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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.
 
DeviceLSC REVISION SYSTEM
Generic NameProsthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
ApplicantDepuy, Inc.
P.O. Box 988
700 Orthopaedic Dr.
Warsaw, IN 46581
PMA NumberP830055
Supplement NumberS064
Date Received08/30/1999
Decision Date10/04/1999
Product Code NJL 
Advisory Committee Orthopedic
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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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