FDA product code KMB: Prosthesis, Knee, Non-Constrained (Metal-Carbon Reinforced Polyethylene) Cemented
KMB is the FDA product code for prosthesis, knee, non-constrained (metal-carbon reinforced polyethylene) cemented. It is a Class II device, regulated under 21 CFR 888.3490 and reviewed by the Orthopedic panel. Devices under KMB reach the market by 510(k); FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Prosthesis, Knee, Non-Constrained (Metal-Carbon Reinforced Polyethylene) Cemented |
| Device class | Class II |
| Regulation | 21 CFR 888.3490 |
| Review panel | OR — Orthopedic |
| Medical specialty | Orthopedic |
| Premarket route | 510(k) |
| Implant | Yes |
Recalls for KMB devices
openFDA lists no recalls for product code KMB.
Frequently asked questions
What is FDA product code KMB?
KMB is the FDA product code for prosthesis, knee, non-constrained (metal-carbon reinforced polyethylene) cemented. It is a Class II device, regulated under 21 CFR 888.3490 and reviewed by the Orthopedic panel.
What device class is KMB?
Class II, regulation 21 CFR 888.3490. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code KMB
- Run a recall and safety report across every KMB manufacturer
- Watch product code KMB 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.