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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceNEW JERSEY LCS(R) UNICOMPARTMENTAL KNEE
Classification Nameprosthesis, knee, patello/femorotibial, unconstrained, uncemented, porous, coated, polymer/metal/polymer
Generic Nameprosthesis, knee, patello/femorotibial, unconstrained, uncemented, porous, coated, polymer/metal/polymer
Applicant
DEPUY, INC.
700 orthopaedic dr.
warsaw, IN 46581-0988
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/material
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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