4Web Medical · Class II · Cleared Jan 28, 2026
| K-number | K252834 |
| Device name | Sacroiliac Joint Truss System (SJTS) |
| Applicant | 4Web Medical |
| Product code | OUR |
| Device class | Class II |
| Decision date | Jan 28, 2026 |
| Decision | Substantially Equivalent |
| Regulation | 888.3040 |
The Sacroiliac Joint Truss System (SJTS) is a surgical implant system for sacroiliac joint fusion procedures. It consists of cannulated, fenestrated titanium alloy screws (Ti6Al4V) available in fully threaded and partially threaded lag screw configurations with multiple diameters and lengths. The system is indicated for sacroiliac joint dysfunction, degenerative sacroiliitis, augmentation of lumbar/thoracolumbar fusion, and pelvic fracture fixation in skeletally mature patients.
The subject device and primary predicate (SI-BONE iFuse-TORQ) share similar intended use, materials, design, function, and performance characteristics. Minor differences do not raise new safety or effectiveness concerns. The device maintains compatibility with 4Web Medical's existing cleaning and sterilization protocols, with no new questions introduced compared to the reference predicate.
ASTM F3574 (Static Cantilever Bending, Dynamic Cantilever Bending, Axial Pullout, Static Torsion, Driving Torque); ASTM F2119 (MR Image Artifact); ASTM F2182 (MR Induced Heating); ASTM F2213 (MR Induced Torque); ASTM F2051 (MR Induced Displacement Force).
The SJTS demonstrates substantial equivalence through non-clinical testing showing implant strength is sufficient for intended use and equivalent to predicate devices. Similar technological characteristics, materials, design, and performance to the SI-BONE iFuse-TORQ predicate device, with no new safety or effectiveness issues identified.
View the full FDA submission: accessdata.fda.gov