# JWJ: Prosthesis, Wrist, 3 Part Metal-Plastic-Metal Articulation, Semi-Constrained

- Device class: 2; regulation: 21 CFR 888.3800; FDA's rule: 510(k) required
- FDA decisions: 17
- 510(k) review time 2021–2025: median 196 days (middle half 99–218)
- 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)
- 1994: 1
- 1996: 1
- 1998: 1
- 2002: 2
- 2003: 2
- 2004: 1
- 2008: 1
- 2014: 1
- 2020: 2
- 2024: 3

## Most-cited predicates
- K042032: Maestro Total Wrist (2004), cited by 5
- K802032: Mini Mick Applicator (1980), cited by 4
- K961051: Universal Total Wrist System (Modification) (1996), cited by 3
- K020554: Modification to Universal Total Wrist System (2002), cited by 3
- K021859: Wrist Implant (2002), cited by 3
- K030037: Universal Total Wrist System (2003), cited by 2
- K132250: Integra Freedom Wrist Arthroplasty System (2014), cited by 2
- K031203: Biax a.F. Wrist/Biax Advanced Fixation Wrist (2003), cited by 1
- K233574: Total Wrist Arthroplasty System (TWA) (2024), cited by 1

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