# HRS: Plate, Fixation, Bone

- Device class: 2; regulation: 21 CFR 888.3030; FDA's rule: 510(k) required
- FDA decisions: 1,331
- 510(k) review time 2021–2025: median 101 days (middle half 60–210)
- Recalls: 116 (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: 57
- 2018: 40
- 2019: 46
- 2020: 48
- 2021: 40
- 2022: 47
- 2023: 40
- 2024: 54
- 2025: 54
- 2026: 51

## Most-cited predicates
- K082807: Synthes (Usa) 3.5 and 4.5 MM Locking Compression Plate System with Expanded Indications (2008), cited by 43
- K011335: Synths One-Third Tubular DCL Plate (2001), cited by 43
- K063049: Synthes (Usa) Modular Mini Fragment LCP System (2006), cited by 40
- K041860: Synthes (Usa) LCP Proximal Humerus Plates, Long (2004), cited by 36
- K993106: Smith & Nephew Bone Plate System (Bone Plates, Bone Screws and Accessories) (1999), cited by 36
- K012655: Congruent Bone Plate System (2001), cited by 28
- K033669: Smith & Nephew Locking Bone Plate System (Locking Bone Plates and Screws) (2003), cited by 28
- K100776: Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot System (2010), cited by 26
- K062564: Synthes LCP Distal Femur Plates (2006), cited by 25
- K061808: Darco Locking Bone Plate System (2006), cited by 24

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