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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 MENISCAL UNICOMPARTMENTAL 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 NumberS009
Date Received07/03/2006
Decision Date07/18/2006
Product Code NRA 
Advisory Committee Orthopedic
Supplement TypeSpecial (Immediate Track)
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR CHANGES TO THE PROCESS SPECIFICATIONS FOR THE 9-STAGE KERRY CLEANING PLANT USED IN THE ULTRASONIC CLEANING OF THE OXFORD MENISCAL UNICOMPARTMENTAL KNEE SYSTEM METALLIC COMPONENTS (FEMORAL AND TIBIAL). THE CHANGES REQUIRE DETAILED MONITORING OF THE ULTRASONIC EQUIPMENT TO ENSURE THE ADEQUACY OF ITS OUTPUT.
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