FDA-recognized standard · Orthopedic
ASTM F1223: Standard Test Method for Determination of Total Knee Replacement Constraint
Yes. FDA recognizes ASTM F1223-20 as recognition 11-373, entered 2020-12-21.
Recognized editions of ASTM F1223
| Recognition | Edition | Entered | Extent | Transition ends |
|---|---|---|---|---|
| 11-373 | ASTM F1223-20 | 2020-12-21 | Complete | — |
Regulations
FDA lists these classification regulations against ASTM F1223: 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 ASTM F1223
14 FDA product codes cite ASTM F1223, 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.