# KTW: Appliance, Fixation, Nail/Blade/Plate Combination, Single Component

- Device class: 2; regulation: 21 CFR 888.3030; FDA's rule: 510(k) required
- FDA decisions: 38
- Recalls: 57 (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)
- 1999: 3
- 2000: 2
- 2001: 3
- 2002: 3
- 2006: 1
- 2008: 2
- 2012: 1
- 2016: 1
- 2017: 2
- 2019: 1

## Most-cited predicates
- K011815: Synthes LCP Proximal Humerus Plates (2001), cited by 25
- K010321: Modular Foot System - 2.7 MM Module (2001), cited by 9
- K792291: Synthes Reconstructive Plates 'Y' Plates (1979), cited by 7
- K914546: Angled Blade Plate (1991), cited by 6
- K001614: Stryker Trauma Pelvic Set (2000), cited by 5
- K011458: Synthes Straight Wrist Fusion Plate, 170MM (2001), cited by 3
- K023360: Leforte System Bone Plate (2002), cited by 3
- K781762: Compression Hip Screw System (1978), cited by 3
- K080109: Synthes (Usa) Modular Blade Plate System (2008), cited by 1
- K012634: Reprocessed External Fixation Device (2002), cited by 1

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