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 | S088 |
Date Received | 01/26/2004 |
Decision Date | 07/01/2004 |
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 |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR THE ADDITION OF CEMENTED POSTERIOR STABILIZED (PS) FEMORAL COMPONENTS AND TIBIAL BEARING COMPONENTS TO THE EXISTING LCS TOTAL KNEE SYSTEM. THAT IS, THE ADDITION OF THE LCS COMPLETE M1 PS COMPONENTS (SIZES STANDARD, STANDARD+, AND LARGE). THE LCS COMPLETE M1 PS CEMENTED FEMORAL COMPONENT COMBINES FEATURES OF THE PREVIOUSLY APPROVED LCS PS AND LCS COMPLETE FEMORAL COMPONENTS AND ALSO INCLUDES MODIFICATION TO THE GEOMETRY AND POSITION OF THE ANTERIOR AND POSTERIOR FEMORAL CAMS. ALONG WITH ASSOCIATED MODIFICATION TO THE LENGTH OF THE PATELLO-FEMORAL ARTICULATION. THE LCS COMPLETE M1 PS TIBIAL INSERT COMPONENT COMBINES FEATURES OF THE PREVIOUSLY APPROVED LCS PS AND LCS COMPLETE RP TIBIAL BEARING COMPONENTS AND IS MODIFIED TO ACCOMMODATE THE CHANGES IN ANTERIOR AND POSTERIOR FEMORAL CAM GEOMETRY. |
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