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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.
 
DeviceNEXGEN COMPLETE KNEE SOLUTION
Generic NameProsthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
ApplicantZIMMER, INC.
P.O. Box 708
Warsaw, IN 46581-0708
PMA NumberP060037
Supplement NumberS005
Date Received09/29/2008
Decision Date03/26/2009
Product Code NJL 
Advisory Committee Orthopedic
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR CHANGES TO THE NEXGEN FLUTED STEM MOBILE TIBIAL COMPONENT,RESULTING IN THE NEXGEN MINIMALLY INVASIVE SOLUTIONS (MIS) LPS-MOBILE TIBIAL COMPONENT.CHANGES MADE TO THE NEXGEN FLUTED STEM MOBILE TIBIAL COMPONENT INCLUDE SHORTENING THETIBIAL BASEPLATE STEM AND ADDING BROAD PROXIMAL FINS, CHANGING THE OUTER PROFILE RADIUS OF THEBASEPLATE EDGE FROM A VARIABLE RADIUS TO A CONSTANT RADIUS, AND ADDING AN ADDITIONAL SIZE (4-PLUS)TO THE CURRENT RANGE OF SIZES (1 - 8).
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