510(k) Report

Devices descending from K061012

28 later devices reach Axsos Plus Locking Plate System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K123964Axsos 3 TI Locking Plate SystemStryker Trauma AG201319—
+1K123403Axsos Proximal Lateral Tibia Long PlatesStryker Trauma AG20130—
+1K122308Axsos Distal Lateral Femur TS Long PlatesHowmedica Osteonics Corp., Dba Stryker Orthopaedics201220—
+1K110476Axsos (TM) Locking Plate SystemStryker Corp.20110—
+1K093868I.T.S. LRS Locking Reconstruction SystemI.T.S. Implantat-Technologie-Systeme GmbH201011
+1K092178Axsos Stryker Locked Plating System Line Extension of Cable PlugsHowmedica Osteonics Corp.20090—
+1K091619Anglefix T Locking Plate, Models AF-001 (Plate), ST-1 (Locking Screw)Anglefix20090—
+1K092419Axsos Locked Plating System Line Extension of 3MM Locking InsertsHowmedica Osteonics Corp.20090—
+2K260958I.T.S. Clavicle Plates with Angular Stability; I.T.S. Volar Radius Plate with Angular…I.T.S. GmbH20260—
+2K231262Pangea Femur Plating System, Pangea Fibula Plating System, Pangea Tibia Plating System…Stryker GmbH20234—
+2K220199AFFINITY Proximal Tibia SystemTechfit Digital Surgery, Inc.20220—
+2K133440Axsos 3 TI Locking Plate System Line ExtensionStryker Trauma AG201312—
+3K253640T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction SystemStryker GmbH20261—
+3K250163T2 Alpha Femur Retrograde Nailing SystemStryker GmbH20252—
+3K242445Pangea Platform; Pangea Femur Plating System; Pangea Humerus Plating System; Pangea…Stryker GmbH20240—
+3K173166ANTHEM Fracture SystemGlobus Medical, Inc.201711—
+4K261481Pangea Femur Reconstruction SystemStryker GmbH20260—
+4K202496ANTHEM Fracture SystemGlobus Medical, Inc.20208—
+4K180554ANTHEM Fracture SystemGlobus Medical, Inc.201810—
+5K251161ANTHEM® Fracture SystemGlobus Medical, Inc.20250—
+5K234059Forma Medical Optimal Plating SystemForma Medical, Inc.20240—
+5K213591ANTHEM® Fracture SystemGlobus Medical, Inc.20225—
+5K212433Anthem Fracture SystemGlobus Medical, Inc.20217—
+6K241815Protean Fragment Plating SystemSkeletal Dynamics, Inc.20240—
+6K232652Anatomical Plating System (various)Tyber Medical, LLC2023320
+7K242486Tyber Medical Anatomical Plating SystemTyber Medical, LLC20251—
+7K241218Tyber Medical Anatomical Plating SystemTyber Medical, LLC20242—
+8K261207Exalta Proximal Tibia Plating SystemTyber Medical, LLC20260—