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. |
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Device | LCS TOTAL KNEE SYSTEM |
Generic Name | Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing |
Applicant | DEPUY, INC. P.O. BOX 988 700 ORTHOPAEDIC DRIVE WARSAW, IN 46581-0988 |
PMA Number | P830055 |
Supplement Number | S127 |
Date Received | 08/16/2012 |
Decision Date | 11/19/2012 |
Product Code |
NJL |
Advisory Committee |
Orthopedic |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
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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