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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
Classification Nameprosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
ApplicantZIMMER, INC.
PMA NumberP060037
Supplement NumberS005
Date Received09/29/2008
Decision Date03/26/2009
Product Code
NJL[ Registered Establishments with NJL ]
Advisory Committee Orthopedic
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
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 the tibial baseplate stem and adding broad proximal fins, changing the outer profile radius of the baseplate edge from a variable radius to a constant radius, and adding an additional size (4-plus) to the current range of sizes (1 - 8).