# JDQ: Cerclage, Fixation

- Device class: 2; regulation: 21 CFR 888.3010; FDA's rule: 510(k) required
- FDA decisions: 130
- 510(k) review time 2021–2025: median 136 days (middle half 119–238)
- Recalls: 11 (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: 5
- 2016: 4
- 2017: 1
- 2018: 6
- 2020: 4
- 2022: 2
- 2023: 3
- 2024: 3
- 2025: 2
- 2026: 1

## Most-cited predicates
- K935481: Sponger Cable System, Modification (1994), cited by 9
- K060009: Abbott Spine Universal Clamp System (2006), cited by 8
- K031162: Smith & Nephew Orthopaedic Cabling System (2003), cited by 7
- K982545: BMP Cable System (1998), cited by 7
- K922952: Songer Cable System (1993), cited by 7
- K992616: SDB Cerclage System (1999), cited by 6
- K110789: Synthes Sternal Zipfix System (2011), cited by 6
- K971741: Dall-Miles Homogeneous Stainless Steel Cable and Beaded Cable (1997), cited by 5
- K941213: Songer Cable System (1994), cited by 5
- K875156: Stainless Steel Orthopaedic Cable System (1988), cited by 4

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