# NDN: Cement, Bone, Vertebroplasty

- Device class: 2; regulation: 21 CFR 888.3027; FDA's rule: 510(k) required
- FDA decisions: 108
- 510(k) review time 2021–2025: median 90 days (middle half 74–158)
- Recalls: 5 (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: 5
- 2018: 3
- 2019: 2
- 2020: 4
- 2021: 2
- 2022: 2
- 2023: 2
- 2024: 3
- 2025: 2
- 2026: 1

## Most-cited predicates
- K041584: Kyphx HV-R Bone Cement, Model C01A (2004), cited by 10
- K093419: Ivas 2-10MM (10 Gauge) Balloon Catheter, Ivas 2-15 MM (10 Gauge)0705-115-500, Ivas 3-10MM (8 Gauge)Balloon Catheter, Ivas (2010), cited by 8
- K060300: Confidence High Viscosity Bone Cement (2006), cited by 7
- K033801: Kyphx HV-R, Model C01A (2004), cited by 6
- K043518: Radiopaque Bone Cement (2005), cited by 6
- K090211: Inflatable Bone Tamp (2009), cited by 5
- K103807: Ivas 2-10MM (10 Guage) Ballon Catheter (2011), cited by 5
- K042415: Mendec Spine (2005), cited by 5
- K090435: Vertecem (2009), cited by 4
- K093463: Avamax Vertebral Balloon Model VBS1010, VBS1015, VBS1020 (2010), cited by 4

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