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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
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 NumberS143
Date Received04/16/2014
Decision Date05/23/2014
Product Code
NJL[ Registered Establishments with NJL ]
Advisory Committee Orthopedic
Supplement Typespecial (immediate track)
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for an additional inspection step in the manufacturing process for the distal and posterior augments and the revision step wedges that provides additional assurance of purity, identity, strength or reliability of the device.
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