Device Dossier

SignaSure Dual Mobility Logical Insert - Metallic acetabular liner

Device Dossier for SignaSure Dual Mobility Logical Insert - Metallic acetabular liner (Metallic acetabular liner, Class III, sponsor Signature…

Intended purpose

The SignaSure Dual Mobility Logical Insert as part of the Signature Orthopaedics hip replacement range is 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: - 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 SignaSure Dual Mobility Logical Insert is intended to mate with Signature Orthopaedics' Logical Cup Shell to be implanted without bone cement, and houses the SignaSure Poly liner to replace the patient's natural acetabulum as part of a total hip joint replacement. The device is manufactured from Cobalt Chrome (CoCr) alloy.

TGA Public Summary