510(k) Report

Devices descending from K963798

756 later devices reach Synthes Titanium Alloy Volar Distal Radius Plate (TI Alloy VDRP) System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K102597Piccolo Composite Plate SystemN.M.B. Medical Applications, Ltd.201115—
+7K100325Peri-Loc Locking Hole Inserts and Cable AccessoriesSmith & Nephew, Inc.201038—
+7K090304Waveon WRX Bone Fixation SystemSonoma Orthopedic Products, Inc.20090—
+7K092015Peri-Loc Periarticular Locked Plating SystemSmith & Nephew, Inc.2009411
+7K083286Orthopediatrics Pediloc Locking Plate SystemOrthoPediatrics Corp.2009605
+7K083032Peri-Loc Bone Plating and Screw SystemSmith & Nephew, Inc.2009772
+7K082516Peri-Loc Periarticular Locked Plating System Hexalobular Bone ScrewsSmith & Nephew, Inc.200887—
+7K081106Peri-Loc Periarticular Locked Plating System Volar Distal Radius Locking Plate for the…Smith & Nephew, Inc.200834—
+7K071563Peri-Loc Periarticular Locked Plating SystemSmith & Nephew, Inc.2007495—
+7K061352Peri-Loc Periarticular Locked Plating System for the Upper ExtremitySmith & Nephew, Inc.2006108—
+7K060156Straight Plate with Angular Stability & Screw SystemI.T.S. Implantat-Technologie-Systeme GmbH2006272
+7K060041Trimed Bone PlatesTriMed, Inc.2006263
+8K242973CanMINI Hand and Foot SystemCanwell Medical Co., Ltd.20250—
+8K243987TriMed Elbow and Forearm SystemTriMed, Inc.20251—
+8K243999TriMed Ankle Fixation SystemTriMed, Inc.20252—
+8K250498BPS Wrist Fracture SystemOrthonovis, Inc.20250—
+8K242079Arthrex Elbow Fracture Plating SystemArthrex, Inc.20240—
+8K233816REDEMPTION Charcot Plating SystemVilex, LLC20240—
+8K233089NeoSpan® Compression Implant SystemIn2bones USA, LLC20240—
+8K232115TDM Large Bone Plate and Screw SystemTdm Co., Ltd.20240—
+8K231314Fine Osteotomy™Bodycad Laboratories, Inc.20232—
+8K223342MotoBAND™ CP Implant System: DynaBunion™ 4D Minimal-incision Bunion System, DynaMET™…Crossroads Extremity Systems, LLC20232—
+8K223118OIC Variable Angle Small Fragment Locking Plate SystemOrthopaedic Implant Company20231—
+8K203405EVOS Large Fragment Plating SystemSmith & Nephew, Inc.20213—
+8K202348External Remote Controller ERC 4PNuvasive Specialized Orthopedics, Inc.20200—
+8K201918EVOS Large Fragment Plating SystemSmith & Nephew, Inc.202044
+8K200226RetroFixRetrofix Screws, LLC20200—
+8K193617Precice® ScrewsNuvasive Specialized Orthopedics, Inc.20200—
+8K193452MotoBAND CP Implant SystemCrossroads Extemity Systems, LLC20203—
+8K181843MLP Special Locking Bone Plate SystemMaxxion Medical, LLC / Baumer SA20190—
+8K173293EVOS Small Fragment Upper Extremity PlatesSmith & Nephew, Inc.201812—
+8K173121Ankle Fusion Plating SystemIn2bones Sas20172—
+8K170457EVOS Small Fragment Lower Extremity PlatesSmith & Nephew, Inc.2017131
+8K170887EVOS Small Fragment Plating SystemSmith & Nephew, Inc.201713—
+8K162078EVOS Small Fragment Plating SystemSmith & Nephew, Inc.2016261
+8K161292Distal Radius Plating SystemMiami Device Solutions, LLC20164—
+8K161048Conventus Orthopaedics Ulna Fixation SystemConventus Orthopaedics, Inc.20160—
+8K160995NEOVIEW Plating SystemIn2bones Sas201624
+8K160002Piccolo Composite (R) Distal Volar Radius Plate SystemCarboFix Orthopedics, Ltd.20164—
+8K151735TriMed Humeral Supracondylar Fixation SystemTriMed, Inc.20160—
+8K151886Acumed Ankle and Small Fragment Base Set UpdateAcumed, LLC201515—
+8K150693PHIN-FX Cannulated Lag Screw SystemAscent Medical, LLC20159—
+8K151379Conventus PRS SystemConventus Orthopaedics, Inc.20151—
+8K141737Conventus PHS SystemConventus Orthopaedics, Inc.20150—
+8K141430Variax Distal Radius Plating SystemStryker Leibinger GmbH & Co KG201412—
+8K141121Axsos 3 TI Locking Plate SystemStryker Trauma AG201426—
+8K131552Conventus DRSConventus Orthopaedics20142—
+8K130061Piccolo Composite Plate SystemCarboFix Orthopedics, Ltd.201310—
