# K050607: Synthes 1.0MM TI. Cortex, Self-Drilling Screws (Hand & Neuro)

- Pathway: 510(k) (Traditional)
- Applicant: Synthes (Usa)
- Decided: Apr 11, 2005 after 32 days
- Product code: HRS (Plate, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3030
- 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 Plusdrive 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 1.0mrn Ti. Cortex, Self-drilling screws are intended for fracture fixation in hand surgery and neurosurgery.

Source page: https://510kreport.com/device/K050607
Methodology: https://510kreport.com/methodology