FDA product code LXY: Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Polymer/Metal/Polymer
LXY is the FDA product code for prosthesis, knee, patello/femorotibial, semi-constrained, uncemented, polymer/metal/polymer. It is a Class III device, reviewed by the Orthopedic panel. Devices under LXY reach the market by Contact FDA; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Polymer/Metal/Polymer |
| Device class | Class III |
| Review panel | OR — Orthopedic |
| Medical specialty | Unknown |
| Premarket route | Contact FDA |
| Implant | Yes |
Recalls for LXY devices
openFDA lists no recalls for product code LXY.
Frequently asked questions
What is FDA product code LXY?
LXY is the FDA product code for prosthesis, knee, patello/femorotibial, semi-constrained, uncemented, polymer/metal/polymer. It is a Class III device, reviewed by the Orthopedic panel.
What device class is LXY?
Class III. Typical premarket route: Contact FDA.
Next steps
- Run an FDA pathway report with predicate devices for product code LXY
- Run a recall and safety report across every LXY manufacturer
- Watch product code LXY 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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