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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.
 
Trade NameLCS TOTAL KNEE SYSTEM
Classification Nameprosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
Generic Nameprosthesis, knee, patellofemorotibial, semi-cons
ApplicantDEPUY ORTHOPAEDICS, INC.
PMA NumberP830055
Supplement NumberS094
Date Received12/19/2005
Decision Date01/20/2006
Product Code
NJL[ Registered Establishments with NJL ]
Advisory Committee Orthopedic
Supplement Type Special Supplement
Supplement Reason labeling change - instructions
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a change to the labeling in the package insert of the device. This modification clarifies the type of lcs patellar component (lcs pfj modified rotating platform patella) to be used with the lcs pfj trochlear component.
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