# HWC: Screw, Fixation, Bone

- Device class: 2; regulation: 21 CFR 888.3040; FDA's rule: 510(k) required
- FDA decisions: 1,070
- 510(k) review time 2021–2025: median 104 days (middle half 59–190)
- Recalls: 238 (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: 40
- 2018: 20
- 2019: 30
- 2020: 28
- 2021: 26
- 2022: 26
- 2023: 24
- 2024: 17
- 2025: 15
- 2026: 21

## Most-cited predicates
- K021932: Synthes 6.5 MM Cannulated Screw (2002), cited by 62
- K061863: Arthrex Corkscrew Suture Anchor, Tak, and Pushlock Family (2006), cited by 34
- K112583: Synthes Cortical Screws (2011), cited by 28
- K962011: Synthes 7.0/7.3 MM Cannulated Screws (1996), cited by 27
- K963192: Synthes Sterile 3.5 MM and 4.0 MM Cannulated Screws (1996), cited by 23
- K103705: Low Profile Screws (2011), cited by 22
- K000080: Asnis Iii Cannulated Screw System (2000), cited by 21
- K963172: Synthes Sterile 4.5 MM Cannulated Screws (1996), cited by 20
- K962823: Synthes Sterile 3.0 MM Cannulated Screw and Threaded Washer (1996), cited by 20
- K043185: Synthes 3.5MM Cortex Screws (2005), cited by 20

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