# K192974: Tyber Medical Trauma Screw

- Pathway: 510(k) (Traditional)
- Applicant: Tyber Medical, LLC
- Decided: Jan 8, 2020 after 76 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
Longest line of descent: 2 generations back to K973309 (1998). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133842: Tyber Medical Trauma Screw, Tyber Medical, LLC (2014) Summary page 4.

## Most influential descendants
- K253042: Tyber Medical Trauma Screw (2026), 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/K192974
Methodology: https://510kreport.com/methodology