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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.
 
DeviceOSTEOBOND(TM) COPOLYMER BONE CEMENT
Generic NameBONE CEMENT
Regulation Number888.3027
ApplicantZimmer, Inc.
P.O. Box 708
Warsaw, IN 46581
PMA NumberN17755
Supplement NumberS046
Date Received10/11/1995
Decision Date11/20/1995
Reclassified Date10/14/1999
Product Code LOD 
Advisory Committee Orthopedic
Supplement TypeSpecial (Immediate Track)
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR THE ADDITION TO THE LABELING OF THE FOLLOWING WARNING STATEMENT: "DO NOT CENTRIGUGE OSTEOBOND COPOLYMER BONE CEMENT. ALTHOUGH CENTRIFUGATION HAS BEEN SHOWN IN SOME CASES TO IMPROVE THE PHYSICAL STRENGTH OF THE CURED CEMENT BY REMOVAL OF ENTRAPPED AIR AND OTHER GASES, A UNIFORM DISPERSION OF THE RADIOPACIFIER CANNOT BE ASSURED. THEREFORE, THE USE OF CENTRIGUGATION IS NOT ADVISABLE."
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