FDA product code KRN: Metal Cemented Constrained Femorotibial Knee Prosthesis
KRN is the FDA product code for metal cemented constrained femorotibial knee prosthesis. It is a Class III device, regulated under 21 CFR 888.3480 and reviewed by the Orthopedic panel. Devices under KRN reach the market by PMA; FDA lists no cleared 510(k)s for it.
Definition
Call for pmas 12/26/96 ( 61 fr 50710 9/27/96)
Classification
| Field | Value |
|---|---|
| Device name | Metal Cemented Constrained Femorotibial Knee Prosthesis |
| Device class | Class III |
| Regulation | 21 CFR 888.3480 |
| Review panel | OR — Orthopedic |
| Medical specialty | Orthopedic |
| Premarket route | PMA |
| Implant | Yes |
Recalls for KRN devices
openFDA lists no recalls for product code KRN.
Frequently asked questions
What is FDA product code KRN?
KRN is the FDA product code for metal cemented constrained femorotibial knee prosthesis. It is a Class III device, regulated under 21 CFR 888.3480 and reviewed by the Orthopedic panel.
What device class is KRN?
Class III, regulation 21 CFR 888.3480. Typical premarket route: PMA.
Next steps
- Run an FDA pathway report with predicate devices for product code KRN
- Run a recall and safety report across every KRN manufacturer
- Watch product code KRN 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.
All Orthopedic product codes · FDA product code lookup · 510(k) database search · 510(k) review times