510(k) Report

Devices descending from K013563

70 later devices reach Long Trochanteric Nail System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K042325Trochanteric Nail SystemDePuy Orthopaedics, Inc.20041011
+1K033329Depuy Ace Universal and Troch Entry Femoral Nail SystemsDepuy, Inc.200353—
+1K021008Advanced Orthopaedic Solutions Trochanteric NailAdvanced Orthopaedic Solutions, Inc.20021312
+2K230257Arthrex Intramedullary NailsArthrex, Inc.20231—
+2K202099AOS Galileo™ Trochanteric Nail SystemAdvanced Orthopaedic Solutions, Inc.20204—
+2K141228Aos 6.5MM Captured, Fully Threaded Cancellous ScrewAdvanced Orthopaedic Solutions, Inc.20142—
+2K140601Flow-NailFlow-Fx, LLC20142—
+2K133081Trochanteric Nails and ES Trochanteric Nails, Humeral Naisl, Tibial Nails, Antegrade…Advanced Orthopaedic Solutions, Inc.20132—
+2K120148Aos Solid Locking Lag Screw, Aos Telescoping Lag ScrewAdvanced Orthopaedic Solutions, Inc.20126—
+2K111663Trauma Internal Fixation SystemsDePuy Orthopaedics, Inc.2012117
+2K111444Universal and Troch Entry Femoral Nailing Systems Line ExtensionDePuy Orthopaedics, Inc.20110—
+2K103533ES Trochanteric Nail, Left and Right, 10MMAdvanced Orthopaedic Solutions, Inc.201111—
+2K101622Zimmer Natural Nail System Retrograde Femoral NailsZimmer, Inc.2010293
+2K100238HFN 125 Degree 9-13 MM, 180MM, HFN 130 Degree 9-13 MM, HFN RH 125 Degree 9-13MMDePuy Orthopaedics, Inc.20107250
+2K090596Zimmer Natural Nail System Stainless Steel Tibial Nail & Stainless Piriformis Fossa and…Zimmer, Inc.2009316
+2K083497Zimmer Natural Nail System Piriformis Fossa and Greater Trochanter Antegrade Femoral NailsZimmer, Inc.20093916
+2K042440Alphatec Femoral Trochanteric Nail (FTN) SystemAlphatec/Nexmed20040—
+3K253566Affixus Retrograde Femoral Nailing SystemZimmer, Inc.20260—
+3K252025Active Intramedullary (AIM) Tibial Nail SystemSatori Orthopaedics, Inc.20260—
+3K252826ARIX Femur Nail SystemJeil Medical Corporation20250—
+3K243761A.L.P.S. Small Fragment Plating SystemBiomet Orthopedics20250—
+3K243890Arthrex Intramedullary NailsArthrex, Inc.20250—
+3K241651Affixus Tibial and Antegrade Femoral Nailing SystemZimmer, Inc.2024217
+3K221115Flow-NailFlow-Fx, LLC20221—
+3K203819T2 Alpha Femur Retrograde Nailing System, T2 Alpha Femur Antegrade GT/PF Nailing System…Stryker GmbH20217—
+3K192003Auxein Nailing SystemAuxein Medical Private Limited20202—
+3K191598AOS ES Retrograde Femoral NailAdvanced Orthopaedic Solutions, Inc.20190—
+3K191238Zimmer Guide Wire DevicesZimmer, Inc.20190—
+3K183162Affixus Hip Fracture NailBiomet, Inc.20182—
+3K181640X-BOLT Hip Fracture Fixation SystemX-Bolt Orthopaedics20181—
+3K172774T2 Alpha Femur Antegrade GT/PF Nailing System, IMN Screws System, IMN Instruments SystemStryker Trauma GmbH201817—
+3K171108AUTOBAHN Nailing SystemGlobus Medical, Inc.20172—
+3K172114Zimmer Natural Nail SystemZimmer, Inc.201711—
