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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NameNEXGEN LPS-FLEX MOBILE AND LPS-MOBILE BEARING KNEE SYSTEM
Classification Nameprosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
ApplicantZIMMER, INC.
PMA NumberP060037
Date Received12/18/2006
Decision Date12/10/2007
Product Code
NJL[ Registered Establishments with NJL ]
Docket Number 08M-0522
Notice Date 09/26/2008
Advisory Committee Orthopedic
Expedited Review Granted? No
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
Recalls CDRH Recalls
Approval Order Statement 
Approval for the zimmer nexgen lps-flex mobile and lps-mobile bearing knees. These devices are indicated for patients with severe knee pain and disability due to osteoarthritis; primary and secondary traumatic arthritis; avascular necrosis of the femoral condyle; or moderate valgus, varus, or flexion deformities (i. E. , valgus/varus deformity of <=15 degrees, fixed flexion deformity of <=10 degrees). This device is intended for cemented use only.
Approval Order Approval Order
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S001 S003 S004 S005 S006 S007 S008 S009 S010 
S011 S012 S013 S014 S015 S016 S017 S018 S019 
S020 S021 S022 S023 S024 S026 S027 S028 S029 
S030 S032 S033 S034 S035 
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