FDA-recognized standard · Orthopedic
ISO 14879-1: Implants for surgery - Total knee-joint prostheses - Part 1: Determination of endurance properties of knee tibial trays
Yes. FDA recognizes ISO 14879-1 Second edition 2020-07 as recognition 11-370, entered 2020-12-21.
Recognized editions of ISO 14879-1
| Recognition | Edition | Entered | Extent | Transition ends |
|---|---|---|---|---|
| 11-370 | ISO 14879-1 Second edition 2020-07 | 2020-12-21 | Complete | — |
Regulations
FDA lists these classification regulations against ISO 14879-1: 21 CFR 888.3480, 21 CFR 888.3510, 21 CFR 888.3520, 21 CFR 888.3530, 21 CFR 888.3550, 21 CFR 888.3560, 21 CFR 888.3565.
Product codes that cite ISO 14879-1
11 FDA product codes cite ISO 14879-1, including HRY, HSX, JWH, KRN, KRO.
- HRY
- HSX Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer
- JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
- KRN
- KRO Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer
- KRP
- KRQ
- LXY
- MBD
- MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
- MBV
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.