# KGS: Retention Device, Suture

- Device class: 1; regulation: 21 CFR 878.4930; FDA's rule: 510(k) exempt
- FDA decisions: 20
- Recalls: 1 (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)
- 1987: 1
- 1988: 1
- 1989: 3
- 1990: 2
- 1991: 2
- 1993: 1
- 1995: 1
- 1997: 1
- 2002: 1
- 2003: 1

## Most-cited predicates
- K813581: Cruciate Ligament Button (1982), cited by 3
- K020480: RBM (2002), cited by 1
- K896310: Acufex Fixation Button; Retention Bar, Wedge (1989), cited by 1
- K884565: Acufex Fixation Button (1989), cited by 1

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