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(R)TOTAL KNEE SYSTEM |
Generic Name | PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, UNCONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER |
Applicant | DEPUY, INC. 700 ORTHOPAEDIC DR. WARSAW, IN 46581-0988 |
PMA Number | P910016 |
Supplement Number | S009 |
Date Received | 11/25/1997 |
Decision Date | 01/15/1998 |
Withdrawal Date
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04/18/2012 |
Product Code |
MBD |
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 Approval for a change to the name of the Unicompartmental Configuration of the new jersey LCS(R) Total Knee System. This device will now be marketed under the trade name Unicompartmental Configuraiton ofthe LCS(R) Total Knee System and is indicated for uncemented use in patients over 60 years old undergoing unicompartmental knee surgery for rehabilitating knees when only one condyle has been damaged as a result of noninflammatory degenerative joint disease (NIDJD) or its composite diagnoses of osteoarthritis or post-traumatic arthritis. |
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