# DZJ: Driver, Wire, And Bone Drill, Manual

- Device class: 2; regulation: 21 CFR 872.4120; FDA's rule: 510(k) required
- FDA decisions: 33
- 510(k) review time 2021–2025: median 157 days (middle half 131–207)
- Recalls: 10 (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: 2
- 2018: 2
- 2019: 1
- 2020: 4
- 2021: 3
- 2022: 3
- 2023: 3
- 2024: 1
- 2025: 1
- 2026: 2

## Most-cited predicates
- K120956: VSP System (2012), cited by 6
- K943540: Surgical Cutting Burs (1994), cited by 5
- K133907: VSP System (2014), cited by 4
- K182789: KLS Martin Individual Patient Solutions (IPS) Planning System (2019), cited by 4
- K192192: VSP System (2020), cited by 3
- K181241: KLS Martin Individual Patient Solutions (IPS) Planning System (2018), cited by 3
- K192282: MedCAD® AccuPlan® System (2020), cited by 2
- K150392: PROPEL device (2015), cited by 1
- K201353: CenterMed Patient Matched Assisted Surgical Planning (ASP) System (2021), cited by 1
- K040369: Stryker Consolidated Operating Room Equipment (Core) System (2004), cited by 1

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