FDA-recognized standard · Materials
ISO 5834-5: Implants for surgery - Ultra-high-molecular-weight polyethylene - Part 5: Morphology assessment method
Yes. FDA recognizes ISO 5834-5 Second edition 2019-02 as recognition 8-497, entered 2019-07-15.
Recognized editions of ISO 5834-5
| Recognition | Edition | Entered | Extent | Transition ends |
|---|---|---|---|---|
| 8-497 | ISO 5834-5 Second edition 2019-02 | 2019-07-15 | Complete | — |
Regulations
FDA lists these classification regulations against ISO 5834-5: 21 CFR 888.3040, 21 CFR 888.3110, 21 CFR 888.3150, 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 888.3490, 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 ISO 5834-5
55 FDA product codes cite ISO 5834-5, 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
- JDC
- JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
- JDW Pin, Fixation, Threaded
- 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
- MBL
- MBV
- MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
- MJW
- MRY
- NDJ
- NDK
- NDL
- NDM
- NJA
- NJD
- NPJ
- NWN
- OIY
- OOG
- OQH
- OQI
- OUR Sacroiliac Joint Fixation
- OVZ
- OYK
- PAO
- PBI
- PHX Shoulder Prosthesis, Reverse Configuration
- PKC Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained
- PLW
- PPQ
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.