510(k) Report

Devices descending from K981529

211 later devices reach Titanium Intramedullary Nail, Titanium Locking Screw through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K191271T2 Alpha Femur Antegrade GT/PF Nailing System, T2 Alpha Tibia Nailing System, IMN Screws…Stryker Trauma GmbH201915—
+6K173746Activmotion RangeNewclip Technics20181—
+6K173166ANTHEM Fracture SystemGlobus Medical, Inc.201711—
+7K261481Pangea Femur Reconstruction SystemStryker GmbH20260—
+7K241815Protean Fragment Plating SystemSkeletal Dynamics, Inc.20240—
+7K241539Activmotion SNewclip Technics20240—
+7K213591ANTHEM® Fracture SystemGlobus Medical, Inc.20225—
+7K193308T2 Alpha Tibia Nailing System, IMN Screws SystemStryker Trauma GmbH20204—
+8K232652Anatomical Plating System (various)Tyber Medical, LLC2023320
+9K242486Tyber Medical Anatomical Plating SystemTyber Medical, LLC20251—
+9K241218Tyber Medical Anatomical Plating SystemTyber Medical, LLC20242—