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 | S063 |
Date Received | 07/09/1999 |
Decision Date | 08/05/1999 |
Product Code |
NJL |
Advisory Committee |
Orthopedic |
Supplement Type | Real-Time Process |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement Approval to allow DePuy the option of manufacturing the LCS Rotating Platform Tibial Inserts, Meniscal Bearing Tibial Inserts and All Polyethylene Tibial Components from Ultra High Molecular Weight Polyethylene (UHMWPE) that is vacuum packaged in foil barrier bags and gamma sterilized (the GVF process). |
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