510(k) Report

Devices descending from K961732

15 later devices reach KAR through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K093736Depuy Corail Hip System, Revision StemDePuy Orthopaedics, Inc.201114—
+2K231873DePuy SUMMIT Porocoat Hip Prosthesis – MR Conditional, DePuy SUMMIT DuoFix Hip…Depuy Ireland UC20245—
+2K213839DePuy Corail AMT Hip ProsthesisDePuy Orthopaedics, Inc.20220—
+2K203167DePuy Corail AMT Hip ProsthesisDePuy Orthopaedics, Inc.20202—
+2K192946DePuy Corail AMT Hip ProsthesisDePuy Orthopaedics, Inc.201910—
+2K171249Entrada™ hip stemOrtho Development Corporation20172—
+3K251292RECLAIM Monobloc Revision Femoral StemDepuy Ireland UC20251—
+3K243977EMPHASYS Acetabular SystemDepuy Ireland UC20251—
+3K242084EMPHASYS Acetabular Shell with RapiTite HADepuy Ireland UC20240—
+3K233758Trivicta™ Hip StemOrtho Development Corp.20241—
+3K233233EMPHASYS Femoral StemsDepuy Ireland UC20230—
+3K211657EMPHASYS Femoral StemsDepuy Ireland UC20217—
+4K260173M-Vizion Femoral Revision System ExtensionMedacta International S.A.20260—
+4K252067Velora Acetabular SystemRestor3D, Inc.20250—
+4K251052Trivicta® Hip StemOrtho Development Corp.20250—