Device Dossier

JOURNEY II Unicompartmental Knee Tibial Insert - Unicondylar knee insert

Device Dossier for JOURNEY II Unicompartmental Knee Tibial Insert - Unicondylar knee insert (Unicondylar knee insert, Class III, sponsor Smith & Nephew).…

Intended purpose

Unicompartmental knee implants are indicated for restoring either compartment of a knee that has been affected by the following: • Noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis; and • Partial revisions to replace the tibial insert of the previously implanted JOURNEY II UK knee in the case the femoral and tibial components are well-fixed. Unicompartmental knee implants are single use only and 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 made of cross linked polyethylene (XLPE) with a flat articular surface which locks into a cemented tibial baseplate. The locking tabs along the AP edges and interference tabs to the outer periphery ensure stability when engaged in the baseplate.

TGA Public Summary