FDA-recognized standard · Orthopedic
ISO 11491: Implants for surgery - Determination of impact resistance of ceramic femoral heads for hip joint prostheses
Yes. FDA recognizes ISO 11491 First edition 2017-07 as recognition 11-338, entered 2018-09-17.
Recognized editions of ISO 11491
| Recognition | Edition | Entered | Extent | Transition ends |
|---|---|---|---|---|
| 11-338 | ISO 11491 First edition 2017-07 | 2018-09-17 | Complete | — |
Regulations
FDA lists these classification regulations against ISO 11491: 21 CFR 888.3350, 21 CFR 888.3353, 21 CFR 888.3358, 21 CFR 888.3360, 21 CFR 888.3390.
Product codes that cite ISO 11491
11 FDA product codes cite ISO 11491, including JDI, KWY, LPF, LWJ, LZO.
- JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
- KWY Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
- LPF
- LWJ
- LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
- MAY
- MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
- MRA
- OQG
- OQH
- 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.