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New Device Approval

(Image fo the device)Zimmer NexGen® LPS-Flex Mobile and LPS-Mobile Bearing Knees - P060037

This is a brief overview of information related to FDA’s approval to market this product. See the links below to the Summary of Safety and Effectiveness Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for FDA’s approval.

Product Name: NexGen® LPS-Flex Mobile Bearing and LPS-Mobile Bearing Knees
PMA Applicant: Zimmer, Inc.
Address: P.O. Box 708, 1800 West Center Street, Warsaw, Indiana 46581
Approval Date: December 10, 2007
Approval Letter:

What is it? The NexGen ® LPS-Flex Mobile Bearing Knee and LPS-Mobile Bearing Knee are artificial mobile bearing knee systems that are designed to replace the knee joint. The systems have three parts:

The plastic bearing slides (rotates) in between the tibial tray and femoral component, which allows this artificial knee joint to move.

When is it used? A doctor uses these devices in a patient who needs a total knee replacement due to osteoarthritis; primary or secondary traumatic arthritis; avascular necrosis of the femoral condyle; or a moderate varus, valgus or flexion deformity of the knee. Examples of these include, respectively:

What will it accomplish? The NexGen ® LPS-Flex Mobile Bearing Knee and LPS-Mobile Bearing Knee will:

When shouldn't it be used? A doctor should not use the NexGen ® LPS-Flex Mobile Bearing Knee or LPS-Mobile Bearing Knee in a patient who has:

Additional information: The Summary of Safety and Effectiveness and labeling will be available at:

Zimmer web site:

National Institutes of Health (NIH) information on osteoarthritis:

NIH information on avascular necrosis:

NIH information on knee injuries and disorders:

NIH illustrated anatomy of the knee:

Updated December 12, 2007

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