FDA-recognized standard · Orthopedic
ISO 21535: Non-active surgical implants - Joint replacement implants - Specific requirements for hip-joint replacement implants
Yes. FDA recognizes ISO 21535 Third edition 2023-07 as recognition 11-401, entered 2023-09-11.
Recognized editions of ISO 21535
| Recognition | Edition | Entered | Extent | Transition ends |
|---|---|---|---|---|
| 11-401 | ISO 21535 Third edition 2023-07 | 2023-09-11 | Complete | — |
Regulations
FDA lists these classification regulations against ISO 21535: 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 888.3370, 21 CFR 888.3380, 21 CFR 888.3390, 21 CFR 888.3400, 21 CFR 888.3410.
Product codes that cite ISO 21535
30 FDA product codes cite ISO 21535, including JDD, JDG, JDH, JDI, JDL.
- JDD
- JDG
- JDH
- JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
- JDL
- KMC
- KWA
- KWB
- KWL Prosthesis, Hip, Hemi-, Femoral, Metal
- KWY Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
- KWZ
- KXA
- 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
- LZY
- MAY
- MBL
- MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
- MRA
- NXT
- OCG
- 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.