U.S. FDA clearance for Polyethylene knee insert with reduced risk of oxidation

13-Apr-17

The U.S. Food and Drug Administration (FDA) has cleared an E-XPE™ polyethylene knee insert by United Orthopedic Corporation (UOC), a leading international designer, manufacturer and distributor of innovative orthopedic implants and instruments. The knee insert is designed to provide patients with knee replacements with reduced risk of oxidation.
"Clearance of our E-XPE™ polyethylene knee insert represents an important milestone in our knee portfolio," said Calvin Lin, President of United Orthopedic Corporation USA. "Oxidation continues to be a concern for surgeons. The E-XPE™ polyethylene is resistant to oxidation and performs extremely well with respect to abrasive wear resistance."

The E-XPE™ is the new generation of highly cross-linked polyethylene blended with 0.1 percent (w/w) vitamin E to enhance wear resistance without compromising oxidative stability and mechanical properties. UOC's vertically integrated manufacturing process is unique, enabling the company to control the production cycle of their implants, from initial design to distribution in each of its manufacturing facilities. By doing so, UOC is capable of ensuring a stable, quality product supply and a remarkable level of customization to meet the needs of patients.