CoorsTek Medical Announces FDA 510(k) Clearance for Total Hip System Incorporating CeraSurf®-p Implantable Ceramic Components
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US orthopaedic company utilizes ceramics from the world’s largest engineered ceramic
manufacturer in obtaining FDA clearance
Fort Worth, Texas, USA, March 1, 2016
CoorsTek Medical, 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 Medical 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, CEO of CoorsTek Medical 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.”
CoorsTek Medical is featuring its advanced CeraSurf-p implantable components in the
Technical Exhibits at this week’s 2016 AAOS Annual Meeting – Booth #961 – March 2-4.
About CoorsTek Medical
CoorsTek Medical offers the specialized knowledge, experience, world-class infrastructure, and
proven processes required to get medical device innovations to market quickly and
successfully. By working together with our partners in the medical device community, we are
making lives measurably better each and every day. For more information, please visit
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. For more information about CoorsTek, including product information, its history since
1910, and locations throughout Europe, North America, South America, and Asia, visit
Dane Bartlett | CoorsTek
+1 303 271 7000
Bill Fallon | keating/co
+1 973 768 6764