510(k) Report

Devices descending from K180554

10 later devices reach ANTHEM Fracture System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K234059Forma Medical Optimal Plating SystemForma Medical, Inc.20240—
+1K212433Anthem Fracture SystemGlobus Medical, Inc.20217—
+1K202496ANTHEM Fracture SystemGlobus Medical, Inc.20208—
+2K251161ANTHEM® Fracture SystemGlobus Medical, Inc.20250—
+2K241815Protean Fragment Plating SystemSkeletal Dynamics, Inc.20240—
+2K213591ANTHEM® Fracture SystemGlobus Medical, Inc.20225—
+3K232652Anatomical Plating System (various)Tyber Medical, LLC2023320
+4K242486Tyber Medical Anatomical Plating SystemTyber Medical, LLC20251—
+4K241218Tyber Medical Anatomical Plating SystemTyber Medical, LLC20242—
+5K261207Exalta Proximal Tibia Plating SystemTyber Medical, LLC20260—