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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.
 
DeviceTRIDENT SYSTEMS
Generic NameProsthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
ApplicantHowmedica Osteonics Corp.
325 Corporate Dr.
Mahwah, NJ 07430
PMA NumberP000013
Supplement NumberS010
Date Received10/03/2011
Decision Date01/18/2012
Product Code MRA 
Advisory Committee Orthopedic
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR THE ADDITION OF THE TRITANIUM PSF ACETABULAR SHELLS (SOLID-BACKED AND CLUSTER SCREW-HOLE DESIGNS) AS COMPATIBLE COMPONENTS WITH THE TRIDENT CERAMIC INSERTS, AS WELL AS MODIFICATIONS TO THE TOLERANCES AND SURFACE ROUGHNESS VALUES OF THE TAPER REGION OF ALL COMPATIBLE TRIDENT AND TRITANIUM ACETABULAR SHELLS. IN ADDITION, LABELING CHANGES WERE MADE TO ADDRESS THE COMPATIBILITY WITH THE NEW COMPONENTS.
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