# SBF: Orthopedic Augmented Reality

- Device class: 2; regulation: 21 CFR 882.4560; FDA's rule: 510(k) required
- FDA decisions: 43
- 510(k) review time 2021–2025: median 104 days (middle half 88–212)
- 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)
- 2019: 1
- 2020: 2
- 2021: 4
- 2022: 7
- 2023: 7
- 2024: 6
- 2025: 13
- 2026: 3

## Most-cited predicates
- K193559: NextAR TKA Platform (2020), cited by 6
- K190929: xvision Spine system (XVS) (2019), cited by 5
- K210153: NextAR RSA Platform (2021), cited by 4
- K220905: xvision Spine System (2022), cited by 3
- K202152: NextAR TKA Platform (2020), cited by 3
- K210859: NextAR™ Spine Platform (2021), cited by 3
- K243975: Knee+ (2025), cited by 2
- K220104: Knee+ (2022), cited by 2
- K233172: NextAR™ Spine Platform (2024), cited by 1
- K211188: xvision Spine system (XVS) (2021), cited by 1

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