StelKast Receives FDA Clearance of EXp™ for Proven Gen-Flex™ Total Knee System
MCMURRAY, Pa.--(BUSINESS WIRE)
StelKast, designer, manufacturer and distributor of a full line of quality orthopedic implants for knee and hip replacement, today announced that it has 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. StelKast was the first company to introduce this technology in the U.S. as an alternate bearing material in hip replacements in 2011.
"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, Sr. 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."
StelKast's Proven Gen-Flex Total Knee System is a long-term quality solution based on clinically proven designs that provide the flexibility required to address patient needs. EXp will be available on the Proven Gen-Flex for both cruciate retaining and posterior stabilized knee systems. Full commercial launch of the EXp knee products is planned for September 2013.