510(k) Report

Devices descending from K012655

792 later devices reach Congruent Bone Plate System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K202817GEO Bone Screw SystemGramercy Extremity Orthopedics, LLC20201—
+4K201917Piccolo Composite Proximal Tibia Plate SystemCarboFix Orthopedics, Ltd.20200—
+4K201132Arthrex Compression ScrewsArthrex, Inc.202011—
+4K201527EVOS Straight Proximal Humerus 7-15 hole Plates (137-225mm)Smith & Nephew, Inc.20208—
+4K201149CoLink Plating SystemIn2bones USA, LLC20200—
+4K201430InFrame™ Cannulated Fixation SystemExsomed Corp.20201—
+4K200246JPS JuniOrtho Plating SystemOrthofix Srl20201—
+4K200762CoLink Cfx Plating SystemIn2bones USA, LLC20201—
+4K193222Tyber Medical Anatomical Plating SystemTyber Medical, LLC202011—
+4K193543CoLink Plating System, Fracture and Correction System, CoLink Mini Plating System…In2bones USA, LLC20200—
+4K190391TDM Plate and Screw SystemsTdm Co., Ltd.20191—
+4K192181PRECICE Plating SystemNuvasive Specialized Orthopedics, Inc.201921
+4K190921Arthrex Low Profile ScrewsArthrex, Inc.20190—
+4K190953Arthrex Minimally Invasive Ankle Fusion PlateArthrex, Inc.20191—
+4K191412VariAx 2 System, VariAx 2 Mini Fragment SystemStryker GmbH201910—
+4K190385CoLink Plating System, Fracture and Correction System, RTS Implant System, NeoSpan…In2bones USA, LLC20190—
+4K191535CoLink® Mini Plating SystemIn2bones USA, LLC20196—
+4K182785LOQTEQ VA Foot Plates 2.5Aap Implantate AG20190—
+4K181296Syntec Femoral Nail SystemSyntec Scientific Corporation20192—
+4K183232Double ENDOBUTTON Fixation DeviceSmith and Nephew, Inc.20196—
+4K190253EVOS Small Fragment Upper Extremity Plates Line AdditionsSmith & Nephew, Inc.20199—
+4K183317AdvantageRib SystemSig Medical Corporation20194—
+4K182991EPIC Extremity Fusion Plate SystemEpic Extremity, LLC20190—
+4K182307Small Bone Phantom® Intramedullary Nail System; TTC Phantom® Intramedullary Nail SystemParagon 28, Inc.20198—
+4K183011Additive Orthopaedics Patient Specific 3D Locking Lattice PlatesAdditive Orthopaedics20195—
+4K182361Arthrex Compression FT ScrewsArthrex, Inc.20184—
+4K182810Distal Radius Plating SystemMiami Device Solutions, LLC20180—
+4K173556Injection ScrewBiedermann Medtech, Inc.20180—
+4K180377Fracture and Correction SystemIn2bones USA, LLC20187—
+4K181113CoLink™ Afx Plating SystemIn2bones USA, LLC201814—
+4K181067AlignX Ankle Fusion SystemExtremity Medical, LLC20184—
+4K180808Omni Foot Plating SystemExtremity Medical, LLC20183—
+4K172383Arthrosurface Bone ScrewsArthrosurface, Inc.20171—
+4K172617Treace Medical Concepts (TMC) Compression Screw SystemTreace Medical Concepts, Inc.201711—
+4K170704The Locking Pediatric Osteotomy Plate (LolliPOP) SystemPega Medical, Inc.20170—
+4K172262EVOS Small Fragment Plating SystemSmith & Nephew, Inc.20179—
+4K170313ARIX Ankle Distal Tibia SystemJeil Medical Corporation20172—
+4K162153Integra® CAPTURE™ Screw System & Integra® Ti6® Internal Fixation SystemAscension Orthopedics20171—
+4K170687Flower Bone Screw SetFlower Orthopedics Corporation20170—
+4K163650ORTHOLOC® 3Di Ankle Fusion Plating System Line ExtensionWrightmedicaltechnologyinc201712—
+4K162124Synthes 4.5mm VA-LCP Curved Condylar Plate System Line Extension, Variable Angle…DePuy Synthes20176—
+4K162898Olecranon Plating SystemMiami Device Solutions, LLC20171—
+4K162841VariAx Distal Radius Plating System, VariAx 2 SystemStryker GmbH20174—
+4K163440Stealth Staple SystemFirst Ray, LLC20173—
+4K162179osteo-WEDGE II ® Open Wedge Bone Locking Plate SystemGraham Medical Technologies, LLC Dba Gramedica20170—
+4K163086VLP MINI-MOD 2.0mm Column PlatesSmith & Nephew, Inc.20160—
+4K162635Distal Radius Plating SystemMiami Device Solutions, LLC20162—
+4K162307OrthoPediatrics Locking Proximal Femur System Cortical ScrewsOrthoPediatrics Corp.20161—
