Device Dossier

Evolve Stem - Uncoated hip femur prosthesis, modular

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

Intended purpose

The Evolve Stem is part of Signature Orthopaedics' hip replacement range 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 intended for: - Non-inflammatory degenerative joint disease including osteoarthritis or avascular necrosis - Inflammatory joint disease including rheumatoid arthritis - Correction of functional deformity including congenital hip dysplasia - Traumatic injury involving the hip joint including traumatic arthritis or femoral head or neck fracture - Dislocation Risks (when used with SignaSure range)

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.

TGA Public Summary