Device Dossier

Evok Femoral Stem Collarless HA Coated Cementless – Taper 12/14 - Coated hip femur prosthesis, modular

Device Dossier for Evok Femoral Stem Collarless HA Coated Cementless – Taper 12/14 - Coated hip femur prosthesis, modular (Coated hip femur prosthesis,…

Intended purpose

EVOK Cementless femoral stems are intended for use as femoral components for total or partial replacement of the hip joint, in order to reduce pain and restore hip function in comparison to the preoperative status. The EVOK cementless femoral stem is indicated in case of primary total or partial hip arthroplasty for the relief of pain and significant disability following: -Primitive and secondary hip osteoarthritis, -Aseptic osteonecrosis, -Rheumatoid arthritis/inflammatory diseases, -Femur, hip and/or acetabulum fracture, -Hip joint arthroplasty when other conservative devices or treatments have failed.

Functional description

Evok collarless stem is a straight stem with proximal and distal quadrangular cross-sections. The intramedullary part of the stem is fully coated with 155μm HA, that enhances anchorage and bone ongrowth. The stem is made of TA6V ELI, and the neck is mirror polished. The under-taper area is narrowed with two flat surfaces to enlarge range of motion, while reducing dislocation risk with lever-out mechanism. The stem is intended for use with Amplitude 12/14 femoral heads, either ceramic or metal.

TGA Public Summary