Device Dossier
Zimmer® Segmental System, Trabecular Metal™ Proximal Tibial Component - Uncoated knee tibia prosthesis, metallic
Device Dossier for Zimmer® Segmental System, Trabecular Metal™ Proximal Tibial Component - Uncoated knee tibia prosthesis, metallic (Uncoated knee tibia…
- GMDN category: Uncoated knee tibia prosthesis, metallic
Intended purpose
The Proximal Tibial component of the Zimmer® Segmental System 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 proximal tibia, valgus, varus or flexion deformities, the salvage of previously failed surgical attempts.
Functional description
Proximal Tibial component of the Zimmer® Segmental System replaces the proximal tibia. Rotating platform allows the articular surface to rotate 25° in either direction (total rotation of 50°). Largely manufactured from Zimaloy® Co-Cr-Mo alloy, an UHMWPE bushing extends distally from the proximal articulating surface tray to mate with Segmental hinge post. Trabecular Metal pad allows biologic fixation of tissue, bonded to the lateral side with titanium as a bonding interlayer. For cemented use.