510(k) Report

Devices descending from K121349

12 later devices reach IO Fix, IO Fix Plus, Carpalfix, Extremity Medical Screw and Washer through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K201556Intraosseous Fixation SystemExtremity Medical, LLC20200—
+1K192578InCore TMT SystemNextremity Solutions, Inc.20191—
+1K180257InCore® Lapidus SystemNextremity Solutions, Inc.20183—
+1K172260Omni Foot Plating SystemExtremity Medical, LLC20174—
+1K143402Extremity Medical Calcaneal Osteotomy DeviceExtremity Medical, LLC20151—
+2K200124InCore MPJ SystemNextremity Solutions, Inc.20200—
+2K190231InCore® Lapidus Sterile KitsNextremity Solutions, Inc.20190—
+2K180808Omni Foot Plating SystemExtremity Medical, LLC20183—
+2K150309Extremity Medical Calcaneal Osteotomy DeviceExtremity Medical, LLC20150—
+3K212297Omni Foot and Ankle Plating SystemExtremity Medical, LLC20211—
+3K192592Axis Plating SystemExtremity Medical, LLC20190—
+4K221362Omni Foot and Ankle Plating SystemExremity Medical, LLC20220—