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CoorsTek Medical Announces FDA 510(k) Clearance for Total Hip Incorporating CeraSurf-p Implantable Ceramic

CoorsTek Medical, a U.S. manufacturer of implantable ceramic components, announced that its CeraSurf®-p ceramic femoral heads have been incorporated into a U.S. orthopaedic device customer's hip system that has received FDA 510(k) clearance.

CeraSurf-p hip system components have been available in South America and Europe since ANVISA clearance and CE Mark in 2011-2012.

Source: CoorsTek Medical

 

In 3Q15, CoorsTek announced a 5-year, multi-million dollar capital investment program to support a 20-fold production expansion of products that employ CeraSurf medical-grade ceramics.

The company is featuring its CeraSurf-p implantable components at the 2016 AAOS Annual Meeting.