# LXT: Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite

- Device class: 2; regulation: 21 CFR 888.3030; FDA's rule: 510(k) required
- FDA decisions: 57
- 510(k) review time 2021–2025: median 256 days (middle half 256–256)
- Recalls: 11 (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)
- 2003: 7
- 2004: 3
- 2005: 5
- 2006: 3
- 2007: 1
- 2008: 1
- 2009: 1
- 2011: 1
- 2013: 2
- 2023: 1

## Most-cited predicates
- K991407: Synthes Locking Calcaneal Plates (1999), cited by 16
- K000558: Synthes (Usa) Wrist Fusion Plates (WFP) (2000), cited by 8
- K033805: Synthes (Usa) 3.5 / 4.5 MM LCP Metaphyseal Plates (2004), cited by 7
- K031428: Synthes (Usa) Large External Fixation Clamps-MR Safe (2003), cited by 6
- K050932: Distal Volar Radius Anatomical Plate System (2005), cited by 6
- K953397: Hex-Fix Field Fixator (1995), cited by 5
- K060290: Shoulder Fixation System (2006), cited by 4
- K941048: True/Lok Monolateral/Bilateral Fixator (1994), cited by 4
- K051728: Modification to Shoulder Fixation System (2005), cited by 4
- K984357: Transfx External Fixation System (1999), cited by 4

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