FDA-recognized standard · Orthopedic
ISO 14243-2: Implants for surgery - Wear of total knee-joint prostheses - Part 2: Methods of measurement
Yes. FDA recognizes ISO 14243-2 Third edition 2016-09-01 as recognition 11-311, entered 2016-12-23.
Recognized editions of ISO 14243-2
| Recognition | Edition | Entered | Extent | Transition ends |
|---|---|---|---|---|
| 11-311 | ISO 14243-2 Third edition 2016-09-01 | 2016-12-23 | Complete | — |
Regulations
FDA lists these classification regulations against ISO 14243-2: 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 14243-2
14 FDA product codes cite ISO 14243-2, 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
- 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.