# NJL: Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing

- Device class: 3; regulation: 21 CFR —; FDA's rule: PMA required
- FDA decisions: 2
- Recalls: 257 (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: 21
- 2018: 27
- 2019: 30
- 2020: 28
- 2021: 18
- 2022: 30
- 2023: 17
- 2024: 23
- 2025: 23
- 2026: 28

## Most-cited predicates
- P830055: LCS (R) Total Knee System (1985), cited by 1

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