510(k) Report

Devices descending from K221636

7 later devices reach EMPHASYS Acetabular System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K253948Momentum Acetabular Cup SystemUnited Orthopedic Corporation20260—
+1K243977EMPHASYS Acetabular SystemDepuy Ireland UC20251—
+1K242084EMPHASYS Acetabular Shell with RapiTite HADepuy Ireland UC20240—
+1K231873DePuy SUMMIT Porocoat Hip Prosthesis – MR Conditional, DePuy SUMMIT DuoFix Hip…Depuy Ireland UC20245—
+2K252067Velora Acetabular SystemRestor3D, Inc.20250—
+2K251292RECLAIM Monobloc Revision Femoral StemDepuy Ireland UC20251—
+3K260173M-Vizion Femoral Revision System ExtensionMedacta International S.A.20260—