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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, patello/femorotibial, unconstrained, uncemented, porous, coated, polymer/metal/polymer
Generic Nameknee implant - uncemented
ApplicantDEPUY, INC.
PMA NumberP910016
Supplement NumberS015
Date Received11/10/2005
Decision Date12/12/2005
Product Code
MBD[ Registered Establishments with MBD ]
Advisory Committee Orthopedic
Supplement Type Special Supplement
Supplement Reason process change: packaging
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for changes in quality controls to the lcs preservation uni mobile bearing inserts approved in p910016/s012. The changes include modifications to several manufacturing process specifications (mps) for gamma vacuum foil (gvf) packaged products: 1) to add physical separation barriers to the sealing machine to prevent adjacent foil pouches from overlapping during the sealing operation, and 2) to require a second 100% inspection of the seal integrity of each package prior to shipment.