Device Dossier

ORIGIN Patella Cemented - Polyethylene patella prosthesis

Device Dossier for ORIGIN Patella Cemented - Polyethylene patella prosthesis (Polyethylene patella prosthesis, Class III, sponsor Symbios Orthopaedics).…

Intended purpose

A cemented patella component of the ORIGIN Knee System intended to be used in skeletally mature patients to relieve pain, restore knee function, and improve knee mobility by replacing the damaged knee joint in first intention cemented total knee arthroplasty. The device is indicated for patients suffering from a severe painful and/or disabled knee that conservative treatments are no longer considered successful due to: - Painful joint disease due to osteoarthritis, traumatic arthritis, rheumatoid arthritis, polyarthritis, or osteonecrosis of the knee - Moderate varus, valgus, or flexion/extension deformities - Post traumatic loss of joint function - Post osteotomies

Functional description

An all polyethylene asymetric patella component to be cemented onto the patella to replace the bearing surface and allow free movement of a damaged patella on the femoral component. The device has three location lugs and 3 recesses on the back face to allow for strong cement fixation.

TGA Public Summary