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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 NumberS088
Date Received01/26/2004
Decision Date07/01/2004
Product Code
NJL[ Registered Establishments with NJL ]
Advisory Committee Orthopedic
Supplement Typereal-time process
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
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.