510(k) Report

Devices descending from K791619

65 later devices reach Dynamic Hip Screw through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K221787Auxein's DHS/DCS Plate SystemAuxein Medical Private Limited20230—
+1K210247OsteoCentric Integrated Hip Fastener SystemOsteocentric Technologies D.B.A. Osteocentric Trauma20211—
+1K190750DePuy Synthes Plates and Screws PortfolioDePuy Synthes20190—
+1K172872DePuy Synthes Femoral Neck SystemDePuy Synthes20182—
+1K150818Versa-Fx Femoral Fixation System, Versa-Fx II Femoral Fixation System, Free-Lock Femoral…Zimmer, Inc.201526
+1K071852Aap Aps SystemAap Implantate AG20074—
+1K984331Odi Ultimate Compression Hip ScrewOrthopedic Designs, Inc.19993—
+1K971993Odi Compression Hip Screw SystemOrthopaedic Designs, Inc.19970—
+1K972629Depuy AE TK2 Hip Screw SystemDepuy, Inc.1997422
+1K970258Fixano D.S.S. (Double Sliding Screws) System for Osteosynthsis of Unstable Femoral Neck…Ferguson Medical19978—
+1K970280Fixano D.S.S. (Double Sliding Screws) System for Osteosynthesis of Per-Trochanteroam…Ferguson Medical19970—
+1K962644Vigor Compression Hip Screw SystemDeutschland Surgical, Inc.19960—
+2K230764OsteoCentric Integrated Hip Fastener SystemOsteoCentric Technologies20230—
+2K182154Depuy Synthes Femoral Neck SystemSynthes (USA) Products, LLC20181—
+2K140018TSP Hip Fracture Plating SystemBiomet, Inc.201412
+2K120360Ortho Solutions Trauma Plates for OsteosysnthesisOrtho Solutions Limited20122—
+2K111663Trauma Internal Fixation SystemsDePuy Orthopaedics, Inc.2012117
+2K033286Odi Talon Long Proximal Femoral Nail SystemOrthopedic Designs, Inc. (Odi)20042—
+2K031401Fixion Dynamic Hip Screw System (Fixion DHS)Disco-O-Tech Medical Technologies, Ltd.200332—
+2K022139Hip Tool ImplantOrthopedic Sciences, Inc.20027—
+3K243761A.L.P.S. Small Fragment Plating SystemBiomet Orthopedics20250—
+3K210658Volition Plating SystemOrtho Solutions UK, Ltd.20210—
+3K202764Ortho Solutions Plating SystemOrtho Solutions UK, Ltd.20201—
+3K173826THP Hip Fracture Plating SystemBiomet, Inc.20180—
+3K111352Talon Distalfix Proximal Femoral NailOrthopedic Designs North America, Inc.20111—
+3K102597Piccolo Composite Plate SystemN.M.B. Medical Applications, Ltd.201115—
+3K091425Quantum M Composite Nailing SystemN.M.B. Medical Applications, Ltd.201031—
+3K063709TS-Bone Hip ToolOrthopedic Sciences, Inc.20071—
+3K052538S-Bone Hip ToolOrthopedic Sciences, Inc.20050—
+3K051032Titanium-Hip ToolOrthopedic Sciences, Inc.20050—
+3K051181Custom-Hip ToolOrthopedic Sciences, Inc.20050—
+3K040850Tsy Shoulder Plate ImplantOrthopedic Sciences, Inc.20041—
+4K223933Exactech Equinoxe PHx Fracture System; Exactech EPIC ScrewsExactech, Inc.20230—
+4K201917Piccolo Composite Proximal Tibia Plate SystemCarboFix Orthopedics, Ltd.20200—
+4K182015Piccolo Composite® Plate SystemCarboFix Orthopedics, Ltd.20181—
+4K170401Piccolo Composite® Plate SystemCarboFix Orthopedics, Ltd.20173—
+4K160995NEOVIEW Plating SystemIn2bones Sas201624
+4K160002Piccolo Composite (R) Distal Volar Radius Plate SystemCarboFix Orthopedics, Ltd.20164—
+4K151010Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd.201521
+4K143496Piccolo Composite Plate SystemCarboFix Orthopedics, Ltd.20154—
+4K131636Polarus ConnectAcumed, LLC20130—
+4K132774Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd.20133—
+4K130061Piccolo Composite Plate SystemCarboFix Orthopedics, Ltd.201310—
+4K120409Piccolo Composite Plate SystemCarboFix Orthopedics, Ltd.201211—
+4K111056Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd.2011151
+4K102369Piccolo Composite Nailing SystemN.M.B. Medical Applications, Ltd.2011161
+4K100497Quantum IM Composite Nailing System (Quantum Nailing System)N.M.B. Medical Applications, Ltd.201029—
+4K072175Titanium Hip Tool Locking PlateOrthopedic Sciences, Inc.20070—
+4K063033Modification to Titanium Shoulder Plate ImplantOrthopedic Sciences, Inc.20060—
+5K213698CoLink PCR Plating SystemIn2bones USA, LLC20220—
+5K191118Avanti Distal Radius and Forearm SystemAvanti Orthopaedics, Inc.20191—
+5K173652Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd.20170—
+5K153536Piccolo Composite® Nailing SystemCarboFix Orthopedics, Ltd.201611
+5K123810Piccolo Composite Ankle Arthrodesis Nailing SystemCarboFix Orthopedics, Ltd.201314—
+6K261145Avanti Distal Elbow ORIF SystemAvanti Orthopaedics, LLC20260—
+6K182307Small Bone Phantom® Intramedullary Nail System; TTC Phantom® Intramedullary Nail SystemParagon 28, Inc.20198—
+6K163589SIGN IM NailSign Fracture Care International20170—
+7K231231MR Safety and Compatibility Testing and Labeling for Paragon 28 Orthopedic Fixation…Paragon 28, Inc.20231—
+7K192163TTC Phantom® Intramedullary Nail SystemParagon 28, Inc.20206—
+7K191782TTC Phantom Intramedullary Nail SystemParagon 28, Inc.20196—
+8K251850Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20251—
+8K241262Baby Gorilla/Gorilla Plating System; Monster Screw SystemParagon 28, Inc.20240—
+8K201227Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20205—
+9K253591Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20260—
+9K210869Phantom Hindfoot TTC/TC Nail SystemParagon 28, Inc.202123