510(k) Report

Devices descending from K181744

10 later devices reach BI-MENTUM dual mobility system through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K231522EMPHASYS™ Dual Mobility SystemDepuy Ireland UC20240—
+1K223745Novae® Dual Mobility System, Hype® Hip SystemSerf20231—
+1K203532BI-MENTUM™ ALTRX® Dual Mobility LinerDepuy Ireland UC20216—
+2K250989Stryker and Serf hip devicesHowmedica Osteonics Corp (Dba Stryker Orthopaedics)20250—
+2K231873DePuy SUMMIT Porocoat Hip Prosthesis – MR Conditional, DePuy SUMMIT DuoFix Hip…Depuy Ireland UC20245—
+3K251292RECLAIM Monobloc Revision Femoral StemDepuy Ireland UC20251—
+3K243977EMPHASYS Acetabular SystemDepuy Ireland UC20251—
+3K242084EMPHASYS Acetabular Shell with RapiTite HADepuy Ireland UC20240—
+4K260173M-Vizion Femoral Revision System ExtensionMedacta International S.A.20260—
+4K252067Velora Acetabular SystemRestor3D, Inc.20250—