Device Dossier

Pty Ltd - Optetrak Logic RBK Tibial Insert, Posterior Stabilized - Prosthesis, knee, internal, insert component

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

Intended purpose

The Optetrak Logic RBK Tibial Insert connects to a tibial tray and replaces the tibia's articular surface as part of a total knee replacement. The devices are indicated for use in skeletally mature individuals undergoing primary surgery for knee pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders and/or avascular necrosis of the femoral condyle, post-traumatic loss of joint configuration (particularly when there is patellofemoral erosion, dysfunction or prior patellectomy). Additionally, the devices are indicated for cases where revision of previously failed surgical attempts is necessary, if the knee can be satisfactorily balanced and stabilized at the time of surgery.

Functional description

The Optetrak Logic RBK Tibial Insert Posterior Stabilized is made from UHMWPE and 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 components and LOGIC RBK tibial components.

TGA Public Summary