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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 NumberS094
Date Received12/19/2005
Decision Date01/20/2006
Product Code NJL 
Advisory Committee Orthopedic
Supplement TypeSpecial (Immediate Track)
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR A CHANGE TO THE LABELING IN THE PACKAGE INSERT OF THE DEVICE. THIS MODIFICATION CLARIFIES THE TYPE OF LCS PATELLAR COMPONENT (LCS PFJ MODIFIED ROTATING PLATFORM PATELLA) TO BE USED WITH THE LCS PFJ TROCHLEAR COMPONENT.
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