510(k) Report

Devices descending from K123203

38 later devices reach Maxlock Extreme System Model MXL through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K141301Maxlock Extreme Elbow Fracture SystemOrthohelix Surgical Designs, Inc.20140—
+1K132733Orthohelix Syndesmosis Fixation DevicesOrthohelix Surgical Designs, Inc.20143—
+1K132591Maxlock Extreme SystemOrthohelix Surgical Designs, Inc.201332—
+2K181067AlignX Ankle Fusion SystemExtremity Medical, LLC20184—
+2K153379AxSOS 3TiStryker GmbH201625—
+2K160191Align Anterior Ankle Fusion PlateExtremity Medical, LLC20165—
+2K141264Tensyn Band, Tensyn Fracture PlatesDallen Medical, Inc.20142—
+3K231887ARIX Ankle Distal Tibia SystemJeil Medical Corporation20231—
+3K231262Pangea Femur Plating System, Pangea Fibula Plating System, Pangea Tibia Plating System…Stryker GmbH20234—
+3K212297Omni Foot and Ankle Plating SystemExtremity Medical, LLC20211—
+3K172350AxSOS 3 TiStryker GmbH201717—
+3K162439AxSOS 3 Ti; Stryker Plating SystemStryker GmbH201724—
+3K143092Tensyn PlugDallen Medical, Inc.20151—
+4K252246Leforte MMF SystemJeil Medical Corporation20260—
+4K253640T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction SystemStryker GmbH20261—
+4K250163T2 Alpha Femur Retrograde Nailing SystemStryker GmbH20252—
+4K242445Pangea Platform; Pangea Femur Plating System; Pangea Humerus Plating System; Pangea…Stryker GmbH20240—
+4K222381PeriPRO™ Femur System, Variable Angle Fixation System, AxSOS 3Ti, Stryker Plating SystemStryker GmbH20238—
+4K221362Omni Foot and Ankle Plating SystemExremity Medical, LLC20220—
+4K213591ANTHEM® Fracture SystemGlobus Medical, Inc.20225—
+4K203817Tyber Medical Anatomical Plating SystemTyber Medical, LLC202110—
+4K181091AxSOS 3 TiStryker GmbH201811—
+4K150359Tensyn PlugDallen Medical, Inc.20150—
+5K261481Pangea Femur Reconstruction SystemStryker GmbH20260—
+5K251161ANTHEM® Fracture SystemGlobus Medical, Inc.20250—
+5K242436Proximal Humerus Fixation SystemSkeletal Dynamics, Inc.20240—
+5K233423Tyber Medical Anatomical Plating System – Line extension to the Mini-Frag SystemTyber Medical, LLC20232—
+5K233017TM Plating SystemTyber Medical, LLC20231—
+5K232652Anatomical Plating System (various)Tyber Medical, LLC2023320
+5K232693Tyber Medical Distal Radius Plating SystemTyber Medical, LLC20231—
+5K231257Pangea Utility Plating System, Pangea PlatformStryker GmbH20231—
+5K222465Tyber Medical Anatomical Plating SystemTyber Medical, LLC20239—
+5K200398AxSOS 3 AF System and AxSOS 3 Ti SystemStryker GmbH20209—
+6K261207Exalta Proximal Tibia Plating SystemTyber Medical, LLC20260—
+6K260810Anteralign LS coverplateTyber Medical, LLC20260—
+6K251361Tyber Medical Distal Radius Plating SystemTyber Medical, LLC20250—
+6K242486Tyber Medical Anatomical Plating SystemTyber Medical, LLC20251—
+6K241218Tyber Medical Anatomical Plating SystemTyber Medical, LLC20242—