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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameLCS TOTAL KNEE SYSTEM
Classification Nameprosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
Generic Nameprosthesis, knee, patellofemorotibial, semi-cons
ApplicantDEPUY ORTHOPAEDICS, INC.
PMA NumberP830055
Supplement NumberS087
Date Received09/16/2003
Decision Date11/18/2003
Product Code
NJL[ Registered Establishments with NJL ]
Advisory Committee Orthopedic
Supplement Typereal-time process
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a line extension to the p. F. C. Sigma components. That is, the addition of p. F. C. Sigma rpf femoral components and tibial bearings (sizes 1, 1. 5, 2, 2. 5, 3, 4, 5, and 6). The p. F. C. Sigma rpf components allow for a higher than normal degree of flexion after total knee arthroplasty (~155 degrees).
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