Device Dossier

SAIPH Patella Cemented - Polyethylene patella prosthesis

Device Dossier for SAIPH Patella Cemented - Polyethylene patella prosthesis (Polyethylene patella prosthesis, Class III, sponsor MatOrtho). ARTG record,…

Intended purpose

The Saiph cemented patella forms part of the Saiph Knee System that is intended for use of joint replacement prostheses include: 1) painful and disabled joint resulting from osteoarthritis, rheumatoid arthritis where one or more compartments are involved, 2) failure of previous joint replacement procedure, 3) correction of varus, valgus, or post traumatic deformity, and 4) correction or revision of unsuccessful osteotomy or arthrodesis.

Functional description

The Saiph cemented patella is designed to track smoothly throughout the range of motion, preventing anterior knee pain, clunking and crepitus.

TGA Public Summary