|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|| design change - minor|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for the following items: 1) use of the trident acetabular system with v40 alumina heads and additional c-taper alumina head sizes (and associated stems) 2) use of the trident acetabular system with v40/c-taper and morse taper adapter sleeves (and associated femoral stems) 3) use of additional styles of trident acetabular shells; and 4) associated labeling changes due to modifications identified above.