# OWI: Bone Fixation Cerclage, Sublaminar

- Device class: 2; regulation: 21 CFR 888.3010; FDA's rule: 510(k) required
- FDA decisions: 37
- 510(k) review time 2021–2025: median 118 days (middle half 50–212)
- 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)
- 2015: 3
- 2016: 5
- 2017: 7
- 2018: 4
- 2019: 3
- 2020: 3
- 2021: 1
- 2022: 1
- 2023: 2
- 2026: 2

## Most-cited predicates
- K110348: Universal Clamp Spinal Fixation System (2011), cited by 9
- K151740: JAZZ System (2015), cited by 5
- K153348: Jazz Lock (2016), cited by 5
- K142053: Universal Clamp Spinal Fixation System (2014), cited by 5
- K143350: Nile Alternative Fixation (2015), cited by 4
- K173506: LigaPASS (2018), cited by 4
- K172021: LigaPASS (2017), cited by 3
- K133482: Silc Fixation System (2014), cited by 3
- K213659: LigaPASS™ 2.0 Ligament Augmentation System (2022), cited by 2
- K172206: NAJA™ Ligament Correction System (2018), cited by 2

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