# NJD: Prosthesis, Knee, Femorotibial, Unicompartmental/Unicondylar, Uncemented, Porous-Coated, Metal/Polymer

- Device class: 2; regulation: 21 CFR 888.3535; FDA's rule: 510(k) required
- FDA decisions: 5
- 510(k) review time 2021–2025: median 68 days (middle half 63–101)
- Recalls: 0 (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
- 2019: 1
- 2022: 1
- 2024: 1
- 2025: 1

## Most-cited predicates
- K133811: Restoris Porous Partial Knee System (2014), cited by 5
- K190439: Engage™ Partial Knee System (2019), cited by 2
- K242307: ACHIEVE Partial Knee System (2024), cited by 1

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