510(k) Report

Devices descending from K221181

7 later devices reach Treace Medical Concepts (TMC) Plating System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K240173Treace Medical Systems (TMC) Plating SystemTreace Medical Concepts, Inc.202441
+1K233154SkyOPS™ Orthopedic Plate SystemSky Surgical, LLC20231—
+2K251732Wrist Fracture SystemMet One Technologies, LLC20260—
+2K251135Treace Medical Concepts (TMC) Implant Fixation SystemTreace Medical Concepts20251—
+2K242415TMC Compression Implant SystemTreace Medical Concepts20243—
+3K262963TMC Implant Fixation SystemTreace Medical Concepts, Inc.20260—
+3K243658TMC Compression Implant SystemTreace Medical Concepts20242—