# LOD: Bone Cement

- Device class: 2; regulation: 21 CFR 888.3027; FDA's rule: 510(k) required
- FDA decisions: 79
- 510(k) review time 2021–2025: median 177 days (middle half 59–271)
- Recalls: 11 (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: 3
- 2018: 2
- 2019: 4
- 2020: 3
- 2021: 4
- 2022: 3
- 2023: 2
- 2024: 1
- 2025: 1
- 2026: 1

## Most-cited predicates
- K032945: Simplex X (2004), cited by 15
- K030902: Palacos R (2003), cited by 9
- P810020: Palacos R Bone Cement (1984), cited by 9
- K031673: Refobacin -Palacos G (2004), cited by 9
- K033382: Smartset GMV Endurance Gentamicin Bone Cement (2004), cited by 7
- P960001: Depuy 1 Bone Cement (1997), cited by 6
- K050085: Osteopal V (2005), cited by 5
- K000943: Cemex System Gun Application Version (2001), cited by 5
- K041656: Modification to Depuy 1 Gentamicin Bone Cement and Smartset GMV Endurance Gentamicin Bone Cement (2004), cited by 4
- K014199: Surgical Simplex P with Tobramycin (2003), cited by 4

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