510(k) Report

Devices descending from K051682

6 later devices reach Exactech 12/14 Alumina Femoral Heads 36 MM through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K103012Exactech Bioloxdelta / Biolox Femoral Heads, 28MM OD, 32MM OD, 36MM OD, Exactech Biolox…Exactech, Inc.20105—
+2K121392Novation Crown Cup Liners; Neutral, Lipped, +5MM Lateralized, +5/10 DegreeExactech, Inc.201347
+3K173583Exactech® Novation® and AcuMatch® E-HXL Acetabular LinersExactech, Inc.201833
+4K182502Alteon Acetabular Cup SystemExactech, Inc.201922
+5K210614BENCOX Mirabo Z Cup CortiniumCorentec Co., Ltd.20221—
+6K223223BENCOX Mirabo Z Cup CortiniumCorentec Co., Ltd.20230—