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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/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceNEXGEN LPS-FLEX MOBILE AND LPS-MOBILE BEARING KNEE SYSTEM
Generic NameProsthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
ApplicantZIMMER, INC.
P.O. Box 708
Warsaw, IN 46581-0708
PMA NumberP060037
Date Received12/18/2006
Decision Date12/10/2007
Product Code NJL 
Docket Number 08M-0522
Notice Date 09/26/2008
Advisory Committee Orthopedic
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH 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 OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
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 S031 S032 S033 S034 S035 S036 S037 
S038 S039 S040 S041 S042 S043 S044 S045 S046 S047 S048 S049 
S050 S051 S052 S053 S054 S055 S056 S057 S058 S059 S060 S061 
S062 S063 S064 S065 S066 S067 S068 S069 S070 S071 S072 S073 
S074 S075 S076 S077 S078 S079 S080 S081 S082 S083 S084 S085 
S086 S087 S088 S089 S090 S091 
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