Device Dossier

REDAPT MODULAR ACETABULAR SHELL - Acetabular shell

Device Dossier for REDAPT MODULAR ACETABULAR SHELL - Acetabular shell (Acetabular shell, Class III, sponsor Smith & Nephew). ARTG record, intended…

Intended purpose

Hip components are indicated for individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of degenerative joint disease or any of its composite diagnoses of osteoarthritis, avascular necrosis, and traumatic arthritis. Hip components are also indicated for inflammatory degenerative joint disease including rheumatoid arthritis, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques, and fracture-dislocation of the hip.

Functional description

The REDAPT Modular Shell, for use in primary and revision THA, is a cementless titanium acetabular shell. The REDAPT Modular Shellis manufactured from titanium alloy, Ti-6Al-4V (ASTM F1472/ISO 5832-3). It has an outer porous structure. The REDAPT Modular Shell is to be implanted without bone cement.

TGA Public Summary