FDA product code · Orthopedic
Growing Rod System- Magnetic Actuation
9 FDA decisions since 2014. 510(k) reviews decided 2021–2025 took a median of 90 days (half between 90 and 90). 2 recalls name this code, 0 of them Class I. The most-cited predicate is K150885, named by 4 later devices.
Stabilization or correction of spinal deformities without the use of fusion, using non-invasive methods to adjust the spinal rod.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly Download the data (CSV)
Twenty years of PGN at a glance: how often FDA decides these devices, how long 510(k) reviews take, how often they are recalled, and how many adverse event reports name the code.
FDA decisions per year · PGN
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · PGN
Too few PGN 510(k)s in any year since 2007 to give a median.
Recalls per year · PGN
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · PGN
4in 2025
MAUDE reports naming product code PGN, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 2 | — | 0 | 12 |
| 2015 | 2 | — | 0 | 16 |
| 2016 | 2 | — | 0 | 18 |
| 2017 | 1 | — | 0 | 31 |
| 2018 | 0 | — | 0 | 45 |
| 2019 | 0 | — | 1 | 86 |
| 2020 | 1 | — | 0 | 339 |
| 2021 | 0 | — | 0 | 204 |
| 2022 | 0 | — | 1 | 120 |
| 2023 | 0 | — | 0 | 189 |
| 2024 | 1 | — | 0 | 30 |
| 2025 | 0 | — | 0 | 4 |
| 2026 | 0 | — | 0 | — |
Planning a device in PGN? A 510(k) Report ranks candidate predicates in this code by lineage, citations and recall history, with the review-time outlook.
See the 510(k) ReportRelated product codes
Other codes under 21 CFR 888.3070.