# K153575: Tyber Medical Trauma Screw

- Pathway: 510(k) (Traditional)
- Applicant: Tyber Medical, LLC
- Decided: Feb 26, 2016 after 73 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.
12 later devices descend from it; 4 cite it directly.
0 of 17 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
- K203595: DynaFuse Fixation System (2022), 5 descendants of its own
- K241218: Tyber Medical Anatomical Plating System (2024), 2 descendants of its own
- K254110: DynaNail Mini; DynaNail Hybrid; DynaNail Helix; DynaClip; DynaClip Forte; DynaClip Delta; DynaClip Quattro (2026), 1 descendant of its own
- K242486: Tyber Medical Anatomical Plating System (2025), 1 descendant of its own
- K233567: OsteoCoil™ Nitinol Compression System (Multiple Component PNs) (2024), 1 descendant 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/K153575
Methodology: https://510kreport.com/methodology