A Medical Device Daily

Zimmer Holdings (Warsaw, Indiana) reported that its pre-market approval (PMA) application for the Zimmer NexGen LPS-Flex Mobile Knee has been granted by the FDA.

“A number of orthopaedic surgeons prefer mobile bearing designs and we are pleased to be one of only two companies that can offer this treatment option in the U.S.,” said Sheryl Conley, Zimmer chief marketing officer. “Since its launch in Europe in 1999, this product has been well received in Australia and Japan, as well as in Europe. We look forward to being able to provide the mobile bearing option to surgeons here in the U.S., where the majority of the world’s knee-replacement procedures are performed.”

Zimmer said a key strength of its mobile bearing system is its ability to be used in a minimally invasive procedure.

The main difference between a traditional knee-replacement design and a mobile bearing knee is that the polyethylene articulating surface is free to rotate slightly along with the patient’s natural movement. When used with the LPS-Flex femoral component, the knee replacement is designed to safely accommodate active deep flexion of up to 155 degrees for patients who are otherwise capable of that level of flexion.

Many activities of daily living require this range of motion, such as climbing stairs (75 to 140 degrees), sitting in a chair and standing up again (90 to 130 degrees), and squatting (130 to 150 degrees). Generally, knee implants were designed to accommodate flexion of only 120 degrees.

Zimmer officials said they expect to begin the limited release of the LPS-Flex Mobile knee in January, with general availability in the U.S. in mid-2008. /P>