FDA-recognized standard · Materials
ASTM F2224: Standard Specification for High Purity Calcium Sulfate Hemihydrate or Dihydrate for Surgical Implants
Yes. FDA recognizes ASTM F2224-09 (Reapproved 2020) as recognition 8-429, entered 2016-06-27.
Recognized editions of ASTM F2224
| Recognition | Edition | Entered | Extent | Transition ends |
|---|---|---|---|---|
| 8-429 | ASTM F2224-09 (Reapproved 2020) | 2016-06-27 | Complete | — |
Regulations
FDA lists these classification regulations against ASTM F2224: 21 CFR 888.3045, 21 CFR 888.3353, 21 CFR 888.3358.
Product codes that cite ASTM F2224
10 FDA product codes cite ASTM F2224, including LPH, LZO, MAY, MBL, MBP.
- LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
- LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
- MAY
- MBL
- MBP
- MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
- MQV Filler, Bone Void, Calcium Compound
- OIS
- OQG
- OQI
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.