Device Dossier
SignaSure Poly - Non-constrained polyethylene acetabular liner
Device Dossier for SignaSure Poly - Non-constrained polyethylene acetabular liner (Non-constrained polyethylene acetabular liner, Class III, sponsor…
- GMDN category: Non-constrained polyethylene acetabular liner
Intended purpose
The SignaSure Poly as part of 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 Poly consists of outer and inner spherical conforming articulating surfaces. The inner articulating surface mates and retains a femoral head. The outer articular surface articulates within the SignaSure Dual Mobility Logical Insert.