Device Dossier

Biomet Tibial Modular System Polished Finned HA/Porous Tibial Tray - Coated knee tibia prosthesis

Device Dossier for Biomet Tibial Modular System Polished Finned HA/Porous Tibial Tray - Coated knee tibia prosthesis (Coated knee tibia prosthesis, Class…

Intended purpose

Sterile implantable single use device designed to replace the tibial joint surface during total knee arthroplasty due to arthrosis, traumatic arthritis, rheumatoid arthritis, correction of functional deformity and replacement techniques when other treatments have failed. This is a metallic device intended for use without bone cement and designed to articulate with an insert and a femoral prosthetic component.

Functional description

The tibial component of the Biomet Modular Tibial System total knee prosthesis. This cobalt/chrome/molybdenum device has a porous plasma and hydroxyapatite coating and titanium tibial locking bar. The locking mechanism compresses the polyethylene bearing against the tray, thereby reducing micromotion. For cementless use.

TGA Public Summary