Device Dossier

Active Knee Meniscal Insert, Congruent (Regular) - Prosthesis, knee, internal, insert component

Device Dossier for Active Knee Meniscal Insert, Congruent (Regular) - Prosthesis, knee, internal, insert component (Prosthesis, knee, internal, insert…

Intended purpose

The meniscal 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 Congruent (Regular) is a semi-constrained condylar design. 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