510(k) Report

Devices descending from K110135

14 later devices reach Polarcup Dual Mobility System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K220959OR3O Dual Mobility SystemSmith & Nephew, Inc.20223—
+1K211176Smith & Nephew Hip SystemsSmith & Nephew, Inc.202231
+1K191002OR3O Dual Mobility SystemSmith & Nephew, Inc.20195—
+1K181491Delta Dual Mobility SystemLima Corporate S.P.A.20190—
+1K181366REDAPT Porous Acetabular ShellSmith & Nephew, Inc.20181—
+1K171934Birmingham Hip (BH) Dual Mobility InsertSmith & Nephew, Inc.20179—
+1K122244Polarcup Dual Mobility SystemSmith & Nephew, Inc.20125—
+2K253948Momentum Acetabular Cup SystemUnited Orthopedic Corporation20260—
+2K243456ONVOY™ Acetabular SystemGlobus Medical, Inc.20250—
+2K242744Trinity EVO Acetabular ShellCorin U.S.A. Limited20250—
+2K240783Anthology Hip Stems; CPCS Hip Stems; Femoral Heads; R3 Acetabular Liners; Spectron Hip…Smith & Nephew, Inc.20240—
+2K242375OR3O Dual Mobility SystemSmith & Nephew, Inc.20240—
+2K232667OR3O Dual Mobility LinersSmith & Nephew, Inc.20231—
+2K231448TANDEM Hip SystemSmith & Nephew, Inc.202301