# K192975: Tyber Medical Trauma Screws

- Pathway: 510(k) (Traditional)
- Applicant: Tyber Medical, LLC
- Decided: Jan 9, 2020 after 77 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.
1 later device descends from it; 1 cites it directly.
0 of 2 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) Tyber Medical Trauma Screw: named in the summary without a submission number

## Most influential descendants
- K252901: Tyber Medical Trauma Screw (2025), 0 descendants of its own

## Indications for use
The Tyber Medical Trauma Screw is indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation of bones appropriate for the size of the device. Screws are intended for single use only.

Source page: https://510kreport.com/device/K192975
Methodology: https://510kreport.com/methodology