FDA-recognized standard · Orthopedic
ISO 7206-2: Implants for surgery - Partial and total hip joint prostheses - Part 2: Articulating surfaces made of metallic ceramic and plastics materials [Including AMENDMENT1 (2016) ]
Yes. FDA recognizes ISO 7206-2 Third edition 2011-04-01 AMENDMENT 1 2016-09-15 as recognition 11-339, entered 2018-09-17.
Recognized editions of ISO 7206-2
| Recognition | Edition | Entered | Extent | Transition ends |
|---|---|---|---|---|
| 11-339 | ISO 7206-2 Third edition 2011-04-01 AMENDMENT 1 2016-09-15 | 2018-09-17 | Complete | — |
Regulations
FDA lists these classification regulations against ISO 7206-2: 21 CFR 888.3300, 21 CFR 888.3310, 21 CFR 888.3320, 21 CFR 888.3330, 21 CFR 888.3340, 21 CFR 888.3350, 21 CFR 888.3353, 21 CFR 888.3358, 21 CFR 888.3360, 21 CFR 888.3390, 21 CFR 888.3410.
Product codes that cite ISO 7206-2
24 FDA product codes cite ISO 7206-2, including JDD, JDG, JDI, JDL, KMC.
- JDD
- JDG
- JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
- JDL
- KMC
- KWA
- KWL Prosthesis, Hip, Hemi-, Femoral, Metal
- KWY Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
- KWZ
- KXB
- KXD
- LPF
- 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
- OCG
- 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.