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 an articulating component of the LCS Complete – PFC Sigma RP Mobile Bearing Total Knee System. The LCS Complete – PFC Sigma RP Mobile Bearing Total Knee System is intended for cemented use in cases of osteoarthritis and rheumatoid arthritis. The rotating platform stabilised insert is indicated where a higher than normal degree of post-operative flexion is required. The porous coated keeled and non-keeled MBT (Mobile Bearing Tibial) Tray configurations of the LCS Total Knee System are indicated for noncemented 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. The Rotating platform device configuration is indicated for use in knees whose anterior and posterior cruciate ligaments are absent or are in such condition as to justify their sacrifice. The PFC Sigma Curved bearings when used with the PFC Sigma Cruciate Retaining femoral component can be used in posterior cruciate ligament retaining procedures.

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