510(k) Report

Devices descending from K061564

19 later devices reach Portland Ceramic (Biolox-Forte) Femoral Head through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K070928Ceramic Ball Heads, 28, 32 and 36 MMPlus Orthopedics AG200718—
+2K123598Smith & Nephew, Inc. Hip System InstrumentationSmith & Nephew, Inc.201302
+2K073337Mectacer Biolox Forte-Femoral HeadsMedacta International S.A.200816—
+3K131518Mectacer Biolox Option HeadsMedacta International20130—
+3K121665Bencox Foret & Bencox DeltaCorentec Co., Ltd.20128—
+3K112115Mectacer Biolox (R) Delta Femoral HeadsMedacta International201114—
+4K260173M-Vizion Femoral Revision System ExtensionMedacta International S.A.20260—
+4K160895Initia Total Hip System & BIOCERAM AZUL (R) HEADKyocera Medical Corporation20162—
+4K150007Modified Bencox Hip SystemCorentec Co., Ltd.20157—
+4K122783Plasmafit Acetabular Cup and Vitelene InsertAesculap Implant System, Inc.20130—
+5K242045Initia T3 Acetabular Hemispherical Shell SystemKyocera Medical Technologies, Inc.20250—
+5K243444Bioceram Azul® HeadKyocera Corporation20240—
+5K220468BENCOX Mirabo Cup SystemCorentec Co., Ltd.20221—
+5K172806Bencox Mirabo Cup SystemCorentec Co., Ltd.20174—
+5K162127Bencox M Stem Lateralized & Bencox Mirabo Cup SystemCorentec Co., Ltd.201661
+6K223223BENCOX Mirabo Z Cup CortiniumCorentec Co., Ltd.20230—
+6K210614BENCOX Mirabo Z Cup CortiniumCorentec Co., Ltd.20221—
+6K211866Bencox THR SystemCorentec Co., Ltd.20210—
+6K182221Bencox Mirabo Cup Multi HoleCorentec Co., Ltd.20193—