510(k) Report

Devices descending from K032964

25 later devices reach Exactech 12/14 Alumina Femoral Head; Exactech Acumatch M-Series 12/14 Neck… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K103012Exactech Bioloxdelta / Biolox Femoral Heads, 28MM OD, 32MM OD, 36MM OD, Exactech Biolox…Exactech, Inc.20105—
+1K073337Mectacer Biolox Forte-Femoral HeadsMedacta International S.A.200816—
+1K051858Acumatch M-Series LPB 12/14 Femoral StemExactech, Inc.20050—
+1K050398Exactech Ziramic Zirconia 12/14 Femoral HeadsExactech, Inc.200511
+1K051682Exactech 12/14 Alumina Femoral Heads 36 MMExactech, Inc.20056—
+2K131518Mectacer Biolox Option HeadsMedacta International20130—
+2K121392Novation Crown Cup Liners; Neutral, Lipped, +5MM Lateralized, +5/10 DegreeExactech, Inc.201347
+2K121665Bencox Foret & Bencox DeltaCorentec Co., Ltd.20128—
+2K112115Mectacer Biolox (R) Delta Femoral HeadsMedacta International201114—
+2K060107Modification to: Exactech Ziramic Zirconia 12/14 Femoral HeadsExactech, Inc.200601
+3K260173M-Vizion Femoral Revision System ExtensionMedacta International S.A.20260—
+3K173583Exactech® Novation® and AcuMatch® E-HXL Acetabular LinersExactech, Inc.201833
+3K160895Initia Total Hip System & BIOCERAM AZUL (R) HEADKyocera Medical Corporation20162—
+3K150007Modified Bencox Hip SystemCorentec Co., Ltd.20157—
+3K122783Plasmafit Acetabular Cup and Vitelene InsertAesculap Implant System, Inc.20130—
+4K242045Initia T3 Acetabular Hemispherical Shell SystemKyocera Medical Technologies, Inc.20250—
+4K243444Bioceram Azul® HeadKyocera Corporation20240—
+4K220468BENCOX Mirabo Cup SystemCorentec Co., Ltd.20221—
+4K182502Alteon Acetabular Cup SystemExactech, Inc.201922
+4K172806Bencox Mirabo Cup SystemCorentec Co., Ltd.20174—
+4K162127Bencox M Stem Lateralized & Bencox Mirabo Cup SystemCorentec Co., Ltd.201661
+5K223223BENCOX Mirabo Z Cup CortiniumCorentec Co., Ltd.20230—
+5K210614BENCOX Mirabo Z Cup CortiniumCorentec Co., Ltd.20221—
+5K211866Bencox THR SystemCorentec Co., Ltd.20210—
+5K182221Bencox Mirabo Cup Multi HoleCorentec Co., Ltd.20193—