FDA-recognized standard · Orthopedic
ISO 16087: Implants for surgery - Roentgen stereophotogrammetric analysis for the assessment of migration of orthopaedic implants
Yes. FDA recognizes ISO 16087 First edition 2013-10-01 as recognition 11-337, entered 2018-09-17.
Recognized editions of ISO 16087
| Recognition | Edition | Entered | Extent | Transition ends |
|---|---|---|---|---|
| 11-337 | ISO 16087 First edition 2013-10-01 | 2018-09-17 | Complete | — |
Regulations
FDA lists these classification regulations against ISO 16087: 21 CFR 888.3300, 21 CFR 888.3310, 21 CFR 888.3320, 21 CFR 888.3330, 21 CFR 888.3340, 21 CFR 888.3350, 21 CFR 888.3353, 21 CFR 888.3358, 21 CFR 888.3360, 21 CFR 888.3390, 21 CFR 888.3410.
Product codes that cite ISO 16087
23 FDA product codes cite ISO 16087, including JDD, JDG, JDI, JDL, KMC.
- JDD
- JDG
- JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
- JDL
- KMC
- KWA
- KWY Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
- KWZ
- KXB
- KXD
- LPF
- LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
- LWJ
- LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
- MAY
- MBL
- MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
- MRA
- NXT
- OCG
- 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.