510(k) Report

Devices descending from K160191

5 later devices reach Align Anterior Ankle Fusion Plate through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K181067AlignX Ankle Fusion SystemExtremity Medical, LLC20184—
+2K231887ARIX Ankle Distal Tibia SystemJeil Medical Corporation20231—
+2K212297Omni Foot and Ankle Plating SystemExtremity Medical, LLC20211—
+3K252246Leforte MMF SystemJeil Medical Corporation20260—
+3K221362Omni Foot and Ankle Plating SystemExremity Medical, LLC20220—