FDA-recognized standard · Orthopedic
ISO 7207-2: Implants for surgery - Components for partial and total knee joint prostheses - Part 2: Articulating surfaces made of metal ceramic and plastics materials
Yes. FDA recognizes ISO 7207-2 Third edition 2025-08 as recognition 11-436, entered 2025-12-22. FDA also lists ISO 7207-2 Second edition 2011-07-01 (recognition 11-374, transition period ending 2027-12-19).
Recognized editions of ISO 7207-2
| Recognition | Edition | Entered | Extent | Transition ends |
|---|---|---|---|---|
| 11-436 | ISO 7207-2 Third edition 2025-08 | 2025-12-22 | Complete | — |
| 11-374 | ISO 7207-2 Second edition 2011-07-01 | 2020-12-21 | Complete | 2027-12-19 |
Regulations
FDA lists these classification regulations against ISO 7207-2: 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 888.3535, 21 CFR 888.3540, 21 CFR 888.3550, 21 CFR 888.3560, 21 CFR 888.3565.
Product codes that cite ISO 7207-2
20 FDA product codes cite ISO 7207-2, 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.