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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.
 
DeviceLCS TOTAL KNEE SYSTEM
Classification Nameprosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
Generic Nameprosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
Applicant
DEPUY, INC.
p.o. box 988
700 orthopaedic drive
warsaw, IN 46581-0988
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/material
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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