FDA product code · Orthopedic
Growing Rod System
14 FDA decisions since 2014. 510(k) reviews decided 2021–2025 took a median of 355 days (half between 309 and 400). No recall names this code. The most-cited predicate is K133904, named by 9 later devices.
Stabilization or correction of spinal deformities without the use of fusion.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly Download the data (CSV)
Twenty years of PGM 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 · PGM
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · PGM
81in 2014
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · PGM
No recall names PGM since 2007.
Adverse event reports per year · PGM
7in 2025
MAUDE reports naming product code PGM, 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 | 4 | 81 | 0 | 5 |
| 2015 | 1 | — | 0 | 1 |
| 2016 | 1 | — | 0 | 9 |
| 2017 | 1 | — | 0 | 4 |
| 2018 | 2 | — | 0 | 1 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 1 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 5 |
| 2023 | 0 | — | 0 | 3 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 1 | — | 0 | 7 |
| 2026 | 1 | — | 0 | — |
Planning a device in PGM? 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.