FDA-recognized standard · Orthopedic
ASTM F2385: Standard Practice for Determining Femoral Head Penetration into Acetabular Components of Total Hip Replacement Using Clinical Radiographs
Yes. FDA recognizes ASTM F2385-15 (Reapproved 2024) as recognition 11-307, entered 2016-06-27.
Recognized editions of ASTM F2385
| Recognition | Edition | Entered | Extent | Transition ends |
|---|---|---|---|---|
| 11-307 | ASTM F2385-15 (Reapproved 2024) | 2016-06-27 | Complete | — |
Regulations
FDA lists these classification regulations against ASTM F2385: 21 CFR 888.3310, 21 CFR 888.3350, 21 CFR 888.3353, 21 CFR 888.3358.
Product codes that cite ASTM F2385
9 FDA product codes cite ASTM F2385, including JDI, KWZ, LPH, LZO, MAY.
- JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
- KWZ
- LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
- LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
- MAY
- MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
- OQG
- OQH
- OQI
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.