# JWH: Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

- Device class: 2; regulation: 21 CFR 888.3560; FDA's rule: 510(k) required
- FDA decisions: 921
- 510(k) review time 2021–2025: median 60 days (middle half 29–94)
- Recalls: 665 (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: 25
- 2018: 25
- 2019: 28
- 2020: 22
- 2021: 24
- 2022: 17
- 2023: 20
- 2024: 19
- 2025: 20
- 2026: 12

## Most-cited predicates
- K951987: Genesis II Total Knee System (1995), cited by 32
- K991581: Nexgen Complete Knee Solution Legacy Posterior Stabilized (LPS); LPS-Flex Fixed Bearing Femoral and Articular Surface CO (1999), cited by 19
- K113550: Vanguard Complete Knee System (2012), cited by 18
- K090988: GMK Total Knee System (2009), cited by 18
- K113369: Zimmer Persona Knee System (2012), cited by 17
- K040267: Triathlon Cruciate Retaining (CR) Total Knee (2004), cited by 17
- K051640: U2 Total Knee System (2006), cited by 16
- K023546: Maxim Accel Knee System (2003), cited by 15
- K093552: Evolution MP Total Knee System (2010), cited by 15
- K031729: Triathlon Posteriorly Stabilized (PS) Total Knee System (2003), cited by 15

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