SI-TECHNOLOGY® SI-DESIS® X™ Sacroiliac Joint Fusion System

The SI-TECHNOLOGY® SI-DESIS® X™ Sacroiliac Joint Fusion System is an X-shaped titanium implant designed to fuse sacroiliac joints and stabilize the sacroiliac joint for conditions including joint dysfunction, degenerative sacroiliitis, and pregnancy-related symptoms persisting over 6 months. It also augments immobilization during lumbar or thoracolumbar fusion in skeletally mature patients.

The subject device is identical to the predicate in design, function, and operation. The only difference is the addition of select implant size offerings. Both devices consist of a titanium alloy (ASTM F136) X-shaped implant with sacrum and ilium engaging sides connected by a bridge, designed for single-use and steam sterilization prior to use.

ASTM F136 (titanium alloy material standard). The document cites adoption of steam sterilization methods, static shear finite element analysis, and pushout testing standards, though specific ISO/IEC/ASTM test method numbers for these are not explicitly detailed in the summary.

The subject device is substantially equivalent because it has identical technological design, indications for use, principles of operation, inputs, and outputs to the predicate K241813. All prior testing from the predicate remains applicable through formal adoption and justification of steam sterilization, FEA, cross-sectional area assessment, pushout testing, and usability studies, demonstrating equivalent safety and effectiveness.