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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 NameOXFORD MENISCAL UNICOMPARTMENTAL KNEE
Classification Nameprosthesis, knee, femorotibial, unicompartmental, semi-constrained, metal/polymer, mobile bearing
Generic Nameknee, unicompartmental, metal/polymer, cemented, mobile bearing
ApplicantBIOMET ORTHOPEDICS, INC.
PMA NumberP010014
Supplement NumberS017
Date Received08/22/2007
Decision Date02/20/2008
Product Code
NRA[ Registered Establishments with NRA ]
Advisory Committee Orthopedic
Supplement Typereal-time process
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Approval for a product line extension to include a new series of femoral components designed to add an additional fixation peg and extend the articular surface 20 degrees anteriorly.
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