Device Dossier
Pty Ltd - Optetrak Logic Fit RBK Tibial Tray, Cemented - Mobile-bearing total knee prosthesis
Device Dossier for Pty Ltd - Optetrak Logic Fit RBK Tibial Tray, Cemented - Mobile-bearing total knee prosthesis (Mobile-bearing total knee prosthesis,…
- GMDN category: Mobile-bearing total knee prosthesis
Intended purpose
The Optetrak Logic Fit RBK Tibial Tray is implanted at the proximal end of the tibia and is mated with an insert to replace the articular surface of the tibia as part of a knee joint 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 Fit RBK Tibial Tray Cemented is made from CoCr Alloy, and is implanted at the proximal end of the tibia and is mated with an insert to replace the articular surface of the tibia as part of a knee joint replacement. It is intended to be used with LOGIC femoral components and LOGIC RBK tibial components.