# PGM: Growing Rod System

- Device class: 2; regulation: 21 CFR 888.3070; FDA's rule: 510(k) required
- FDA decisions: 14
- 510(k) review time 2021–2025: median 355 days (middle half 309–400)
- Recalls: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2014: 4
- 2015: 1
- 2016: 1
- 2017: 1
- 2018: 2
- 2019: 1
- 2020: 1
- 2022: 1
- 2025: 1
- 2026: 1

## Most-cited predicates
- K133904: CD Horizon Spinal System Growth Rod Set (2014), cited by 9
- K142114: Xia® Growth Rod Conversion Set (2014), cited by 4
- K140750: Shilla Growth Guidance System (2014), cited by 4
- K141509: Isola and Expedium Growing Spine Systems (2014), cited by 2
- K150200: CD HORIZON Growth Rod Conversion Set (2015), cited by 2
- K181068: CREO® Stabilization System, REVERE® Stabilization System (2018), cited by 2
- K193224: Daytona® Small Stature Growth Rod Conversion Set (2020), cited by 1
- K180227: Polaris Spinal Growth System (2018), cited by 1
- K161028: K2M Growing Spine System (2016), cited by 1

Source page: https://510kreport.com/product-code/PGM
Data by year (CSV): https://510kreport.com/product-code/PGM.csv