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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(R)TOTAL KNEE SYSTEM
Generic NamePROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, UNCONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER
ApplicantDEPUY, INC.
700 ORTHOPAEDIC DR.
WARSAW, IN 46581-0988
PMA NumberP910016
Supplement NumberS009
Date Received11/25/1997
Decision Date01/15/1998
Withdrawal Date 04/18/2012
Product Code MBD 
Advisory Committee Orthopedic
Supplement TypeReal-Time Process
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for a change to the name of the Unicompartmental Configuration of the new jersey LCS(R) Total Knee System. This device will now be marketed under the trade name Unicompartmental Configuraiton ofthe LCS(R) Total Knee System and is indicated for uncemented use in patients over 60 years old undergoing unicompartmental knee surgery for rehabilitating knees when only one condyle has been damaged as a result of noninflammatory degenerative joint disease (NIDJD) or its composite diagnoses of osteoarthritis or post-traumatic arthritis.
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