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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.
Classification Nameprosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
Generic Nameprosthesis, knee, patellofemorotibial, semi-cons
PMA NumberP830055
Supplement NumberS077
Date Received09/26/2000
Decision Date11/13/2000
Product Code
NJL[ Registered Establishments with NJL ]
Advisory Committee Orthopedic
Supplement Typereal-time process
Supplement Reason labeling change - instructions
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a change to the package insert regarding the indicated uses for the p. F. C. Sigma rp curved tibial bearings. This change in indication would allow the p. F. C. Sigma rp curved bearings to be used in posterior cruciate retaining procedures when used with the p. F. C. Sigma cruciate retaining femoral component.