FDA product code PGN: Growing Rod System- Magnetic Actuation
PGN is the FDA product code for growing rod system- magnetic actuation. It is a Class II device, regulated under 21 CFR 888.3070 and reviewed by the Orthopedic panel. FDA has cleared 9 510(k) submissions under PGN, 1 in the last five years, from 4 different applicants. The average 510(k) review took 126 days (median 76); 90 days on average over the last three years. FDA has posted 4 recalls for PGN devices, 2 initiated in the last five years.
Definition
Stabilization or correction of spinal deformities without the use of fusion, using non-invasive methods to adjust the spinal rod.
Classification
| Field | Value |
|---|---|
| Device name | Growing Rod System- Magnetic Actuation |
| Device class | Class II |
| Regulation | 21 CFR 888.3070 |
| Review panel | OR — Orthopedic |
| Medical specialty | Orthopedic |
| Premarket route | 510(k) |
| Implant | Yes |
510(k) clearances per year for PGN
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 76 |
| 2020 | 1 | 51 |
| 2024 | 1 | 90 |
Compare with all 510(k) review times · Search every PGN clearance
Top PGN applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Nuvasive Specialized Orthopedics, Inc. | 3 | 2020-07-30 |
| Ellipse Technologies, Inc. | 3 | 2015-03-24 |
| Nuvasive Specialized Orthopedics, Incorporated | 2 | 2024-02-06 |
| Ellipse Technologies, Incorporated | 1 | 2015-05-29 |
Most recent PGN clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K233593 | Nuvasive Specialized Orthopedics, Incorporated | MAGEC Spinal Bracing and Distraction System | 2024-02-06 | 90 |
| K201543 | Nuvasive Specialized Orthopedics, Inc. | MAGEC® System | 2020-07-30 | 51 |
| K171791 | Nuvasive Specialized Orthopedics, Incorporated | MAGEC® System | 2017-08-31 | 76 |
| K160352 | Nuvasive Specialized Orthopedics, Inc. | MAGEC® Spinal Bracing and Distraction System | 2016-10-21 | 256 |
| K161751 | Nuvasive Specialized Orthopedics, Inc. | MAGEC® Spinal Bracing and Distraction System | 2016-09-02 | 70 |
Recalls for PGN devices
4 product recalls in 4 recall events; 2 initiated in the last five years and 3 still open. Most recent: 2025-04-03.
| Year | Recalls |
|---|---|
| 2019 | 1 |
| 2020 | 1 |
| 2022 | 1 |
| 2025 | 1 |
Frequently asked questions
What is FDA product code PGN?
PGN is the FDA product code for growing rod system- magnetic actuation. It is a Class II device, regulated under 21 CFR 888.3070 and reviewed by the Orthopedic panel.
What device class is PGN?
Class II, regulation 21 CFR 888.3070. Typical premarket route: 510(k).
How long does a 510(k) take for product code PGN?
Across 9 cleared submissions the average was 126 days from receipt to decision (median 76).
Which companies have the most PGN clearances?
Nuvasive Specialized Orthopedics, Inc. (3); Ellipse Technologies, Inc. (3); Nuvasive Specialized Orthopedics, Incorporated (2); Ellipse Technologies, Incorporated (1).
Have PGN devices been recalled?
Yes: 4 product recalls across 4 recall events; the most recent began 2025-04-03.
Next steps
- Run an FDA pathway report with predicate devices for product code PGN
- Run a recall and safety report across every PGN manufacturer
- Watch product code PGN 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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