510(k) Report

Devices descending from K101438

25 later devices reach T2 Greater Trochanter Nail through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K200880T2 Tibial Nailing System, T2 Femoral Nail System, T2 Supracondylar Nail System, T2 Recon…Stryker GmbH202011—
+1K172774T2 Alpha Femur Antegrade GT/PF Nailing System, IMN Screws System, IMN Instruments SystemStryker Trauma GmbH201817—
+1K150655OIC Intramedullary Nail SystemOrthopaedic Implant Company20152—
+2K253155Fule Metallic Lockable Intramedullary Nail SystemsBeijing Fule Science & Technology Development Co., Ltd.20260—
+2K230088Ankle Truss System (ATS)4Web Medical, Inc.20241—
+2K203819T2 Alpha Femur Retrograde Nailing System, T2 Alpha Femur Antegrade GT/PF Nailing System…Stryker GmbH20217—
+2K181184OIC Intramedullary Nail SystemThe Orthopaedic Implant Company20181—
+2K180436T2 Alpha Tibia Nailing System, T2 Alpha Femur Antegrade GT/PF Nailing System, IMN Screws…Stryker Trauma GmbH201816—
+3K250163T2 Alpha Femur Retrograde Nailing SystemStryker GmbH20252—
+3K242356TIDAL Fusion Cage SystemRestor3D, Inc.20250—
+3K230512Gamma4 SystemStryker GmbH20230—
+3K223761OIC Intramedullary Screw SystemOrthopaedic Implant Company20230—
+3K213328Gamma4 System, Gamma3 System, IMN Screws System, T2 Tibial Nailing SystemStryker GmbH202231
+3K191271T2 Alpha Femur Antegrade GT/PF Nailing System, T2 Alpha Tibia Nailing System, IMN Screws…Stryker Trauma GmbH201915—
+4K253640T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction SystemStryker GmbH20261—
+4K251400T2 Alpha Humerus Nailing System; IMN Screws System; T2 Nailing SystemStryker GmbH20250—
+4K222309Gamma4 SystemStryker GmbH20220—
+4K200869Gamma3 SystemStryker Trauma GmbH20209—
+4K193308T2 Alpha Tibia Nailing System, IMN Screws SystemStryker Trauma GmbH20204—
+5K261481Pangea Femur Reconstruction SystemStryker GmbH20260—
+5K261043AUTOBAHN™ Nailing SystemGlobus Medical, Inc.20260—
+5K252826ARIX Femur Nail SystemJeil Medical Corporation20250—
+5K242247ARIX Femur Nail SystemJeil Medical Corporation20251—
+5K233134I.T.S. INS Proximal Femur NailI.T.S. GmbH20240—
+5K221021Femoral Trochanteric Nail System – NeonailNeoortho Produtos Ortopédicos S/A20220—