510(k) Report

Devices descending from K161233

6 later devices reach OXINIUM DH Fermoral Heads through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K191002OR3O Dual Mobility SystemSmith & Nephew, Inc.20195—
+2K243456ONVOY™ Acetabular SystemGlobus Medical, Inc.20250—
+2K242375OR3O Dual Mobility SystemSmith & Nephew, Inc.20240—
+2K232667OR3O Dual Mobility LinersSmith & Nephew, Inc.20231—
+2K220959OR3O Dual Mobility SystemSmith & Nephew, Inc.20223—
+3K253948Momentum Acetabular Cup SystemUnited Orthopedic Corporation20260—