# JEY: Plate, Bone

- Device class: 2; regulation: 21 CFR 872.4760; FDA's rule: 510(k) required
- FDA decisions: 294
- 510(k) review time 2021–2025: median 188 days (middle half 129–263)
- Recalls: 101 (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: 5
- 2018: 7
- 2019: 6
- 2020: 6
- 2021: 4
- 2022: 5
- 2023: 2
- 2024: 5
- 2025: 2
- 2026: 3

## Most-cited predicates
- K944565: KLS-Martin Micro Osteosythesis System (1.5MM) (1994), cited by 15
- K022185: Universal CMF System (2002), cited by 12
- K944561: Micro Osteosynthesis System (1.0) (1994), cited by 10
- K854886: Wuerzburg Titanium Mini Bone Plates & Bone Screws (1986), cited by 10
- K010352: CPS 1.5/2.0/2.5 Bioabsorbable Fixation System (2001), cited by 9
- K953385: Lorenz 1.0MM, 1.5MM, 2.0MM System (1995), cited by 8
- K953806: Synthes (Usa) Midfacial System (1996), cited by 8
- K972463: The Bioplate Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery (1997), cited by 7
- K924138: Osteomed M3 System (SBF System) (1993), cited by 7
- K063790: The Synthes Matrixmandible Plate and Screw System (2007), cited by 7

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