510(k) Report

Devices descending from K171004

2 later devices reach Hintermann Series H2 Total Ankle System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K240475Hintermann Series H2 Total Ankle SystemVilex, LLC20240—
+1K230462OPTIX H2 Patient Specific Instrument SystemVilex, LLC20230—