KYOCERA Medical Receives FDA 510(k) Clearance for Initia Total Hip

By Julie A. Vetalice

Kyocera Medical received FDA 510(k) clearance for the Initia® Total Hip System, designed for use with BIOCERAM AZUL® zirconia-toughened alumina ceramic or cobalt chrome femoral heads. Initia includes 16 tapered-wedge stem sizes, 12 of which are available in the U.S., with standard and high femoral offsets.

BIOCERAM AZUL ceramic material is also available to medical device OEMs for us in implantable components. (For instance, Amedica is partnered with Kyocera for the manufacture of spinal interbody devices.)

Sources: Kyocera Medical Corporation; ORTHOWORLD Inc.

Product Labels: Hip Replacement

Tags: 510(k) Clearance, Regulatory