FDA-recognized standard · Orthopedic
ASTM F2381: Standard Test Method for Evaluating Trans-Vinylene Yield in Irradiated Ultra-High Molecular Weight Polyethylene Fabricated Forms Intended for Surgical Implants by Infrared Spectroscopy
Yes. FDA recognizes ASTM F2381-19 as recognition 11-366, entered 2020-07-06.
Recognized editions of ASTM F2381
| Recognition | Edition | Entered | Extent | Transition ends |
|---|---|---|---|---|
| 11-366 | ASTM F2381-19 | 2020-07-06 | Complete | — |
Regulations
FDA lists these classification regulations against ASTM F2381: 21 CFR 888.3160, 21 CFR 888.3310, 21 CFR 888.3340, 21 CFR 888.3350, 21 CFR 888.3353, 21 CFR 888.3358, 21 CFR 888.3390, 21 CFR 888.3410, 21 CFR 888.3490, 21 CFR 888.3500, 21 CFR 888.3510, 21 CFR 888.3520, 21 CFR 888.3530, 21 CFR 888.3535, 21 CFR 888.3540, 21 CFR 888.3560, 21 CFR 888.3650, 21 CFR 888.3660, 21 CFR 888.3670, 21 CFR 888.3800, 21 CFR 888.3810.
Product codes that cite ASTM F2381
36 FDA product codes cite ASTM F2381, including HRY, HSX, JDB, JDI, JWH.
- HRY
- HSX Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer
- JDB
- JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
- JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
- JWI
- JWJ
- KMB
- KMC
- KRO Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer
- KRR
- KTX
- KWM
- KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
- KWT Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
- KWY Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
- KWZ
- KXE
- KYK
- LGE
- LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
- LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
- MAY
- MBF Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented
- MBL
- MBV
- MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
- NJD
- NPJ
- OCG
- OIY
- OQG
- OQH
- OQI
- PAO
- PBI
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.