Device Dossier

Aria Stem - Coated hip femur prosthesis, modular

Device Dossier for Aria Stem - Coated hip femur prosthesis, modular (Coated hip femur prosthesis, modular, Class III, sponsor Signature Orthopaedics).…

Intended purpose

The Aria Stem is intended to connect the modular femoral head to the patient's femur as part of a hip joint replacement, where bone stock is sufficient to support the implant. The device is indicated for use in skeletally mature individuals undergoing primary surgery for hip replacement due to osteoarthritis, avascular necrosis, rheumatoid arthritis, congenital hip dysplasia, traumatic injury of the proximal femur, or failed previous hip surgery.

Functional description

The Aria Stem has a proximal dual layer plasma sprayed Ti and HA coating to promote bone ongrowth when implanted in the patient's femoral canal. The device includes a taper at the end of its neck which mates to a modular femoral head as part of a hip joint replacement. The device is manufactured from Ti6Al4V alloy.

TGA Public Summary