• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Premarket Approval (PMA)

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
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
Applicant
ZIMMER, 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 Product No
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
Summary Summary of Safety and Effectiveness
Labeling Labeling
Post-Approval StudyShow Report Schedule and Study Progress
Supplements:  S045 S048 S046 S049 S044 S011 S008 S001 
S033 S023 S016 S039 S035 S022 S015 S034 S037 
S029 S042 S041 S040 S018 S047 S010 S007 S003 
S009 S013 S006 S005 S012 S004 S024 S043 S020 
S030 S028 S032 S027 S017 S038 S019 S036 S031 
S026 S021 S014 S070 S065 S066 S062 S068 S067 
S064 S057 S061 S060 S055 S056 S051 S053 S054 
S050 S052 S059 S063 S069 S058 
-
-