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Zimmer receives FDA approval to market new mobile bearing knee prosthesis
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The approval brings only the second mobile bearing TKA device to the United
States market.
1st on the web (December 12, 2007)
December 2007
WARSAW, Ind. � The U.S. Food and Drug Administration has approved Zimmer's
premarket approval application for its NexGen LPS-Flex Mobile Knee, the company
announced in a press release.
The NexGen LPS-Flex Mobile Knee prosthesis features a polyethylene articulating
surface that allows for slight rotation in concert with the patient's natural
movement. When used with Zimmer's LPS-Flex femoral component, the device is
designed to safely accommodate active deep flexion of up to 155? in patients who
are capable of such flexion, the release said.
The NexGen LPS-Flex Mobile Knee prosthesis can be used in minimally invasive
total knee arthroplasty (TKA) procedures and is compatible with the company's
Minimally Invasive Solutions Systems and Technologies knee replacement
instrumentation, the release said.
"A number of orthopedic 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, in the release.
"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 United States where
the majority of the world's knee replacement procedures are performed," she
said.
Zimmer expects to begin releasing the device on a limited basis in January, with
general availability in the U.S. by the middle of 2008, the release said.
For more information:
Zimmer, Web site: www.zimmer.com
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