FDA product code KTX: Prosthesis, Knee, Femorotibial, Non-Constrained, Metal/Composite Cemented
KTX is the FDA product code for prosthesis, knee, femorotibial, non-constrained, metal/composite cemented. It is a Class II device, regulated under 21 CFR 888.3490 and reviewed by the Orthopedic panel. Devices under KTX reach the market by 510(k); FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Prosthesis, Knee, Femorotibial, Non-Constrained, Metal/Composite 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 KTX devices
openFDA lists no recalls for product code KTX.
Frequently asked questions
What is FDA product code KTX?
KTX is the FDA product code for prosthesis, knee, femorotibial, non-constrained, metal/composite cemented. It is a Class II device, regulated under 21 CFR 888.3490 and reviewed by the Orthopedic panel.
What device class is KTX?
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 KTX
- Run a recall and safety report across every KTX manufacturer
- Watch product code KTX 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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