Device Dossier

Journey Uni Tibial Insert - Unicondylar knee insert

Device Dossier for Journey Uni Tibial Insert - Unicondylar knee insert (Unicondylar knee insert, Class III, sponsor Smith & Nephew). ARTG record,…

Intended purpose

UHMWPE unicompartmental knee tibial insert component. Unicompartmental knee implants are indicated for restoring either compartment of a knee that has been affected by the following: 1. Noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis; 2. Correction of functional deformity; 3. Revision procedures where other treatments or devices have failed; and 4. Treatment of fractures that are unmanageable using other techniques. Unicompartmental knee implants are single use only and the femoral components and tibial baseplates are intended for implantation only with bone cement.

Functional description

An implantable device designed to articulate with the femoral component of a unicompartmental knee joint prosthesis during primary knee joint replacement. It is a one-piece ultra-high molecular weight polyethylene (UHMWPE) insert with a flat articular surface which locks into a cemented tibial baseplate.

TGA Public Summary