+8K120409Piccolo Composite Plate SystemCarboFix Orthopedics, Ltd.201211—
+8K120689Synthes 3.5 MM VA-LCP Proximal Tibia Plate SystemSynthes (USA) Products, LLC201228—
+8K110895Ortho Solutions Trauma Implants for OsteosynthesisOrtho Solutions Limited20118—
+8K110959Orthopediatrics Blade Plate SystemOrthoPediatrics Corp.201123
+8K102095Suspension Clavicle Fracture Fixation SystemSuspension Orthopaedic Solutions, LLC20102—
+8K100944Clavicle Locking Plate SystemNewclip Technics20109—
+8K100240Orthopediatrics Pediloc Tibia Plate SystemOrthoPediatrics Corp.201013—
+8K093983Smple Plate and ScrewsBiomet Trauma (Aka Ebi, Lp)20100—
+8K091156Trimed Sterile ProductTriMed, Inc.20090—
+8K090675Smith & Nephew, Inc. VLP Foot Plating, Screw System and AccessoriesSmith & Nephew, Inc.2009487—
+8K063166I.T.S. Pelvic Reconstruction SystemI.T.S. Implantat-Technologie-Systeme GmbH200692
+9K262649Alians ForearmNewclip Technics20260—
+9K260323OrthoPediatrics® Locking Cannulated Blade Plate SystemOrthoPediatrics Corp.20260—
+9K260054I.T.S. PRS Phoenix III.T.S. GmbH20260—
+9K251945TriMed Total Wrist Fusion System (Total Wrist Fusion Plate)TriMed, Inc.20251—
+9K250155Xpert KneeNewclip Technics20250—
+9K241387CoLink NeoFuse MIS Plating System (see attached parts list)In2bones USA20240—
+9K240066Fine Osteotomy™Bodycad Laboratories, Inc.20241—
+9K230591TriLEAP Plating SystemCrossroads Extremity Systems20231—
+9K210935I.T.S. Pelvic Reconstruction System (PRS RX & PRS Phoenix)I.T.S. GmbH202231
+9K213572JuniOrtho Plating System™Orthofix Srl20220—
+9K213069CoLink NeoFuse Plating SystemIn2bones USA, LLC20211—
+9K211051DePuy Synthes 2.7mm Straight and 2.7mm Adaption Plates (Modular Mini Fragment LCP System)DePuy Synthes20211—
+9K201527EVOS Straight Proximal Humerus 7-15 hole Plates (137-225mm)Smith & Nephew, Inc.20208—
+9K200246JPS JuniOrtho Plating SystemOrthofix Srl20201—
+9K191118Avanti Distal Radius and Forearm SystemAvanti Orthopaedics, Inc.20191—
+9K190253EVOS Small Fragment Upper Extremity Plates Line AdditionsSmith & Nephew, Inc.20199—
+9K181113CoLink™ Afx Plating SystemIn2bones USA, LLC201814—
+9K170704The Locking Pediatric Osteotomy Plate (LolliPOP) SystemPega Medical, Inc.20170—
+9K172262EVOS Small Fragment Plating SystemSmith & Nephew, Inc.20179—
+9K162153Integra® CAPTURE™ Screw System & Integra® Ti6® Internal Fixation SystemAscension Orthopedics20171—
+9K170310Alians Clavicle rangeNewclip Technics20170—
+9K162124Synthes 4.5mm VA-LCP Curved Condylar Plate System Line Extension, Variable Angle…DePuy Synthes20176—
+9K162898Olecranon Plating SystemMiami Device Solutions, LLC20171—
+9K163489OrthoSolutions 'System26' Bone ScrewsOrtho Solutions UK Limited201731
+9K161904GEO Bone Screw SystemGramercy Extremity Orthopeidics, LLC20174—
+9K162635Distal Radius Plating SystemMiami Device Solutions, LLC20162—
+9K153379AxSOS 3TiStryker GmbH201625—
+9K151407RECON systemNormed Medizin-Technik GmbH20154—
+9K150889Suture Wires and Wire LoopsZimmer, Inc.20152—
+9K150626Rush Medullary PinsZimmer, Inc.20150—
+9K141527Depuy Synthes Variable Angle Locking Hand SystemSynthes USA20157—
+9K143039CrossRoads Screw SystemOrthodiscovery Group, LLC (D.B.A. Crossroads Extrem201579—
+9K140792Salvation 3DI Plating SystemWrightmedicaltechnologyinc201421
+9K140408Salvation Osteopenic ScrewWrightmedicaltechnologyinc20141—
+9K132774Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd.20133—
+9K131722I.T.S. Extremity Fixation SystemsI.T.S. GmbH2013242
+9K130479Ilizarov Drill Tip WiresSmith & Nephew, Inc.20136—
+9K124027Monster Screw SystemApogee Orthosolutions201341—
+9K122334Checkmate Small Bone Fusion SystemArthrosurface, Inc.20125—
+9K122538Acumed Pelvic Bone Plate SystemAcumed, LLC201241
+9K113405Suspension Clavicle Fracture Repair SystemSuspension Orthopaedic Solutions, LLC20120—