Recognized standard
F3210-22e1
FDA recognition 11-397 · ASTM · Orthopedic
Key facts
| Recognition number | 11-397 |
|---|---|
| Designation | F3210-22e1 |
| Title | Standard Test Method for Fatigue Testing of Total Knee Femoral Components Under Closing Conditions |
| Standards developer | ASTM International |
| Specialty area | Orthopedic |
| Date of entry | Dec 19, 2022 |
| Device classes | Class 2, Class 3 |
| Scope (excerpt) | 1.1 This standard applies to metallic total knee femoral components used in total knee arthroplasty (TKA). Femoral components made of nonmetallic materials (for example, ceramic, polymer) could possibly be evaluated using this test method. However, such materials may include risks of new failure… |
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: