FDA-recognized standard · Materials
ASTM F2820: Standard Specification for Polyetherketoneketone (PEKK) Polymers for Surgical Implant Applications
Yes. FDA recognizes ASTM F2820-24 as recognition 8-643, entered 2025-12-22. FDA also lists ASTM F2820-12(2021)e1 (recognition 8-574, transition period ending 2027-12-19).
Recognized editions of ASTM F2820
| Recognition | Edition | Entered | Extent | Transition ends |
|---|---|---|---|---|
| 8-643 | ASTM F2820-24 | 2025-12-22 | Complete | — |
| 8-574 | ASTM F2820-12(2021)e1 | 2021-12-20 | Complete | 2027-12-19 |
Regulations
FDA lists these classification regulations against ASTM F2820: 21 CFR 888.3030, 21 CFR 888.3040, 21 CFR 888.3060, 21 CFR 888.3070.
Product codes that cite ASTM F2820
12 FDA product codes cite ASTM F2820, including HRS, HWC, JDO, JDP, KTT.
- HRS Plate, Fixation, Bone
- HWC Screw, Fixation, Bone
- JDO
- JDP
- KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
- KTW
- KWK
- LXT
- MNH
- MNI
- MQP Spinal Vertebral Body Replacement Device
- NKB Thoracolumbosacral Pedicle Screw System
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.