Device Dossier

Active Knee Meniscal Insert, ultracongruent+ - Prosthesis, knee, internal, insert component

Device Dossier for Active Knee Meniscal Insert, ultracongruent+ - Prosthesis, knee, internal, insert component (Prosthesis, knee, internal, insert…

Intended purpose

The ultracongruent+ mensical insert implant is a component of the Active Knee System. The patient should be skeletally mature to receive a knee replacement. Patients should have adequate bone stock and size to support prosthesis. It is intended for Non-inflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis; Inflammatory degenerative joint disease including rheumatoid arthritis; Functional deformity such as varus, valgus or flexion deformities; Revision procedures where other treatments or devices have failed; Fractures that are unmanageable using other techniques.

Functional description

A low-friction Ultra-High Molecular Weight polyethylene liner component designed to provide the articulating bearing surface between the femoral and tibial components of a total knee replacement. The Ultracongruent+ is designed for use in patients with an absent or severely deficient posterior cruciate ligament. The posterior flanges are keyed into the matching flanges on the tibial tray and then seated home by finger pressure and tibial punch.

TGA Public Summary