# KYJ: Prosthesis, Finger, Constrained, Polymer

- Device class: 2; regulation: 21 CFR 888.3230; FDA's rule: 510(k) required
- FDA decisions: 14
- 510(k) review time 2021–2025: median 441 days (middle half 235–445)
- Recalls: 3 (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)
- 1979: 1
- 1987: 1
- 1994: 1
- 1997: 1
- 2000: 1
- 2002: 2
- 2009: 2
- 2015: 1
- 2022: 1
- 2023: 2

## Most-cited predicates
- K970544: Depuy Dupont Orthopaedics Finger Joint Prosthesis (1997), cited by 4
- K022892: Ascension Sillicone MCP (2002), cited by 3
- K870200: Sutter Finger Joint Prosthesis (1987), cited by 2
- K082231: Ascension Silicone Pip (2009), cited by 2
- K001922: Depuy Neuflex Pip Finger (2000), cited by 2
- K013629: Finger Joint Prosthesis (2002), cited by 1
- K083107: Modification to Depuy Neuflex Pip Finger (2009), cited by 1
- K931588: Sutter Proximal Interphalangeal Joint (1994), cited by 1

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