510(k) Report

Devices descending from K042396

55 later devices reach T2 Proximal Humeral Nail through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K141103Intramedullary Nail and Screws-NeonailNeoortho Produtos Ortopedicos S/A20141—
+1K132945CFN-Cannulated Femur Nail, CTN-Cannulated Tibia Nail, CHN-Cannulated Humeral NailI.T.S. GmbH201410—
+1K100497Quantum IM Composite Nailing System (Quantum Nailing System)N.M.B. Medical Applications, Ltd.201029—
+1K082754Aequalis Humeral Nail SystemTornier2009222
+2K260958I.T.S. Clavicle Plates with Angular Stability; I.T.S. Volar Radius Plate with Angular…I.T.S. GmbH20260—
+2K221021Femoral Trochanteric Nail System – NeonailNeoortho Produtos Ortopédicos S/A20220—
+2K170972Apex Tibial Nailing SystemOrthoxel20171—
+2K161327Syntec Humeral Nail SystemSyntec Scientific Corporation20173—
+2K151010Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd.201521
+2K141228Aos 6.5MM Captured, Fully Threaded Cancellous ScrewAdvanced Orthopaedic Solutions, Inc.20142—
+2K133376Aequalis Humeral Nail; Sizes 7MM & 8MM X 210, 230, 250, 270MM; Left and RightTornier, Inc.20133—
+2K132774Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd.20133—
+2K111056Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd.2011151
+2K103002Synthes Multiloc Proximal Humeral Nailing SystemSynthes (Usa)2011172
+2K102597Piccolo Composite Plate SystemN.M.B. Medical Applications, Ltd.201115—
+2K102369Piccolo Composite Nailing SystemN.M.B. Medical Applications, Ltd.2011161
+3K252016Arthrex Humeral NailsArthrex, Inc.20260—
+3K252025Active Intramedullary (AIM) Tibial Nail SystemSatori Orthopaedics, Inc.20260—
+3K230352Tornier Humeral Nail and Tornier Long Humeral NailTornier, Inc.20231—
+3K230257Arthrex Intramedullary NailsArthrex, Inc.20231—
+3K201917Piccolo Composite Proximal Tibia Plate SystemCarboFix Orthopedics, Ltd.20200—
+3K200127TELEGRAPH® EVOLUTION Humeral Nailing SystemFH Industrie20200—
+3K181296Syntec Femoral Nail SystemSyntec Scientific Corporation20192—
+3K182015Piccolo Composite® Plate SystemCarboFix Orthopedics, Ltd.20181—
+3K173652Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd.20170—
+3K160553DePuy Synthes 4.0 mm and 5.0 mm Locking Screws – MR Conditional, DePuy Synthes Wrist…Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.20170—
+3K170401Piccolo Composite® Plate SystemCarboFix Orthopedics, Ltd.20173—
+3K160995NEOVIEW Plating SystemIn2bones Sas201624
+3K160002Piccolo Composite (R) Distal Volar Radius Plate SystemCarboFix Orthopedics, Ltd.20164—
+3K153536Piccolo Composite® Nailing SystemCarboFix Orthopedics, Ltd.201611
+3K143496Piccolo Composite Plate SystemCarboFix Orthopedics, Ltd.20154—
+3K123810Piccolo Composite Ankle Arthrodesis Nailing SystemCarboFix Orthopedics, Ltd.201314—
+3K130061Piccolo Composite Plate SystemCarboFix Orthopedics, Ltd.201310—
+3K120409Piccolo Composite Plate SystemCarboFix Orthopedics, Ltd.201211—
+3K120807Synthes Multiloc Humeral Nailing SystemSynthes USA Products, LLC201215—
+4K251400T2 Alpha Humerus Nailing System; IMN Screws System; T2 Nailing SystemStryker GmbH20250—
+4K243890Arthrex Intramedullary NailsArthrex, Inc.20250—
+4K213698CoLink PCR Plating SystemIn2bones USA, LLC20220—
+4K202935Syntec Femoral Nail Extended SystemSyntec Scientific Corporation20200—
+4K192003Auxein Nailing SystemAuxein Medical Private Limited20202—
+4K191118Avanti Distal Radius and Forearm SystemAvanti Orthopaedics, Inc.20191—
+4K191617Syntec Tibial Nail SystemSyntec Scientific Corporation20190—
+4K182307Small Bone Phantom® Intramedullary Nail System; TTC Phantom® Intramedullary Nail SystemParagon 28, Inc.20198—
+4K163589SIGN IM NailSign Fracture Care International20170—
+5K261145Avanti Distal Elbow ORIF SystemAvanti Orthopaedics, LLC20260—
+5K230071Femur Reconstruction Interlocking Nail System, Femur Retrograde Interlocking Nail…Tdm Co., Ltd.20240—
+5K231231MR Safety and Compatibility Testing and Labeling for Paragon 28 Orthopedic Fixation…Paragon 28, Inc.20231—
+5K210792Auxein Nailing SystemAuxein Medical Private Limited20210—
+5K192163TTC Phantom® Intramedullary Nail SystemParagon 28, Inc.20206—
+5K191782TTC Phantom Intramedullary Nail SystemParagon 28, Inc.20196—
+6K251850Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20251—
+6K241262Baby Gorilla/Gorilla Plating System; Monster Screw SystemParagon 28, Inc.20240—
+6K201227Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20205—
+7K253591Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20260—
+7K210869Phantom Hindfoot TTC/TC Nail SystemParagon 28, Inc.202123