Kyocera Medical has secured 510(k) clearance from the US Food and Drug Administration (FDA) for its Initia total hip system.
The system, which was developed along with US surgeons, features Bioceramazul (blue) zirconia-toughened alumina (ZTA) ceramic femoral heads.
Kyocera is also offering the system with cobalt chrome (CoCr) femoral heads, providing surgeons with an option of ceramic or metal heads corresponded to cross-linked polyethylene acetabular liners.
Initia system is available in 16 tapered-wedge stem sizes with both standard and high femoral offsets. It is available in 12 sizes in the US.
The company will showcase Initia hip system and other Bioceramazul compnenets at the AAOS annual meeting, which will take place from 15 to 17 March.
Since 1982, Kyocera has been manufacturing artificial hips, knees and other implantable systems.
The company, which is one of Japan’s leading suppliers of surgical orthopedic products, also produces a range of implantable ceramic components.
Its ceramic component products such as alumina and ZTA ceramic femoral heads, hip liners and shoulder liners are used by the original equipment manufacturers (OEMs) in the US and Europe.
Kyocera is specialized in combining ceramic engineered materials with other technologies to create medical orthopedic implants and implantable ceramic components, ceramic cutlery and cookware.
Other products created include cutting tools, industrial components, electronic devices, semiconductor packages, solar power generating systems, printers, copiers and mobile phones.