510(k) Report

Devices descending from K013658

3 later devices reach Modification to Reflection Cross-Linked Uhmwpe Acetabular Components through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K160895Initia Total Hip System & BIOCERAM AZUL (R) HEADKyocera Medical Corporation20162—
+2K242045Initia T3 Acetabular Hemispherical Shell SystemKyocera Medical Technologies, Inc.20250—
+2K243444Bioceram Azul® HeadKyocera Corporation20240—