Kyocera Medical Corporation, a Japanese manufacturer of implantable systems and advanced ceramic components, has received the U.S. Food and Drug Administration’s 510(k) clearance for its Initia Total Hip System.
U.S. surgeons collaborated with Kyocera to develop the Initia Total Hip System which makes use of the company’s core technology. That technology is BIOCERAM AZUL® zirconia-toughened alumina ceramic femoral heads. Initia is also available with cobalt chrome femoral heads, giving surgeons the option of ceramic or metal heads matched to highly cross-linked polyethylene acetabular liners.
The product is designed for distribution to a global population. The initial system includes a total of 16 tapered wedge stem sizes, 12 of which are available in the U.S. with both standard and high femoral offsets.
In addition to the Initia Total Hip System, Kyocera Medical makes its BIOCERAM AZUL ceramic material available to medical device original equipment manufacturers who demand a durable, high-quality, biocompatible solution for implantable components.
Kyocera International, Inc., headquartered in San Diego, California, serves as the U.S. sales and marketing arm for Kyocera Medical Corporation. Both companies are wholly owned subsidiaries of Kyoto, a Japan-based Kyocera Corporation.
Does the Initia total hip system use an Aquala acetabular liner? And can you please give me the names of hospitals or orthopedic surgeons in the U.S. who are using the Initia system? Thank you.
Shigeru Satake, manager of global business development section, medical division, at Kyocera, told OTW,“We plan to expand the technology to the U.S. market as well as displaying it at the AAOS [American Academy of Orthopaedic Surgeons] to be held during next spring.”
JULY 16h,2018
Will you give me the hospital name and doctor who use system for surgeries