Ankle Trauma System-Anterolateral Distal Tibia PlateSynthes USA20126—
+3K111039Zimmer Periarticular Locking Plate SystemZimmer, Inc.201134
+3K1101252.4 MM VA-LCP Volar Rim Distal Radius SystemSynthes USA20115—
+3K100271Vari AX Distal Radius Line Extensions of XXL PlatesHowmedica Osteonics Corp.201080—
+3K073312Osteotrans-OT ScrewTakiron Co., Ltd.20080—
+3K080184Distal Humeral Plates with Angular StabilityI.T.S. Implantat-Technologie-Systeme GmbH2008151
+3K063672Fibula Plate Prolock with Angular StabilityI.T.S. Implantat-Technologie-Systeme GmbH2007251
+3K060969Polyax Locked Plating SystemDePuy Orthopaedics, Inc.20061010
+3K052624Inion Otps Biodegradable Distal Radius PlateInion, Ltd.20050—
+3K052294Shoulder Nail PlateHand Innovations, LLC20050—
+3K052248Dorsal Nail Plate, AnatomicalHand Innovations, LLC200535
+3K051567Aptus Titanium Osteosynthesis SystemMedartis, Inc.20051571
+3K051098Periarticular Locking Plates and Screws, Model 2358 SeriesZimmer, Inc.200513—
+3K043145BI-Cortical Bio-Post and Washer, Model AR-1367BArthrex, Inc.200501
+3K043560Periarticular Locking Plates and Screws, Series 2358 and 2359Zimmer, Inc.200513—
+3K043227Periarticular Locking Plates, 2358 SeriesZimmer, Inc.200413—
+3K042598Periarticular Locking Plates and Screws, 2357 and 2359 SeriesZimmer, Inc.2004311
+3K042295Smartscrew II, Models 232010, 232012, 232014, 232016, 232018, 232020Linvatec Biomaterials, Ltd.20041—
+3K040265Little Grafter ScrewBiocomposites, Ltd.20041—
+3K030900Inion Otps Biodegradable Fixaton SystemInion, Ltd.2003333—
+3K030388Impact Suture Anchor. Model 433510Bionx Implants, Ltd.200377—
+3K030198Hand Innovations, Inc. Distal Radius Fracture Repair SystemHand Innovations, Inc.2003678—
+3K020056Duet Suture AnchorBionx Implants, Ltd.200278—
+4K261830FRAXION 3.5 Plate System (Various - See Catalog);FRAXION 4.5 Plate System (Various - See…Ortler Global Tibbi Gerecler Anonim Sirketi20260—
+4K262537Versalock Sterile Plating SystemGM Dos Reis Industria e Comercio Ltda.20260—
+4K260277Mikron Trauma Bone Plate& Screw SystemMikron Makina San. ve Tic. Ltd. Sti.20260—
+4K261351SALGINA 2.5mm Distal Radius SystemBonebridge AG20260—
+4K260958I.T.S. Clavicle Plates with Angular Stability; I.T.S. Volar Radius Plate with Angular…I.T.S. GmbH20260—
+4K253906Xpert HandNewclip Technics20260—
+4K243469SignexOsteonic Co., Ltd.20250—
+4K243610APTUS Hand System; APTUS Elbow Dorsal OlecranonMedartis AG20252—
+4K241599Signature Osteosynthesis Plate SystemSignature Orthopaedic Pty, Ltd.20250—
+4K241128TDM Plate and Screw SystemTdm Co., Ltd.20240—
+4K241539Activmotion SNewclip Technics20240—
+4K234059Forma Medical Optimal Plating SystemForma Medical, Inc.20240—
+4K231684Quick - Radius Disposable SetGM Dos Reis Industria e Comercio Ltda.20240—
+4K232144Sterile Products of the APTUS SystemMedartis AG20233—
+4K213864Bonebridge Osteosynthesis Plating SystemBonebridge AG20228—
+4K213591ANTHEM® Fracture SystemGlobus Medical, Inc.20225—
+4K210198GPC 2.4mm Variable Angle Locking Twon Column Volar Distal Radius Plates, 6 head Holes…Gpc Medical Limited20220—
+4K213214Xpert WristNewclip Technics20210—
+4K212433Anthem Fracture SystemGlobus Medical, Inc.20217—
+4K200575Truemed Hand, Foot and Ankle Plates SystemTruemed Group, LLC20210—
+4K200062Foot and Ankle SystemLeith Medical, LLC20210—
+4K200701Skeletal Dynamics Midshaft Humerus Plating SystemSkeletal Dynamics, Inc.20200—
+4K200043Field Orthopaedics Bony Trauma Extremity System (BTES) Plate Range and Plate Screws…Field Orthopaedics Pty, Ltd.20201—
+4K191972ARIX Wrist SystemJeil Medical Corporation20190—
+4K182810Distal Radius Plating SystemMiami Device Solutions, LLC20180—
+4K180310DePuy Synthes Trauma Orthopedic Plates and ScrewsSynthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.20184—
+4K180972ARIX Clavicle SystemJeil Medical Corporation20181—
+4K181009APTUS CMC-I Fusion Plate SystemMedartis AG20180—
+4K180348Field Orthopaedics Micro Screw SystemField Orthopaedics Pty, Ltd.20183—
+4K173556Injection ScrewBiedermann Medtech, Inc.20180—
+4K171624IXOS Radius Plate SystemStuckenbrock Medizintechnik GmbH20180—
+4K171808TDM Plate and Screw SystemTdm Co., Ltd.20186—
+4K172170APTUS (R) Wrist 2.5 SystemMedartis AG20178—
+4K162674BioPro Foot Plating SystemsBiopro, Inc.201719—
+4K161894SurgTech Trauma SystemSurgtech, Inc.20173—