# NKB: Thoracolumbosacral Pedicle Screw System

- Device class: 2; regulation: 21 CFR 888.3070; FDA's rule: 510(k) required
- FDA decisions: 914
- 510(k) review time 2021–2025: median 63 days (middle half 31–123)
- Recalls: 91 (1 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: 63
- 2018: 56
- 2019: 39
- 2020: 48
- 2021: 32
- 2022: 34
- 2023: 44
- 2024: 39
- 2025: 24
- 2026: 30

## Most-cited predicates
- K113174: CD Horizon Spinal System (2011), cited by 37
- K033901: Merlin Spine System (2004), cited by 35
- K061202: Revere Stabilization System (2006), cited by 30
- K091445: CD Horizon Spinal System (2010), cited by 27
- K071373: Stryker Spine Xia Iii Spinal System (2007), cited by 24
- K082572: Uss Iliosacral, Uss Polyaxial (2008), cited by 22
- K113666: Xia 3 Spinal System (2012), cited by 21
- K090648: Viper 2 System (2009), cited by 20
- K060361: Xia Spinal System, Xia 4.5 Spinal System (2006), cited by 19
- K091974: Modification to CD Horizon Spinal System (2009), cited by 18

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