Device Dossier

PFC Sigma Curved GVF Insert (I2 lock) - Prosthesis, knee, internal, insert component

Device Dossier for PFC Sigma Curved GVF Insert (I2 lock) - Prosthesis, knee, internal, insert component (Prosthesis, knee, internal, insert component,…

Intended purpose

The PFC Sigma Curved GVF Insert (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.

Functional description

The PFC Sigma Curved GVF Insert (I2 lock) articulates with the femoral component and snap locks into the tibial tray of a knee joint prosthesis. It is a one-piece contoured polyethylene insert.

TGA Public Summary