| K-number | K253611 |
| Device name | Falco Fusion System |
| Applicant | Mcnicoll Surgical, Inc. |
| Product code | OUR |
| Device class | Class II |
| Decision date | Jan 29, 2026 |
| Decision | Substantially Equivalent |
| Regulation | 888.3040 |
The Falco Fusion System is a sacroiliac joint fusion device consisting of titanium alloy screws (11mm and 13mm diameter, 35-75mm length), disposable guide wires, and reusable stainless steel surgical instruments. It is intended to stabilize or fuse the sacroiliac joint to treat sacroiliac joint disruptions and degenerative sacroiliitis, typically using 2-4 screws implanted across the joint.
The device features cannulated, fully threaded screws with fenestration, dual-pitch design, and self-drilling/self-tapping capability for efficient bone purchase without pilot hole drilling. The screws are made from Ti-6Al-4V ELI titanium alloy (ASTM F136), guide wires from 316-LVM stainless steel (ASTM F138), and instruments from medical-grade stainless steel (ASTM F899) and silicone. These characteristics are similar to the predicate device with no new safety or effectiveness concerns.
Mechanical testing per ASTM F543 (pull-out strength, driving torque, torsional properties) and ASTM F2193 (static and dynamic cantilever bending). Design reviewed against ASTM F3574-22. Passivation per ASTM F86 (titanium) and ASTM A967 (stainless steel). Final cleaning per ISO 19227. Biocompatibility per ISO 10993-1. Sterilization validation per ANSI/AAMI ST98:2022.
The Falco Fusion System has the same intended use and similar technological characteristics as the predicate Outlet Sacroiliac Joint Fusion System (K181881). Performance testing demonstrates comparable mechanical properties and reprocessing validation. Any differences do not raise new questions of safety or effectiveness, establishing substantial equivalence.
View the full FDA submission: accessdata.fda.gov