Tyber Medical Trauma Screw

The Tyber Medical Trauma Screw is a metallic bone fixation device intended for bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation. The screws are available in thread diameters ranging from 2.0 to 7.5 mm with full or partial threading options, and are designed for single use only in bones appropriate for the device size. The device is not intended for spinal use.

The subject device adds new screw sizes and an additional sterile packaging option compared to previously cleared Tyber Medical Trauma Screws (K133842 and K192974). The screws and trays are substantially equivalent in material, design, and operational principles to the predicate devices, with multiple thread length options available in various sizes for different bone fixation applications.

Testing performed in accordance with ASTM F543 (torsional strength and driving torque), ASTM F543 (pullout strength), ISO 10993-1 (biocompatibility), ASTM F2052 and F2213 (MR safety assessment), ASTM F2182 (RF-induced heating), ASTM F2119 (MR conditional designation), and ANSI/AAMI ST79, ISO 17665, ISO 11137-1, ISO 11137-2, and ISO 11737-1 (sterilization and packaging).

The Tyber Medical Trauma Screws are substantially equivalent to predicates K133842 and K192974 because they have identical intended use, material composition, and manufacturing processes. Comparative engineering analysis and testing demonstrate that the subject devices have the same technological characteristics and performance equivalent to the predicate devices, supporting substantial equivalence for the stated indications for use.