510(k) Report

Devices descending from K162241

2 later devices reach TITAN 3-D™ Wedge System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K252733ATLAS™ Expandable Osteotomy Wedge SystemMiRus, LLC20260—
+1K231496TITAN 3-D Wedge SystemParagon 28, Inc.20230—