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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 
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