+3K142281Zimmer M/DN Intramedullary Fixation SystemZimmer, Inc.2014107
+3K130595Zimmer Natural Nail System Tibial Nail and Stainless Steel Tibial NailZimmer, Inc.201323
+3K091566Zimmer Natural Nail System Cephalomedullary NailsZimmer GmbH2009165
+4K261043AUTOBAHN™ Nailing SystemGlobus Medical, Inc.20260—
+4K250163T2 Alpha Femur Retrograde Nailing SystemStryker GmbH20252—
+4K243907Affixus Tibial Nailing System - 4mm screwsZimmer, Inc.20250—
+4K230071Femur Reconstruction Interlocking Nail System, Femur Retrograde Interlocking Nail…Tdm Co., Ltd.20240—
+4K233910Vertex Hip Fracture Nailing SystemOrthoxel Dac20240—
+4K234075Flow-NailFlow-Fx, LLC20240—
+4K231114Zimmer® Natural Nail® System Cephalomedullary Nails; Affixus® Natural Nail® Humeral Nail…Zimmer Switzerland Manufacturing GmbH20234—
+4K230512Gamma4 SystemStryker GmbH20230—
+4K221621Pro-X1™ Trochanteric Nailing SystemX-Bolt Orthopedics20230—
+4K221489Artemis Proximal Femoral Nail SystemGlw, Inc.20220—
+4K220659AUTOBAHN (R) EVO Femoral NailsGlobus Medical, Inc.20221—
+4K213328Gamma4 System, Gamma3 System, IMN Screws System, T2 Tibial Nailing SystemStryker GmbH202231
+4K210792Auxein Nailing SystemAuxein Medical Private Limited20210—
+4K210285Adaptable Ortho Innovations Intramedullary Nail SystemAdaptable Ortho Innovations, LLC20210—
+4K200869Gamma3 SystemStryker Trauma GmbH20209—
+4K192312Zimmer Natural Nail System Cephalomedullary NailsZimmer GmbH20194—
+4K181827Affixus Natural Nail System Humeral NailZimmer GmbH20186—
+4K181184OIC Intramedullary Nail SystemThe Orthopaedic Implant Company20181—
+4K181375Apex Femoral Nailing SystemOrthoxel20180—
+4K180436T2 Alpha Tibia Nailing System, T2 Alpha Femur Antegrade GT/PF Nailing System, IMN Screws…Stryker Trauma GmbH201816—
+4K143321ITST Intertrochanteric/Subtrochanteric Fixation SystemZimmer, Inc.201502
+4K120715Zimmer Natural Nail System Cephalomedullary Femoral Nail - Asia ShortZimmer GmbH201210—
+5K253640T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction SystemStryker GmbH20261—
+5K253749Affixus® Natural Nail® Proximal Humeral SystemZimmer Switzerland Manufacturing GmbH20250—
+5K251400T2 Alpha Humerus Nailing System; IMN Screws System; T2 Nailing SystemStryker GmbH20250—
+5K242247ARIX Femur Nail SystemJeil Medical Corporation20251—
+5K233134I.T.S. INS Proximal Femur NailI.T.S. GmbH20240—
+5K223761OIC Intramedullary Screw SystemOrthopaedic Implant Company20230—
+5K221021Femoral Trochanteric Nail System – NeonailNeoortho Produtos Ortopédicos S/A20220—
+5K222309Gamma4 SystemStryker GmbH20220—
+5K200814Affixus (R) Natural Nail (R) System Humeral NailZimmer GmbH20201—
+5K191271T2 Alpha Femur Antegrade GT/PF Nailing System, T2 Alpha Tibia Nailing System, IMN Screws…Stryker Trauma GmbH201915—
+6K261481Pangea Femur Reconstruction SystemStryker GmbH20260—
+6K193308T2 Alpha Tibia Nailing System, IMN Screws SystemStryker Trauma GmbH20204—