510(k) Report

Devices descending from K931617

26 later devices reach Exactech Ziramic Femoral Head Component through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K032964Exactech 12/14 Alumina Femoral Head; Exactech Acumatch M-Series 12/14 Neck SegmentsExactech, Inc.2003251
+2K103012Exactech Bioloxdelta / Biolox Femoral Heads, 28MM OD, 32MM OD, 36MM OD, Exactech Biolox…Exactech, Inc.20105—
+2K073337Mectacer Biolox Forte-Femoral HeadsMedacta International S.A.200816—
+2K051858Acumatch M-Series LPB 12/14 Femoral StemExactech, Inc.20050—
+2K050398Exactech Ziramic Zirconia 12/14 Femoral HeadsExactech, Inc.200511
+2K051682Exactech 12/14 Alumina Femoral Heads 36 MMExactech, Inc.20056—
+3K131518Mectacer Biolox Option HeadsMedacta International20130—
+3K121392Novation Crown Cup Liners; Neutral, Lipped, +5MM Lateralized, +5/10 DegreeExactech, Inc.201347
+3K121665Bencox Foret & Bencox DeltaCorentec Co., Ltd.20128—
+3K112115Mectacer Biolox (R) Delta Femoral HeadsMedacta International201114—
+3K060107Modification to: Exactech Ziramic Zirconia 12/14 Femoral HeadsExactech, Inc.200601
+4K260173M-Vizion Femoral Revision System ExtensionMedacta International S.A.20260—
+4K173583Exactech® Novation® and AcuMatch® E-HXL Acetabular LinersExactech, Inc.201833
+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—
+5K182502Alteon Acetabular Cup SystemExactech, Inc.201922
+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—