510(k) Report

Devices descending from K023007

681 later devices reach Distal Radius Fracture Repair System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K201917Piccolo Composite Proximal Tibia Plate SystemCarboFix Orthopedics, Ltd.20200—
+6K200226RetroFixRetrofix Screws, LLC20200—
+6K200538Skeletal Dynamics Forearm Plating SystemSkeletal Dynamics, Inc.20201—
+6K181843MLP Special Locking Bone Plate SystemMaxxion Medical, LLC / Baumer SA20190—
+6K182015Piccolo Composite® Plate SystemCarboFix Orthopedics, Ltd.20181—
+6K173293EVOS Small Fragment Upper Extremity PlatesSmith & Nephew, Inc.201812—
+6K173121Ankle Fusion Plating SystemIn2bones Sas20172—
+6K173135VariAx 2 SystemStryker GmbH201713—
+6K170457EVOS Small Fragment Lower Extremity PlatesSmith & Nephew, Inc.2017131
+6K170401Piccolo Composite® Plate SystemCarboFix Orthopedics, Ltd.20173—
+6K170887EVOS Small Fragment Plating SystemSmith & Nephew, Inc.201713—
+6K162841VariAx Distal Radius Plating System, VariAx 2 SystemStryker GmbH20174—
+6K162078EVOS Small Fragment Plating SystemSmith & Nephew, Inc.2016261
+6K161292Distal Radius Plating SystemMiami Device Solutions, LLC20164—
+6K161058Cannulated ScrewMiami Device Solutions, LLC20161—
+6K161048Conventus Orthopaedics Ulna Fixation SystemConventus Orthopaedics, Inc.20160—
+6K160995NEOVIEW Plating SystemIn2bones Sas201624
+6K160633G3(TM) Active Plate (R) Small Fragment SystemGenesis Fracture Care, Inc.20160—
+6K160002Piccolo Composite (R) Distal Volar Radius Plate SystemCarboFix Orthopedics, Ltd.20164—
+6K151735TriMed Humeral Supracondylar Fixation SystemTriMed, Inc.20160—
+6K151886Acumed Ankle and Small Fragment Base Set UpdateAcumed, LLC201515—
+6K150693PHIN-FX Cannulated Lag Screw SystemAscent Medical, LLC20159—
+6K151379Conventus PRS SystemConventus Orthopaedics, Inc.20151—
+6K143496Piccolo Composite Plate SystemCarboFix Orthopedics, Ltd.20154—
+6K141737Conventus PHS SystemConventus Orthopaedics, Inc.20150—
+6K142938G3 Active Plate Large Fragment SystemGenesis Fracture Care, Inc.20143—
+6K140431Pediloc Fragment SystemOrthoPediatrics Corp.20141—
+6K141430Variax Distal Radius Plating SystemStryker Leibinger GmbH & Co KG201412—
+6K141121Axsos 3 TI Locking Plate SystemStryker Trauma AG201426—
+6K131552Conventus DRSConventus Orthopaedics20142—
+6K130810Zimmer Motionloc Screw for Periarticular Locking Plate SystemZimmer, Inc.20131—
+6K130061Piccolo Composite Plate SystemCarboFix Orthopedics, Ltd.201310—
+6K122310Geminus Fossa Specific Plate SystemSkeletal Dynamics, LLC20130—
+6K120409Piccolo Composite Plate SystemCarboFix Orthopedics, Ltd.201211—
+6K120689Synthes 3.5 MM VA-LCP Proximal Tibia Plate SystemSynthes (USA) Products, LLC201228—
+6K110895Ortho Solutions Trauma Implants for OsteosynthesisOrtho Solutions Limited20118—
+6K110959Orthopediatrics Blade Plate SystemOrthoPediatrics Corp.201123
+6K111086Orthopediatrics Fracture and Osteotomy Bone Plate SystemOrthoPediatrics Corp.201171
+6K102095Suspension Clavicle Fracture Fixation SystemSuspension Orthopaedic Solutions, LLC20102—
+6K100944Clavicle Locking Plate SystemNewclip Technics20109—
+6K093868I.T.S. LRS Locking Reconstruction SystemI.T.S. Implantat-Technologie-Systeme GmbH201011
+6K100240Orthopediatrics Pediloc Tibia Plate SystemOrthoPediatrics Corp.201013—
+6K093983Smple Plate and ScrewsBiomet Trauma (Aka Ebi, Lp)20100—
+6K091156Trimed Sterile ProductTriMed, Inc.20090—
+6K090675Smith & Nephew, Inc. VLP Foot Plating, Screw System and AccessoriesSmith & Nephew, Inc.2009487—
+6K063166I.T.S. Pelvic Reconstruction SystemI.T.S. Implantat-Technologie-Systeme GmbH200692
+7K262649Alians ForearmNewclip Technics20260—
+7K260323OrthoPediatrics® Locking Cannulated Blade Plate SystemOrthoPediatrics Corp.20260—
+7K260054I.T.S. PRS Phoenix III.T.S. GmbH20260—
+7K251945TriMed Total Wrist Fusion System (Total Wrist Fusion Plate)TriMed, Inc.20251—
