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…
- GMDN category: Femoral head/stem prosthesis adaptor
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.