# MQP: Spinal Vertebral Body Replacement Device

- Device class: 2; regulation: 21 CFR 888.3060; FDA's rule: 510(k) required
- FDA decisions: 279
- 510(k) review time 2021–2025: median 187 days (middle half 163–275)
- Recalls: 42 (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: 5
- 2015: 8
- 2017: 9
- 2018: 6
- 2019: 8
- 2020: 3
- 2022: 1
- 2023: 1
- 2024: 4
- 2026: 3

## Most-cited predicates
- K003043: Surgical Titanium Mesh System (2001), cited by 26
- K990148: Stackable Cage System (1999), cited by 21
- K012254: VBR (2001), cited by 18
- K043479: MC+ Partial VBR (2005), cited by 18
- K001340: Stackable Cage System (2000), cited by 17
- K003709: Surgical Dynamics Mesh Cage System (2001), cited by 14
- K031757: Peek Tetris Spinal Implant (2003), cited by 13
- K003275: Synthes Synmesh Spacer System (2001), cited by 13
- K043206: Pioneer Vertebral Body Replacement Device (Pioneer Vertebral Spacer) (2005), cited by 12
- K021791: Verte-Stack Spinal System (2002), cited by 12

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