FDA product code MPW: Filler, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold, Osteoinduction
MPW is the FDA product code for filler, recombinant human bone morphogenetic protein, collagen scaffold, osteoinduction. It is a Class III device, reviewed by the Orthopedic panel. Devices under MPW 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 MPW devices.
Definition
Pma approved: P000054
Classification
| Field | Value |
|---|---|
| Device name | Filler, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold, Osteoinduction |
| Device class | Class III |
| Review panel | OR — Orthopedic |
| Medical specialty | Unknown |
| Premarket route | PMA |
| Implant | Yes |
Recalls for MPW devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2008-06-24.
Frequently asked questions
What is FDA product code MPW?
MPW is the FDA product code for filler, recombinant human bone morphogenetic protein, collagen scaffold, osteoinduction. It is a Class III device, reviewed by the Orthopedic panel.
What device class is MPW?
Class III. Typical premarket route: PMA.
Have MPW devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2008-06-24.
Next steps
- Run an FDA pathway report with predicate devices for product code MPW
- Run a recall and safety report across every MPW manufacturer
- Watch product code MPW 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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