FDA-recognized standard · Materials
ASTM F2695: Standard Specification for Ultra-High Molecular Weight Polyethylene Powder Blended With Alpha-Tocopherol (Vitamin E) and Fabricated Forms for Surgical Implant Applications
Yes. FDA recognizes ASTM F2695-12(2025) as recognition 8-573, entered 2021-12-20.
Recognized editions of ASTM F2695
| Recognition | Edition | Entered | Extent | Transition ends |
|---|---|---|---|---|
| 8-573 | ASTM F2695-12(2025) | 2021-12-20 | Complete | — |
Regulations
FDA lists these classification regulations against ASTM F2695: 21 CFR 888.3040, 21 CFR 888.3110, 21 CFR 888.3310, 21 CFR 888.3340, 21 CFR 888.3350, 21 CFR 888.3353, 21 CFR 888.3390, 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, 21 CFR 888.4210.
Product codes that cite ASTM F2695
51 FDA product codes cite ASTM F2695, including HRY, HSN, HSX, HTY, HWC.
- HRY
- HSN Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer
- HSX Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer
- HTY Pin, Fixation, Smooth
- HWC Screw, Fixation, Bone
- JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
- JDW Pin, Fixation, Threaded
- JDZ
- JEC
- 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
- LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
- MAY
- MBF Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented
- MBI Fastener, Fixation, Nondegradable, Soft Tissue
- MBV
- MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
- MRY
- NDJ
- NDK
- NDL
- NDM
- NJA
- NJD
- NPJ
- NWN
- OIY
- OOG
- OQH
- OQI
- OUR Sacroiliac Joint Fixation
- OVZ
- OYK
- PAO
- PBI
- PKC Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained
- PLW
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.