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
+6K060156Straight Plate with Angular Stability & Screw SystemI.T.S. Implantat-Technologie-Systeme GmbH2006272
+6K060041Trimed Bone PlatesTriMed, Inc.2006263
+7K242973CanMINI Hand and Foot SystemCanwell Medical Co., Ltd.20250—
+7K243987TriMed Elbow and Forearm SystemTriMed, Inc.20251—
+7K243999TriMed Ankle Fixation SystemTriMed, Inc.20252—
+7K250498BPS Wrist Fracture SystemOrthonovis, Inc.20250—
+7K242079Arthrex Elbow Fracture Plating SystemArthrex, Inc.20240—
+7K233816REDEMPTION Charcot Plating SystemVilex, LLC20240—
+7K233089NeoSpan® Compression Implant SystemIn2bones USA, LLC20240—
+7K232115TDM Large Bone Plate and Screw SystemTdm Co., Ltd.20240—
+7K231314Fine Osteotomy™Bodycad Laboratories, Inc.20232—
+7K223342MotoBAND™ CP Implant System: DynaBunion™ 4D Minimal-incision Bunion System, DynaMET™…Crossroads Extremity Systems, LLC20232—
+7K223118OIC Variable Angle Small Fragment Locking Plate SystemOrthopaedic Implant Company20231—
+7K203405EVOS Large Fragment Plating SystemSmith & Nephew, Inc.20213—
+7K202348External Remote Controller ERC 4PNuvasive Specialized Orthopedics, Inc.20200—
+7K201918EVOS Large Fragment Plating SystemSmith & Nephew, Inc.202044
+7K200226RetroFixRetrofix Screws, LLC20200—
+7K200538Skeletal Dynamics Forearm Plating SystemSkeletal Dynamics, Inc.20201—
+7K193617Precice® ScrewsNuvasive Specialized Orthopedics, Inc.20200—
+7K193452MotoBAND CP Implant SystemCrossroads Extemity Systems, LLC20203—
+7K181843MLP Special Locking Bone Plate SystemMaxxion Medical, LLC / Baumer SA20190—
+7K173293EVOS Small Fragment Upper Extremity PlatesSmith & Nephew, Inc.201812—
+7K173121Ankle Fusion Plating SystemIn2bones Sas20172—
+7K170457EVOS Small Fragment Lower Extremity PlatesSmith & Nephew, Inc.2017131
+7K170887EVOS Small Fragment Plating SystemSmith & Nephew, Inc.201713—
+7K162078EVOS Small Fragment Plating SystemSmith & Nephew, Inc.2016261
+7K161292Distal Radius Plating SystemMiami Device Solutions, LLC20164—
+7K161048Conventus Orthopaedics Ulna Fixation SystemConventus Orthopaedics, Inc.20160—
+7K160995NEOVIEW Plating SystemIn2bones Sas201624
+7K160002Piccolo Composite (R) Distal Volar Radius Plate SystemCarboFix Orthopedics, Ltd.20164—
+7K151735TriMed Humeral Supracondylar Fixation SystemTriMed, Inc.20160—
+7K151886Acumed Ankle and Small Fragment Base Set UpdateAcumed, LLC201515—
+7K150693PHIN-FX Cannulated Lag Screw SystemAscent Medical, LLC20159—
+7K151379Conventus PRS SystemConventus Orthopaedics, Inc.20151—
+7K141737Conventus PHS SystemConventus Orthopaedics, Inc.20150—
+7K141430Variax Distal Radius Plating SystemStryker Leibinger GmbH & Co KG201412—
+7K141121Axsos 3 TI Locking Plate SystemStryker Trauma AG201426—
+7K131552Conventus DRSConventus Orthopaedics20142—
+7K130061Piccolo Composite Plate SystemCarboFix Orthopedics, Ltd.201310—
+7K122310Geminus Fossa Specific Plate SystemSkeletal Dynamics, LLC20130—
+7K120409Piccolo Composite Plate SystemCarboFix Orthopedics, Ltd.201211—
+7K120689Synthes 3.5 MM VA-LCP Proximal Tibia Plate SystemSynthes (USA) Products, LLC201228—
+7K110895Ortho Solutions Trauma Implants for OsteosynthesisOrtho Solutions Limited20118—
+7K110959Orthopediatrics Blade Plate SystemOrthoPediatrics Corp.201123
+7K102095Suspension Clavicle Fracture Fixation SystemSuspension Orthopaedic Solutions, LLC20102—
+7K100944Clavicle Locking Plate SystemNewclip Technics20109—
+7K100240Orthopediatrics Pediloc Tibia Plate SystemOrthoPediatrics Corp.201013—
+7K093983Smple Plate and ScrewsBiomet Trauma (Aka Ebi, Lp)20100—
+7K091156Trimed Sterile ProductTriMed, Inc.20090—
+7K090675Smith & Nephew, Inc. VLP Foot Plating, Screw System and AccessoriesSmith & Nephew, Inc.2009487—
