FDA-recognized standard · Orthopedic
ISO 21536: Non-active surgical implants - Joint replacement implants - Specific requirements for knee-joint replacement implants
Yes. FDA recognizes ISO 21536 Third edition 2023-07 as recognition 11-400, entered 2023-09-11.
Recognized editions of ISO 21536
| Recognition | Edition | Entered | Extent | Transition ends |
|---|---|---|---|---|
| 11-400 | ISO 21536 Third edition 2023-07 | 2023-09-11 | Complete | — |
Regulations
FDA lists these classification regulations against ISO 21536: 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 21536
22 FDA product codes cite ISO 21536, 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
- LGE
- LXY
- MBD
- MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
- MBV
- NJD
- NJL
- NPJ
- 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.