FDA product code MPK: Semi-Constrained Metal/Polymer Finger Joint Prosthesis
MPK is the FDA product code for semi-constrained metal/polymer finger joint prosthesis. It is a HDE device, reviewed by the Orthopedic panel. Devices under MPK reach the market by Unclassified; FDA lists no cleared 510(k)s for it. FDA has posted 1 recall for MPK devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Semi-Constrained Metal/Polymer Finger Joint Prosthesis |
| Device class | HDE |
| Review panel | OR — Orthopedic |
| Medical specialty | Unknown |
| Premarket route | Unclassified |
| Implant | Yes |
Recalls for MPK devices
1 product recalls in 1 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2022-07-27.
| Year | Recalls |
|---|---|
| 2022 | 1 |
Frequently asked questions
What is FDA product code MPK?
MPK is the FDA product code for semi-constrained metal/polymer finger joint prosthesis. It is a HDE device, reviewed by the Orthopedic panel.
What device class is MPK?
HDE. Typical premarket route: Unclassified.
Have MPK devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2022-07-27.
Next steps
- Run an FDA pathway report with predicate devices for product code MPK
- Run a recall and safety report across every MPK manufacturer
- Watch product code MPK 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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