FDA-recognized standard · Materials
ISO 13779-2: Implants for surgery - Hydroxyapatite - Part 2: Thermally sprayed coatings of hydroxyapatite
Yes. FDA recognizes ISO 13779-2 Third edition 2018-12 as recognition 8-493, entered 2019-07-15.
Recognized editions of ISO 13779-2
| Recognition | Edition | Entered | Extent | Transition ends |
|---|---|---|---|---|
| 8-493 | ISO 13779-2 Third edition 2018-12 | 2019-07-15 | Complete | — |
Regulations
FDA lists these classification regulations against ISO 13779-2: 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 ISO 13779-2
13 FDA product codes cite ISO 13779-2, 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.