# KWI: Prosthesis, Elbow, Hemi-, Radial, Polymer

- Device class: 2; regulation: 21 CFR 888.3170; FDA's rule: 510(k) required
- FDA decisions: 34
- 510(k) review time 2021–2025: median 128 days (middle half 119–136)
- Recalls: 5 (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)
- 2013: 1
- 2014: 1
- 2017: 1
- 2019: 1
- 2020: 1
- 2021: 1
- 2022: 1
- 2023: 1
- 2024: 1
- 2026: 1

## Most-cited predicates
- K991915: Modular Radial Head (1999), cited by 9
- K982288: Radial Head Implant (1998), cited by 5
- K060731: Evolve Modular Radial Head (2006), cited by 5
- K002644: Radial Head Implant (2000), cited by 5
- K051385: Explor Modular Radial Head Replacement Device (2005), cited by 4
- K984290: Implex Radial Head Replacement System (1999), cited by 4
- K032686: Ascension Modular Radial Head (2003), cited by 3
- K944507: Metallic Radial Head Implants (1995), cited by 3
- K183618: Revolution Radial Head (2019), cited by 2
- K041858: Acumed Anatomic Radial Head System (2004), cited by 2

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