510(k) Report

Devices descending from K100151

4 later devices reach Apex Hip System Bipolar Head, Model H3-822XX (OD 38 to 43MM), H3-828XX (OD44… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K201657Corin Ltd. Hip Products: Trinity™ Acetabular System, Trinity™ PLUS Acetabular Shell…Corin, Ltd.20212—
+1K171156OMNI Anseris Hip StemOmnilife Science20170—
+2K241472Icona Hip StemCorin U.S.A. Limited20241—
+3K261576Icona Hip StemCorin, Ltd.20260—