510(k) Report

Devices descending from K200398

9 later devices reach AxSOS 3 AF System and AxSOS 3 Ti System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K231262Pangea Femur Plating System, Pangea Fibula Plating System, Pangea Tibia Plating System…Stryker GmbH20234—
+1K231257Pangea Utility Plating System, Pangea PlatformStryker GmbH20231—
+1K222381PeriPRO™ Femur System, Variable Angle Fixation System, AxSOS 3Ti, Stryker Plating SystemStryker GmbH20238—
+2K261481Pangea Femur Reconstruction SystemStryker GmbH20260—
+2K253640T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction SystemStryker GmbH20261—
+2K250163T2 Alpha Femur Retrograde Nailing SystemStryker GmbH20252—
+2K242445Pangea Platform; Pangea Femur Plating System; Pangea Humerus Plating System; Pangea…Stryker GmbH20240—
+2K233017TM Plating SystemTyber Medical, LLC20231—
+3K261207Exalta Proximal Tibia Plating SystemTyber Medical, LLC20260—