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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceOXFORD(TM) MENISCAL UNICOMPARTMENTAL 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
Date Received03/01/2001
Decision Date04/21/2004
Product Code NRA 
Docket Number 04M-0200
Notice Date 05/05/2004
Advisory Committee Orthopedic
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR THE OXFORD MENISCAL UNICOMPARTMENTAL KNEE SYSTEM (PHASE 3). THE DEVICE IS INDICATED FOR USE IN PATIENTS WITH OSTEOARTHRITIS OR AVASCULAR NECROSIS LIMITED TO THE MEDIAL COMPARTMENT OF THE KNEE AND INTENDED TO BE IMPLANTED WITH BONE CEMENT.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S032  S030 S031 S042 S043 S052 S053 S040 S050 S047 S039 
S048 S037 S008 S016 S017 S011 S012 S026 S029 S027 S028 S003 
S004 S005 S006 S009 S046 S041 S035 S036 S033 S049 S051 S044 
S045 S002 S001 S024 S022 S014 S015 S018 S020 S021 S056 S057 
S058 S059 S054 S063 S060 S061 S055 S062 S081 S068 S071 S072 
S073 S074 S091 S092 S093 S094 S085 S086 S087 S088 S089 S065 
S069 S070 S075 S076 S077 S066 S067 S079 S080 S082 S083 S084 
S096 S097 S098 S100 S090 S103 S104 S102 S101 
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