FDA-recognized standard · Materials
ASTM F1185: Standard Specification for Composition of Hydroxylapatite for Surgical Implants
Yes. FDA recognizes ASTM F1185-03 (Reapproved 2014) as recognition 8-427, entered 2016-06-27.
Recognized editions of ASTM F1185
| Recognition | Edition | Entered | Extent | Transition ends |
|---|---|---|---|---|
| 8-427 | ASTM F1185-03 (Reapproved 2014) | 2016-06-27 | Complete | — |
Regulations
FDA lists these classification regulations against ASTM F1185: 21 CFR 888.3045, 21 CFR 888.3353, 21 CFR 888.3358, 21 CFR 888.3535, 21 CFR 888.3565, 21 CFR 888.3670.
Product codes that cite ASTM F1185
13 FDA product codes cite ASTM F1185, including LPH, LZO, MAY, MBF, MBH.
- LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
- LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
- MAY
- MBF Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented
- MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
- MBL
- MBP
- MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
- MQV Filler, Bone Void, Calcium Compound
- NJD
- 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.