510(k) Report

Devices descending from K162439

24 later devices reach AxSOS 3 Ti; Stryker Plating System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K222381PeriPRO™ Femur System, Variable Angle Fixation System, AxSOS 3Ti, Stryker Plating SystemStryker GmbH20238—
+1K203817Tyber Medical Anatomical Plating SystemTyber Medical, LLC202110—
+1K172350AxSOS 3 TiStryker GmbH201717—
+2K261481Pangea Femur Reconstruction SystemStryker GmbH20260—
+2K233423Tyber Medical Anatomical Plating System – Line extension to the Mini-Frag SystemTyber Medical, LLC20232—
+2K233017TM Plating SystemTyber Medical, LLC20231—
+2K232652Anatomical Plating System (various)Tyber Medical, LLC2023320
+2K232693Tyber Medical Distal Radius Plating SystemTyber Medical, LLC20231—
+2K231262Pangea Femur Plating System, Pangea Fibula Plating System, Pangea Tibia Plating System…Stryker GmbH20234—
+2K231257Pangea Utility Plating System, Pangea PlatformStryker GmbH20231—
+2K222465Tyber Medical Anatomical Plating SystemTyber Medical, LLC20239—
+2K213591ANTHEM® Fracture SystemGlobus Medical, Inc.20225—
+2K181091AxSOS 3 TiStryker GmbH201811—
+3K261207Exalta Proximal Tibia Plating SystemTyber Medical, LLC20260—
+3K260810Anteralign LS coverplateTyber Medical, LLC20260—
+3K253640T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction SystemStryker GmbH20261—
+3K251161ANTHEM® Fracture SystemGlobus Medical, Inc.20250—
+3K250163T2 Alpha Femur Retrograde Nailing SystemStryker GmbH20252—
+3K251361Tyber Medical Distal Radius Plating SystemTyber Medical, LLC20250—
+3K242486Tyber Medical Anatomical Plating SystemTyber Medical, LLC20251—
+3K242436Proximal Humerus Fixation SystemSkeletal Dynamics, Inc.20240—
+3K242445Pangea Platform; Pangea Femur Plating System; Pangea Humerus Plating System; Pangea…Stryker GmbH20240—
+3K241218Tyber Medical Anatomical Plating SystemTyber Medical, LLC20242—
+3K200398AxSOS 3 AF System and AxSOS 3 Ti SystemStryker GmbH20209—