510(k) Report

Devices descending from K160895

2 later devices reach Initia Total Hip System & BIOCERAM AZUL (R) HEAD through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K242045Initia T3 Acetabular Hemispherical Shell SystemKyocera Medical Technologies, Inc.20250—
+1K243444Bioceram Azul® HeadKyocera Corporation20240—