Device Dossier

Triathlon All Poly Tibial Component PS - Uncoated knee tibia prosthesis, polyethylene

Device Dossier for Triathlon All Poly Tibial Component PS - Uncoated knee tibia prosthesis, polyethylene (Uncoated knee tibia prosthesis, polyethylene,…

Intended purpose

A tibial component of the Triathlon Total Knee used to replace the tibial plateau of the knee joint. General Total Knee Arthroplasty (TKR) Indications: Painful, disabling joint disease of the knee resulting from non-inflammatory degenerative joint disease; Moderate varus, valgus, or flexion deformity in which the ligamentous structures can be returned to adequate function and stability. Additional Indications for Posterior Stabilized (PS) Components: Ligamentous instability requiring implant bearing surface geometries with increased constraint; Absent or non-functioning Posterior Cruciate Ligament; Severe anteroposterior instability of the knee joint.

Functional description

A sterile implantable all polyethylene tibial component, designed to be cemented into the tibia and to articulate with an artificial femoral component for a Total Knee Arthroplasty (TKA).

TGA Public Summary