# JDW: Pin, Fixation, Threaded

- Device class: 2; regulation: 21 CFR 888.3040; FDA's rule: 510(k) required
- FDA decisions: 94
- 510(k) review time 2021–2025: median 105 days (middle half 62–226)
- Recalls: 99 (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)
- 2014: 2
- 2015: 1
- 2017: 1
- 2018: 1
- 2019: 1
- 2020: 2
- 2021: 2
- 2022: 2
- 2025: 2
- 2026: 1

## Most-cited predicates
- K994143: Smith & Nephew External Fixation System [Unilateral (Linear) & Multilateral (Circular) Fixators and Accessories] (2000), cited by 19
- K955848: Orthofix Modulsystem (1996), cited by 14
- K970097: Proximal Femoral Nail (PFN) System (1997), cited by 8
- K970713: Compass Universal Hinge (1997), cited by 8
- K061493: Apex Pins (2006), cited by 7
- K023921: Jet-X HA Coated Half Pins (2003), cited by 6
- K991649: Depuy Rockwood Clavicle Pin (1999), cited by 6
- K103001: Rockwood Clavicle Pins (2011), cited by 4
- K011136: Apex Fixation Pins (2001), cited by 4
- K861766: Howmedica Hoffmann Fixation Pin System (1986), cited by 4

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