KYOCERA Medical Corp. Receives FDA 510(k) Clearance for Initia® Total Hip System, Featuring BIOCERAM AZUL® Ceramic Femoral ...
December 05 2016 - 08:05AM
Business Wire
Kyocera Medical Corporation, a leading manufacturer of
implantable systems and advanced ceramic components, today
announced it has received the U.S. Food and Drug Administration’s
510(k) clearance for its Initia® Total Hip System.
Developed in collaboration with leading U.S. surgeons, the
Initia Total Hip System features Kyocera Medical Corporation’s core
technologies — including its own BIOCERAM AZUL® (blue)
zirconia-toughened alumina (ZTA) ceramic femoral heads. Initia is
also available with cobalt chrome (CoCr) femoral heads, giving
surgeons the option of ceramic or metal heads matched to highly
cross-linked polyethylene acetabular liners. Designed for a global
patient population, the Initia 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.
Kyocera has manufactured artificial hips, knees and other
implantable systems since 1982, and is now one of Japan’s leading
suppliers of surgical orthopedic products. Kyocera also
manufactures a wide range of implantable ceramic components,
including alumina and ZTA ceramic femoral heads, hip liners and
shoulder liners, available to original equipment manufacturers
(OEMs) in the U.S. and Europe.
In addition to the Initia Total Hip System, Kyocera Medical
Corporation’s BIOCERAM AZUL ceramic material is available to
medical device OEMs who demand a durable, high-quality,
biocompatible solution for implantable components.
The Initia Hip System, along with BIOCERAM AZUL components, will
be the highlight of Kyocera Medical Corporation’s technology
presentation at the AAOS Annual Meeting, March 15-17, 2017 – booth
#4908.
ABOUT KYOCERA
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, Japan-based Kyocera Corporation.
Kyocera Medical Corporation, headquartered in Osaka,
Japan, is a producer of ceramic and metal orthopedic systems and
components, dental systems and components, and cardiovascular
devices.
Kyocera Corporation (NYSE:KYO) (TOKYO: 6971), the
parent and global headquarters of the Kyocera Group, was founded in
1959 as a producer of fine ceramics (also known as “advanced
ceramics”). Kyocera specializes in combining these engineered
materials with other technologies to create medical orthopedic
implants and implantable ceramic components, ceramic cutlery and
cookware, cutting tools, industrial components, electronic devices,
semiconductor packages, solar power generating systems, printers,
copiers and mobile phones. During the year ended March 31, 2016,
Kyocera Corporation’s consolidated net sales totaled
$13.1 billion.
© 2016 KYOCERA Corporation. All rights reserved. Kyocera is a
registered trademark of Kyocera Corporation. Initia and BIOCERAM
AZUL are registered trademarks of Kyocera Medical Corporation. All
other marks are properties of their respective owners.
Photos available by request.
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version on businesswire.com: http://www.businesswire.com/news/home/20161205005416/en/
Kyocera Medical CorporationKen Kaneko, (908)
227-4376Ken.Kaneko@kyocera.com
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