Recognized standard
F2777-23
FDA recognition 11-408 · ASTM · Orthopedic
Key facts
| Recognition number | 11-408 |
|---|---|
| Designation | F2777-23 |
| Title | Standard Test Method for Evaluating Knee Bearing (Tibial Insert) Endurance and Deformation Under High Flexion |
| Standards developer | ASTM International |
| Specialty area | Orthopedic |
| Date of entry | Dec 18, 2023 |
| Device classes | Class 2, Class 3 |
| Scope (excerpt) | 1.1 This standard specifies a test method for determining the endurance properties and deformation, under specified laboratory conditions, of ultra high molecular weight polyethylene (UHMWPE) tibial bearing components used in bicompartmental or tricompartmental knee prosthesis designs. 1.2 This test… |
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: