# KTT: Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component

- Device class: 2; regulation: 21 CFR 888.3030; FDA's rule: 510(k) required
- FDA decisions: 405
- 510(k) review time 2021–2025: median 74 days (middle half 30–119)
- Recalls: 53 (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)
- 2017: 11
- 2018: 6
- 2019: 8
- 2020: 9
- 2021: 10
- 2022: 3
- 2023: 7
- 2024: 5
- 2025: 10
- 2026: 5

## Most-cited predicates
- K000684: Small Fragment Dynamic Compression Locking (DCL) System (2000), cited by 69
- K000682: Synthes Large Fragment Dynamic Compression Locking (DCL) System (2000), cited by 25
- K033995: 3.5 MM LCP Distal Humerus System (2004), cited by 24
- K953406: Ebi X Fix Dynafix System (DFS) (1995), cited by 17
- K970748: Taylor Spatial Frame External Fixation System (1997), cited by 14
- K993289: Smith & Nephew Compression Hip Screw System, Intramedullary Hip Screw System (1999), cited by 13
- K093047: Smith & Nephew Circular Fixation System (2010), cited by 13
- K791619: Dynamic Hip Screw (1979), cited by 12
- K072212: Jet-X Bar System Clamps, Bars and Posts-MR Safe (2008), cited by 12
- K870961: Richards External Fixation System (1987), cited by 10

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