+7K063166I.T.S. Pelvic Reconstruction SystemI.T.S. Implantat-Technologie-Systeme GmbH200692
+8K262649Alians ForearmNewclip Technics20260—
+8K260323OrthoPediatrics® Locking Cannulated Blade Plate SystemOrthoPediatrics Corp.20260—
+8K260054I.T.S. PRS Phoenix III.T.S. GmbH20260—
+8K251945TriMed Total Wrist Fusion System (Total Wrist Fusion Plate)TriMed, Inc.20251—
+8K250155Xpert KneeNewclip Technics20250—
+8K241387CoLink NeoFuse MIS Plating System (see attached parts list)In2bones USA20240—
+8K242055Freefix Forearm Plating SystemSkeletal Dynamics, Inc.20240—
+8K240066Fine Osteotomy™Bodycad Laboratories, Inc.20241—
+8K230591TriLEAP Plating SystemCrossroads Extremity Systems20231—
+8K210935I.T.S. Pelvic Reconstruction System (PRS RX & PRS Phoenix)I.T.S. GmbH202231
+8K213572JuniOrtho Plating System™Orthofix Srl20220—
+8K213069CoLink NeoFuse Plating SystemIn2bones USA, LLC20211—
+8K211051DePuy Synthes 2.7mm Straight and 2.7mm Adaption Plates (Modular Mini Fragment LCP System)DePuy Synthes20211—
+8K201527EVOS Straight Proximal Humerus 7-15 hole Plates (137-225mm)Smith & Nephew, Inc.20208—
+8K200246JPS JuniOrtho Plating SystemOrthofix Srl20201—
+8K191118Avanti Distal Radius and Forearm SystemAvanti Orthopaedics, Inc.20191—
+8K190253EVOS Small Fragment Upper Extremity Plates Line AdditionsSmith & Nephew, Inc.20199—
+8K181113CoLink™ Afx Plating SystemIn2bones USA, LLC201814—
+8K170704The Locking Pediatric Osteotomy Plate (LolliPOP) SystemPega Medical, Inc.20170—
+8K172262EVOS Small Fragment Plating SystemSmith & Nephew, Inc.20179—
+8K162153Integra® CAPTURE™ Screw System & Integra® Ti6® Internal Fixation SystemAscension Orthopedics20171—
+8K170310Alians Clavicle rangeNewclip Technics20170—
+8K162124Synthes 4.5mm VA-LCP Curved Condylar Plate System Line Extension, Variable Angle…DePuy Synthes20176—
+8K162898Olecranon Plating SystemMiami Device Solutions, LLC20171—
+8K163489OrthoSolutions 'System26' Bone ScrewsOrtho Solutions UK Limited201731
+8K161904GEO Bone Screw SystemGramercy Extremity Orthopeidics, LLC20174—
+8K162635Distal Radius Plating SystemMiami Device Solutions, LLC20162—
+8K153379AxSOS 3TiStryker GmbH201625—
+8K151407RECON systemNormed Medizin-Technik GmbH20154—
+8K150889Suture Wires and Wire LoopsZimmer, Inc.20152—
+8K150626Rush Medullary PinsZimmer, Inc.20150—
+8K141527Depuy Synthes Variable Angle Locking Hand SystemSynthes USA20157—
+8K143039CrossRoads Screw SystemOrthodiscovery Group, LLC (D.B.A. Crossroads Extrem201579—
+8K140792Salvation 3DI Plating SystemWrightmedicaltechnologyinc201421
+8K140408Salvation Osteopenic ScrewWrightmedicaltechnologyinc20141—
+8K132774Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd.20133—
+8K131722I.T.S. Extremity Fixation SystemsI.T.S. GmbH2013242
+8K130479Ilizarov Drill Tip WiresSmith & Nephew, Inc.20136—
+8K124027Monster Screw SystemApogee Orthosolutions201341—
+8K122334Checkmate Small Bone Fusion SystemArthrosurface, Inc.20125—
+8K122538Acumed Pelvic Bone Plate SystemAcumed, LLC201241
+8K113405Suspension Clavicle Fracture Repair SystemSuspension Orthopaedic Solutions, LLC20120—
+8K112923Suspension Clavicle Fracture Fixation SystemSuspension Orthopaedic Solutions, LLC20110—
+8K112509Trimed Clavicle Fixation SystemTriMed, Inc.20111—
+8K111994Smith & Nephew Cannulated Screws and WashersSmith & Nephew, Inc.2011161—
+8K110670VLP Foot Talus Plates, VLP Percutaneous Calcaneus Plates and Misc VLP Bone Screws…Smith & Nephew, Inc.201169—
+8K093047Smith & Nephew Circular Fixation SystemSmith & Nephew, Inc.2010511
+8K100776Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot SystemSynthes (Usa)2010228—
+9K262032TriMed Non-Spanning Wrist Fusion Plates (NSFL-STD);TriMed Non-Spanning Wrist Fusion…TriMed, Inc.20260—