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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 NameNEW JERSEY LCS(R) UNICOMPARTMENTAL KNEE
Classification Nameprosthesis, knee, patello/femorotibial, unconstrained, uncemented, porous, coated, polymer/metal/polymer
Generic Nameknee implant - uncemented
ApplicantDEPUY, INC.
PMA NumberP910016
Supplement NumberS008
Date Received12/23/1996
Decision Date01/29/1997
Product Code
MBD[ Registered Establishments with MBD ]
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 six size options, two fixation pegs on the femoral component, a 7 degree distal bone cut surface on the femoral component, and a single meniscal bearing track across all sizes of the tibial component for the second generation of th e new jersey lcs total knee system unicompartmental device configuration.
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