Device Dossier

BioBall Head Adaptor - Femoral head/stem prosthesis adaptor

Device Dossier for BioBall Head Adaptor - Femoral head/stem prosthesis adaptor (Femoral head/stem prosthesis adaptor, Class III, sponsor Corin). ARTG…

Intended purpose

The BioBall™ Head Adaptor 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, and - 12/14 Adapter: Intra-operative correction of offset, neck length, lateralization and anteversion/retroversion during primary operation as well

Functional description

The BioBall Adapter is primarily used in revision of an existing prosthetic stem. However, the BioBall Adapter 12/14 can also be used during primary operation. The BioBall Adapters are made of Ti6Al4V ELI and the use of the BioBall Adapter is exclusively allowed in combination with BioBall Heads.

TGA Public Summary