Recognized standard
F3140-23
FDA recognition 11-407 · ASTM · Orthopedic
Key facts
| Recognition number | 11-407 |
|---|---|
| Designation | F3140-23 |
| Title | Standard Test Method for Cyclic Fatigue Testing of Metal Tibial Tray Components of Unicondylar Knee Joint Replacements |
| Standards developer | ASTM International |
| Specialty area | Orthopedic |
| Date of entry | Dec 18, 2023 |
| Device classes | Class 2, Class 3 |
| Scope (excerpt) | 1.1 This test method covers a procedure for the fatigue testing of metallic tibial trays used in partial knee joint replacements. 1.2 This test method covers the procedures for the performance of fatigue tests on metallic tibial components using a cyclic, constant-amplitude force. It applies to… |
At a glance
- 1–9 Product codes
- 1–9 FDA guidance documents
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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: