# MJO: Prosthesis, Intervertebral Disc

- Device class: 3; regulation: 21 CFR —; FDA's rule: PMA required
- FDA decisions: 15
- Recalls: 8 (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: 15
- 2018: 9
- 2019: 12
- 2020: 21
- 2021: 17
- 2022: 11
- 2023: 12
- 2024: 13
- 2025: 13
- 2026: 14

## Most-cited predicates
- P200022: Simplify® Cervical Artificial Disc (2020), cited by 1
- P070001: Prodisc TM-C Total Disc Replacement (2007), cited by 1

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