Device Dossier

Pty Ltd - Optetrak Tibial Insert, CC w/ Retaining Screw - Prosthesis, knee, internal, insert component

Device Dossier for Pty Ltd - Optetrak Tibial Insert, CC w/ Retaining Screw - Prosthesis, knee, internal, insert component (Prosthesis, knee, internal,…

Intended purpose

The Optetrak Tibial Insert mates with the tibial tray and replaces the articular surface of the patient's tibia as part of a knee joint replacement. A screw is provided to enhance the integrity of the spine and stabilize the insert and tray. 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 Tibial Insert mates with the tibial tray and replaces the articular surface of the patient's tibia as part of a knee joint replacement. A screw is provided to enhance the integrity of the spine and stabilize the insert and tray. The device is made of (Ti6Al-4V, UHMWPE).

TGA Public Summary