510(k) Report

Devices descending from K040762

48 later devices reach Synthes (Usa) Tibial Nail System EX through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K201336DePuy Synthes Tibial Nail Advanced, Depuy Synthes Locking Screws Medullary Nails, 4.0…Synthes (USA) Products, LLC202002
+1K192003Auxein Nailing SystemAuxein Medical Private Limited20202—
+1K193308T2 Alpha Tibia Nailing System, IMN Screws SystemStryker Trauma GmbH20204—
+1K191617Syntec Tibial Nail SystemSyntec Scientific Corporation20190—
+1K180436T2 Alpha Tibia Nailing System, T2 Alpha Femur Antegrade GT/PF Nailing System, IMN Screws…Stryker Trauma GmbH201816—
+1K171108AUTOBAHN Nailing SystemGlobus Medical, Inc.20172—
+1K160553DePuy Synthes 4.0 mm and 5.0 mm Locking Screws – MR Conditional, DePuy Synthes Wrist…Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.20170—
+1K143245GPC Intramedullary Nailing SystemsGpc Medical Limited20152—
+1K131609Double Engine Intrameddullary Nail SystemXiamen Double Engine Medical Material Co., Ltd.20141—
+1K111667Synthes Suprapatellar Insertion InstrumentsSynthes (Usa)2011181
+1K080706Connexx Locking Tibia NailI.T.S. Implantat-Technologie-Systeme GmbH200811—
+2K253046HERA Interlocking Intramedullary Nailing SystemZheJiang Decans Medical Devices Co., Ltd.20260—
+2K261043AUTOBAHN™ Nailing SystemGlobus Medical, Inc.20260—
+2K253517Reselute Tibial NailReselute, Inc.20260—
+2K230071Femur Reconstruction Interlocking Nail System, Femur Retrograde Interlocking Nail…Tdm Co., Ltd.20240—
+2K220659AUTOBAHN (R) EVO Femoral NailsGlobus Medical, Inc.20221—
+2K213328Gamma4 System, Gamma3 System, IMN Screws System, T2 Tibial Nailing SystemStryker GmbH202231
+2K203811GPC Intraheal Intramedullary Nailing SystemGpc Medical Limited20220—
+2K210792Auxein Nailing SystemAuxein Medical Private Limited20210—
+2K191271T2 Alpha Femur Antegrade GT/PF Nailing System, T2 Alpha Tibia Nailing System, IMN Screws…Stryker Trauma GmbH201915—
+2K132945CFN-Cannulated Femur Nail, CTN-Cannulated Tibia Nail, CHN-Cannulated Humeral NailI.T.S. GmbH201410—
+2K131365T2 Tibial Nailing SystemStryker Trauma AG2013174
+3K260958I.T.S. Clavicle Plates with Angular Stability; I.T.S. Volar Radius Plate with Angular…I.T.S. GmbH20260—
+3K251400T2 Alpha Humerus Nailing System; IMN Screws System; T2 Nailing SystemStryker GmbH20250—
+3K230512Gamma4 SystemStryker GmbH20230—
+3K222309Gamma4 SystemStryker GmbH20220—
+3K203819T2 Alpha Femur Retrograde Nailing System, T2 Alpha Femur Antegrade GT/PF Nailing System…Stryker GmbH20217—
+3K200869Gamma3 SystemStryker Trauma GmbH20209—
+3K200880T2 Tibial Nailing System, T2 Femoral Nail System, T2 Supracondylar Nail System, T2 Recon…Stryker GmbH202011—
+3K170972Apex Tibial Nailing SystemOrthoxel20171—
+3K161327Syntec Humeral Nail SystemSyntec Scientific Corporation20173—
+3K141103Intramedullary Nail and Screws-NeonailNeoortho Produtos Ortopedicos S/A20141—
+3K141228Aos 6.5MM Captured, Fully Threaded Cancellous ScrewAdvanced Orthopaedic Solutions, Inc.20142—
+4K253155Fule Metallic Lockable Intramedullary Nail SystemsBeijing Fule Science & Technology Development Co., Ltd.20260—
+4K252025Active Intramedullary (AIM) Tibial Nail SystemSatori Orthopaedics, Inc.20260—
+4K252826ARIX Femur Nail SystemJeil Medical Corporation20250—
+4K250163T2 Alpha Femur Retrograde Nailing SystemStryker GmbH20252—
+4K242247ARIX Femur Nail SystemJeil Medical Corporation20251—
+4K230088Ankle Truss System (ATS)4Web Medical, Inc.20241—
+4K233134I.T.S. INS Proximal Femur NailI.T.S. GmbH20240—
+4K230257Arthrex Intramedullary NailsArthrex, Inc.20231—
+4K221021Femoral Trochanteric Nail System – NeonailNeoortho Produtos Ortopédicos S/A20220—
+4K181296Syntec Femoral Nail SystemSyntec Scientific Corporation20192—
+5K253640T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction SystemStryker GmbH20261—
+5K242356TIDAL Fusion Cage SystemRestor3D, Inc.20250—
+5K243890Arthrex Intramedullary NailsArthrex, Inc.20250—
+5K202935Syntec Femoral Nail Extended SystemSyntec Scientific Corporation20200—
+6K261481Pangea Femur Reconstruction SystemStryker GmbH20260—