510(k) Report

Devices descending from K033893

8 later devices reach Spectrum Modular System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K102080Depuy Reclaim Revision Hip SystemDepuy (Ireland)201073
+2K260173M-Vizion Femoral Revision System ExtensionMedacta International S.A.20260—
+2K231873DePuy SUMMIT Porocoat Hip Prosthesis – MR Conditional, DePuy SUMMIT DuoFix Hip…Depuy Ireland UC20245—
+2K221462DePuy Reclaim Monobloc Revision Femoral StemDepuy Ireland UC20226—
+3K251292RECLAIM Monobloc Revision Femoral StemDepuy Ireland UC20251—
+3K243977EMPHASYS Acetabular SystemDepuy Ireland UC20251—
+3K242084EMPHASYS Acetabular Shell with RapiTite HADepuy Ireland UC20240—
+4K252067Velora Acetabular SystemRestor3D, Inc.20250—