# MBB: Bone Cement, Antibiotic

- Device class: 2; regulation: 21 CFR 888.3027; FDA's rule: 510(k) required
- FDA decisions: 19
- 510(k) review time 2021–2025: median 142 days (middle half 89–211)
- Recalls: 6 (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)
- 2014: 1
- 2015: 1
- 2016: 2
- 2017: 1
- 2019: 2
- 2020: 1
- 2021: 1
- 2022: 3
- 2024: 2
- 2025: 1

## Most-cited predicates
- K161273: StageOne Disposable Cement Spacer Molds for Temporary Knee Prosthesis (2017), cited by 3
- K161166: StageOne Select Cement Spacer Molds for Temporary Hip Replacement (2016), cited by 2
- K160071: StageOne Disposable Cement Spacer Molds for Temporary Hemi-Shoulder Prosthesis (2016), cited by 2
- K053002: Depuy CMW 1 Gentamicin Bone Cement (2005), cited by 2
- K190216: SpaceFlex Knee (2019), cited by 1
- K131135: Biomet Stage One Disposable Cement Spacer Molds for Temporary Hemi-Shoulder Prosthesis (2014), cited by 1
- K202338: SpaceFlex Shoulder (2021), cited by 1

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