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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 NumberS088
Date Received01/26/2004
Decision Date07/01/2004
Product Code NJL 
Advisory Committee Orthopedic
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR THE ADDITION OF CEMENTED POSTERIOR STABILIZED (PS) FEMORAL COMPONENTS AND TIBIAL BEARING COMPONENTS TO THE EXISTING LCS TOTAL KNEE SYSTEM. THAT IS, THE ADDITION OF THE LCS COMPLETE M1 PS COMPONENTS (SIZES STANDARD, STANDARD+, AND LARGE). THE LCS COMPLETE M1 PS CEMENTED FEMORAL COMPONENT COMBINES FEATURES OF THE PREVIOUSLY APPROVED LCS PS AND LCS COMPLETE FEMORAL COMPONENTS AND ALSO INCLUDES MODIFICATION TO THE GEOMETRY AND POSITION OF THE ANTERIOR AND POSTERIOR FEMORAL CAMS. ALONG WITH ASSOCIATED MODIFICATION TO THE LENGTH OF THE PATELLO-FEMORAL ARTICULATION. THE LCS COMPLETE M1 PS TIBIAL INSERT COMPONENT COMBINES FEATURES OF THE PREVIOUSLY APPROVED LCS PS AND LCS COMPLETE RP TIBIAL BEARING COMPONENTS AND IS MODIFIED TO ACCOMMODATE THE CHANGES IN ANTERIOR AND POSTERIOR FEMORAL CAM GEOMETRY.
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