PFC Sigma Stabilised GVF Fixed Bearing Tibial Insert with i2 lock - Prosthesis, knee, internal, insert component

Intended purpose

The PFC Sigma Stabilised GVF Fixed Bearing Tibial Insert with i2 lock is the articulating component of a total knee arthroplasty and is intended to provide increased patient mobility and reduced pain by replacing the damaged knee joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components. Total knee replacement may be considered for younger patients if, in the opinion of the surgeon, an unequivocal indication for total knee replacement outweighs the risks associated with the age of the patient, and if limited demands regarding activity and knee joint loading can be assured. This includes severely crippled patients with multiple joint involvement for whom a gain in knee mobility may lead to an expectation of significant improvement in the quality of their lives. Candidates for total knee replacement include patients with a severely painful and/or severely disabled joint resulting from osteoarthritis, post-traumatic arthritis, rheumatoid arthritis, or a failed previous implant.

Functional description

The PFC Sigma Stabilised GVF Fixed Bearing Tibial Insert with i2 lock articulates with the femoral component and locks into the tibial tray by an i2 locking mechanism. It is a one-piece contoured polyethylene insert and packed in gamma vacuum foil (GVF) for increased wear resistance.