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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 Dr.
Warsaw, IN 46581
PMA NumberP830055
Supplement NumberS198
Date Received03/29/2018
Decision Date06/27/2018
Product Code NJL 
Advisory Committee Orthopedic
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for adding the ATTUNE Cemented Tibial Bases, Rotating Platform (RP) as an extension to the ATTUNE Knee System, and to expand compatibility of the ATTUNE Cementless PS Femoral device to both the ATTUNE Cemented Tibial Base, RP and the ATTUNE Cementless RP Tibial Base.
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