|Trade Name||OSTEONICS ABC/TRIDENT SYSTEMS|
|Classification Name||prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented|
|Applicant||HOWMEDICA OSTEONICS CORP.|
|Supplement Type||real-time process|
|Supplement Reason|| labeling change - instructions|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for revisions to the trident acetabular system package insert and patient labeling. These changes include editing text for conciseness and clarity, reorganizing elements to more clearly convey intent, and presenting data in a manner that is less confusing and more meaningful to patients and surgeons.