# OSH: Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis

- Device class: 2; regulation: 21 CFR 888.3070; FDA's rule: 510(k) required
- FDA decisions: 19
- Recalls: 1 (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)
- 2012: 3
- 2013: 14
- 2014: 1
- 2016: 1

## Most-cited predicates
- K124058: Creo Stabilization System (2013), cited by 15
- K131802: Expedium, Viper. Viper 2 Spine System (2013), cited by 14
- K121630: Range Spinal System (2012), cited by 12
- K123138: Pass LP Spinal System (2013), cited by 6
- K131615: Polaris Spinal System (2013), cited by 4
- K120291: OP Spine System (2012), cited by 4
- K130330: Range Spinal System (2013), cited by 3
- K140276: CD Horizon Spinal System (2014), cited by 3
- K131321: CD Horizon Spinal System (2013), cited by 2
- K122877: Range Spinal System, Small Stature (2013), cited by 2

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