# K041887: Synthes (Usa) 1.0/1.22 MM Craniofacial Screws

- Pathway: 510(k) (Traditional)
- Applicant: Synthes (Usa)
- Decided: Aug 19, 2004 after 38 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
No predicates in its family tree.
3 later devices descend from it; 3 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) KLS Martin 1.0amm System Center-Drive Screw System: named in the summary without a submission number
- (no number) Synthes Maxillofacial Titanium Micro Set: named in the summary without a submission number

## Most influential descendants
- K192702: DePuy Synthes Craniomaxillofacial Neuro Devices - MR Conditional (2020), 0 descendants of its own
- K183113: DePuy Synthes Maxillofacial Portfolio - MR Conditional (2019), 0 descendants of its own
- K132212: Dental Bone Screws; Dental Bone Screws, Continuing; Screw System TX; Screw System TX Professional (2014), 0 descendants of its own

## Indications for use
The Synthes 1.0/1.2 mm craniofacial screws are intended for use as follows: Specific Indications: * Nasoethmoidal fractures * Infraorbital area fractures * Frontal sinus wall fractures * Infant craniofacial surgery General Indications: * Maxillofacial surgery

Source page: https://510kreport.com/device/K041887
Methodology: https://510kreport.com/methodology