Device Dossier
Zimmer® Unicompartmental Knee System, All-Poly Tibial Component - Prosthesis, knee, internal, insert component
Device Dossier for Zimmer® Unicompartmental Knee System, All-Poly Tibial Component - Prosthesis, knee, internal, insert component (Prosthesis, knee,…
- GMDN category: Prosthesis, knee, internal, insert component
Intended purpose
The Zimmer® Unicompartmental Knee System, All-Poly Tibial Component is an implantable device used to repair or replace the tibial components of a knee joint prosthesis, for patients with: - Painful and/or disabling knee joints due to osteoarthritis or traumatic arthritis. - Previous tibial condyle or plateau fractures with loss of anatomy or function. - Varus or valgus deformities. It is designed for use when load bearing ROM is expected to be less than or equal to 155 degrees.
Functional description
All-Poly Tibial Component of the Unicompartmental Knee System is designed for the surface reconstruction of individual tibial condyles.Stable implant fixation is provided by 2 hourglass-shaped pegs projecting into the tibial bone & by multiple machined islands undercut about their perimeters for cement interdigitation.Composed of Ultra-High Molecular Weight polyethylene, except for a 316L stainless steel radiographic indicator wire embedded in the polyethylene.Intended for cemented fixation only