| K-number | K250647 |
| Device name | SImmetry+ System |
| Applicant | Sivantage |
| Product code | OUR |
| Device class | Class II |
| Decision date | Jul 29, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 888.3040 |
The SImmetry+ System is a sacroiliac joint fusion device consisting of fully threaded titanium implants designed to stabilize the sacrum and ilium for bony fusion. It is intended for treating sacroiliac joint disruptions and degenerative sacroiliitis. The implants are available in various diameters (9.5–14.5 mm) and lengths (30–110 mm) and are additively manufactured from titanium alloy.
The SImmetry+ System shares the same intended use, design principles, material composition (Ti-6Al4V ELI), and operational approach as the predicate devices. Both the subject device and predicates are fully threaded metallic bone fixation fasteners for sacroiliac joint fusion, packaged and sterilized using similar methods.
ASTM F2193 (static and dynamic cantilever testing), ASTM F543 (axial pullout, torsional properties, and driving torque testing), and additive manufacturing characterization testing.
The SImmetry+ System demonstrates substantial equivalence because it has identical indications for use and similar technological characteristics to the predicate devices (SImmetry® Sacroiliac Joint Fusion System and Synthes 6.5mm Cannulated Screw). The device uses the same material (titanium alloy), similar packaging and sterilization methods, and non-clinical testing data show it performs as well as or better than the predicates in cantilever strength, pullout resistance, torsional properties, and torque delivery.
View the full FDA submission: accessdata.fda.gov