FDA-recognized standard · Orthopedic
ISO 7206-12: Implants for surgery - Partial and total hip joint prostheses - Part 12: Deformation test method for press-fit acetabular components
Yes. FDA recognizes ISO 7206-12 Second edition 2025-11 as recognition 11-442, entered 2026-05-25. FDA also lists ISO 7206-12 First edition 2016-10-01 (recognition 11-319, transition period ending 2028-07-02).
Recognized editions of ISO 7206-12
| Recognition | Edition | Entered | Extent | Transition ends |
|---|---|---|---|---|
| 11-442 | ISO 7206-12 Second edition 2025-11 | 2026-05-25 | Complete | — |
| 11-319 | ISO 7206-12 First edition 2016-10-01 | 2016-12-23 | Complete | 2028-07-02 |
Regulations
FDA lists these classification regulations against ISO 7206-12: 21 CFR 888.3300, 21 CFR 888.3310, 21 CFR 888.3330, 21 CFR 888.3340, 21 CFR 888.3350, 21 CFR 888.3353, 21 CFR 888.3358, 21 CFR 888.3360.
Product codes that cite ISO 7206-12
17 FDA product codes cite ISO 7206-12, including KMC, KWA, KWZ, KXD, LPH.
- KMC
- KWA
- KWZ
- KXD
- LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
- LWJ
- LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
- MAY
- MBL
- MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
- MRA
- NXT
- OQG
- OQH
- OQI
- OVO
- PBI
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.