Abstract
DePuy Orthopaedics, Inc. (DePuy) has received Premarket Approval (PMA) from the U.S. Food and Drug Administration (FDA) for use of the new AOX ™ Antioxidant Polyethylene material with its SIGMA ® Rotating Platform Knee System and LCS ® COMPLETE ® Mobile Bearing Knee System. DePuy’s market-leading rotating-platform and mobile bearing knee systems and the new antioxidant polyethylene are designed for optimal wear resistance and long-term oxidative stability.
Background
In knee implants, polyethylene is a very strong plastic that is highly durable, but it has the potential to oxidize over time. To help prevent oxidation, AOX Polyethylene utilizes a new antioxidant that stabilizes free radicals without affecting the mechanical properties or strength of the polyethylene. Lab tests show that the AOX material provides high material strength.
“AOX Antioxidant Polyethylene, which was developed by DePuy, represents a next generation polyethylene material that when coupled with the design benefits of rotating platform technology offers function, wear resistance and oxidative stability,” said Andrew Ekdahl, President, DePuy Orthopaedics. “AOX Polyethylene provides surgeons with another advancement from DePuy Orthopaedics to meet the needs of their patients.”
The FDA approval of DePuy’s rotating platform knee systems with AOX Polyethylene was based in part on mechanical, material, biocompatibility and wear testing. It follows CE mark approval which was attained in July 2009.
Source: DePuy Orthopaedics
published: December 13, 2011 in: Approval/Clearance, DePuy, Knee, Orthopaedics, Regulatory, USA