FDA-recognized standard · Orthopedic
ISO 14242-4: Implants for surgery - Wear of total hip-joint prostheses - Part 4: Testing hip prostheses under variations in component positioning which results in direct edge loading
Yes. FDA recognizes ISO 14242-4 First edition 2018-05 as recognition 11-358, entered 2019-07-15.
Recognized editions of ISO 14242-4
| Recognition | Edition | Entered | Extent | Transition ends |
|---|---|---|---|---|
| 11-358 | ISO 14242-4 First edition 2018-05 | 2019-07-15 | Complete | — |
Regulations
FDA lists these classification regulations against ISO 14242-4: 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 14242-4
23 FDA product codes cite ISO 14242-4, including JDI, JDL, KMC, KWA, KWY.
- JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
- JDL
- KMC
- KWA
- 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
- 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.