# MQN: External Mandibular Fixator And/Or Distractor

- Device class: 2; regulation: 21 CFR 872.4760; FDA's rule: 510(k) required
- FDA decisions: 60
- 510(k) review time 2021–2025: median 217 days (middle half 217–217)
- 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)
- 2007: 4
- 2008: 3
- 2012: 1
- 2014: 1
- 2015: 1
- 2016: 1
- 2017: 1
- 2018: 1
- 2019: 1
- 2022: 1

## Most-cited predicates
- K010139: Zurich Distraction System (2001), cited by 8
- K032442: KLS-Martin Mandibular/Reconstruction System II (2003), cited by 7
- K060138: Synthes (Usa) Craniomaxillofacial Distraction System (2006), cited by 5
- K973275: KLS-Martin Intraoral Distractor (1997), cited by 5
- K960297: Mandibular Bone Distractor II (1996), cited by 5
- K962272: Synthes Mandible Distractor (1996), cited by 4
- K002152: Track 1.0 & 1.5 MM Systems-Tissue Regeneration by Alveolar Callus Distraction (2000), cited by 4
- K992952: Lorenz Distraction System (1999), cited by 3
- K981075: Synthes (Usa) (Synthes) Single Vector Distractor with Detachable Feet (1998), cited by 2
- K043434: Osteomed Pediatric Intraoral Mandibular Distraction System (2005), cited by 2

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