Recognized standard
F1223-20
FDA recognition 11-373 · ASTM · Orthopedic
Key facts
| Recognition number | 11-373 |
|---|---|
| Designation | F1223-20 |
| Title | Standard Test Method for Determination of Total Knee Replacement Constraint |
| Standards developer | ASTM International |
| Specialty area | Orthopedic |
| Date of entry | Dec 21, 2020 |
| Device classes | Class 3, Class 2, LXY, MBD |
| Scope (excerpt) | 1.1 This test method may be used to compare the constraint characteristics of total knee replacements (TKRs) with the intent of comparing new designs to existing clinically successful designs or to determine the constraint differences between two similar or dissimilar designs. 1.2 This test method… |
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: