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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameZIMMER NEXGEN LPS-FLEX MOBILE AND LPS-MOBILE BEARING KNEE SYSTEM
Classification Nameprosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
ApplicantZIMMER, INC.
PMA NumberP060037
Supplement NumberS007
Date Received11/25/2008
Decision Date01/23/2009
Product Code
NJL[ Registered Establishments with NJL ]
Advisory Committee Orthopedic
Supplement Typereal-time process
Supplement Reason labeling change - instructions
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a modification to the approved surgical technique to add an optional technique for making the femoral bone cuts for the lps-flex mobile femoral component. The device, as modified, will be marketed under the trade name zimmer nexgen lps-flex mobile and lps-mobile bearing knee systems and is indicated for patients with severe knee pain and disability due to osteoarthritis, primary and secondary traumatic arthritis, avascular necrosis of the femoral condyle, and moderate valgus, varus, or flexion deformities (i. E. , valgus/varus deformity of <=15 degrees, fixed flexion deformity of <=10 degrees).
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