FDA-recognized standard · Orthopedic
ASTM F2345: Standard Test Methods for Determination of Cyclic Fatigue Strength of Ceramic Modular Femoral Heads
Yes. FDA recognizes ASTM F2345-21 as recognition 11-385, entered 2021-12-20.
Recognized editions of ASTM F2345
| Recognition | Edition | Entered | Extent | Transition ends |
|---|---|---|---|---|
| 11-385 | ASTM F2345-21 | 2021-12-20 | Complete | — |
Regulations
FDA lists these classification regulations against ASTM F2345: 21 CFR 888.3300, 21 CFR 888.3310, 21 CFR 888.3320, 21 CFR 888.3330, 21 CFR 888.3340, 21 CFR 888.3350, 21 CFR 888.3353, 21 CFR 888.3358, 21 CFR 888.3360, 21 CFR 888.3390.
Product codes that cite ASTM F2345
23 FDA product codes cite ASTM F2345, including JDD, JDG, JDI, JDL, KMC.
- JDD
- JDG
- JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
- JDL
- KMC
- KWA
- KWL Prosthesis, Hip, Hemi-, Femoral, Metal
- KWY Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
- KWZ
- KXD
- LPF
- LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
- LWJ
- LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
- MAY
- MBL
- MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
- MRA
- OQG
- OQH
- OQI
- OVO
- PBI
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.