Device Dossier

PFC Sigma Curved RP Insert - Prosthesis, knee, internal, insert component

Device Dossier for PFC Sigma Curved RP Insert - Prosthesis, knee, internal, insert component (Prosthesis, knee, internal, insert component, Class III,…

Intended purpose

The PFC Sigma Curved RP Insert is the articulating component of a total knee arthroplasty and is intended to replace the damaged knee joint articulation in patients with osteoarthritis and rheumatoid arthritis. Indicated for use in skeletally mature individuals undergoing primary surgery for reconstructing knees damaged as a result of noninflammatory degenerative joint disease (NIDJD) or either of its composite diagnoses of osteoarthritis and post-traumatic arthritis pathologies and for revision of failed knee prostheses.

Functional description

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

TGA Public Summary