Device Dossier

SAIPH APS Knee Fixed Tibial Tray Cemented - Uncoated knee tibia prosthesis, metallic

Device Dossier for SAIPH APS Knee Fixed Tibial Tray Cemented - Uncoated knee tibia prosthesis, metallic (Uncoated knee tibia prosthesis, metallic, Class…

Intended purpose

The Saiph cemented fixed tibial tray 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 APS Knee fixed tibial tray is part of the Saiph Knee that features a spherical ball-and-socket geometry on the medial condyle. This design provides a unique level of stability with full congruency maintained throughout flexion and internal tibial rotation. The lateral geometry is designed to permit limited rollback in flexion whilst acting as a stabilising outrigger.

TGA Public Summary