FDA-recognized standard · Materials
ASTM F2026: Standard Specification for Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications
Yes. FDA recognizes ASTM F2026-23 as recognition 8-609, entered 2023-12-18. FDA also lists ASTM F2026-17 (recognition 8-475, transition period ending 2026-12-20).
Recognized editions of ASTM F2026
| Recognition | Edition | Entered | Extent | Transition ends |
|---|---|---|---|---|
| 8-609 | ASTM F2026-23 | 2023-12-18 | Complete | — |
| 8-475 | ASTM F2026-17 | 2018-09-17 | Complete | 2026-12-20 |
Regulations
FDA lists these classification regulations against ASTM F2026: 21 CFR 888.3030, 21 CFR 888.3040, 21 CFR 888.3060, 21 CFR 888.3070.
Product codes that cite ASTM F2026
12 FDA product codes cite ASTM F2026, 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.