Device Dossier

Optimys Uncemented Stem - Press-fit hip femur prosthesis, one-piece

Device Dossier for Optimys Uncemented Stem - Press-fit hip femur prosthesis, one-piece (Press-fit hip femur prosthesis, one-piece, Class III, sponsor…

Intended purpose

The Optimys stem is intended for primary or secondary osteoarthritis of the hip as long as stable anchoring of the implant is not jeopardized; femoral head and femoral neck fractures as long as stable anchoring of the implant is guaranteed; after failed previous surgery such as osteosynthesis.

Functional description

Optimys stem is manufactured from titanium. It features trapezoidal neck geometry with a 12/14 cone. The titanium plasma coating offers a secure anchorage in the bone and the calcium phosphate coating promotes a rapid osseointegration for secondary stability. The triple taper design ensures a rotational stable fixation in the metaphyseal region, and the polished distal section features a round tip to minimise the risk of thigh pain.

TGA Public Summary