Recognized standard
F2723-21
FDA recognition 11-392 · ASTM · Orthopedic
Key facts
| Recognition number | 11-392 |
|---|---|
| Designation | F2723-21 |
| Title | Standard Test Method for Evaluating Mobile Bearing Knee Tibial Baseplate/Bearing Resistance to Dynamic Disassociation |
| Standards developer | ASTM International |
| Specialty area | Orthopedic |
| Date of entry | Dec 20, 2021 |
| Device classes | Class 3 |
| Scope (excerpt) | 1.1 This test method describes a laboratory method for evaluating the potential for mobile bearing knee tibial baseplate/bearing disassociation under repeated forces. 1.2 The test described is applicable to any bicompartmental mobile bearing knee with a bearing retention mechanism. With… |
At a glance
- 1–9 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: