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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 NameLSC REVISION SYSTEM
Classification Nameprosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
Generic Nameprosthesis, knee, patellofemorotibial, semi-cons
ApplicantDEPUY, INC.
PMA NumberP830055
Supplement NumberS064
Date Received08/30/1999
Decision Date10/04/1999
Product Code
NJL[ Registered Establishments with NJL ]
Advisory Committee Orthopedic
Supplement Typereal-time process
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a line extension consisting of the addition of lcs revision system components include lcs cemented revision femoral, tibial tray, and augment components. The stems of the lcs revision tibial tray and femoral components are designed to allow for the use of ancillary stem extensions and sleeves from cleared and currently marketed devices. The device is indicated for the cemented revision of failed knee prostheses.
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