Coated knee tibia prosthesis

A coated knee tibia prosthesis is a sterile implantable device used to replace the tibial component of the knee joint during primary total knee arthroplasty or revision surgery. It is constructed from metal, such as cobalt-chrome, and features a surface coating—such as hydroxyapatite, beads, or mesh—designed to enhance bone ingrowth and improve long-term fixation and stability of the implant.

This category of device is intended for implantation with or without bone cement and articulates with a tibial insert and femoral prosthesis to restore knee joint function. Regulatory oversight applies to these implants as active implantable medical devices, with classification and conformity assessment requirements determined by the specific jurisdiction and intended use, based on their role in load-bearing joint replacement.