# HBW: Fastener, Plate, Cranioplasty

- Device class: 2; regulation: 21 CFR 882.5360; FDA's rule: 510(k) required
- FDA decisions: 7
- 510(k) review time 2021–2025: median 84 days (middle half 72–97)
- Recalls: 0 (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)
- 2001: 1
- 2010: 1
- 2015: 2
- 2017: 1
- 2023: 1
- 2025: 1

## Most-cited predicates
- K001353: Memograph; Osstaple - Neurosurgical Uses for Craniofacial Fractures and Cranioplasty for the Memograph Staple System (2001), cited by 3
- K151387: Stryker Universal Neuro III System: UN III AXS Screw, UN III AXS Screwdriver Blade (2015), cited by 1
- K171152: Stryker Universal Neuro III System AXS Screw (2017), cited by 1

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