510(k) Report

Devices descending from K131365

17 later devices reach T2 Tibial Nailing System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K200880T2 Tibial Nailing System, T2 Femoral Nail System, T2 Supracondylar Nail System, T2 Recon…Stryker GmbH202011—
+1K171108AUTOBAHN Nailing SystemGlobus Medical, Inc.20172—
+1K141103Intramedullary Nail and Screws-NeonailNeoortho Produtos Ortopedicos S/A20141—
+2K253155Fule Metallic Lockable Intramedullary Nail SystemsBeijing Fule Science & Technology Development Co., Ltd.20260—
+2K261043AUTOBAHN™ Nailing SystemGlobus Medical, Inc.20260—
+2K230088Ankle Truss System (ATS)4Web Medical, Inc.20241—
+2K221021Femoral Trochanteric Nail System – NeonailNeoortho Produtos Ortopédicos S/A20220—
+2K220659AUTOBAHN (R) EVO Femoral NailsGlobus Medical, Inc.20221—
+2K203819T2 Alpha Femur Retrograde Nailing System, T2 Alpha Femur Antegrade GT/PF Nailing System…Stryker GmbH20217—
+3K250163T2 Alpha Femur Retrograde Nailing SystemStryker GmbH20252—
+3K242356TIDAL Fusion Cage SystemRestor3D, Inc.20250—
+3K230512Gamma4 SystemStryker GmbH20230—
+3K213328Gamma4 System, Gamma3 System, IMN Screws System, T2 Tibial Nailing SystemStryker GmbH202231
+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—
+5K261481Pangea Femur Reconstruction SystemStryker GmbH20260—