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 | S136 |
Date Received | 07/29/2013 |
Decision Date | 08/28/2013 |
Product Code |
NJL |
Advisory Committee |
Orthopedic |
Supplement Type | Special (Immediate Track) |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE ADDITION OF INSPECTIONS TO CHECK THE PROFILE OF THE DISTAL CONDYLES AS WELL AS THE MEDIAL-LATERAL (M/L) WIDTH AND TRUE POSITION OF THE SIGMA CR150 SIZE 5 & 6 FEMORAL COMPONENTS DURING THE MANUFACTURING PROCESS. THE SIGMA CR150 FEMORAL COMPONENTS WERE PREVIOUSLY APPROVED AS COMPATIBLE COMPONENTS TO THE PRIMARY CURVED RP BEARING INSERTS AND MBT TIBIAL TRAYS. |
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