Device Dossier

-PFC Sigma Tibial Inserts Fixed Bearing TC3 - Prosthesis, knee, internal, insert component

Device Dossier for -PFC Sigma Tibial Inserts Fixed Bearing TC3 - Prosthesis, knee, internal, insert component (Prosthesis, knee, internal, insert…

Intended purpose

The SIGMA Revision Knee System is intended to replace articulating elements of a damaged knee joint where there is evidence of sufficient sound bone to seat and support the components.

Functional description

The PFC Sigma TC3 Fixed Bearing Inserts are made from UHMWPE and reinforced with titanium pins. The pin is part of the spine and protrudes down through the bottom of the insert. It is inserted into the hole of the modular tibial tray. The PFC Sigma TC3 Fixed Bearing Insert locks into the tibial tray and articulates with the femoral component. P.F.C Sigma TC3 Tibial Fixed Bearing Inserts are offered in the same sizes as the femoral components with dimensions that correspond to the tibial tray.

TGA Public Summary