# LYT: Fixation Accessory

- Device class: 2; regulation: 21 CFR 888.3030; FDA's rule: 510(k) required
- FDA decisions: 9
- Recalls: 4 (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)
- 1983: 1
- 1988: 1
- 1990: 2
- 1991: 1
- 1992: 1
- 1998: 2
- 2004: 1

## Most-cited predicates
- K040363: Ceramic Tipped Skull Pin (2004), cited by 1
- K980594: Osteonics FX-Cablelok Grip Components (1998), cited by 1
- K831072: Jurgan Pin Ball (1983), cited by 1
- K914812: K-Cap-E, Sterile (1992), cited by 1

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