FDA product code KMD: Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Composite
KMD is the FDA product code for prosthesis, ankle, semi-constrained, cemented, metal/composite. It is a Class II device, regulated under 21 CFR 888.3100 and reviewed by the Orthopedic panel. Devices under KMD reach the market by 510(k); FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Composite |
| Device class | Class II |
| Regulation | 21 CFR 888.3100 |
| Review panel | OR — Orthopedic |
| Medical specialty | Orthopedic |
| Premarket route | 510(k) |
| Implant | Yes |
Recalls for KMD devices
openFDA lists no recalls for product code KMD.
Frequently asked questions
What is FDA product code KMD?
KMD is the FDA product code for prosthesis, ankle, semi-constrained, cemented, metal/composite. It is a Class II device, regulated under 21 CFR 888.3100 and reviewed by the Orthopedic panel.
What device class is KMD?
Class II, regulation 21 CFR 888.3100. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code KMD
- Run a recall and safety report across every KMD manufacturer
- Watch product code KMD for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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