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..
FDA 510(k) Cleared Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented Devices (Product Code JDI)
About Product Code JDI - Regulatory Context
510(k) Submission Activity
562 total 510(k) submissions under product code JDI since 1977, with 562 receiving FDA clearance (average review time: 124 days).
Submission volume has declined in recent years - 3 submissions in the last 24 months compared to 4 in the prior period.
FDA Review Time
Recent submissions under JDI have taken an average of 173 days to reach a decision - up from 124 days historically. Manufacturers should account for longer review timelines in current project planning.
JDI devices are reviewed by the Orthopedic panel. Browse all Orthopedic devices →