Device Dossier

ZCA® All-Poly Acetabular Cup with Spacer - Polyethylene acetabulum prosthesis

Device Dossier for ZCA® All-Poly Acetabular Cup with Spacer - Polyethylene acetabulum prosthesis (Polyethylene acetabulum prosthesis, Class III, sponsor…

Intended purpose

The acetabular cup is indicated for cemented use in skeletally mature individuals undergoing primary or revision surgery for rehabilitating hips damaged as a result of noninflammatory degenerative joint disease(NIDJD) or its composite diagnoses of osteoarthritis, avascular necrosis, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis, and diastrophic variant.

Functional description

The acetabular cups are for use in primary or revision surgery. It is comprised of a neutral cup and an Inclined Face Cup – A 10° inclined face designed to help prevent dislocation in the area in which the elevation is placed. They are made from ultra-high molecular-weight polyethylene (UHMWPE).

TGA Public Summary