CoorsTek Announces FDA 510(k) Clearance for Total Hip System Incorporating CeraSurf®-p Implantable Ceramic Components
March 01 2016
US orthopaedic company utilizes ceramics from the world’s largest engineered ceramic manufacturer in obtaining FDA clearance
“This is a ‘game changer’ for US orthopaedic companies as they can now source ceramic hip system components from the leading US-based engineered ceramics manufacturer."
- Jonathan Coors, co-CEO
Fort Worth, Texas, USA — CoorsTek Bioceramics, a leading US manufacturer of advanced implantable ceramic components, today announced that its CeraSurf®-p ceramic femoral heads have been incorporated into a US orthopaedic device company’s hip system that has received FDA 510(k) clearance.
CoorsTek Bioceramics has developed a range of ceramic femoral heads and acetabular liners in CeraSurf-p material for use in an array of orthopaedic implant systems around the world. Surgeons 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 US market.
Jonathan Coors, co-CEO of CoorsTek explains, “This is a ‘game changer’ for US orthopaedic companies as they can now source ceramic hip system components from the leading US-based engineered ceramics manufacturer. Not only does this provide more choice to the US orthopaedic 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,” adds Mr. Coors.
“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,” added Coors. “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.”
About CoorsTek CoorsTek makes the world measurably better as the partner of choice for technology and manufacturing companies worldwide whose success requires the unique, high-performance properties of products manufactured from engineered ceramics and advanced materials. CoorsTek products and components touch people’s lives through amazing solutions to global challenges in energy, transportation, information technology, healthcare, and defense, among others.
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