FDA-recognized standard · Orthopedic
ASTM F384: Standard Specifications and Test Methods for Metallic Angled Orthopedic Fracture Fixation Devices
Yes. FDA recognizes ASTM F384-24 as recognition 11-431, entered 2025-12-22. FDA also lists ASTM F384-17 (recognition 11-326, transition period ending 2027-12-19).
Recognized editions of ASTM F384
| Recognition | Edition | Entered | Extent | Transition ends |
|---|---|---|---|---|
| 11-431 | ASTM F384-24 | 2025-12-22 | Complete | — |
| 11-326 | ASTM F384-17 | 2018-09-17 | Complete | 2027-12-19 |
Regulations
FDA lists these classification regulations against ASTM F384: 21 CFR 888.3020, 21 CFR 888.3030.
Product codes that cite ASTM F384
6 FDA product codes cite ASTM F384, including HSB, JDO, JDS, KTT, KTW.
- HSB Rod, Fixation, Intramedullary And Accessories
- JDO
- JDS
- KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
- KTW
- LXT
Source: FDA Recognized Consensus Standards database, snapshot of 2026-09-01. Search every recognition in the Consensus Standards Lookup, or browse all standards with a page.