Device Dossier

PFC Sigma Rotating Platform Stabilised Tibial Insert - Prosthesis, knee, internal, insert component

Device Dossier for PFC Sigma Rotating Platform Stabilised Tibial Insert - Prosthesis, knee, internal, insert component (Prosthesis, knee, internal,…

Intended purpose

The PFC Sigma RP Stabilised Tibial Insert 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 RP Stabilised Insert articulates with the femoral component and rotates on the suface tibial tray of a knee joint prosthesis. It is a one-piece contoured polymer insert.

TGA Public Summary