510(k) Report

Devices descending from K163039

15 later devices reach ORTHOLOC® 3Di Small Bones Plating through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K203817Tyber Medical Anatomical Plating SystemTyber Medical, LLC202110—
+1K201259ORTHOLOC 2 with 3Di Technology Pilon Fracture Plating SystemWrightmedicaltechnologyinc20210—
+1K191867ATLAS Plating SystemMiRus, LLC20200—
+1K190970PROSTEP™ TBI™ (Tailors Bunion Implant) SystemWrightmedicaltechnologyinc20191—
+2K262963TMC Implant Fixation SystemTreace Medical Concepts, Inc.20260—
+2K233423Tyber Medical Anatomical Plating System – Line extension to the Mini-Frag SystemTyber Medical, LLC20232—
+2K232652Anatomical Plating System (various)Tyber Medical, LLC2023320
+2K232693Tyber Medical Distal Radius Plating SystemTyber Medical, LLC20231—
+2K222465Tyber Medical Anatomical Plating SystemTyber Medical, LLC20239—
+3K260810Anteralign LS coverplateTyber Medical, LLC20260—
+3K251361Tyber Medical Distal Radius Plating SystemTyber Medical, LLC20250—
+3K242486Tyber Medical Anatomical Plating SystemTyber Medical, LLC20251—
+3K241218Tyber Medical Anatomical Plating SystemTyber Medical, LLC20242—
+3K233017TM Plating SystemTyber Medical, LLC20231—
+4K261207Exalta Proximal Tibia Plating SystemTyber Medical, LLC20260—