Device Dossier

Pty Ltd - Alteon Tapered Wedge Femoral Stem - Press-fit femoral stem prosthesis

Device Dossier for Pty Ltd - Alteon Tapered Wedge Femoral Stem - Press-fit femoral stem prosthesis (Press-fit femoral stem prosthesis, Class III, sponsor…

Intended purpose

The Alteon Tapered Wedge Femoral Stems are intended to connect the modular femoral head to the patient's femur as part of a hip joint replacement. The device is indicated for use in skeletally mature individuals undergoing primary surgery for hip replacement due to osteoarthritis, rheumatoid arthritis, osteonecrosis, post-traumatic degenerative problems of the hip, and for treatment of proximal femoral fractures where prosthetic replacement is determined by the surgeon as the preferred treatment. Components of Exactech Hip Systems are also potentially indicated for ankylosing spondylitis, congenital hip dysplasia, revision of failed previous reconstructions where sufficient bone stock is present, and to restore mobility resulting from previous fusion.

Functional description

The Alteon Tapered Wedge Femoral Stem is implanted in the patient's femoral canal, and includes a taper at the end of its neck which mates to a modular femoral head as part of a hip joint replacement. The devices are intended for press-fit, cementless implantation, have a 12/14 taper, and are made from Ti Alloy with CpTi plasma coating.

TGA Public Summary