+4K153379AxSOS 3TiStryker GmbH201625—
+4K161041OsteoMed ExtremiLOCK Wrist Plating SystemOsteomed20160—
+4K160191Align Anterior Ankle Fusion PlateExtremity Medical, LLC20165—
+4K160058Biomet Variable Pitch Compression Screw SystemBiomet, Inc.20160—
+4K151848Cable-Ready® Cable Grip System: Cable-Ready Pin System, Cable-Ready Needle SystemZimmer, Inc.20161—
+4K152306MotoBand¿ CP Implant SystemCrossroads Extremity Systems, LLC20157—
+4K152242G3¿ Active Plate® Large Fragment SystemGenesis Fracture Care, Inc.20151—
+4K152976VLP Mini-Mod Talus PlatesSmith & Nephew, Inc.20158—
+4K143721PRCT2Fx Solutions20150—
+4K151407RECON systemNormed Medizin-Technik GmbH20154—
+4K151241Synchro-Medical TIGER TRACK Screw SystemSynchro Medical20150—
+4K150126Life Spine Cannulated ScrewsLife Spine, Inc.20153—
+4K150649G3 Active Plate Large Fragment SystemGenesis Fracture Care, Inc.20152—
+4K143702Arthrex Blunt Tip Screws with Fiber TapeArthrex, Inc.20154—
+4K141527Depuy Synthes Variable Angle Locking Hand SystemSynthes USA20157—
+4K143365Eminent Foot Plate SystemEminent Spine20151—
+4K150309Extremity Medical Calcaneal Osteotomy DeviceExtremity Medical, LLC20150—
+4K143039CrossRoads Screw SystemOrthodiscovery Group, LLC (D.B.A. Crossroads Extrem201579—
+4K143614Arthrex Low Profile ScrewsArthrex, Inc.201519—
+4K142057Infix Cannulated Screw SystemInfix Medical, LLC20151—
+4K143050VLP Mini-Mod Small Bone Plating System 1.5mm Plates and ScrewsSmith & Nephew, Inc.20148—
+4K142418I.T.S. Hand Locking Plates System - HLSI.T.S. GmbH201411
+4K141784Ortho Solutions Ultos Plating SystemOrtho Solutions Limited2014282
+4K140792Salvation 3DI Plating SystemWrightmedicaltechnologyinc201421
+4K133662Smith & Nephew Cannulated Captured ScrewSmith & Nephew, Inc.20148—
+4K140408Salvation Osteopenic ScrewWrightmedicaltechnologyinc20141—
+4K140216Orthopedic Fixation SystemsImpact Medical, LLC20140—
+4K140769Variax 2 SystemStryker Trauma AG201419—
+4K132911I.B.S Snap-Off Screw / Solafix Snap-Off ScrewIn2bones Sas20140—
+4K133930Flower Rear Foot Plating Set, Flower Calcaneus Planting Set, Flower Rearfoot Plating SetFlower Orthopedics Corporation201406
+4K130614Bone Fragment and Fixation Plates, Screws and WashersLaura Cattabriga20142—
+4K132217Arthrex Compression FT ScrewsArthrex, Inc.201318—
+4K133102Flower Ankle Plating SetFlower Orthopedics Corporation20130—
+4K132248Flower Bone Screw SetFlower Orthopedics Corporation20131—
+4K131186Synthes 2.7MM and 3.5MM Variable Angle LCP Midfoot/Hindfoot SystemSynthes (USA) Products, LLC20138—
+4K131061Restore Bunion Correction SystemNextremity Solutions201315—
+4K131657Flower Small and Medium Implant SetFlower Orthopedics Corporation2013111
+4K123347Normed Ankle Fix System 4.0 and Normed Ankle Fix Plus System 4.0Normed Medizin-Technik GmbH201322
+4K131474Arthrex Distal Radius Plate SystemArthrex, Inc.201320—
+4K130479Ilizarov Drill Tip WiresSmith & Nephew, Inc.20136—
+4K124027Monster Screw SystemApogee Orthosolutions201341—
+4K122334Checkmate Small Bone Fusion SystemArthrosurface, Inc.20125—
+4K120667VLP 2.7MM Extra Large Percutaneous Calcaneus Plate, Peri-Loc 3.5MM Anterior Ankle Fusion…Smith & Nephew, Inc.20129—
+4K113405Suspension Clavicle Fracture Repair SystemSuspension Orthopaedic Solutions, LLC20120—
+4K112923Suspension Clavicle Fracture Fixation SystemSuspension Orthopaedic Solutions, LLC20110—
+4K112437Arthrex Fracture SystemArthrex, Inc.201191—
+4K111994Smith & Nephew Cannulated Screws and WashersSmith & Nephew, Inc.2011161—
+4K111253Arthrex Distal Extremity Plate SystemArthrex, Inc.2011135—
+4K093047Smith & Nephew Circular Fixation SystemSmith & Nephew, Inc.2010511
+4K100776Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot SystemSynthes (Usa)2010228—
+5K262618Arthrex Spine Compression FT ScrewArthrex, Inc.20260—
+5K254280F.A.S.T ScrewSteps Ortho20260—