FDA product code OMX: High Demand, Revision, Semi-Constrained, Pyrolytic Carbon, Uncemented Finger Prosthesis
OMX is the FDA product code for high demand, revision, semi-constrained, pyrolytic carbon, uncemented finger prosthesis. It is a HDE device, reviewed by the Orthopedic panel. Devices under OMX reach the market by Unclassified; FDA lists no cleared 510(k)s for it.
Definition
For use in arthroplasty of the proximal interphalangeal (PIP) joint when the patient: a) has soft tissue and bone that can provide adequate stabilization and fixation under high-demand loading conditions after reconstruction; and b) needs a revision of a failed PIP prosthesis, or has pain, limited motion, or joint subluxation/disloation secondary to damage or destruction of the articular cartilage.
Classification
| Field | Value |
|---|---|
| Device name | High Demand, Revision, Semi-Constrained, Pyrolytic Carbon, Uncemented Finger Prosthesis |
| Device class | HDE |
| Review panel | OR — Orthopedic |
| Medical specialty | Unknown |
| Premarket route | Unclassified |
| Implant | Yes |
Recalls for OMX devices
openFDA lists no recalls for product code OMX.
Frequently asked questions
What is FDA product code OMX?
OMX is the FDA product code for high demand, revision, semi-constrained, pyrolytic carbon, uncemented finger prosthesis. It is a HDE device, reviewed by the Orthopedic panel.
What device class is OMX?
HDE. Typical premarket route: Unclassified.
Next steps
- Run an FDA pathway report with predicate devices for product code OMX
- Run a recall and safety report across every OMX manufacturer
- Watch product code OMX 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.