# HTN: Washer, Bolt Nut

- Device class: 2; regulation: 21 CFR 888.3030; FDA's rule: 510(k) required
- FDA decisions: 93
- 510(k) review time 2021–2025: median 88 days (middle half 58–104)
- Recalls: 2 (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)
- 2017: 6
- 2018: 2
- 2019: 5
- 2020: 3
- 2021: 2
- 2022: 5
- 2023: 2
- 2024: 6
- 2025: 4
- 2026: 2

## Most-cited predicates
- K043248: Tightrope Syndesmosis Repair Kit, Titanium, Model AR-8920DS; Stainless Steel. Model AR-8921DS (2005), cited by 26
- K052776: Tightrope Acromioclavicular (AC) Device, Titanium, Stainless Steel , Models AR-2257, AR-TBD (2005), cited by 15
- K061925: Mini Tightrope Repair Kit, Model AR-8911DS (2006), cited by 11
- K090107: Mini Tightrope (2009), cited by 7
- K112437: Arthrex Fracture System (2011), cited by 6
- K003496: Cannulated Screw System (2001), cited by 6
- K201522: Arthrex Syndesmosis TightRope XP Buttress Plate Implant System (2020), cited by 5
- K112111: Acu-Sinch Repair System and Acumed Suture Anchor (2011), cited by 5
- K140328: CMC Mini Tightrope (2014), cited by 5
- K221485: Arthrex FiberTape and TigerTape Cerclage Sutures (2022), cited by 3

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