510(k) Report

Devices descending from K163650

12 later devices reach ORTHOLOC® 3Di Ankle Fusion Plating System Line Extension through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K202307Activ FuseNewclip Technics20200—
+1K200398AxSOS 3 AF System and AxSOS 3 Ti SystemStryker GmbH20209—
+1K182991EPIC Extremity Fusion Plate SystemEpic Extremity, LLC20190—
+2K231262Pangea Femur Plating System, Pangea Fibula Plating System, Pangea Tibia Plating System…Stryker GmbH20234—
+2K231257Pangea Utility Plating System, Pangea PlatformStryker GmbH20231—
+2K222381PeriPRO™ Femur System, Variable Angle Fixation System, AxSOS 3Ti, Stryker Plating SystemStryker GmbH20238—
+3K261481Pangea Femur Reconstruction SystemStryker GmbH20260—
+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—
+3K233017TM Plating SystemTyber Medical, LLC20231—
+4K261207Exalta Proximal Tibia Plating SystemTyber Medical, LLC20260—