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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 NumberS136
Date Received07/29/2013
Decision Date08/28/2013
Product Code NJL 
Advisory Committee Orthopedic
Supplement TypeSpecial (Immediate Track)
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE ADDITION OF INSPECTIONS TO CHECK THE PROFILE OF THE DISTAL CONDYLES AS WELL AS THE MEDIAL-LATERAL (M/L) WIDTH AND TRUE POSITION OF THE SIGMA CR150 SIZE 5 & 6 FEMORAL COMPONENTS DURING THE MANUFACTURING PROCESS. THE SIGMA CR150 FEMORAL COMPONENTS WERE PREVIOUSLY APPROVED AS COMPATIBLE COMPONENTS TO THE PRIMARY CURVED RP BEARING INSERTS AND MBT TIBIAL TRAYS.
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