FDA product code MJO: Prosthesis, Intervertebral Disc
MJO is the FDA product code for prosthesis, intervertebral disc. It is a Class III device, reviewed by the Orthopedic panel. Devices under MJO reach the market by PMA; FDA lists no cleared 510(k)s for it. 15 PMA applications cite this product code. FDA has posted 15 recalls for MJO devices, 7 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Prosthesis, Intervertebral Disc |
| Device class | Class III |
| Review panel | OR — Orthopedic |
| Medical specialty | Unknown |
| Premarket route | PMA |
| Implant | Yes |
Recalls for MJO devices
15 product recalls in 8 recall events; 7 initiated in the last five years and 7 still open. Most recent: 2026-03-20.
| Year | Recalls |
|---|---|
| 2018 | 1 |
| 2021 | 1 |
| 2022 | 1 |
| 2023 | 1 |
| 2024 | 2 |
| 2025 | 1 |
| 2026 | 2 |
Frequently asked questions
What is FDA product code MJO?
MJO is the FDA product code for prosthesis, intervertebral disc. It is a Class III device, reviewed by the Orthopedic panel.
What device class is MJO?
Class III. Typical premarket route: PMA.
Have MJO devices been recalled?
Yes: 15 product recalls across 8 recall events; the most recent began 2026-03-20.
Next steps
- Run an FDA pathway report with predicate devices for product code MJO
- Run a recall and safety report across every MJO manufacturer
- Watch product code MJO 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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