| K-number | K252901 |
| Device name | Tyber Medical Trauma Screw |
| Applicant | Tyber Medical, LLC |
| Product code | HWC |
| Device class | Class II |
| Decision date | Dec 31, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 888.3040 |
The Tyber Medical Trauma Screw is a bone fixation device designed to allow compression and fixation between two adjacent bone segments. It is indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation of bones appropriate for the device size, and is not intended for spinal use.
The screw is available with thread diameters ranging from 1.5 to 9.0 mm and can be configured with full thread, long thread, or short thread options. The submission also includes washers and trays specific to the Tyber Medical Trauma Screws. Materials, design, and operational principles are substantially equivalent to the predicate devices.
Not stated in this summary.
The Tyber Medical Trauma Screws have similar indications for use, intended use, and identical materials as the predicate devices (K153575 and K192975). Comparative engineering analysis and mechanical testing demonstrated substantial equivalence, and biocompatibility evaluation leveraged equivalence in materials and manufacturing to previously cleared implants.
View the full FDA submission: accessdata.fda.gov