FDA product code PIX: Elbow Joint Metal/Polymer, Constrained, Porous Coated, Uncemented Prosthesis
PIX is the FDA product code for elbow joint metal/polymer, constrained, porous coated, uncemented prosthesis. It is a Not classified device, reviewed by the Orthopedic panel. Devices under PIX reach the market by Contact FDA; FDA lists no cleared 510(k)s for it. FDA has posted 1 recall for PIX devices.
Definition
An elbow joint metal/polymer constrained uncemented prosthesis is a device intended to be implanted to replace an elbow joint.
Classification
| Field | Value |
|---|---|
| Device name | Elbow Joint Metal/Polymer, Constrained, Porous Coated, Uncemented Prosthesis |
| Device class | Not classified |
| Review panel | OR — Orthopedic |
| Medical specialty | Unknown |
| Premarket route | Contact FDA |
| Implant | Yes |
Recalls for PIX devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2019-08-21.
| Year | Recalls |
|---|---|
| 2019 | 1 |
Frequently asked questions
What is FDA product code PIX?
PIX is the FDA product code for elbow joint metal/polymer, constrained, porous coated, uncemented prosthesis. It is a Not classified device, reviewed by the Orthopedic panel.
What device class is PIX?
Not classified. Typical premarket route: Contact FDA.
Have PIX devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2019-08-21.
Next steps
- Run an FDA pathway report with predicate devices for product code PIX
- Run a recall and safety report across every PIX manufacturer
- Watch product code PIX 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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