Device Dossier

FIXA DUPLEX Cross-Linked PE Insert - Femoral head bipolar component

Device Dossier for FIXA DUPLEX Cross-Linked PE Insert - Femoral head bipolar component (Femoral head bipolar component, Class III, sponsor Adler Ortho).…

Intended purpose

A sterile bipolar implantable acetabular component of a total hip prosthesis designed to replace the articulating surfaces of the hip in conjunction with an acetabular insert. Indicated for; - Primary and secondary arthrosis - Rheumatoid and degenerative arthritis - Deformities, such as dysplasia - Fractures and necrosis of bone - Revisions, where other devices or treatments have failed - Metastatic diseases

Functional description

Mobile cross-linked (gamma 75kGy) UHMWPE retentive implant sterilised with ethylene oxide. Bipolar insert designed to articulate with FIXA DUPLEX Dual Mobility Cups. Joint stability is increased by employing a large diameter mobile UHMWPE insert that captures and provides secure articulation of the femoral head whilst also permitting articulation with the outer metal shell. Compatible with CoCrMo or ceramic heads with diameters of 22.2 mm (all sizes) or 28 mm (from size 48upwards).

TGA Public Summary