510(k) Report

Devices descending from K191002

5 later devices reach OR3O Dual Mobility System through their predicates, nearest generation first.

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