StelKast Receives FDA Clearance of New Knee System Component

StelKast received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market EXp for the Proven Gen-Flex total knee system.

EXp is a blend of the antioxidant vitamin E (a-tocopherol) and a highly cross-linked polyethylene technology for long-term oxidative stability that preserves mechanical properties to ensure lasting implant performance, according to StelKast, which claims it was the first company to introduce this technology in the United States in 2011 as an alternate bearing material in hip replacements.

“Incorporating our unique EXp polyethylene technology with our Proven Gen-Flex total knee system allows our knee patients to benefit from the extraordinary success currently offered by our hip products,” said John Reyher, senior vice president and general manager of StelKast. “EXp will further enhance the durability of our knee devices providing orthopedic surgeons with more advanced, cost-effective solutions for their patients.”

EXp will be available on the Proven Gen-Flex for both cruciate retaining and posterior stabilized knee systems.

McMurray, Pa.-based StelKast specializes in hip and knee implant systems.