FDA-recognized standard · Orthopedic
ASTM F2028: Standard Test Methods for Dynamic Evaluation of Glenoid Loosening
Yes. FDA recognizes ASTM F2028-25a as recognition 11-433, in part, entered 2025-12-22. FDA also lists ASTM F2028-17 (recognition 11-330, transition period ending 2027-12-19).
Recognized editions of ASTM F2028
| Recognition | Edition | Entered | Extent | Transition ends |
|---|---|---|---|---|
| 11-433 | ASTM F2028-25a | 2025-12-22 | Partial | — |
| 11-330 | ASTM F2028-17 | 2020-12-21 | Partial | 2027-12-19 |
What FDA does not recognize in ASTM F2028-25a
Recognition 11-433 is partial. FDA's statement of the extent, verbatim:
Partial recognition. The following part(s) of the standard is (are) not recognized: - Subclause 16.2.4 Procedure (number of cycles)
What FDA does not recognize in ASTM F2028-17
Recognition 11-330 is partial. FDA's statement of the extent, verbatim:
Partial recognition. The following part(s) of the standard is (are) not recognized: - Subclause 24.2.4 Procedure (number of cycles) - Subclause X2.9 in APPENDIX X2 Rationale for Reverse Shoulder Glenoid Loosening/Disassociation Test (number of cycles)
Regulations
FDA lists these classification regulations against ASTM F2028: 21 CFR 888.3640, 21 CFR 888.3650, 21 CFR 888.3660, 21 CFR 888.3670, 21 CFR 888.3680.
Product codes that cite ASTM F2028
7 FDA product codes cite ASTM F2028, including KWR, KWS, KWT, KYM, MBF.
- KWR
- KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
- KWT Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
- KYM
- MBF Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented
- PAO
- PHX Shoulder Prosthesis, Reverse Configuration
Source: FDA Recognized Consensus Standards database, snapshot of 2026-09-01. Search every recognition in the Consensus Standards Lookup, or browse all standards with a page.