Device Dossier

DURACON CONDYLAR STABILIZING (CS) LIPPED TIBIAL INSERT - Prosthesis, knee, internal, insert component

Device Dossier for DURACON CONDYLAR STABILIZING (CS) LIPPED TIBIAL INSERT - Prosthesis, knee, internal, insert component (Prosthesis, knee, internal,…

Intended purpose

A component of a reconstructive knee system, connects with a tibial base plate and articulates with a femoral knee component. Indications for use of total knee replacement prostheses include: 1) non-inflammatory degenerative joint disease including osteoarthritis, traumatic arthritis or avascular necrosis; 2) rheumatoid arthritis; 3) correction of functional deformity; 4) revision procedures where other treatments or devices have failed; 5) post-traumatic loss of joint anatomy, particularly when there is patello-femoral erosion, dysfunction or prior patellectomy; and, 6) irreparable fracture of the knee.

Functional description

A sterile implantable Tibial Insert, designed to be connected with a Tibial Tray/ Baseplate for fixation and to articulate with an artificial Femoral Component of a Total Knee Arthroplasty (TKA). Designed with an anterior constraint which allows the Posterior Cruciate Ligament to be retained or sacrificed. It is a component of the Duracon Knee System which typically includes Femoral, Tibial, and Patellar components that articulate. Made of Polyethylene (UHWMPE).

TGA Public Summary