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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
Classification Nameprosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
Generic Nameprosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
Applicant
DEPUY, INC.
p.o. box 988
700 orthopaedic drive
warsaw, IN 46581-0988
PMA NumberP830055
Supplement NumberS101
Date Received01/14/2008
Decision Date03/13/2008
Product Code
NJL[ Registered Establishments with NJL ]
Advisory Committee Orthopedic
Supplement Typereal-time process
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL FOR THE FOLLOWING CHANGES TO THE EXISTING LCS COMPLETE RPS FEMORAL COMPONENTS: 1) CHANGES TO INCLUDE MINOR DIMENSIONAL AND TOLERANCE CHANGES; 2) THE DESCRIPTION OF THE DEVICE WILL CHANGE TO LCS COMPLETE RPS FLEXION; AND3) ADDITIONAL LABELING FOR USE IN PATIENTS REQUIRING A HIGHER THAN NORMAL DEGREE OF FLEXION.
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