FDA Clearance for UOC’s E-XPE Knee Insert

By Julie A. Vetalice

United Orthopedic Corporation (UOC) received FDA 510(k) clearance to market the E-XPE™ polyethylene knee insert.

The device comprises highly cross-linked polyethylene + 0.1% vitamin E, and is designed to enhance wear resistance without compromising oxidative stability and mechanical properties. The clearance addresses E-XPE tibial inserts (CR, PS, UC and PSA type) and the E-XPE patella, and is an extension of the UNITED/U2 Total Knee.

Headquartered in Taiwan, UOC received its first FDA clearance—for the U1 Hip System—at the end of 2000. In 2014, UOC USA was established to regionally market the company's cost-effective hip and knee arthroplasty implants and instruments. In 1Q16, UOC launched a U.S. follow-up study of its U-Motion II+ Acetabular System and UTF Reduced Stem in primary total hip arthroplasty patients. Estimated primary completion for that study is January 2019.

Sources: United Orthopedic Corporation; clinicaltrials.gov; FDA.gov; ORTHOWORLD Inc.

 

Product Labels: Knee Replacement

Tags: 510(k) Clearance, Regulatory