Implantable medical systems maker Kyocera Medical said today it won FDA 510(k) clearance for its Initia total hip implant system.
The Japanese company’s Initia total hip system includes Bioceram Azul zirconia-toughened alumina ceramic femoral heads, or can be requested with cobalt chrome femoral heads.
The system includes a total 16 tapered-wedge stem sizes, with 12 available in the US, according to a press release.
In late 2013, Amedica Corp. entered into an agreement with Kyocera to manufacture Amedica’s silicon nitride biomaterial at Kyocera’s Vancouver, Wash., facility.
The FDA-cleared silicon nitride has the potential to promote bone growth defend against infection. Devices made from silicon nitride are semi-radiolucent with clearly visible boundaries, enabling an exact view of intra-operative placement and postoperative fusion assessment via common imaging modalities, according to a press release.
The deal is expected to help Amedica meet demand for the technology, including spinal interbody devices. Amedica has sold over 14,000 of these devices worldwide, according to a company statement.
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