FDA-recognized standard · Orthopedic
ASTM F382: Standard Specification and Test Method for Metallic Bone Plates
Yes. FDA recognizes ASTM F382-24 as recognition 11-414, entered 2024-12-23. FDA also lists ASTM F382-17 (recognition 11-333, transition period ending 2026-12-20).
Recognized editions of ASTM F382
| Recognition | Edition | Entered | Extent | Transition ends |
|---|---|---|---|---|
| 11-414 | ASTM F382-24 | 2024-12-23 | Complete | — |
| 11-333 | ASTM F382-17 | 2018-09-17 | Complete | 2026-12-20 |
Regulations
FDA lists these classification regulations against ASTM F382: 21 CFR 888.3030, 21 CFR 888.4540.
Product codes that cite ASTM F382
8 FDA product codes cite ASTM F382, including HRS, HXP, HXW, JDP, KTT.
- HRS Plate, Fixation, Bone
- HXP
- HXW
- JDP
- KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
- KTW
- KWK
- 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.