Device Dossier

Evolve Taper Sleeve, 12/14 taper - Femoral head/stem prosthesis adaptor

Device Dossier for Evolve Taper Sleeve, 12/14 taper - Femoral head/stem prosthesis adaptor (Femoral head/stem prosthesis adaptor, Class III, sponsor…

Intended purpose

The Evolve Taper Sleeve is intended to connect the unipolar head to the stem as part of a partial hip joint replacement. The device is indicated 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 · Failed previous hip surgery including internal fixation or joint fusion,reconstruction, hemiarthroplasty, surface replacement.

Functional description

The Evolve Sleeve connects the unipolar head to the stem via matching tapers, as part of a partial hip joint replacement. The device is manufactured from CoCr alloy and has a 12/14 taper.

TGA Public Summary