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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 NumberS127
Date Received08/16/2012
Decision Date11/19/2012
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 THE ADDITION OF MOBILE BEARING ATTUNE PS RP TIBIAL INSERTS THAT ARE MODIFICATIONS TO THE PREVIOUSLY APPROVED LCS COMPLETE/PFC SIGMA RP/ATTUNE RP TIBIAL INSERTS, AND ARE INTENDED TO BE USED WITH THE CLEARED ATTUNE TOTAL KNEE SYSTEM FEMORAL, PATELLA, AND COMPONENTS. THE SUPPLEMENT ALSO REQUESTS THE ADDITION OF A 9MM TIBIAL INSERT THICKNESS FOR ALL SIZES (I - I 0) OF ATTUNE CR RP TIBIAL INSERTS. THE NEWINSERTS ARE MANUFACTURED FROM THE ANTIOXIDANT POLYETHYLENE MATERIAL (AOX). THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ATTUNE AND IS INDICATED FOR USE IN TOTAL KNEE REPLACEMENT IN PATIENTS WITH A SEVERELY PAINFUL AND/OR SEVERELY DISABLED JOINT RESULTING FROM OSTEOARTHRITIS, POST-TRAUMATIC ARTHRITIS, RHEUMATOID ARTHRITIS, OR A FAILED PREVIOUS IMPLANT.
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