510(k) Report

Devices descending from K890939

793 later devices reach Dupont Distal Humeral Nail through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K202307Activ FuseNewclip Technics20200—
+5K202817GEO Bone Screw SystemGramercy Extremity Orthopedics, LLC20201—
+5K201917Piccolo Composite Proximal Tibia Plate SystemCarboFix Orthopedics, Ltd.20200—
+5K201132Arthrex Compression ScrewsArthrex, Inc.202011—
+5K201527EVOS Straight Proximal Humerus 7-15 hole Plates (137-225mm)Smith & Nephew, Inc.20208—
+5K201149CoLink Plating SystemIn2bones USA, LLC20200—
+5K201430InFrame™ Cannulated Fixation SystemExsomed Corp.20201—
+5K200246JPS JuniOrtho Plating SystemOrthofix Srl20201—
+5K200762CoLink Cfx Plating SystemIn2bones USA, LLC20201—
+5K193222Tyber Medical Anatomical Plating SystemTyber Medical, LLC202011—
+5K193543CoLink Plating System, Fracture and Correction System, CoLink Mini Plating System…In2bones USA, LLC20200—
+5K190391TDM Plate and Screw SystemsTdm Co., Ltd.20191—
+5K192181PRECICE Plating SystemNuvasive Specialized Orthopedics, Inc.201921
+5K190921Arthrex Low Profile ScrewsArthrex, Inc.20190—
+5K190953Arthrex Minimally Invasive Ankle Fusion PlateArthrex, Inc.20191—
+5K191412VariAx 2 System, VariAx 2 Mini Fragment SystemStryker GmbH201910—
+5K190385CoLink Plating System, Fracture and Correction System, RTS Implant System, NeoSpan…In2bones USA, LLC20190—
+5K191535CoLink® Mini Plating SystemIn2bones USA, LLC20196—
+5K182785LOQTEQ VA Foot Plates 2.5Aap Implantate AG20190—
+5K181296Syntec Femoral Nail SystemSyntec Scientific Corporation20192—
+5K183232Double ENDOBUTTON Fixation DeviceSmith and Nephew, Inc.20196—
+5K190253EVOS Small Fragment Upper Extremity Plates Line AdditionsSmith & Nephew, Inc.20199—
+5K183317AdvantageRib SystemSig Medical Corporation20194—
+5K182991EPIC Extremity Fusion Plate SystemEpic Extremity, LLC20190—
+5K182307Small Bone Phantom® Intramedullary Nail System; TTC Phantom® Intramedullary Nail SystemParagon 28, Inc.20198—
+5K183011Additive Orthopaedics Patient Specific 3D Locking Lattice PlatesAdditive Orthopaedics20195—
+5K182361Arthrex Compression FT ScrewsArthrex, Inc.20184—
+5K182810Distal Radius Plating SystemMiami Device Solutions, LLC20180—
+5K173556Injection ScrewBiedermann Medtech, Inc.20180—
+5K180377Fracture and Correction SystemIn2bones USA, LLC20187—
+5K181113CoLink™ Afx Plating SystemIn2bones USA, LLC201814—
+5K181067AlignX Ankle Fusion SystemExtremity Medical, LLC20184—
+5K180808Omni Foot Plating SystemExtremity Medical, LLC20183—
+5K172383Arthrosurface Bone ScrewsArthrosurface, Inc.20171—
+5K172617Treace Medical Concepts (TMC) Compression Screw SystemTreace Medical Concepts, Inc.201711—
+5K170704The Locking Pediatric Osteotomy Plate (LolliPOP) SystemPega Medical, Inc.20170—
+5K172262EVOS Small Fragment Plating SystemSmith & Nephew, Inc.20179—
+5K170313ARIX Ankle Distal Tibia SystemJeil Medical Corporation20172—
+5K162153Integra® CAPTURE™ Screw System & Integra® Ti6® Internal Fixation SystemAscension Orthopedics20171—
+5K170687Flower Bone Screw SetFlower Orthopedics Corporation20170—
+5K163650ORTHOLOC® 3Di Ankle Fusion Plating System Line ExtensionWrightmedicaltechnologyinc201712—
+5K162124Synthes 4.5mm VA-LCP Curved Condylar Plate System Line Extension, Variable Angle…DePuy Synthes20176—
+5K162898Olecranon Plating SystemMiami Device Solutions, LLC20171—
+5K162841VariAx Distal Radius Plating System, VariAx 2 SystemStryker GmbH20174—
+5K163440Stealth Staple SystemFirst Ray, LLC20173—
+5K162179osteo-WEDGE II ® Open Wedge Bone Locking Plate SystemGraham Medical Technologies, LLC Dba Gramedica20170—
+5K163086VLP MINI-MOD 2.0mm Column PlatesSmith & Nephew, Inc.20160—
+5K162635Distal Radius Plating SystemMiami Device Solutions, LLC20162—
+5K162307OrthoPediatrics Locking Proximal Femur System Cortical ScrewsOrthoPediatrics Corp.20161—
