Device Dossier

Scorpio HA Tibial Tray - Coated knee tibia prosthesis

Device Dossier for Scorpio HA Tibial Tray - Coated knee tibia prosthesis (Coated knee tibia prosthesis, Class III, sponsor Stryker). ARTG record,…

Intended purpose

A total knee implant intended to be used in primary or revision joint arthroplasty of the knee. Indications for use of total knee replacement include: Painful, disabling joint disease of the knee resulting from: degenerative arthritis, rheumatoid arthritis or post-traumatic arthritis. Post-traumatic loss of knee joint configuration and function. Moderate varus, valgus, or flexion deformity in which the ligamentous structures can be returned to adequate function and stability. Revision of previous unsuccessful knee replacement or other procedure.

Functional description

This Total Knee System includes femoral, patella, tibial tray, tibal bearing and bone augmentation components which are designed to be used together to achieve total reconstructive replacement of the knee joint. These Tibial Tray components are permanently implantable and are available in various sizes to address varying patient and surgeon requirements for primary and revision applications. All devices feature a coating of HA on their external surface to encourage bone in growth.

TGA Public Summary