# JEC: Component, Traction, Invasive

- Device class: 2; regulation: 21 CFR 888.3040; FDA's rule: 510(k) required
- FDA decisions: 85
- 510(k) review time 2021–2025: median 134 days (middle half 134–134)
- Recalls: 5 (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)
- 2007: 1
- 2008: 1
- 2009: 1
- 2011: 1
- 2014: 1
- 2016: 1
- 2018: 2
- 2019: 1
- 2020: 1
- 2021: 1

## Most-cited predicates
- K831576: Orthofix (1983), cited by 6
- K971755: Hoffmann II Compact External Fixation System (1997), cited by 6
- K952730: Hoffmann II External Fixation System (1995), cited by 3
- K944092: Additional Accessories for the Orthofix System (1995), cited by 3
- K792561: Mini-H-Fixation (1979), cited by 3
- K984442: Agee-Wristjack Fracture Reaction System (Sterile Version), Model CFD-147 (1999), cited by 2
- K993099: Bremer Halo System Titanium Skull Pin (1999), cited by 2
- K961916: Hoffmann II Carbon Connecting Rod (1996), cited by 2
- K880282: Lima-Lto. Sem Modular External Stablizer (1988), cited by 2
- K193256: Anjon Bremer Halo System (2020), cited by 2

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