Device Dossier

Link Vario-cup prosthesis with Safety ring– Cementless - Femoral head bipolar component

Device Dossier for Link Vario-cup prosthesis with Safety ring– Cementless - Femoral head bipolar component (Femoral head bipolar component, Class III,…

Intended purpose

The femoral prosthesis head component of the Vario-Cup Prosthesis system indicated for use in treatment of mobility-limiting diseases, fractures or defects which cannot be treated by conservative or osteosynthetic procedures • Necrosis of the femoral head • Femoral neck fractures

Functional description

Vario-Cup System part of mechanical reconstruction of the hip joint; consists of UHMWPE component encased in ultra-smooth polished EndoDur (CoCrMo) outer metal casing, for articulation in bony acetabulum; used with femoral components from LINK Hip Systems. Self-centering Vario-Cups provide functional view of position in Post-op X-rays. With anti-luxation system to prevent dislocation. UHMWPE Safety Ring is placed in groove at entrance of polyethylene insert after assembly of components.

TGA Public Summary