Device Dossier

Pty Ltd - Optetrak Patellar Component, 3-peg, Cemented - Polyethylene patella prosthesis

Device Dossier for Pty Ltd - Optetrak Patellar Component, 3-peg, Cemented - Polyethylene patella prosthesis (Polyethylene patella prosthesis, Class III,…

Intended purpose

The Optetrak Patellar Component is intended to replace the articular surface of the patient's patella 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 Patellar Component is intended to replace the articular surface of the patient's patella as part of a total knee replacement. The device is made of UHMWPE and is for cemented use only.

TGA Public Summary