Device Dossier
The BioBall Metal Head Vivium - Metallic femoral head prosthesis
Device Dossier for The BioBall Metal Head Vivium - Metallic femoral head prosthesis (Metallic femoral head prosthesis, Class III, sponsor Corin). ARTG…
- GMDN category: Metallic femoral head prosthesis
Intended purpose
The BioBall™ Metal Head Vivium is part of the BioBall™ System which is designed for use in either primary or revision hip arthroplasty. It is intended to be used in the following indications: - Sliding pair revisions; and - Intra?operative correction of offset, neck length, lateralization and anteversion/retroversion with anchored prosthesis stem.
Functional description
The BioBall™ Metal Head Vivium provides the femoral articular surface during primary and revision hip replacement operations. The BioBall metal heads may only be combined with UHMWPE inlays or cups. The device is made of Vivium (high nitrogen stainless steel) and can only be combined with BioBall Adaptors.