Device Dossier

Evolis Postero-Stabilized Insert + Screw - Prosthesis, knee, internal, insert component

Device Dossier for Evolis Postero-Stabilized Insert + Screw - Prosthesis, knee, internal, insert component (Prosthesis, knee, internal, insert component,…

Intended purpose

Polyethylene posterior stabilised tibial insert and titanium screw 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 posterior stabilised tibial insert is manufactured from UHMWPE and is attached to the tibial tray with a titanium screw. The insert is designed to be used with the posterior stabilised femoral 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