# MRW: System, Facet Screw Spinal Device

- Device class: U; regulation: 21 CFR —; FDA's rule: 510(k) required
- FDA decisions: 79
- 510(k) review time 2021–2025: median 93 days (middle half 49–253)
- Recalls: 3 (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)
- 2015: 2
- 2016: 2
- 2017: 1
- 2018: 2
- 2019: 3
- 2022: 3
- 2023: 3
- 2024: 7
- 2025: 7
- 2026: 5

## Most-cited predicates
- K012773: Discovery Facet Screw Fixation System (2001), cited by 14
- K020411: Nuvasive Triad Facet Screw System (2002), cited by 11
- K073515: TRANS1 Facet Screw (2008), cited by 11
- K071420: Chameleon Fixation System (2008), cited by 11
- K211855: Ion Facet Screw System (2022), cited by 6
- K230840: PMT Facet Fixation System, Lumbar (PMT FFS-LX) (2023), cited by 6
- K953076: Townley Facet/Pedicular Screw Plating System (1997), cited by 5
- K003928: Townley Transfacetpedicular Screw Fixation System (2001), cited by 5
- K083442: Corridor Fixation System (2009), cited by 5
- K120340: Venus Facet Screw System (2012), cited by 4

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