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 | S121 |
Date Received | 07/18/2011 |
Decision Date | 02/09/2012 |
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 CR (CRUCIATE RETAINING) RP (ROTATING PLATFORM) TIBIAL BASES AND TIBIAL INSERTS FOR USE WITH PREVIOUSLY CLEARED FEMORAL AND PATELLAR COMPONENTS. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ATTUNE ROTATING PLATFORM (RP) TOTAL KNEE SYSTEM AND IS INDICATED FOR USE IN TOTAL KNEEREPLACEMENT 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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