# HTY: Pin, Fixation, Smooth

- Device class: 2; regulation: 21 CFR 888.3040; FDA's rule: 510(k) required
- FDA decisions: 206
- 510(k) review time 2021–2025: median 107 days (middle half 58–154)
- Recalls: 9 (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: 4
- 2019: 4
- 2020: 5
- 2021: 5
- 2022: 4
- 2023: 5
- 2024: 1
- 2025: 5
- 2026: 2

## Most-cited predicates
- K022599: Newdeal K Wire (2002), cited by 23
- K960385: Sterile Kirschner Wires and Steinmann Pins (1996), cited by 17
- K050259: Arthrex Bio-Pin (2005), cited by 16
- K070598: Memometal Intra-Medullary Bone Fastener, Models Smart Toe / X-Fuse (2007), cited by 14
- K971783: Synthes Elastic Intramedullary Nail (Ein) System (1997), cited by 13
- K100736: Kirschner and Guide Wires (2010), cited by 12
- K112990: Acl Tightrope,Acl Tightrope Duuble Bundle (2011), cited by 10
- K132895: WMT Implantable K-Wire (2013), cited by 9
- K092038: Aptus K-Wire System (2009), cited by 7
- K983121: Non-Sterile Kirschner Wires and Steinmann Pins, Models #'S 290-101/160, 290-201/216, 290-060/330, 290-161/220 (1998), cited by 7

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