Device Dossier

TC-PLUS Patellar Component Polyethylene 3-Peg - Polyethylene patella prosthesis

Device Dossier for TC-PLUS Patellar Component Polyethylene 3-Peg - Polyethylene patella prosthesis (Polyethylene patella prosthesis, Class III, sponsor…

Intended purpose

The TC-PLUS Patellar Component is a sterile, ultra high molecular weight polyethylene patellar component of the TC-PLUS Revision Knee System. Indications for implantation are: - Degenerative or post traumatic arthrosis; - Rheumatoid arthritis; - Avascular necrosis of the femoral condyles; - Joint destruction with restricted function and requirement for additional stabilization with longer stems and reconstruction of bone defects; - Marked contractures and axial deformity less than 20 - 25 degrees; - Failure after surface replacement (e.g. infection, loosening) - Revision of a primary prostheses; - Trauma - induced femoral or tibial fractures.

Functional description

A cemented all-polyethylene (UHMWPE) patellar component with a symmetrical biconcave surface for better tracking. Following resection of the patella, the patellar component is implanted with a slight medial offset matching the position of the natural patellar ridge and may be either inlayed into three drilled anchoring holes or onlayed. Patellar size can be determined using the patellar sizer.

TGA Public Summary