510(k) Report

Devices descending from K123964

19 later devices reach Axsos 3 TI Locking Plate System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K231262Pangea Femur Plating System, Pangea Fibula Plating System, Pangea Tibia Plating System…Stryker GmbH20234—
+1K220199AFFINITY Proximal Tibia SystemTechfit Digital Surgery, Inc.20220—
+1K133440Axsos 3 TI Locking Plate System Line ExtensionStryker Trauma AG201312—
+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—
+2K173166ANTHEM Fracture SystemGlobus Medical, Inc.201711—
+3K261481Pangea Femur Reconstruction SystemStryker GmbH20260—
+3K202496ANTHEM Fracture SystemGlobus Medical, Inc.20208—
+3K180554ANTHEM Fracture SystemGlobus Medical, Inc.201810—
+4K251161ANTHEM® Fracture SystemGlobus Medical, Inc.20250—
+4K234059Forma Medical Optimal Plating SystemForma Medical, Inc.20240—
+4K213591ANTHEM® Fracture SystemGlobus Medical, Inc.20225—
+4K212433Anthem Fracture SystemGlobus Medical, Inc.20217—
+5K241815Protean Fragment Plating SystemSkeletal Dynamics, Inc.20240—
+5K232652Anatomical Plating System (various)Tyber Medical, LLC2023320
+6K242486Tyber Medical Anatomical Plating SystemTyber Medical, LLC20251—
+6K241218Tyber Medical Anatomical Plating SystemTyber Medical, LLC20242—
+7K261207Exalta Proximal Tibia Plating SystemTyber Medical, LLC20260—