FDA-recognized standard · Orthopedic
ISO 7207-1: Implants for surgery - Components for partial and total knee joint prostheses - Part 1: Classification definitions and designation of dimensions
Yes. FDA recognizes ISO 7207-1 Third edition 2007-02-01 as recognition 11-232, entered 2014-01-30.
Recognized editions of ISO 7207-1
| Recognition | Edition | Entered | Extent | Transition ends |
|---|---|---|---|---|
| 11-232 | ISO 7207-1 Third edition 2007-02-01 | 2014-01-30 | Complete | — |
Regulations
FDA lists these classification regulations against ISO 7207-1: 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 888.3535, 21 CFR 888.3540, 21 CFR 888.3550, 21 CFR 888.3560, 21 CFR 888.3565.
Product codes that cite ISO 7207-1
20 FDA product codes cite ISO 7207-1, including HRY, HRZ, HSX, JWH, KMB.
- HRY
- HRZ
- 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
- KRR
- KTX
- KYK
- LXY
- MBD
- MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
- MBV
- NJD
- NJL
- NRA
- 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.