510(k) Report

Devices descending from K123401

20 later devices reach GAMMA3 and T2 Recon Targeting Devices through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K200869Gamma3 SystemStryker Trauma GmbH20209—
+1K181848ADAPT for Gamma3, Gamma3Stryker GmbH20181—
+1K172774T2 Alpha Femur Antegrade GT/PF Nailing System, IMN Screws System, IMN Instruments SystemStryker Trauma GmbH201817—
+2K261043AUTOBAHN™ Nailing SystemGlobus Medical, Inc.20260—
+2K252826ARIX Femur Nail SystemJeil Medical Corporation20250—
+2K242247ARIX Femur Nail SystemJeil Medical Corporation20251—
+2K233134I.T.S. INS Proximal Femur NailI.T.S. GmbH20240—
+2K221021Femoral Trochanteric Nail System – NeonailNeoortho Produtos Ortopédicos S/A20220—
+2K213328Gamma4 System, Gamma3 System, IMN Screws System, T2 Tibial Nailing SystemStryker GmbH202231
+2K202749ADAPT for Gamma3Stryker GmbH20200—
+2K180436T2 Alpha Tibia Nailing System, T2 Alpha Femur Antegrade GT/PF Nailing System, IMN Screws…Stryker Trauma GmbH201816—
+3K251400T2 Alpha Humerus Nailing System; IMN Screws System; T2 Nailing SystemStryker GmbH20250—
+3K230512Gamma4 SystemStryker GmbH20230—
+3K222309Gamma4 SystemStryker GmbH20220—
+3K191271T2 Alpha Femur Antegrade GT/PF Nailing System, T2 Alpha Tibia Nailing System, IMN Screws…Stryker Trauma GmbH201915—
+4K203819T2 Alpha Femur Retrograde Nailing System, T2 Alpha Femur Antegrade GT/PF Nailing System…Stryker GmbH20217—
+4K193308T2 Alpha Tibia Nailing System, IMN Screws SystemStryker Trauma GmbH20204—
+5K250163T2 Alpha Femur Retrograde Nailing SystemStryker GmbH20252—
+6K253640T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction SystemStryker GmbH20261—
+7K261481Pangea Femur Reconstruction SystemStryker GmbH20260—