FDA product code KRQ: Prosthesis, Knee, Patello/Femorotibial, Constrained, Cemented, Polymer/Metal/Polymer
KRQ is the FDA product code for prosthesis, knee, patello/femorotibial, constrained, cemented, polymer/metal/polymer. It is a Class II device, regulated under 21 CFR 888.3550 and reviewed by the Orthopedic panel. Devices under KRQ reach the market by 510(k); FDA lists no cleared 510(k)s for it. FDA has posted 1 recall for KRQ devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Prosthesis, Knee, Patello/Femorotibial, Constrained, Cemented, Polymer/Metal/Polymer |
| Device class | Class II |
| Regulation | 21 CFR 888.3550 |
| Review panel | OR — Orthopedic |
| Medical specialty | Orthopedic |
| Premarket route | 510(k) |
| Implant | Yes |
Recalls for KRQ devices
1 product recalls in 1 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2022-08-24.
| Year | Recalls |
|---|---|
| 2022 | 1 |
Frequently asked questions
What is FDA product code KRQ?
KRQ is the FDA product code for prosthesis, knee, patello/femorotibial, constrained, cemented, polymer/metal/polymer. It is a Class II device, regulated under 21 CFR 888.3550 and reviewed by the Orthopedic panel.
What device class is KRQ?
Class II, regulation 21 CFR 888.3550. Typical premarket route: 510(k).
Have KRQ devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2022-08-24.
Next steps
- Run an FDA pathway report with predicate devices for product code KRQ
- Run a recall and safety report across every KRQ manufacturer
- Watch product code KRQ 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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