# K253042: Tyber Medical Trauma Screw

- Pathway: 510(k) (Traditional)
- Applicant: Tyber Medical, LLC
- Decided: Apr 3, 2026 after 193 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: 3 generations back to K973309 (1998). 5 ancestors in all.
No later device cites it as a predicate yet.
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 5.
- K192974: Tyber Medical Trauma Screw, Tyber Medical, LLC (2020) Summary page 5.

## Indications for use
The Tyber Medical Trauma Screw System 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. Tyber Medical Trauma Screws are not for spinal use.

Source page: https://510kreport.com/device/K253042
Methodology: https://510kreport.com/methodology