Device Dossier

Bionit 2 Hip Head - Prosthesis, internal, joint, hip, femoral component

Device Dossier for Bionit 2 Hip Head - Prosthesis, internal, joint, hip, femoral component (Prosthesis, internal, joint, hip, femoral component, Class…

Intended purpose

Bionit 2 femoral head manufactured from Al2O3 for treating diseased hip joints for primary and revision surgery.

Functional description

A ceramic femoral head to be used in conjunction with a femoral stem to articulate against an acetabular component for primary and revision hip surgery. When used in a ceramic-ceramic pairing the ceramys femoral heads must only be used with ceramic inlays by Mathys.

TGA Public Summary