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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
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 NumberS021
Date Received06/18/2008
Decision Date08/15/2008
Product Code NRA 
Advisory Committee Orthopedic
Supplement TypeReal-Time Process
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE ADDITION OF COMPUTER AIDED SURGERY (CAS) NAVIGATION SURGICAL INSTRUMENTS FOR USE WITH THE BRAINLAB UNI-KNEE IMAGE GUIDANCE SYSTEM FOR USE WITH THE OXFORD PARTIAL KNEE SYSTEM. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME OXFORD PARTIAL KNEE SYSTEM AND IS INTENDED FOR USE IN INDIVIDUALS WITH OSTEOARTHRITIS OR AVASCULAR NECROSIS LIMITED TO THE MEDIAL COMPARTMENT OF THE KNEE AND IS INTENDED TO BE IMPLANTED WITH BONE CEMENT.
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