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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameTRIDENT SYSTEMS
Classification Nameprosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
ApplicantHOWMEDICA OSTEONICS CORP.
PMA NumberP000013
Supplement NumberS010
Date Received10/03/2011
Decision Date01/18/2012
Product Code
MRA[ Registered Establishments with MRA ]
Advisory Committee Orthopedic
Supplement Typereal-time process
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
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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