510(k) Report

Devices descending from K033329

53 later devices reach Depuy Ace Universal and Troch Entry Femoral Nail Systems through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K141228Aos 6.5MM Captured, Fully Threaded Cancellous ScrewAdvanced Orthopaedic Solutions, Inc.20142—
+1K111663Trauma Internal Fixation SystemsDePuy Orthopaedics, Inc.2012117
+1K111444Universal and Troch Entry Femoral Nailing Systems Line ExtensionDePuy Orthopaedics, Inc.20110—
+1K101622Zimmer Natural Nail System Retrograde Femoral NailsZimmer, Inc.2010293
+1K090596Zimmer Natural Nail System Stainless Steel Tibial Nail & Stainless Piriformis Fossa and…Zimmer, Inc.2009316
+1K083497Zimmer Natural Nail System Piriformis Fossa and Greater Trochanter Antegrade Femoral NailsZimmer, Inc.20093916
+2K253566Affixus Retrograde Femoral Nailing SystemZimmer, Inc.20260—
+2K243761A.L.P.S. Small Fragment Plating SystemBiomet Orthopedics20250—
+2K241651Affixus Tibial and Antegrade Femoral Nailing SystemZimmer, Inc.2024217
+2K230257Arthrex Intramedullary NailsArthrex, Inc.20231—
+2K203819T2 Alpha Femur Retrograde Nailing System, T2 Alpha Femur Antegrade GT/PF Nailing System…Stryker GmbH20217—
+2K191238Zimmer Guide Wire DevicesZimmer, Inc.20190—
+2K181640X-BOLT Hip Fracture Fixation SystemX-Bolt Orthopaedics20181—
+2K172774T2 Alpha Femur Antegrade GT/PF Nailing System, IMN Screws System, IMN Instruments SystemStryker Trauma GmbH201817—
+2K171108AUTOBAHN Nailing SystemGlobus Medical, Inc.20172—
+2K172114Zimmer Natural Nail SystemZimmer, Inc.201711—
+2K142281Zimmer M/DN Intramedullary Fixation SystemZimmer, Inc.2014107
+2K130595Zimmer Natural Nail System Tibial Nail and Stainless Steel Tibial NailZimmer, Inc.201323
+2K091566Zimmer Natural Nail System Cephalomedullary NailsZimmer GmbH2009165
+3K261043AUTOBAHN™ Nailing SystemGlobus Medical, Inc.20260—
+3K250163T2 Alpha Femur Retrograde Nailing SystemStryker GmbH20252—
+3K243907Affixus Tibial Nailing System - 4mm screwsZimmer, Inc.20250—
+3K243890Arthrex Intramedullary NailsArthrex, Inc.20250—
+3K231114Zimmer® Natural Nail® System Cephalomedullary Nails; Affixus® Natural Nail® Humeral Nail…Zimmer Switzerland Manufacturing GmbH20234—
+3K230512Gamma4 SystemStryker GmbH20230—
+3K221621Pro-X1™ Trochanteric Nailing SystemX-Bolt Orthopedics20230—
+3K220659AUTOBAHN (R) EVO Femoral NailsGlobus Medical, Inc.20221—
+3K213328Gamma4 System, Gamma3 System, IMN Screws System, T2 Tibial Nailing SystemStryker GmbH202231
+3K210285Adaptable Ortho Innovations Intramedullary Nail SystemAdaptable Ortho Innovations, LLC20210—
+3K200869Gamma3 SystemStryker Trauma GmbH20209—
+3K192312Zimmer Natural Nail System Cephalomedullary NailsZimmer GmbH20194—
+3K181827Affixus Natural Nail System Humeral NailZimmer GmbH20186—
+3K181184OIC Intramedullary Nail SystemThe Orthopaedic Implant Company20181—
+3K181375Apex Femoral Nailing SystemOrthoxel20180—
+3K180436T2 Alpha Tibia Nailing System, T2 Alpha Femur Antegrade GT/PF Nailing System, IMN Screws…Stryker Trauma GmbH201816—
+3K143321ITST Intertrochanteric/Subtrochanteric Fixation SystemZimmer, Inc.201502
+3K140601Flow-NailFlow-Fx, LLC20142—
+3K120715Zimmer Natural Nail System Cephalomedullary Femoral Nail - Asia ShortZimmer GmbH201210—
+4K253640T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction SystemStryker GmbH20261—
+4K253749Affixus® Natural Nail® Proximal Humeral SystemZimmer Switzerland Manufacturing GmbH20250—
+4K252826ARIX Femur Nail SystemJeil Medical Corporation20250—
+4K251400T2 Alpha Humerus Nailing System; IMN Screws System; T2 Nailing SystemStryker GmbH20250—
+4K242247ARIX Femur Nail SystemJeil Medical Corporation20251—
+4K233134I.T.S. INS Proximal Femur NailI.T.S. GmbH20240—
+4K223761OIC Intramedullary Screw SystemOrthopaedic Implant Company20230—
+4K221021Femoral Trochanteric Nail System – NeonailNeoortho Produtos Ortopédicos S/A20220—
+4K222309Gamma4 SystemStryker GmbH20220—
+4K221115Flow-NailFlow-Fx, LLC20221—
+4K200814Affixus (R) Natural Nail (R) System Humeral NailZimmer GmbH20201—
+4K191271T2 Alpha Femur Antegrade GT/PF Nailing System, T2 Alpha Tibia Nailing System, IMN Screws…Stryker Trauma GmbH201915—
+5K261481Pangea Femur Reconstruction SystemStryker GmbH20260—
+5K234075Flow-NailFlow-Fx, LLC20240—
+5K193308T2 Alpha Tibia Nailing System, IMN Screws SystemStryker Trauma GmbH20204—