# KWS: Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented

- Device class: 2; regulation: 21 CFR 888.3660; FDA's rule: 510(k) required
- FDA decisions: 191
- 510(k) review time 2021–2025: median 156 days (middle half 99–216)
- Recalls: 107 (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: 7
- 2018: 4
- 2019: 9
- 2020: 3
- 2021: 5
- 2022: 5
- 2023: 4
- 2024: 2
- 2025: 3
- 2026: 2

## Most-cited predicates
- K952928: Aequalis Shoulder System for Total & Hemishoulder Applications (1995), cited by 19
- K122698: Aequalis Ascend Flex Shoulder System (2013), cited by 16
- K042021: Exactech Equinoxe Shoulder System (2004), cited by 14
- K992065: Global Advantage Shoulder, Global Advantage Humeral Stem, Global Advantage Eccentric Head (1999), cited by 14
- K992119: Bio-Modular Shoulder System (1999), cited by 13
- K060209: Aequalis Shoulder Fracture System & Aequalis Shoulder System (2006), cited by 12
- K981487: Depuy Global Shoulder Glenoid (1998), cited by 12
- K994392: Aequalis Shoulder Fracture System (2000), cited by 10
- K030259: Amatomical Shoulder with Removable Head (2003), cited by 9
- K000575: Global Advantage Extended Humeral Head (2000), cited by 9

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