FDA-recognized standard · Materials
ISO 13179-1: Implants for surgery -- Coatings on metallic surgical implants -- Part 1: Plasma-sprayed coatings derived from titanium or titanium-6 aluminum-4 vanadium alloy powders
Yes. FDA recognizes ISO 13179-1 Second Edition 2021-09 as recognition 8-577, entered 2021-12-20.
Recognized editions of ISO 13179-1
| Recognition | Edition | Entered | Extent | Transition ends |
|---|---|---|---|---|
| 8-577 | ISO 13179-1 Second Edition 2021-09 | 2021-12-20 | Complete | — |
Regulations
FDA lists these classification regulations against ISO 13179-1: 21 CFR 888.3030, 21 CFR 888.3040, 21 CFR 888.3060, 21 CFR 888.3070, 21 CFR 888.3080, 21 CFR 888.3110, 21 CFR 888.3353, 21 CFR 888.3358, 21 CFR 888.3535, 21 CFR 888.3565, 21 CFR 888.3670, 21 CFR 888.3800.
Product codes that cite ISO 13179-1
13 FDA product codes cite ISO 13179-1, including HRS, HSN, HWC, JWJ, LPH.
- HRS Plate, Fixation, Bone
- HSN Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer
- HWC Screw, Fixation, Bone
- JWJ
- LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
- LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
- MAX Intervertebral Fusion Device With Bone Graft, Lumbar
- MBF Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented
- MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
- MBL
- MNI
- NJD
- OJB
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.