# K990351: Bone Screws

- Pathway: 510(k) (Traditional)
- Applicant: Bregma International Trading Company, Ltd.
- Decided: Jun 1, 1999 after 116 days
- Product code: HWC (Screw, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3040
- 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
Bone screws are used to fix fractured long and shorl bones. They are also used to fasten bone plates. Bregma International manufactures three kinds of bonc screws, each with its own intended use. Cortical bune screws are used to augment compact and hard bones (diaphyseal reglons of the bones). Cancellous bone screws ure used Iln the epiphyseal and metaphyseal reglons of the bones which are largely coft and spongy. Cannulated bone screws, are used in situations where surglcal wire is required to pass through the central axis of the screw, along which a holes has been drilled.

Source page: https://510kreport.com/device/K990351
Methodology: https://510kreport.com/methodology