Device Dossier

ATTUNE Fixed Bearing Tibial Base with AFFIXIUM - Coated knee tibia prosthesis

Device Dossier for ATTUNE Fixed Bearing Tibial Base with AFFIXIUM - Coated knee tibia prosthesis (Coated knee tibia prosthesis, Class III, sponsor DePuy…

Intended purpose

The ATTUNE Fixed Bearing Tibial Base with AFFIXIUM is a component of the ATTUNE Total Knee System which is intended to provide increased patient mobility and reduced pain by replacing the damaged knee joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components.

Functional description

The ATTUNE Fixed Bearing Tibial Base with AFFIXIUM is a modular tibial base composed of titanium alloy with a porous coating. The ATTUNE Fixed Bearing Tibial Base with AFFIXIUM is intended for use as part of a total knee construct.

TGA Public Summary