510(k) Report

Devices descending from K002775

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K223226Trigon™ HA Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies, Inc.20220—
+5K221558ALPHALOK Plating SystemVilex, LLC20222—
+5K221360Medline UNITE® Medial Malleolus Peg Plate SystemMedline Industries, LP20220—
+5K213591ANTHEM® Fracture SystemGlobus Medical, Inc.20225—
+5K212433Anthem Fracture SystemGlobus Medical, Inc.20217—
+5K203817Tyber Medical Anatomical Plating SystemTyber Medical, LLC202110—
+5K203445Trigon HA Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies, Inc.20205—
+5K202657Javelin Tailor's Bunion Fixation SystemNvision Biomedical Technologies, Inc.20201—
+5K202912ARIX Ankle Distal Tibia SystemJeil Medical Corporation20201—
+5K201149CoLink Plating SystemIn2bones USA, LLC20200—
+5K191867ATLAS Plating SystemMiRus, LLC20200—
+5K193543CoLink Plating System, Fracture and Correction System, CoLink Mini Plating System…In2bones USA, LLC20200—
+5K190385CoLink Plating System, Fracture and Correction System, RTS Implant System, NeoSpan…In2bones USA, LLC20190—
+5K181091AxSOS 3 TiStryker GmbH201811—
+5K180972ARIX Clavicle SystemJeil Medical Corporation20181—
+5K182402CoLink View Plating SystemIn2bones USA, LLC20182—
+5K182148SILVERBACK Gorilla Plating SystemParagon 28, Inc.20183—
+5K173556Injection ScrewBiedermann Medtech, Inc.20180—
+5K181113CoLink™ Afx Plating SystemIn2bones USA, LLC201814—
+5K173652Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd.20170—
+5K172383Arthrosurface Bone ScrewsArthrosurface, Inc.20171—
+5K172886Breakaway Screw SystemParagon 2820174—
+5K172786MDS Plating SystemMiami Device Solutions, LLC20170—
+5K172178Minimally Invasive Bunion Plating SystemTrilliant Surgical, Ltd.20174—
+5K172260Omni Foot Plating SystemExtremity Medical, LLC20174—
+5K170693Phantom Small Bone Intramedullary Nail SystemParagon 28, Inc.20179—
+5K170214Additive Orthopaedics Locking Lattice PlateAdditive Orthopaedics, LLC20178—
+5K161041OsteoMed ExtremiLOCK Wrist Plating SystemOsteomed20160—
+5K153536Piccolo Composite® Nailing SystemCarboFix Orthopedics, Ltd.201611
+5K141677Variax Elbow Plating SystemStryker Trauma AG20140—
+5K140769Variax 2 SystemStryker Trauma AG201419—
+5K133939Modified Distal Radius Plating SystemBiomet2014112
+5K140259Variax Clavicle Hook PlateStryker Trauma AG201413—
+5K132733Orthohelix Syndesmosis Fixation DevicesOrthohelix Surgical Designs, Inc.20143—
+5K132591Maxlock Extreme SystemOrthohelix Surgical Designs, Inc.201332—
+5K130116Superior Lateral Variax Clavicle PlateStryker Trauma AG201316—
+5K111663Trauma Internal Fixation SystemsDePuy Orthopaedics, Inc.2012117
+5K090374Sterile DVR Anatomic Plates Various Configurations) Model (S) 131212001,2, 5-10 2.5MM…DePuy Orthopaedics, Inc.200918—
+5K071809Ensplintrx Bone Fixation SystemSonoma Orthopedic Products, Inc.20086—
+5K060864Multidirectional Threaded PegHand Innovations, LLC200618—
+5K051735Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper ExtremitySmith & Nephew, Inc.2005584—
+6K262098EnHAnce PEEK Bunion SystemNvision Biomedical Technologies20260—
+6K261481Pangea Femur Reconstruction SystemStryker GmbH20260—
+6K261154CoLink® & CoLag® Non-Sterile ScrewsIn2Bones USA, LLC20260—
+6K260291Vortex5 Tailor's Bunion Correction SystemNvision Biomedical Technologies, Inc.20260—
+6K253423ToeJack MIS Bunion SystemNvision Biomedical Technologies, Inc.20250—
+6K252254Osteotomy Wedge SystemSinaptic Surgical20250—
+6K243761A.L.P.S. Small Fragment Plating SystemBiomet Orthopedics20250—
+6K242436Proximal Humerus Fixation SystemSkeletal Dynamics, Inc.20240—
+6K242343BPS Wrist Fracture SystemOrthonovis, Inc.20241—
