510(k) Report

Devices descending from K181872

14 later devices reach MIS Bunion System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K253423ToeJack MIS Bunion SystemNvision Biomedical Technologies, Inc.20250—
+1K240173Treace Medical Systems (TMC) Plating SystemTreace Medical Concepts, Inc.202441
+1K221181Treace Medical Concepts (TMC) Plating SystemTreace Medical Concepts, Inc.20237—
+1K211650The Radian MIS Bunion SystemNvision Biomedical Technologies, Inc.20213—
+1K212487CoLink Vallux Plating SystemIn2bones USA, LLC20214—
+1K190658MIS Bunion Plating SystemCrossroads Extremity Systems, LLC20192—
+2K253718enHAnce PEEK Bunion SystemNvision Biomedical Technologies, Inc.20261—
+2K251135Treace Medical Concepts (TMC) Implant Fixation SystemTreace Medical Concepts20251—
+2K242415TMC Compression Implant SystemTreace Medical Concepts20243—
+2K233154SkyOPS™ Orthopedic Plate SystemSky Surgical, LLC20231—
+3K262098EnHAnce PEEK Bunion SystemNvision Biomedical Technologies20260—
+3K262963TMC Implant Fixation SystemTreace Medical Concepts, Inc.20260—
+3K251732Wrist Fracture SystemMet One Technologies, LLC20260—
+3K243658TMC Compression Implant SystemTreace Medical Concepts20242—