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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 POSTERIOR STABILIZED TIBIAL INSERTS
Classification Nameprosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
Generic Nameprosthesis, knee, patellofemorotibial, semi-cons
ApplicantDEPUY, INC.
PMA NumberP830055
Supplement NumberS066
Date Received09/20/1999
Decision Date10/07/1999
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 design modification to the lcs ps (posterior stabilized) tibial inserts of the lcs total knee system. The proposed modifications to the ps tibial inserts include a reduction in the height of the anterior lip and a change in the medial/lateral angle of the tibial spine.
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