+6K241815Protean Fragment Plating SystemSkeletal Dynamics, Inc.20240—
+6K233816REDEMPTION Charcot Plating SystemVilex, LLC20240—
+6K232115TDM Large Bone Plate and Screw SystemTdm Co., Ltd.20240—
+6K233423Tyber Medical Anatomical Plating System – Line extension to the Mini-Frag SystemTyber Medical, LLC20232—
+6K232652Anatomical Plating System (various)Tyber Medical, LLC2023320
+6K222465Tyber Medical Anatomical Plating SystemTyber Medical, LLC20239—
+6K213069CoLink NeoFuse Plating SystemIn2bones USA, LLC20211—
+6K211650The Radian MIS Bunion SystemNvision Biomedical Technologies, Inc.20213—
+6K212487CoLink Vallux Plating SystemIn2bones USA, LLC20214—
+6K212640Stratum® Ankle Fusion Plating SystemNextremity Solutions, Inc.20210—
+6K210750Acumed Clavicle Hook Plating SystemAcumed, LLC20210—
+6K210060CoLink Mfx Implant SystemIn2bones USA, LLC20211—
+6K200226RetroFixRetrofix Screws, LLC20200—
+6K200398AxSOS 3 AF System and AxSOS 3 Ti SystemStryker GmbH20209—
+6K200762CoLink Cfx Plating SystemIn2bones USA, LLC20201—
+6K191535CoLink® Mini Plating SystemIn2bones USA, LLC20196—
+6K182307Small Bone Phantom® Intramedullary Nail System; TTC Phantom® Intramedullary Nail SystemParagon 28, Inc.20198—
+6K183011Additive Orthopaedics Patient Specific 3D Locking Lattice PlatesAdditive Orthopaedics20195—
+6K181067AlignX Ankle Fusion SystemExtremity Medical, LLC20184—
+6K180808Omni Foot Plating SystemExtremity Medical, LLC20183—
+6K173135VariAx 2 SystemStryker GmbH201713—
+6K162841VariAx Distal Radius Plating System, VariAx 2 SystemStryker GmbH20174—
+6K161665VLP Wrist Fracture SystemSmith & Nephew, Inc.201610—
+6K160191Align Anterior Ankle Fusion PlateExtremity Medical, LLC20165—
+6K141493Proximal Humerus Plating SystemMiami Device Solutions201571
+6K141264Tensyn Band, Tensyn Fracture PlatesDallen Medical, Inc.20142—
+6K140357Oic Variable Angle Small Fragment Locking Plate SystemOrthopaedic Implant Company20142—
+6K132296D-Rad Smart PackSmith & Nephew, Inc.2014114
+6K131636Polarus ConnectAcumed, LLC20130—
+6K123055Smith & Nephew, Inc Screw and Plate System InstrumentationSmith & Nephew, Inc.201333—
+6K102689Conventus Orthopaedics Fracture Fixation SystemConventus Orthopaedics20134—
+6K122737Geminus Fossa Specific Plate SystemSkeletal Dynamics, LLC20123—
+6K100325Peri-Loc Locking Hole Inserts and Cable AccessoriesSmith & Nephew, Inc.201038—
+6K090304Waveon WRX Bone Fixation SystemSonoma Orthopedic Products, Inc.20090—
+6K092015Peri-Loc Periarticular Locked Plating SystemSmith & Nephew, Inc.2009411
+6K083286Orthopediatrics Pediloc Locking Plate SystemOrthoPediatrics Corp.2009605
+6K083032Peri-Loc Bone Plating and Screw SystemSmith & Nephew, Inc.2009772
+6K082516Peri-Loc Periarticular Locked Plating System Hexalobular Bone ScrewsSmith & Nephew, Inc.200887—
+6K081106Peri-Loc Periarticular Locked Plating System Volar Distal Radius Locking Plate for the…Smith & Nephew, Inc.200834—
+6K071563Peri-Loc Periarticular Locked Plating SystemSmith & Nephew, Inc.2007495—
+6K061352Peri-Loc Periarticular Locked Plating System for the Upper ExtremitySmith & Nephew, Inc.2006108—
+6K060156Straight Plate with Angular Stability & Screw SystemI.T.S. Implantat-Technologie-Systeme GmbH2006272
+6K060041Trimed Bone PlatesTriMed, Inc.2006263
+7K260810Anteralign LS coverplateTyber Medical, LLC20260—
+7K242973CanMINI Hand and Foot SystemCanwell Medical Co., Ltd.20250—
+7K243987TriMed Elbow and Forearm SystemTriMed, Inc.20251—
+7K243999TriMed Ankle Fixation SystemTriMed, Inc.20252—
+7K242486Tyber Medical Anatomical Plating SystemTyber Medical, LLC20251—
+7K250498BPS Wrist Fracture SystemOrthonovis, Inc.20250—
+7K242079Arthrex Elbow Fracture Plating SystemArthrex, Inc.20240—