# PGN: Growing Rod System- Magnetic Actuation

- Device class: 2; regulation: 21 CFR 888.3070; FDA's rule: 510(k) required
- FDA decisions: 9
- 510(k) review time 2021–2025: median 90 days (middle half 90–90)
- Recalls: 2 (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: 2
- 2015: 2
- 2016: 2
- 2017: 1
- 2020: 1
- 2024: 1

## Most-cited predicates
- K150885: MAGEC 2 Spinal Bracing and Distraction System (2015), cited by 4
- K140178: Ellipse Magec Spinal Bracing and Distraction System (2014), cited by 4
- K140613: Magec Spinal Bracing and Distraction System (2014), cited by 2
- K161751: MAGEC® Spinal Bracing and Distraction System (2016), cited by 2
- K171791: MAGEC® System (2017), cited by 1
- K160352: MAGEC® Spinal Bracing and Distraction System (2016), cited by 1
- K201543: MAGEC® System (2020), cited by 1

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