# JDS: Nail, Fixation, Bone

- Device class: 2; regulation: 21 CFR 888.3030; FDA's rule: 510(k) required
- FDA decisions: 53
- 510(k) review time 2021–2025: median 146 days (middle half 86–202)
- Recalls: 14 (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)
- 2006: 2
- 2007: 2
- 2008: 1
- 2011: 1
- 2013: 1
- 2015: 1
- 2020: 3
- 2023: 1
- 2024: 3
- 2025: 1

## Most-cited predicates
- K983942: Intramedullary Nail System, Locking Screw, Nail Cap (1998), cited by 18
- K040212: Trigen Intertan (2004), cited by 17
- K981529: Titanium Intramedullary Nail, Titanium Locking Screw (1998), cited by 16
- K061019: Trigen Meta-Nail Retrograde Femoral and Tibial Nails (2006), cited by 13
- K914453: Universal Tibial Nail and Unreamed Tibial Nail (1992), cited by 13
- K040762: Synthes (Usa) Tibial Nail System EX (2004), cited by 11
- K962047: Titanium Cannulated Tibial Nail (TI CTN) (1996), cited by 7
- K051557: Trigen Retrograde Femoral, Supracondylar and Tibial Nails (2005), cited by 6
- K033071: Synthes (Usa) Cannulated Titanium Humeral Nail System (2003), cited by 6
- K003212: Fixion Intramedullary Nailing System (Fixion IM Nail) (2000), cited by 4

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