|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 Name||OSTEONICS CONSTRAINED ACETABULAR INSERT|
|Applicant||HOWMEDICA OSTEONICS CORP.|
|Supplement Type||real-time process|
|Supplement Reason|| change design/components/specifications/material|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for the addition of the trident constrained acetabular insert design, and the modified pca co cr, modified v40 co cr, pca cocr+15 mm, pca zirconia and v40 zirconia femoral heads to the osteonics constrained acetabular insert pma.