CoorsTek Medical03.02.16
CoorsTek Medical has announced that its CeraSurf-p ceramic femoral heads have been incorporated into an American orthopedic device company's hip system that recently received U.S. Food and Drug Administration 510(k) clearance.
CoorsTek Medical has developed a range of ceramic femoral heads and acetabular liners in CeraSurf-p material for use in various orthopedic implant systems worldwide. Surgeons have been implanting CeraSurf-p hip system components in South America and Europe since the initial ANVISA clearance and CE Mark in 2011-2012.
"This is a game-changer for U.S. orthopedic companies as they can now source ceramic hip system components from a U.S.-based engineered ceramics manufacturer," CoorsTek CEO Jonathan Coors said. "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 which will ultimately help hospitals, surgeons, and patients."
CoorsTek did not name the company that incorporated the CeraSurf-p system into his artificial hip portfolio.
"The clearance our customer received is the culmination of many years of research, development, testing, and qualification at our manufacturing facility in Colorado," Coors added. "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."
Based in Fort Worth, Texas, CoorsTek Medical develops and manufactures advanced implantable ceramic components.
CoorsTek Medical has developed a range of ceramic femoral heads and acetabular liners in CeraSurf-p material for use in various orthopedic implant systems worldwide. Surgeons have been implanting CeraSurf-p hip system components in South America and Europe since the initial ANVISA clearance and CE Mark in 2011-2012.
"This is a game-changer for U.S. orthopedic companies as they can now source ceramic hip system components from a U.S.-based engineered ceramics manufacturer," CoorsTek CEO Jonathan Coors said. "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 which will ultimately help hospitals, surgeons, and patients."
CoorsTek did not name the company that incorporated the CeraSurf-p system into his artificial hip portfolio.
"The clearance our customer received is the culmination of many years of research, development, testing, and qualification at our manufacturing facility in Colorado," Coors added. "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."
Based in Fort Worth, Texas, CoorsTek Medical develops and manufactures advanced implantable ceramic components.