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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 NumberS157
Date Received03/23/2015
Decision Date06/05/2015
Product Code NJL 
Advisory Committee Orthopedic
Supplement TypeReal-Time Process
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR THE ADDITION OF ATTUNE CEMENTLESS CRUCIATE RETAINING(CR) AND POSTERIOR STABILIZED (PS) FEMORAL COMPONENTS AS COMPATIBLE COMPONENTS WITH THEAPPROVED ATTUNE CR AND PS ROTATING PLATFORM (RP) TIBIAL INSERTS AND ATTUNE RP (CEMENTED) TIBIAL BASES. INCLUDING STERILE SINGLE USE INSTRUMENTATION, TO BE USED WITH THE APPROVED ATTUNE RP COMPONENTS.
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