Device Dossier

Evolve Stem with Centraliser, Cemented - Uncoated hip femur prosthesis, modular

Device Dossier for Evolve Stem with Centraliser, Cemented - Uncoated hip femur prosthesis, modular (Uncoated hip femur prosthesis, modular, Class III,…

Intended purpose

Signature Orthopaedics' hip replacement range are intended to replace a hip joint where bone stock is sufficient to support the implant. When a surgeon has selected prosthetic replacement as the preferred treatment, the devices are indicated for: o Non-inflammatory degenerative joint disease including osteoarthritis or avascular Necrosis o Inflammatory joint disease including rheumatoid arthritis o Correction of functional deformity including congenital hip dysplasia o Traumatic injury involving the hip joint including traumatic arthritis or femoral head or neck fracture o Failed previous hip surgery including internal fixation or joint fusion, reconstruction, hemiarthroplasty, surface replacement, or total replacement All forms of femurs can be treated with the Evolve stem prosthesis, except those with extreme curvature, e.g. after angulation osteotomies. In these cases, a prior corrective osteotomy could be considered.

Functional description

The Evolve Stem has a 12/14 taper for connection to a modular femoral head as part of a hip joint replacement. The collarless neck helps to facilitate intraoperative adjustments and PMMA distal centraliser reduces point loading onto the cement mantle. Polished double taper design helps to create compressive radial loading, and reduce friction between cement and mantle. For cemented use. The device is manufactured from Stainless Steel.

TGA Public Summary