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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
Generic NameProsthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
ApplicantDEPUY, INC.
P.O. BOX 988
700 ORTHOPAEDIC DRIVE
WARSAW, IN 46581-0988
PMA NumberP830055
Supplement NumberS126
Date Received01/31/2012
Decision Date03/30/2012
Product Code NJL 
Advisory Committee Orthopedic
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL TO ADD THE DEPUY UNIVERSAL STEM EXTENSIONS AS COMPATIBLE COMPONENTS TO THE PREVIOUSLY APPROVED LCS COMPLETE MODULAR FEMORAL COMPONENTS, LCS COMPLETE REVISION FEMORAL COMPONENTS, AND MBT TIBIAL TRAYS, AND TO ADD THE DEPUY UNIVERSAL FEMORAL METAPHYSEAL SLEEVES AS COMPATIBLE COMPONENTS TO THE LCS COMPLETE REVISION FEMORAL COMPONENTS.
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