Device Dossier

Evolis Ultra-Congruent Flex Insert - Prosthesis, knee, internal, insert component

Device Dossier for Evolis Ultra-Congruent Flex Insert - Prosthesis, knee, internal, insert component (Prosthesis, knee, internal, insert component, Class…

Intended purpose

Polyethylene ultra congruent flex tibial insert that forms part of the Evolis Total Knee System, which is designed for tri-compartmental replacement of the natural knee joint. It is available for primary and revision surgery.

Functional description

The ultra-congruent flex tibial insert is manufactured from UHMWPE is designed to be used with a femoral and tibial component in primary or revision knee surgery. The total knee arthroplasty is intended to provide increased patient mobility and reduced pain by replacing the damaged knee joint, if there is evidence of sufficient sound bone to seat and support the components.

TGA Public Summary