# K021850: Synthes (Usa) 1.3 MM Craniofacial Screws

- Pathway: 510(k) (Special)
- Applicant: Synthes (Usa)
- Decided: Jun 10, 2002 after 5 days
- Product code: DZL (Screw, Fixation, Intraosseous)
- Device class: 2
- Regulation: 21 CFR 872.4880
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K953806 (1996). 2 ancestors in all.
32 later devices descend from it; 2 cite it directly.
0 of 35 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K983485: Synthes 1.3 MM Self-Drilling Screw, Synthes (Usa) (1998) Summary page 1.

## Most influential descendants
- K091686: Leforte Neurosystem Bone Screw (2009), 29 descendants of its own
- K112457: Leforte System Bone Plate & Screw (2012), 16 descendants of its own
- K112812: Leforte Neuro System Bone Plate (2012), 11 descendants of its own
- K131311: Arix Foot System (2013), 9 descendants of its own
- K161864: ARIX Foot System (2016), 5 descendants of its own

## Indications for use
Synthes Craniofacial Screws are intended for selective trauma of the midface and craniofacial skeleton; craniofacial surgery; reconstructive procedures; and selective orthognathic surgery of the maxilla and chin.

Source page: https://510kreport.com/device/K021850
Methodology: https://510kreport.com/methodology