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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.
 
DeviceOXFORD PARTIAL KNEE SYSTEM
Generic NameProsthesis, knee, femorotibial, unicompartmental, semi-constrained, metal/polymer, mobile bearing
ApplicantBIOMET MANUFACTURING CORP.
56 EAST BELL DRIVE
P.O. BOX 587
WARSAW, IN 46581-0587
PMA NumberP010014
Supplement NumberS046
Date Received09/20/2013
Decision Date10/17/2013
Product Code NRA 
Advisory Committee Orthopedic
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
CHANGE TO USE A DIFFERENT MOLD RELEASE AGENT IN THE MANUFACTURING OF THE BEARING COMPONENTS OF BIOMET'S OXFORD PARTIAL KNEE SYSTEM.
Post-Approval StudyShow Report Schedule and Study Progress
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