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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 NumberS090
Date Received07/18/2005
Decision Date09/26/2005
Product Code
NJL[ Registered Establishments with NJL ]
Advisory Committee Orthopedic
Supplement Typereal-time process
Supplement Reason design change - minor
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval to: change the name of the lcs complete m1 ps femoral component to the lcs complete rps femoral component, add new sizes along with some minor design changes to the rps femoral components, change the name of the lcs complete m1 ps tibial bearing component to the lcs complete rps tibial bearing component, add new bearing thicknesses to the rps tibial bearing components, and make dimensional changes to the tibial reinforcement pin used with the rps tibial bearings; change the cam and spine mechanisms for the lcs complete revision femoral and tibial bearing components, add a medium size to the lcs complete revision femoral and tibial bearing components, change the name of the lcs complete revision tibial bearing component from vvc1 to vvc, and modify the tibial reinforcement pin used with the vvc tibial bearings.
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