# DZL: Screw, Fixation, Intraosseous

- Device class: 2; regulation: 21 CFR 872.4880; FDA's rule: 510(k) required
- FDA decisions: 81
- 510(k) review time 2021–2025: median 258 days (middle half 230–301)
- Recalls: 5 (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)
- 2015: 1
- 2016: 1
- 2017: 3
- 2019: 2
- 2020: 1
- 2021: 1
- 2023: 2
- 2024: 2
- 2025: 4
- 2026: 1

## Most-cited predicates
- K983485: Synthes 1.3 MM Self-Drilling Screw (1998), cited by 8
- K973180: Imtec Bone Tac (1997), cited by 4
- K911936: Osteomed SBF System (SBF) (1991), cited by 4
- K093719: Pro-Fix Precision Fixation System Model PFM#, PFB#, PFT# (2010), cited by 4
- K980760: KLS-Martin MMF Screw (1999), cited by 3
- K955369: Memfix (1996), cited by 3
- K981666: 2.5 MM Lactosorb Screws (1998), cited by 3
- K041887: Synthes (Usa) 1.0/1.22 MM Craniofacial Screws (2004), cited by 3
- K963546: SMF Titanium (TI) Alloy Bone Screws (1997), cited by 3
- K981362: Synthes (Usa) External Multi Vector Mandible Distractor (1998), cited by 3

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