+5K153379AxSOS 3TiStryker GmbH201625—
+5K161041OsteoMed ExtremiLOCK Wrist Plating SystemOsteomed20160—
+5K160191Align Anterior Ankle Fusion PlateExtremity Medical, LLC20165—
+5K160058Biomet Variable Pitch Compression Screw SystemBiomet, Inc.20160—
+5K151848Cable-Ready® Cable Grip System: Cable-Ready Pin System, Cable-Ready Needle SystemZimmer, Inc.20161—
+5K152306MotoBand¿ CP Implant SystemCrossroads Extremity Systems, LLC20157—
+5K152242G3¿ Active Plate® Large Fragment SystemGenesis Fracture Care, Inc.20151—
+5K152976VLP Mini-Mod Talus PlatesSmith & Nephew, Inc.20158—
+5K143721PRCT2Fx Solutions20150—
+5K151407RECON systemNormed Medizin-Technik GmbH20154—
+5K151241Synchro-Medical TIGER TRACK Screw SystemSynchro Medical20150—
+5K150126Life Spine Cannulated ScrewsLife Spine, Inc.20153—
+5K150649G3 Active Plate Large Fragment SystemGenesis Fracture Care, Inc.20152—
+5K143702Arthrex Blunt Tip Screws with Fiber TapeArthrex, Inc.20154—
+5K141527Depuy Synthes Variable Angle Locking Hand SystemSynthes USA20157—
+5K143365Eminent Foot Plate SystemEminent Spine20151—
+5K150309Extremity Medical Calcaneal Osteotomy DeviceExtremity Medical, LLC20150—
+5K143039CrossRoads Screw SystemOrthodiscovery Group, LLC (D.B.A. Crossroads Extrem201579—
+5K143614Arthrex Low Profile ScrewsArthrex, Inc.201519—
+5K142057Infix Cannulated Screw SystemInfix Medical, LLC20151—
+5K143050VLP Mini-Mod Small Bone Plating System 1.5mm Plates and ScrewsSmith & Nephew, Inc.20148—
+5K142418I.T.S. Hand Locking Plates System - HLSI.T.S. GmbH201411
+5K141784Ortho Solutions Ultos Plating SystemOrtho Solutions Limited2014282
+5K140792Salvation 3DI Plating SystemWrightmedicaltechnologyinc201421
+5K133662Smith & Nephew Cannulated Captured ScrewSmith & Nephew, Inc.20148—
+5K140408Salvation Osteopenic ScrewWrightmedicaltechnologyinc20141—
+5K140216Orthopedic Fixation SystemsImpact Medical, LLC20140—
+5K140769Variax 2 SystemStryker Trauma AG201419—
+5K132911I.B.S Snap-Off Screw / Solafix Snap-Off ScrewIn2bones Sas20140—
+5K133930Flower Rear Foot Plating Set, Flower Calcaneus Planting Set, Flower Rearfoot Plating SetFlower Orthopedics Corporation201406
+5K130614Bone Fragment and Fixation Plates, Screws and WashersLaura Cattabriga20142—
+5K132217Arthrex Compression FT ScrewsArthrex, Inc.201318—
+5K133102Flower Ankle Plating SetFlower Orthopedics Corporation20130—
+5K132248Flower Bone Screw SetFlower Orthopedics Corporation20131—
+5K131186Synthes 2.7MM and 3.5MM Variable Angle LCP Midfoot/Hindfoot SystemSynthes (USA) Products, LLC20138—
+5K131061Restore Bunion Correction SystemNextremity Solutions201315—
+5K131657Flower Small and Medium Implant SetFlower Orthopedics Corporation2013111
+5K123347Normed Ankle Fix System 4.0 and Normed Ankle Fix Plus System 4.0Normed Medizin-Technik GmbH201322
+5K131474Arthrex Distal Radius Plate SystemArthrex, Inc.201320—
+5K130479Ilizarov Drill Tip WiresSmith & Nephew, Inc.20136—
+5K124027Monster Screw SystemApogee Orthosolutions201341—
+5K122334Checkmate Small Bone Fusion SystemArthrosurface, Inc.20125—
+5K120667VLP 2.7MM Extra Large Percutaneous Calcaneus Plate, Peri-Loc 3.5MM Anterior Ankle Fusion…Smith & Nephew, Inc.20129—
+5K113405Suspension Clavicle Fracture Repair SystemSuspension Orthopaedic Solutions, LLC20120—
+5K112923Suspension Clavicle Fracture Fixation SystemSuspension Orthopaedic Solutions, LLC20110—
+5K112437Arthrex Fracture SystemArthrex, Inc.201191—
+5K111994Smith & Nephew Cannulated Screws and WashersSmith & Nephew, Inc.2011161—
+5K111253Arthrex Distal Extremity Plate SystemArthrex, Inc.2011135—
+5K093047Smith & Nephew Circular Fixation SystemSmith & Nephew, Inc.2010511
+5K100776Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot SystemSynthes (Usa)2010228—
+6K262618Arthrex Spine Compression FT ScrewArthrex, Inc.20260—