# KWT: Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented

- Device class: 2; regulation: 21 CFR 888.3650; FDA's rule: 510(k) required
- FDA decisions: 72
- 510(k) review time 2021–2025: median 226 days (middle half 134–252)
- Recalls: 22 (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: 1
- 2018: 2
- 2019: 4
- 2020: 1
- 2021: 1
- 2022: 1
- 2023: 1
- 2024: 1
- 2025: 4
- 2026: 1

## Most-cited predicates
- K030710: Bio-Modular Shoulder System (2003), cited by 20
- K984541: Global FX Humeral Stem, Global Advantage Humeral Head (1999), cited by 10
- K100858: Lima-Lio SMR Shoulder System - Humeral Stems, Lima-Lio SMR Shoulder System - Humeral Bodies, (2010), cited by 9
- K101263: Lima-Lto SMR Shoulder System - Finned Humeral Stems, Lima-Lto SMR Shoulder System - Finned Humeral Bodies, (2011), cited by 9
- K991585: Bipolar Shoulder Prosthesis (1999), cited by 7
- K982981: New Zimmer Shoulder System (1998), cited by 7
- K020045: 3-Piece Proximal Humeral Replacement System (2002), cited by 6
- K023063: Comprehensive Humeral Fracture System (2002), cited by 5
- K022377: The Trabecular Metal Glenoid-Bigliani/Flatow the Complete Shoulder Solution, Model 4306 (2002), cited by 5
- K152825: Catalyst CSR Shoulder System (2016), cited by 4

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