Device Dossier

Pty Ltd - Optetrak Logic Tibial Insert, PSC - Prosthesis, knee, internal, insert component

Device Dossier for Pty Ltd - Optetrak Logic Tibial Insert, PSC - Prosthesis, knee, internal, insert component (Prosthesis, knee, internal, insert…

Intended purpose

The Optetrak Logic Tibial Insert connects to a tibial tray and replaces the tibia's articular surface as part of a total knee replacement. The device is indicated for use in skeletally mature individuals undergoing primary surgery for total knee replacement due to osteoarthritis, osteonecrosis, rheumatoid arthritis and/or post-traumatic degenerative problems. They are also indicated for revision of failed previous reconstructions where sufficient bone stock and soft tissue integrity are present.

Functional description

The Optetrak Logic Tibial Insert PSC, made from UHMWPE, connects to a tibial tray and replaces the tibia's articular surface as part of a total knee replacement. It is intended to be used with LOGIC femoral and tibial components.

TGA Public Summary