# QAD: Rod, Fixation, Intramedullary And Accessories, In-Vivo Cured, Light-Activated

- Device class: 2; regulation: 21 CFR 888.3023; FDA's rule: 510(k) required
- FDA decisions: 7
- 510(k) review time 2021–2025: median 98 days (middle half 98–98)
- 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)
- 2017: 1
- 2018: 2
- 2020: 3
- 2024: 1

## Most-cited predicates
- K181228: IlluminOss Bone Stabilization System (2018), cited by 1
- K202887: IlluminOss Bone Stabilization System (2020), cited by 1
- K201961: IlluminOss Photodynamic Bone Stabilization System (2020), cited by 1

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