510(k) Report

Devices descending from K972629

42 later devices reach Depuy AE TK2 Hip Screw System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K140018TSP Hip Fracture Plating SystemBiomet, Inc.201412
+1K111663Trauma Internal Fixation SystemsDePuy Orthopaedics, Inc.2012117
+1K071852Aap Aps SystemAap Implantate AG20074—
+1K031401Fixion Dynamic Hip Screw System (Fixion DHS)Disco-O-Tech Medical Technologies, Ltd.200332—
+2K243761A.L.P.S. Small Fragment Plating SystemBiomet Orthopedics20250—
+2K221787Auxein's DHS/DCS Plate SystemAuxein Medical Private Limited20230—
+2K173826THP Hip Fracture Plating SystemBiomet, Inc.20180—
+2K120360Ortho Solutions Trauma Plates for OsteosysnthesisOrtho Solutions Limited20122—
+2K102597Piccolo Composite Plate SystemN.M.B. Medical Applications, Ltd.201115—
+2K091425Quantum M Composite Nailing SystemN.M.B. Medical Applications, Ltd.201031—
+3K210658Volition Plating SystemOrtho Solutions UK, Ltd.20210—
+3K202764Ortho Solutions Plating SystemOrtho Solutions UK, Ltd.20201—
+3K201917Piccolo Composite Proximal Tibia Plate SystemCarboFix Orthopedics, Ltd.20200—
+3K182015Piccolo Composite® Plate SystemCarboFix Orthopedics, Ltd.20181—
+3K170401Piccolo Composite® Plate SystemCarboFix Orthopedics, Ltd.20173—
+3K160995NEOVIEW Plating SystemIn2bones Sas201624
+3K160002Piccolo Composite (R) Distal Volar Radius Plate SystemCarboFix Orthopedics, Ltd.20164—
+3K151010Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd.201521
+3K143496Piccolo Composite Plate SystemCarboFix Orthopedics, Ltd.20154—
+3K131636Polarus ConnectAcumed, LLC20130—
+3K132774Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd.20133—
+3K130061Piccolo Composite Plate SystemCarboFix Orthopedics, Ltd.201310—
+3K120409Piccolo Composite Plate SystemCarboFix Orthopedics, Ltd.201211—
+3K111056Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd.2011151
+3K102369Piccolo Composite Nailing SystemN.M.B. Medical Applications, Ltd.2011161
+3K100497Quantum IM Composite Nailing System (Quantum Nailing System)N.M.B. Medical Applications, Ltd.201029—
+4K213698CoLink PCR Plating SystemIn2bones USA, LLC20220—
+4K191118Avanti Distal Radius and Forearm SystemAvanti Orthopaedics, Inc.20191—
+4K173652Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd.20170—
+4K153536Piccolo Composite® Nailing SystemCarboFix Orthopedics, Ltd.201611
+4K123810Piccolo Composite Ankle Arthrodesis Nailing SystemCarboFix Orthopedics, Ltd.201314—
+5K261145Avanti Distal Elbow ORIF SystemAvanti Orthopaedics, LLC20260—
+5K182307Small Bone Phantom® Intramedullary Nail System; TTC Phantom® Intramedullary Nail SystemParagon 28, Inc.20198—
+5K163589SIGN IM NailSign Fracture Care International20170—
+6K231231MR Safety and Compatibility Testing and Labeling for Paragon 28 Orthopedic Fixation…Paragon 28, Inc.20231—
+6K192163TTC Phantom® Intramedullary Nail SystemParagon 28, Inc.20206—
+6K191782TTC Phantom Intramedullary Nail SystemParagon 28, Inc.20196—
+7K251850Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20251—
+7K241262Baby Gorilla/Gorilla Plating System; Monster Screw SystemParagon 28, Inc.20240—
+7K201227Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20205—
+8K253591Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20260—
+8K210869Phantom Hindfoot TTC/TC Nail SystemParagon 28, Inc.202123