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 Howmedica Osteonics Corp., Dba Stryker Orthopaedics, Zimmer, Inc. and Microport Orthopedics, Inc..
List of Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented devices cleared through 510(k)
How to use this database
This page lists all FDA 510(k) submissions for Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented devices (product code JDI). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.
These devices fall under the Orthopedic FDA review panel. Browse all Orthopedic devices →