510(k) Report

Devices descending from K012918

7 later devices reach Apex Modular Alumina Femoral Head through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K171156OMNI Anseris Hip StemOmnilife Science20170—
+1K101451Apex Module Hip System Biolox Delta Femoral HeadOmni Life Science, Inc.20104—
+1K042035Alumina HeadFournitures Hospitalieres Industrie20041—
+2K201657Corin Ltd. Hip Products: Trinity™ Acetabular System, Trinity™ PLUS Acetabular Shell…Corin, Ltd.20212—
+2K050556Alumina HeadFournitures Hospitalieres Industrie20050—
+3K241472Icona Hip StemCorin U.S.A. Limited20241—
+4K261576Icona Hip StemCorin, Ltd.20260—