FDA approves hip implant using CoorsTek ceramic

The US Food and Drug Administration (FDA) has approved hip replacement implants that use ceramic made by CoorsTek Medical

CoorsTek Medical’s CeraSurf-p ceramic femoral heads have been incorporated into a US orthopaedic device company’s hip system that has received FDA 510(k) clearance.

The implant’s femoral head — the ball that fits into a patient’s hip socket — is made using a special zirconia-hardened ceramic CoorsTek Medical developed in Grand Junction, reported the Denver Business Journal.

CoorsTek Medical said it has developed a range of ceramic femoral heads and acetabular liners in CeraSurf-p material for use in an array of orthopaedic implant systems.

Jonathan Coors, CEO of CoorsTek Medical, said: “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.

“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.”