FDA-recognized standard · Orthopedic
ASTM F3161: Standard Test Method for Finite Element Analysis (FEA) of Metallic Orthopaedic Total Knee Femoral Components under Closing Conditions
Yes. FDA recognizes ASTM F3161-24 as recognition 11-410, entered 2024-12-23. FDA also lists ASTM F3161-16 (recognition 11-308, transition period ending 2026-12-20).
Recognized editions of ASTM F3161
| Recognition | Edition | Entered | Extent | Transition ends |
|---|---|---|---|---|
| 11-410 | ASTM F3161-24 | 2024-12-23 | Complete | — |
| 11-308 | ASTM F3161-16 | 2016-06-27 | Complete | 2026-12-20 |
Regulations
FDA lists these classification regulations against ASTM F3161: 21 CFR 888.3490, 21 CFR 888.3500, 21 CFR 888.3520, 21 CFR 888.3530, 21 CFR 888.3560, 21 CFR 888.3565.
Product codes that cite ASTM F3161
13 FDA product codes cite ASTM F3161, including HRY, HSX, JWH, KMB, KTX.
- HRY
- HSX Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer
- JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
- KMB
- KTX
- KYK
- LGE
- 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.