Recognized standard
F2722-21
FDA recognition 11-391 · ASTM · Orthopedic
Key facts
| Recognition number | 11-391 |
|---|---|
| Designation | F2722-21 |
| Title | Standard Practice for Evaluating Mobile Bearing Knee Tibial Baseplate Rotational Stops |
| Standards developer | ASTM International |
| Specialty area | Orthopedic |
| Date of entry | Dec 20, 2021 |
| Device classes | Class 3 |
| Scope (excerpt) | 1.1 This practice covers a laboratory-based in-vitro method for evaluating the mechanical performance of materials and devices being considered for replacement of the tibio-femoral joint in human knee joint replacement prostheses in mobile bearing knee systems. 1.2 Mobile bearing knee systems permit… |
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: