FDA product code KRP: Prosthesis, Knee, Patello/Femorotibial, Constrained, Cemented, Polymer/Metal/Metal
KRP is the FDA product code for prosthesis, knee, patello/femorotibial, constrained, cemented, polymer/metal/metal. It is a Class III device, regulated under 21 CFR 888.3550 and reviewed by the Orthopedic panel. Devices under KRP reach the market by PMA; FDA lists no cleared 510(k)s for it. FDA has posted 1 recall for KRP devices.
Definition
Call for PMAs to be filed by 12/26/96 per 61 FR 50710 on 9/27/96
Classification
| Field | Value |
|---|---|
| Device name | Prosthesis, Knee, Patello/Femorotibial, Constrained, Cemented, Polymer/Metal/Metal |
| Device class | Class III |
| Regulation | 21 CFR 888.3550 |
| Review panel | OR — Orthopedic |
| Medical specialty | Orthopedic |
| Premarket route | PMA |
| Implant | Yes |
Recalls for KRP devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2004-08-20.
Frequently asked questions
What is FDA product code KRP?
KRP is the FDA product code for prosthesis, knee, patello/femorotibial, constrained, cemented, polymer/metal/metal. It is a Class III device, regulated under 21 CFR 888.3550 and reviewed by the Orthopedic panel.
What device class is KRP?
Class III, regulation 21 CFR 888.3550. Typical premarket route: PMA.
Have KRP devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2004-08-20.
Next steps
- Run an FDA pathway report with predicate devices for product code KRP
- Run a recall and safety report across every KRP manufacturer
- Watch product code KRP 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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