510(k) Report

Devices descending from K081566

8 later devices reach Smith & Nephew Oxinium DH Femoral Heads through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K161233OXINIUM DH Fermoral HeadsSmith & Nephew, Inc.20166—
+1K123598Smith & Nephew, Inc. Hip System InstrumentationSmith & Nephew, Inc.201302
+2K191002OR3O Dual Mobility SystemSmith & Nephew, Inc.20195—
+3K243456ONVOY™ Acetabular SystemGlobus Medical, Inc.20250—
+3K242375OR3O Dual Mobility SystemSmith & Nephew, Inc.20240—
+3K232667OR3O Dual Mobility LinersSmith & Nephew, Inc.20231—
+3K220959OR3O Dual Mobility SystemSmith & Nephew, Inc.20223—
+4K253948Momentum Acetabular Cup SystemUnited Orthopedic Corporation20260—