FDA-recognized standard · Orthopedic
ASTM F3334: Standard Practice for Finite Element Analysis (FEA) of Metallic Orthopaedic Total Knee Tibial Components
Yes. FDA recognizes ASTM F3334-19 as recognition 11-368, entered 2020-07-06.
Recognized editions of ASTM F3334
| Recognition | Edition | Entered | Extent | Transition ends |
|---|---|---|---|---|
| 11-368 | ASTM F3334-19 | 2020-07-06 | Complete | — |
Regulations
FDA lists these classification regulations against ASTM F3334: 21 CFR 888.3480, 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 F3334
12 FDA product codes cite ASTM F3334, including HRY, HSX, JWH, KRN, KRP.
- HRY
- HSX Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer
- JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
- KRN
- KRP
- KRQ
- LXY
- MBD
- MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
- MBV
- NJL
- 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.