Device Dossier

Zimmer Segmental System, Polyethylene Insert XT - Uncoated knee femur prosthesis

Device Dossier for Zimmer Segmental System, Polyethylene Insert XT - Uncoated knee femur prosthesis (Uncoated knee femur prosthesis, Class III, sponsor…

Intended purpose

The Polyethylene Insert XT is part of the Zimmer Segmental System and is indicated for moderate to severe knee instability, significant bone loss and/or ligament deficiencies caused by neoplasms, trauma, rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, and/or avascular necrosis of the proximal and/or distal femur and/or proximal tibia; Valgus, varus or flexion deformities; The salvage of previously failed surgical attempts.

Functional description

The ZSS Poly Insert is designed to have greater resistance to increased forces with a corresponding projection to the cavity in the XT femoral component. Features a raised boss anteriorly that nests into a corresponding recess in the XT Distal Femur at full knee extension, providing a hyperextension stop with greater polyethylene thickness and larger surface area of contact than existed previously. Made with UHMWPE.

TGA Public Summary