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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceZIMMER NEXGEN 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
PMA NumberP060037
Supplement NumberS007
Date Received11/25/2008
Decision Date01/23/2009
Product Code NJL 
Advisory Committee Orthopedic
Supplement TypeReal-Time Process
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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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