510(k) Report

Devices descending from K200869

9 later devices reach Gamma3 System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K261043AUTOBAHN™ Nailing SystemGlobus Medical, Inc.20260—
+1K252826ARIX Femur Nail SystemJeil Medical Corporation20250—
+1K242247ARIX Femur Nail SystemJeil Medical Corporation20251—
+1K233134I.T.S. INS Proximal Femur NailI.T.S. GmbH20240—
+1K221021Femoral Trochanteric Nail System – NeonailNeoortho Produtos Ortopédicos S/A20220—
+1K213328Gamma4 System, Gamma3 System, IMN Screws System, T2 Tibial Nailing SystemStryker GmbH202231
+2K251400T2 Alpha Humerus Nailing System; IMN Screws System; T2 Nailing SystemStryker GmbH20250—
+2K230512Gamma4 SystemStryker GmbH20230—
+2K222309Gamma4 SystemStryker GmbH20220—