Recognized standard
F2033-20
FDA recognition 11-376 · ASTM · Orthopedic
Key facts
| Recognition number | 11-376 |
|---|---|
| Designation | F2033-20 |
| Title | Standard Specification for Total Hip Joint Prosthesis and Hip Endoprosthesis Bearing Surfaces Made of Metallic, Ceramic, and Polymeric Materials |
| Standards developer | ASTM International |
| Specialty area | Orthopedic |
| Date of entry | Jun 7, 2021 |
| Device classes | Class 3, Class 2 |
| Scope (excerpt) | 1.1 This specification covers the requirements for the mating bearing surfaces of total hip joint prostheses or resurfacing hip devices, intended for total hip arthroplasty; and hip endoprostheses, intended for hemiarthroplasty. More specifically, this specification covers hip joint replacement of… |
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: