510(k) Report

Devices descending from K153379

25 later devices reach AxSOS 3Ti through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K231262Pangea Femur Plating System, Pangea Fibula Plating System, Pangea Tibia Plating System…Stryker GmbH20234—
+1K172350AxSOS 3 TiStryker GmbH201717—
+1K162439AxSOS 3 Ti; Stryker Plating SystemStryker GmbH201724—
+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—
+2K222381PeriPRO™ Femur System, Variable Angle Fixation System, AxSOS 3Ti, Stryker Plating SystemStryker GmbH20238—
+2K213591ANTHEM® Fracture SystemGlobus Medical, Inc.20225—
+2K203817Tyber Medical Anatomical Plating SystemTyber Medical, LLC202110—
+2K181091AxSOS 3 TiStryker GmbH201811—
+3K261481Pangea Femur Reconstruction SystemStryker GmbH20260—
+3K251161ANTHEM® Fracture SystemGlobus Medical, Inc.20250—
+3K242436Proximal Humerus Fixation SystemSkeletal Dynamics, Inc.20240—
+3K233423Tyber Medical Anatomical Plating System – Line extension to the Mini-Frag SystemTyber Medical, LLC20232—
+3K233017TM Plating SystemTyber Medical, LLC20231—
+3K232652Anatomical Plating System (various)Tyber Medical, LLC2023320
+3K232693Tyber Medical Distal Radius Plating SystemTyber Medical, LLC20231—
+3K231257Pangea Utility Plating System, Pangea PlatformStryker GmbH20231—
+3K222465Tyber Medical Anatomical Plating SystemTyber Medical, LLC20239—
+3K200398AxSOS 3 AF System and AxSOS 3 Ti SystemStryker GmbH20209—
+4K261207Exalta Proximal Tibia Plating SystemTyber Medical, LLC20260—
+4K260810Anteralign LS coverplateTyber Medical, LLC20260—
+4K251361Tyber Medical Distal Radius Plating SystemTyber Medical, LLC20250—
+4K242486Tyber Medical Anatomical Plating SystemTyber Medical, LLC20251—
+4K241218Tyber Medical Anatomical Plating SystemTyber Medical, LLC20242—