# OUR: Sacroiliac Joint Fixation

- Device class: 2; regulation: 21 CFR 888.3040; FDA's rule: 510(k) required
- FDA decisions: 133
- 510(k) review time 2021–2025: median 88 days (middle half 31–166)
- Recalls: 2 (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)
- 2017: 4
- 2018: 7
- 2019: 7
- 2020: 7
- 2021: 9
- 2022: 14
- 2023: 20
- 2024: 15
- 2025: 14
- 2026: 6

## Most-cited predicates
- K161210: RIALTO (TM) SI Fusion System, Medtronic Reusable Instruments for Use with the IPC (TM) Powerease (TM) System, and Medtronic Navigated Manual Reusable Instruments for use with the StealthStation (TM) and IPC (TM) Powerease (TM) Systems (2016), cited by 27
- K092375: Modification to SI Joint Fusion System (2009), cited by 14
- K080398: SI Joint Fusion System (2008), cited by 11
- K110838: Ifuse Implant System (2011), cited by 11
- K180818: Catamaran Sacroiliac Joint Fixation System (CAT SIJ Fixation System) (2018), cited by 11
- K131405: Ifuse Implant System (2013), cited by 10
- K122074: Ifuse Implant System (2012), cited by 9
- K193524: SI-BONE iFuse Implant System® (2020), cited by 9
- K123850: Ifuse Implant System (2013), cited by 7
- K141549: SImmetry Sacroiliac Joint Fusion System (2015), cited by 7

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