| K-number | K243838 |
| Device name | NEXXT MATRIXX® SI System |
| Applicant | Nexxt Spine |
| Product code | OUR |
| Device class | Class II |
| Decision date | Mar 14, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 888.3040 |
The NEXXT MATRIXX® SI System is a collection of additively manufactured titanium implants designed for sacroiliac joint fusion and pelvic fracture fixation. It includes three types of implants: the IMPAXX SI (press-fit), HELIXX SI Fully Threaded, and HELIXX SI Lag screws, available in various sizes to accommodate patient anatomy.
The subject device and predicate devices share similar technological characteristics in intended use, materials of manufacture, design, and function. The NEXXT MATRIXX® SI System is manufactured from Ti-6Al-4V or Ti-6Al-4V ELI titanium alloy per ASTM F3001 or ASTM F136, with minor design differences that do not raise new safety or effectiveness concerns.
Static Cantilever Bending per ASTM F2193, Dynamic Cantilever Bending per ASTM F2193, and Axial Pullout per ASTM F543.
The device demonstrates mechanical strength and performance substantially equivalent to predicate devices (iFuse TORQ® Implant System, iFuse Implant System, and Synthes 6.5mm Cannulated Screw) through non-clinical testing showing sufficient strength for intended use. The similar materials, intended clinical applications, and comparable performance characteristics across all tested modes establish substantial equivalence despite minor design differences.
View the full FDA submission: accessdata.fda.gov