# MNI: Orthosis, Spinal Pedicle Fixation

- Device class: 2; regulation: 21 CFR 888.3070; FDA's rule: 510(k) required
- FDA decisions: 303
- Recalls: 52 (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)
- 2008: 23
- 2009: 18
- 2010: 16
- 2011: 17
- 2012: 19
- 2013: 14
- 2014: 6
- 2015: 12
- 2016: 7
- 2017: 1

## Most-cited predicates
- K024096: Optima, Spinal System (2003), cited by 30
- K031655: CD Horizon Spinal System (2003), cited by 25
- K070229: Range Spinal System (2007), cited by 24
- K022949: Synthes Uss, Click'x, Uss Vas, Dual-Opening Uss and Small Stature Uss (2003), cited by 21
- K071877: Lanx Spinal Fixation System (2007), cited by 18
- K080792: K2M Cocr Rod (2008), cited by 18
- K052398: Mesa Spinal System (2005), cited by 17
- K980485: Isola Spinal System (1998), cited by 14
- K032394: Stryker Spine Oasys System (2004), cited by 14
- K994121: Small Stature Uss (2000), cited by 13

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