Device Dossier

Everglade Stem - Coated hip femur prosthesis, modular

Device Dossier for Everglade Stem - Coated hip femur prosthesis, modular (Coated hip femur prosthesis, modular, Class III, sponsor Signature…

Intended purpose

The Everglade Stem is intended to connect the modular femoral head to the patient's femur as part of a hip joint replacement, where bone stck 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, or traumatic injury of the proximal femur

Functional description

The Everglade 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