+7K250155Xpert KneeNewclip Technics20250—
+7K242486Tyber Medical Anatomical Plating SystemTyber Medical, LLC20251—
+7K250498BPS Wrist Fracture SystemOrthonovis, Inc.20250—
+7K241387CoLink NeoFuse MIS Plating System (see attached parts list)In2bones USA20240—
+7K242055Freefix Forearm Plating SystemSkeletal Dynamics, Inc.20240—
+7K241218Tyber Medical Anatomical Plating SystemTyber Medical, LLC20242—
+7K210935I.T.S. Pelvic Reconstruction System (PRS RX & PRS Phoenix)I.T.S. GmbH202231
+7K213698CoLink PCR Plating SystemIn2bones USA, LLC20220—
+7K213572JuniOrtho Plating System™Orthofix Srl20220—
+7K213069CoLink NeoFuse Plating SystemIn2bones USA, LLC20211—
+7K211051DePuy Synthes 2.7mm Straight and 2.7mm Adaption Plates (Modular Mini Fragment LCP System)DePuy Synthes20211—
+7K201527EVOS Straight Proximal Humerus 7-15 hole Plates (137-225mm)Smith & Nephew, Inc.20208—
+7K200246JPS JuniOrtho Plating SystemOrthofix Srl20201—
+7K191118Avanti Distal Radius and Forearm SystemAvanti Orthopaedics, Inc.20191—
+7K192181PRECICE Plating SystemNuvasive Specialized Orthopedics, Inc.201921
+7K191641AFFINITY – Variable Angle Distal Radius System, AFFINITY – Variable Angle Distal Radius…Industrias Medicas Sampedro S.A.S20193—
+7K190253EVOS Small Fragment Upper Extremity Plates Line AdditionsSmith & Nephew, Inc.20199—
+7K182810Distal Radius Plating SystemMiami Device Solutions, LLC20180—
+7K181113CoLink™ Afx Plating SystemIn2bones USA, LLC201814—
+7K170704The Locking Pediatric Osteotomy Plate (LolliPOP) SystemPega Medical, Inc.20170—
+7K172262EVOS Small Fragment Plating SystemSmith & Nephew, Inc.20179—
+7K162153Integra® CAPTURE™ Screw System & Integra® Ti6® Internal Fixation SystemAscension Orthopedics20171—
+7K160553DePuy Synthes 4.0 mm and 5.0 mm Locking Screws – MR Conditional, DePuy Synthes Wrist…Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.20170—
+7K162674BioPro Foot Plating SystemsBiopro, Inc.201719—
+7K170310Alians Clavicle rangeNewclip Technics20170—
+7K162124Synthes 4.5mm VA-LCP Curved Condylar Plate System Line Extension, Variable Angle…DePuy Synthes20176—
+7K162898Olecranon Plating SystemMiami Device Solutions, LLC20171—
+7K163489OrthoSolutions 'System26' Bone ScrewsOrtho Solutions UK Limited201731
+7K161904GEO Bone Screw SystemGramercy Extremity Orthopeidics, LLC20174—
+7K162635Distal Radius Plating SystemMiami Device Solutions, LLC20162—
+7K162307OrthoPediatrics Locking Proximal Femur System Cortical ScrewsOrthoPediatrics Corp.20161—
+7K153379AxSOS 3TiStryker GmbH201625—
+7K152242G3¿ Active Plate® Large Fragment SystemGenesis Fracture Care, Inc.20151—
+7K151407RECON systemNormed Medizin-Technik GmbH20154—
+7K150889Suture Wires and Wire LoopsZimmer, Inc.20152—
+7K150626Rush Medullary PinsZimmer, Inc.20150—
+7K150649G3 Active Plate Large Fragment SystemGenesis Fracture Care, Inc.20152—
+7K141527Depuy Synthes Variable Angle Locking Hand SystemSynthes USA20157—
+7K143039CrossRoads Screw SystemOrthodiscovery Group, LLC (D.B.A. Crossroads Extrem201579—
+7K140792Salvation 3DI Plating SystemWrightmedicaltechnologyinc201421
+7K140408Salvation Osteopenic ScrewWrightmedicaltechnologyinc20141—
+7K133930Flower Rear Foot Plating Set, Flower Calcaneus Planting Set, Flower Rearfoot Plating SetFlower Orthopedics Corporation201406
+7K132774Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd.20133—
+7K131722I.T.S. Extremity Fixation SystemsI.T.S. GmbH2013242
+7K130479Ilizarov Drill Tip WiresSmith & Nephew, Inc.20136—
+7K124027Monster Screw SystemApogee Orthosolutions201341—
+7K122334Checkmate Small Bone Fusion SystemArthrosurface, Inc.20125—
+7K122538Acumed Pelvic Bone Plate SystemAcumed, LLC201241
+7K113405Suspension Clavicle Fracture Repair SystemSuspension Orthopaedic Solutions, LLC20120—
+7K112923Suspension Clavicle Fracture Fixation SystemSuspension Orthopaedic Solutions, LLC20110—