# K050606: Synthes 1.0MM TI. Cortex, Self-Drilling Screws (Carniofacial)

- Pathway: 510(k) (Traditional)
- Applicant: Synthes (Usa)
- Decided: Apr 6, 2005 after 27 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.
No later device cites it as a predicate yet.
0 of 1 device 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) Synthes 1.0 / 1.2 mm Craniofacial Screws: named in the summary without a submission number
- (no number) KLS Martin 1.0mm System Center-Drive Screw System: named in the summary without a submission number

## Indications for use
The Synthes 1.0mm Ti. Cortex, Self-drilling 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/K050606
Methodology: https://510kreport.com/methodology