Recognized standard
F2385-15 (Reapproved 2019)
FDA recognition 11-307 · ASTM · Orthopedic
Key facts
| Recognition number | 11-307 |
|---|---|
| Designation | F2385-15 (Reapproved 2019) |
| Title | Standard Practice for Determining Femoral Head Penetration into Acetabular Components of Total Hip Replacement Using Clinical Radiographs |
| Standards developer | ASTM International |
| Specialty area | Orthopedic |
| Date of entry | Jun 27, 2016 |
| Device classes | Class 2 |
| Scope (excerpt) | 1.1 This practice provides guidance for the measurement of the relative displacement of the femoral head and acetabular component that result from wear and deformation occurring at the articular interface of a total hip replacement from sequential clinical radiographs. 1.2 This practice is primarily… |
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: