FDA-recognized standard · Orthopedic
ISO 14243-3: Implants for surgery - Wear of total knee-joint prostheses - Part 3: Loading and displacement parameters for wear-testing machines with displacement control and corresponding environmental conditions for test [Including AMENDMENT1 (2020)]
Yes. FDA recognizes ISO 14243-3 Second edition 2014-11-01 as recognition 11-367, entered 2020-07-06.
Recognized editions of ISO 14243-3
| Recognition | Edition | Entered | Extent | Transition ends |
|---|---|---|---|---|
| 11-367 | ISO 14243-3 Second edition 2014-11-01 | 2020-07-06 | Complete | — |
Regulations
FDA lists these classification regulations against ISO 14243-3: 21 CFR 888.3480, 21 CFR 888.3490, 21 CFR 888.3500, 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 14243-3
14 FDA product codes cite ISO 14243-3, including HRY, HSX, JWH, KMB, KRN.
- HRY
- HSX Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer
- JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
- KMB
- KRN
- KRO Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer
- KRP
- KRQ
- KTX
- KYK
- LXY
- MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
- MBV
- OIY
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.