FDA product code MRA: Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented
MRA is the FDA product code for prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented. It is a Class III device, reviewed by the Orthopedic panel. Devices under MRA reach the market by PMA; FDA lists no cleared 510(k)s for it. 13 PMA applications cite this product code. FDA has posted 23 recalls for MRA devices.
Classification
| Field | Value |
|---|---|
| Device name | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented |
| Device class | Class III |
| Review panel | OR — Orthopedic |
| Medical specialty | Unknown |
| Premarket route | PMA |
| Implant | Yes |
Recalls for MRA devices
23 product recalls in 8 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2016-04-12.
Frequently asked questions
What is FDA product code MRA?
MRA is the FDA product code for prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented. It is a Class III device, reviewed by the Orthopedic panel.
What device class is MRA?
Class III. Typical premarket route: PMA.
Have MRA devices been recalled?
Yes: 23 product recalls across 8 recall events; the most recent began 2016-04-12.
Next steps
- Run an FDA pathway report with predicate devices for product code MRA
- Run a recall and safety report across every MRA manufacturer
- Watch product code MRA 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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