Recognized standard
F1800-19 e1
FDA recognition 11-365 · ASTM · Orthopedic
Key facts
| Recognition number | 11-365 |
|---|---|
| Designation | F1800-19 e1 |
| Title | Standard Practice for Cyclic Fatigue Testing of Metal Tibial Tray Components of Total Knee Joint Replacements |
| Standards developer | ASTM International |
| Specialty area | Orthopedic |
| Date of entry | Jul 6, 2020 |
| Device classes | Class 3, Class 2, LXY, MBD |
| Scope (excerpt) | 1.1 This practice covers a procedure for the fatigue testing of metallic tibial trays used in knee joint replacements using a cyclic, constant-amplitude force. It applies to tibial trays that cover both the medial and lateral plateaus of the tibia. This practice may require modifications to… |
At a glance
- 1–9 Product codes
- 1–9 FDA guidance documents
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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: