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, ATTUNE Revision Cones |
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 | S316 |
Date Received | 09/29/2023 |
Decision Date | 12/22/2023 |
Product Code |
NJL |
Advisory Committee |
Orthopedic |
Supplement Type | Real-Time Process |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement for addition of the ATTUNE® Revision Cones to the LCS® Total Knee System, P830055, as compatible with currently existing and approved ATTUNE Revision Knee System (specifically the ATTUNE Revision Rotating Platform (RP) Tibial Bases). |
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