Recognized standard
F2345-21
FDA recognition 11-385 · ASTM · Orthopedic
Key facts
| Recognition number | 11-385 |
|---|---|
| Designation | F2345-21 |
| Title | Standard Test Methods for Determination of Cyclic Fatigue Strength of Ceramic Modular Femoral Heads |
| Standards developer | ASTM International |
| Specialty area | Orthopedic |
| Date of entry | Dec 20, 2021 |
| Device classes | Class 3, Class 2 |
| Scope (excerpt) | 1.1 These test methods cover the evaluation of the cyclic fatigue strength of ceramic modular femoral heads, mounted on a cone as used on the femoral stem of the total hip arthroplasty. 1.2 These test methods were primarily developed for evaluation of ceramic (Specification F603, ISO 6474-1, ISO… |
At a glance
- 10–99 Product codes
- 1–9 FDA guidance documents
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA-recognized consensus standards
The FDA recognizes voluntary consensus standards that manufacturers can cite in premarket submissions to show conformity with specific requirements.
Source: U.S. Food and Drug Administration (FDA), Recognized Consensus Standards database · Source date: