Zimmer mobile bearing knee
This article was originally published in The Gray Sheet
Executive Summary
Orthopedic implant maker gains PMA approval for its NexGen LPS-Flex mobile bearing knee Dec. 10, setting the stage for a limited market release in January. The device should be available throughout the United States by mid-2008, according to the company. Johnson & Johnson/DePuy is the only other firm to have received PMA approval for mobile bearing knees. In contrast to traditional artificial knees, the polyethylene articulating surface of mobile bearing knees is "free to rotate slightly along with the patient's natural movement," Zimmer explains. LPS-Flex facilitates minimally invasive placement and "when used with the LPS-Flex femoral component ... is designed to safely accommodate active deep flexion of up to 155 degrees." FDA notes that Zimmer will conduct a 10-year postapproval study to evaluate long-term safety and effectiveness