FDA product code QWK: Prosthesis, Posterior Spinal Elements
QWK is the FDA product code for prosthesis, posterior spinal elements. It is a Class III device, reviewed by the Orthopedic panel. Devices under QWK 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 QWK devices, 1 initiated in the last five years.
Definition
This device is a non-fusion, load-bearing implanted prosthesis that stabilizes the spine following resection of posterior spinal elements.
Classification
| Field | Value |
|---|---|
| Device name | Prosthesis, Posterior Spinal Elements |
| Device class | Class III |
| Review panel | OR — Orthopedic |
| Medical specialty | Unknown |
| Premarket route | PMA |
| Implant | Yes |
Recalls for QWK devices
1 product recalls in 1 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2025-07-16.
| Year | Recalls |
|---|---|
| 2025 | 1 |
Frequently asked questions
What is FDA product code QWK?
QWK is the FDA product code for prosthesis, posterior spinal elements. It is a Class III device, reviewed by the Orthopedic panel.
What device class is QWK?
Class III. Typical premarket route: PMA.
Have QWK devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2025-07-16.
Next steps
- Run an FDA pathway report with predicate devices for product code QWK
- Run a recall and safety report across every QWK manufacturer
- Watch product code QWK 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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