# HSB: Rod, Fixation, Intramedullary And Accessories

- Device class: 2; regulation: 21 CFR 888.3020; FDA's rule: 510(k) required
- FDA decisions: 532
- 510(k) review time 2021–2025: median 138 days (middle half 97–246)
- Recalls: 421 (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: 23
- 2018: 17
- 2019: 13
- 2020: 17
- 2021: 10
- 2022: 12
- 2023: 11
- 2024: 13
- 2025: 15
- 2026: 18

## Most-cited predicates
- K043431: GAMMA3 Nail System (2005), cited by 16
- K003018: Titan Tibial Nail (2000), cited by 13
- K982953: Titanium Intramedullary Nails-Various Styles (1998), cited by 12
- K010988: Fixion Interlocking Proximal Femoral Nailing System (2001), cited by 12
- K010801: T2 Femoral Nail (2001), cited by 12
- K051590: T2 Ankle Arthrodesis Nail (2005), cited by 10
- K965098: Intramedullary Nail System (1997), cited by 9
- K042135: Synthes (Usa) Elastic Intramedullary Nail (Ein) System (Line Extension) (2004), cited by 9
- K031438: Acumed Small Bone Locking Rod System II (2003), cited by 9
- K012967: Modification to Fixion Interlocking Proximal Femoral Intramedullary Nailing System (2001), cited by 9

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