510(k) Report

Devices descending from K153204

20 later devices reach In2Bones Kirschner wire through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K212487CoLink Vallux Plating SystemIn2bones USA, LLC20214—
+1K203698CoLink Sfx Implant SystemIn2bones USA, LLC20211—
+1K203475LimaCorporate Kirschner WireLima Corporate S.P.A.20210—
+1K191803Orthopedic Fixation PinTinavi (Anhui) Medical Technologies Co., Ltd.20200—
+1K181872MIS Bunion SystemCrossroads Extremity Systems, LLC201914—
+1K163327Precifit Medical Kirschner WiresPrecifit Medical, Ltd.20170—
+2K253423ToeJack MIS Bunion SystemNvision Biomedical Technologies, Inc.20250—
+2K240173Treace Medical Systems (TMC) Plating SystemTreace Medical Concepts, Inc.202441
+2K231905Electro-Spec Steri-CapsElectro-Spec, Inc.20230—
+2K221181Treace Medical Concepts (TMC) Plating SystemTreace Medical Concepts, Inc.20237—
+2K211650The Radian MIS Bunion SystemNvision Biomedical Technologies, Inc.20213—
+2K190658MIS Bunion Plating SystemCrossroads Extremity Systems, LLC20192—
+3K253718enHAnce PEEK Bunion SystemNvision Biomedical Technologies, Inc.20261—
+3K251135Treace Medical Concepts (TMC) Implant Fixation SystemTreace Medical Concepts20251—
+3K242415TMC Compression Implant SystemTreace Medical Concepts20243—
+3K233154SkyOPS™ Orthopedic Plate SystemSky Surgical, LLC20231—
+4K262098EnHAnce PEEK Bunion SystemNvision Biomedical Technologies20260—
+4K262963TMC Implant Fixation SystemTreace Medical Concepts, Inc.20260—
+4K251732Wrist Fracture SystemMet One Technologies, LLC20260—
+4K243658TMC Compression Implant SystemTreace Medical Concepts20242—