# K133842: Tyber Medical Trauma Screw

- Pathway: 510(k) (Traditional)
- Applicant: Tyber Medical, LLC
- Decided: Mar 20, 2014 after 92 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: 1 generation back to K973309 (1998). 3 ancestors in all.
23 later devices descend from it; 8 cite it directly.
0 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082320: Darco Small Screw, Wrightmedicaltechnologyinc (2008) Summary page 1.
- K021556: Synthes 2.4 MM Cannulated Compression Screw, Synthes (Usa) (2002)
- K973309: Vilex Cannulated Bone Screw, Duval Cannulated Bone Screw, Vilex, Inc. (1998) Summary page 1.

## Most influential descendants
- K153575: Tyber Medical Trauma Screw (2016), 12 descendants of its own
- K203595: DynaFuse Fixation System (2022), 5 descendants of its own
- K213596: OSSIOfiber Compression Screw, 3.5mm (2021), 4 descendants of its own
- K231272: OSSIOfiber® Pin Product Family, OSSIOfiber® Compression Screw, OSSIOfiber® Trimmable Fixation Nail (2023), 3 descendants of its own
- K241218: Tyber Medical Anatomical Plating System (2024), 2 descendants of its own

## Indications for use
The Tyber Medical Trauma Screws are indicated for use in bone reconstruction, osteotomy, artkirodesis, 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/K133842
Methodology: https://510kreport.com/methodology