CoorsTek Medical Announces FDA Clearance for Total Hip System Incorporating Ceramic Components
CoorsTek Medical recently announced that its CeraSurf®-p ceramic femoral heads have been incorporated into a U.S. orthopedic device company’s hip system that has received FDA 510(k) clearance. CoorsTek Medical has developed a range of ceramic femoral heads and acetabular liners in CeraSurf-p material for use in an array of orthopedic implant systems around the world. Surgeons reportedly have been implanting CoorsTek Medical CeraSurf-p hip system components in South America and Europe since the initial ANVISA clearance and CE mark in 2011-2012, and now the availability of these components has expanded to the U.S. market.
“This is a ‘game changer’ for U.S. orthopedic companies as they can now source ceramic hip system components from the leading U.S.-based engineered ceramics manufacturer,” said Jonathan Coors, CEO. “Not only does this provide more choice to the U.S. orthopedic market in terms of quality, technology, and supply chain reliability, but it also enables major medical device OEMs to develop efficiencies that will ultimately help hospitals, surgeons, and patients. The clearance our customer received is the culmination of many years of research, development, testing and qualification at our state-of-the-art manufacturing facility in Colorado. For CoorsTek, it is also a critical next step to support growing demand from our worldwide customer base, following fast on the heels of major capacity expansion in North America, Europe, and Asia.”
For more information, visit www.coorstekmedical.com.