FDA product code PNW: Prosthesis, Metatarsophalangeal Joint Cartilage Replacement Implant
PNW is the FDA product code for prosthesis, metatarsophalangeal joint cartilage replacement implant. It is a Class III device, reviewed by the Orthopedic panel. Devices under PNW reach the market by PMA; FDA lists no cleared 510(k)s for it. 1 PMA application cites this product code. FDA has posted 1 recall for PNW devices, 1 initiated in the last five years.
Definition
The device is a metatarsophalangeal joint cartilage replacement device that is implanted in the metatarsal head of the first metatarsophalangeal joint.
Classification
| Field | Value |
|---|---|
| Device name | Prosthesis, Metatarsophalangeal Joint Cartilage Replacement Implant |
| Device class | Class III |
| Review panel | OR — Orthopedic |
| Medical specialty | Unknown |
| Premarket route | PMA |
| Implant | Yes |
Recalls for PNW devices
1 product recalls in 1 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2024-10-31.
| Year | Recalls |
|---|---|
| 2024 | 1 |
Frequently asked questions
What is FDA product code PNW?
PNW is the FDA product code for prosthesis, metatarsophalangeal joint cartilage replacement implant. It is a Class III device, reviewed by the Orthopedic panel.
What device class is PNW?
Class III. Typical premarket route: PMA.
Have PNW devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2024-10-31.
Next steps
- Run an FDA pathway report with predicate devices for product code PNW
- Run a recall and safety report across every PNW manufacturer
- Watch product code PNW 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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