Recognized standard
F2665-21
FDA recognition 11-386 · ASTM · Orthopedic
Key facts
| Recognition number | 11-386 |
|---|---|
| Designation | F2665-21 |
| Title | Standard Specification for Total Ankle Replacement Prosthesis |
| Standards developer | ASTM International |
| Specialty area | Orthopedic |
| Date of entry | Dec 20, 2021 |
| Device classes | Class 2, Class 3 |
| Scope (excerpt) | 1.1 This specification covers total ankle replacement (TAR) prostheses used to provide functioning articulation by employing talar and tibial components that allow for a minimum of 15° of dorsiflexion and 15 to 25° (1)2 of plantar flexion, as determined by non-clinical testing. 1.2 Included within… |
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: