United Orthopedic wins FDA nod for E-XPE hip liner

United Orthopedic Corp said today that it won FDA clearance for its E-XPE vitamin E highly cross-linked polyethylene hip liner. The Irvine, Calif.-based company said that the E-XPE is a next-gen version of its highly cross-linked polyethylene blended with vitamin E intended to improve wear resistance and maintain oxidative stability and mechanical properties. United Orthopedic said that accelerated aging tests showed that its E-XPE inserts and liners exhibited a 60% to 75% reduction in gravimetric wear, respectively. “Oxidation continues to be a concern for surgeons. Over time, wear of conventional polyethylene can generate debris in the joint, triggering local inflammation that results in bone loss which is one of the biggest causes of late-term failure in hip and knee replacements. Clearance of our E-XPETM, a vitamin E highly cross-linked polyethylene, provides surgeons with an alternative implant for their patient. Our vertically integrated manufacturing process affords us the flexibility to design, manufacture and distribute implants or instruments that address many of the most significant needs in the orthopedic industry,” prez Calvin Lin said in a press release. Last May, United Ortho said that it launched a trial of its U2 total knee arthroplasty system and enrolled the 1st patient in the trial. The post United Orthopedic wins FDA nod for E-XPE hip liner appeared first on MassDevice.
Source: Mass Device - Category: Medical Devices Authors: Tags: Food & Drug Administration (FDA) Orthopedics Regulatory/Compliance unitedorthopedic Source Type: news