Device Dossier
Evolve AP Cup - Polyethylene acetabulum prosthesis
Device Dossier for Evolve AP Cup - Polyethylene acetabulum prosthesis (Polyethylene acetabulum prosthesis, Class III, sponsor Signature Orthopaedics).…
- GMDN category: Polyethylene acetabulum prosthesis
Intended purpose
The Evolve AP Cup is indicated for use in total hip arthroplasty with PMMA bone cement fixation, where bone stock is sufficient to support the implant. Indications: - Non-inflammatory degenerative joint disease including osteoarthritis or avascular necrosis - Inflammatory joint disease including rheumatoid arthritis (excluding TSI stem) - 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, or total replacement
Functional description
The device is manufactured from cross-linked polyethylene and incorporates a stainless steel ring to allow radiographic identification. Geometric design of the articulating face of the cup includes a 20 degree inclination providing more coverage of the femoral head in the superoposterior aspect while maintaining the centre of head rotation with the same centre as the radius of the outer surface of the cup.