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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 NumberS106
Date Received09/30/2008
Decision Date11/23/2011
Product Code NJL 
Advisory Committee Orthopedic
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL TO MANUFACTURE THE SUBJECT COMPONENTS FROM GUR 1020 POLYETHYLENE WITH AN ANTIOXIDANT (AOX), TO CHANGE THE PACKAGING COMPONENTS AND MATERIALS, AND TO REQUEST APPROVAL OF A SHELF-LIFE TESTING PROTOCOL FOR THE SUBJECT P.F.C SIGMA RP CURVED AND STABILIZED TIBIAL INSERTS.
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