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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 NumberS084
Date Received04/22/2003
Decision Date06/10/2003
Product Code
NJL[ Registered Establishments with NJL ]
Advisory Committee Orthopedic
Supplement Typereal-time process
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for two line extensions: the addition of pfc sigma rp tc3 tibial inserts that are compatible with the mbt revision tibial tray components, and adding a smaller (size 1. 5) pfc sigma rp tibial insert in both curved and stabilized versions.
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