510(k) Report

Devices descending from K181067

4 later devices reach AlignX Ankle Fusion System through their predicates, nearest generation first.

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