# NQP: Posterior Metal/Polymer Spinal System, Fusion

- Device class: 2; regulation: 21 CFR 888.3070; FDA's rule: 510(k) required
- FDA decisions: 22
- 510(k) review time 2021–2025: median 29 days (middle half 29–29)
- Recalls: 50 (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)
- 2004: 1
- 2005: 1
- 2006: 3
- 2007: 2
- 2008: 6
- 2009: 3
- 2010: 2
- 2014: 1
- 2019: 2
- 2021: 1

## Most-cited predicates
- K031511: Dynesys Spinal System (2004), cited by 8
- K080241: DDS Stabilization System (2008), cited by 5
- K182928: CD Horizon™ Spinal System (2019), cited by 4
- K043565: Modification to Dynesys Spinal System (2005), cited by 3
- K061774: Nfix II Pedicle Screw System (2006), cited by 2
- K101083: DSS Stabilization System (2010), cited by 2
- K061304: CD Horizon Spinal System (2006), cited by 2
- K060638: Dynesys Spinal System with HA Coated Screws (2006), cited by 2
- K203678: CD HORIZON™ Spinal System (2021), cited by 2
- K092234: Dynesys Top-Loading Spinal System (2009), cited by 1

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