FDA Product Code JDI: Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented

Cemented hip replacement has decades of clinical evidence supporting its durability. FDA product code JDI covers cemented semi-constrained hip prostheses with metal and polymer bearing surfaces.

These implants use bone cement — typically polymethylmethacrylate — to fix the femoral stem and acetabular component to the surrounding bone. Cemented fixation provides immediate stability and is preferred in elderly patients with poor bone quality.

JDI devices are Class II medical devices, regulated under 21 CFR 888.3350 and reviewed by the FDA Orthopedic panel.

Leading manufacturers include Biomet, Inc., Depuy, Inc. and Howmedica Corp..