510(k) Report

Devices descending from K112115

14 later devices reach Mectacer Biolox (R) Delta Femoral Heads through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K260173M-Vizion Femoral Revision System ExtensionMedacta International S.A.20260—
+1K160895Initia Total Hip System & BIOCERAM AZUL (R) HEADKyocera Medical Corporation20162—
+1K150007Modified Bencox Hip SystemCorentec Co., Ltd.20157—
+1K131518Mectacer Biolox Option HeadsMedacta International20130—
+1K122783Plasmafit Acetabular Cup and Vitelene InsertAesculap Implant System, Inc.20130—
+2K242045Initia T3 Acetabular Hemispherical Shell SystemKyocera Medical Technologies, Inc.20250—
+2K243444Bioceram Azul® HeadKyocera Corporation20240—
+2K220468BENCOX Mirabo Cup SystemCorentec Co., Ltd.20221—
+2K172806Bencox Mirabo Cup SystemCorentec Co., Ltd.20174—
+2K162127Bencox M Stem Lateralized & Bencox Mirabo Cup SystemCorentec Co., Ltd.201661
+3K223223BENCOX Mirabo Z Cup CortiniumCorentec Co., Ltd.20230—
+3K210614BENCOX Mirabo Z Cup CortiniumCorentec Co., Ltd.20221—
+3K211866Bencox THR SystemCorentec Co., Ltd.20210—
+3K182221Bencox Mirabo Cup Multi HoleCorentec Co., Ltd.20193—