510(k) Report

Devices descending from K110947

6 later devices reach Apex K1 Hip Stem through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K201657Corin Ltd. Hip Products: Trinity™ Acetabular System, Trinity™ PLUS Acetabular Shell…Corin, Ltd.20212—
+1K133381Omni Arc Monoblock Hip StemOmnilife Science20142—
+2K241472Icona Hip StemCorin U.S.A. Limited20241—
+2K172467OMNI ARC Anteverted Neck Hip StemOmnilife Science20170—
+2K171156OMNI Anseris Hip StemOmnilife Science20170—
+3K261576Icona Hip StemCorin, Ltd.20260—