510(k) Report

Devices descending from K040336

74 later devices reach Synthes (Usa) Lateral Entry Femoral Nail System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K233150NET BRAND Osteosynthesis Nailing SystemNarang Medical, Ltd.20240—
+1K203811GPC Intraheal Intramedullary Nailing SystemGpc Medical Limited20220—
+1K192003Auxein Nailing SystemAuxein Medical Private Limited20202—
+1K182783DePuy Synthes Trauma Orthopedic Nail ImplantsDePuy Synthes20182—
+1K172830Double Medical Femoral Nail SystemDouble Medical Technology, Inc.20182—
+1K172157DePuy Synthes Femoral Recon Nail SystemSynthes (USA) Products, LLC20172—
+1K111891Synthes Brainlab Trauma Compatible InstrumentsSynthes (USA) Products, LLC20110—
+1K083726Pedinail Intramedullary Nailing SystemOrthoPediatrics Corp.2009627
+1K043270Sirus Intramedullary Nail-Femoral and Tibial Nails, Models 02.02631, 02.02651, 02.02652…Zimmer GmbH2005532
+2K253080AND Medical Femoral Nail System (PFNA01); AND Medical Femoral Nail System (PFNA02)Suzhou and Science & Technology Development Corp.20260—
+2K253155Fule Metallic Lockable Intramedullary Nail SystemsBeijing Fule Science & Technology Development Co., Ltd.20260—
+2K253046HERA Interlocking Intramedullary Nailing SystemZheJiang Decans Medical Devices Co., Ltd.20260—
+2K230071Femur Reconstruction Interlocking Nail System, Femur Retrograde Interlocking Nail…Tdm Co., Ltd.20240—
+2K220659AUTOBAHN (R) EVO Femoral NailsGlobus Medical, Inc.20221—
+2K210792Auxein Nailing SystemAuxein Medical Private Limited20210—
+2K201830ANSER Clavicle PinBAAT Medical Products B.V.20200—
+2K172583OrthoPediatrics PediNail Intramedullary PlatformOrthopediatrics, Inc.201843
+2K172699Agile NailOrthofix Srl20180—
+2K132945CFN-Cannulated Femur Nail, CTN-Cannulated Tibia Nail, CHN-Cannulated Humeral NailI.T.S. GmbH201410—
+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
+2K082770Zimmer Natural Nail System Tibial NailZimmer, Inc.20083515
+2K080706Connexx Locking Tibia NailI.T.S. Implantat-Technologie-Systeme GmbH200811—
+3K261345Pediatric Nailing Platform FemurOrthoPediatrics Corp.20260—
+3K260958I.T.S. Clavicle Plates with Angular Stability; I.T.S. Volar Radius Plate with Angular…I.T.S. GmbH20260—
+3K261043AUTOBAHN™ Nailing SystemGlobus Medical, Inc.20260—
+3K252025Active Intramedullary (AIM) Tibial Nail SystemSatori Orthopaedics, Inc.20260—
+3K250623Pediatric Nailing Platform Tibia Pediatric Nailing Platform FemurOrthoPediatrics Corp.20251—
+3K243907Affixus Tibial Nailing System - 4mm screwsZimmer, Inc.20250—
+3K241651Affixus Tibial and Antegrade Femoral Nailing SystemZimmer, Inc.2024217
+3K220679Pediatric Nailing Platform FemurOrthoPediatrics Corp.20222—
+3K190321Pediatric Nailing PlatformFemurOrthoPediatrics Corp.20190—
+3K181640X-BOLT Hip Fracture Fixation SystemX-Bolt Orthopaedics20181—
+3K180436T2 Alpha Tibia Nailing System, T2 Alpha Femur Antegrade GT/PF Nailing System, IMN Screws…Stryker Trauma GmbH201816—
+3K172774T2 Alpha Femur Antegrade GT/PF Nailing System, IMN Screws System, IMN Instruments SystemStryker Trauma GmbH201817—
+3K171108AUTOBAHN Nailing SystemGlobus Medical, Inc.20172—
+3K170972Apex Tibial Nailing SystemOrthoxel20171—
+3K172114Zimmer Natural Nail SystemZimmer, Inc.201711—
+3K161327Syntec Humeral Nail SystemSyntec Scientific Corporation20173—
+3K141228Aos 6.5MM Captured, Fully Threaded Cancellous ScrewAdvanced Orthopaedic Solutions, Inc.20142—
+3K130595Zimmer Natural Nail System Tibial Nail and Stainless Steel Tibial NailZimmer, Inc.201323
+3K091566Zimmer Natural Nail System Cephalomedullary NailsZimmer GmbH2009165
+4K253566Affixus Retrograde Femoral Nailing SystemZimmer, Inc.20260—
+4K231114Zimmer® Natural Nail® System Cephalomedullary Nails; Affixus® Natural Nail® Humeral Nail…Zimmer Switzerland Manufacturing GmbH20234—
+4K230257Arthrex Intramedullary NailsArthrex, Inc.20231—
+4K221621Pro-X1™ Trochanteric Nailing SystemX-Bolt Orthopedics20230—
+4K200869Gamma3 SystemStryker Trauma GmbH20209—
+4K192312Zimmer Natural Nail System Cephalomedullary NailsZimmer GmbH20194—
+4K191271T2 Alpha Femur Antegrade GT/PF Nailing System, T2 Alpha Tibia Nailing System, IMN Screws…Stryker Trauma GmbH201915—
+4K181296Syntec Femoral Nail SystemSyntec Scientific Corporation20192—
+4K181184OIC Intramedullary Nail SystemThe Orthopaedic Implant Company20181—
+4K181375Apex Femoral Nailing SystemOrthoxel20180—
+4K140601Flow-NailFlow-Fx, LLC20142—
+4K120715Zimmer Natural Nail System Cephalomedullary Femoral Nail - Asia ShortZimmer GmbH201210—
+5K253749Affixus® Natural Nail® Proximal Humeral SystemZimmer Switzerland Manufacturing GmbH20250—
+5K252826ARIX Femur Nail SystemJeil Medical Corporation20250—
+5K242247ARIX Femur Nail SystemJeil Medical Corporation20251—
+5K243890Arthrex Intramedullary NailsArthrex, Inc.20250—
+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—
+5K221115Flow-NailFlow-Fx, LLC20221—
+5K213328Gamma4 System, Gamma3 System, IMN Screws System, T2 Tibial Nailing SystemStryker GmbH202231
+5K203819T2 Alpha Femur Retrograde Nailing System, T2 Alpha Femur Antegrade GT/PF Nailing System…Stryker GmbH20217—
+5K202935Syntec Femoral Nail Extended SystemSyntec Scientific Corporation20200—
+5K193308T2 Alpha Tibia Nailing System, IMN Screws SystemStryker Trauma GmbH20204—
+5K191617Syntec Tibial Nail SystemSyntec Scientific Corporation20190—
+6K251400T2 Alpha Humerus Nailing System; IMN Screws System; T2 Nailing SystemStryker GmbH20250—
+6K250163T2 Alpha Femur Retrograde Nailing SystemStryker GmbH20252—
+6K234075Flow-NailFlow-Fx, LLC20240—
+6K230512Gamma4 SystemStryker GmbH20230—
+6K222309Gamma4 SystemStryker GmbH20220—
+7K253640T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction SystemStryker GmbH20261—
+8K261481Pangea Femur Reconstruction SystemStryker GmbH20260—