FDA-recognized standard · Orthopedic
ASTM F1378: Standard Specification for Shoulder Prostheses
Yes. FDA recognizes ASTM F1378-18e1 as recognition 11-360, entered 2019-12-23.
Recognized editions of ASTM F1378
| Recognition | Edition | Entered | Extent | Transition ends |
|---|---|---|---|---|
| 11-360 | ASTM F1378-18e1 | 2019-12-23 | Complete | — |
Regulations
FDA lists these classification regulations against ASTM F1378: 21 CFR 888.3640, 21 CFR 888.3650, 21 CFR 888.3660, 21 CFR 888.3670, 21 CFR 888.3680, 21 CFR 888.3690.
Product codes that cite ASTM F1378
8 FDA product codes cite ASTM F1378, including HSD, KWR, KWS, KWT, KYM.
- HSD
- 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
- MJT
- PAO
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.