Spinal Simplicity, LLC · Class II · Cleared Dec 1, 2025
| K-number | K253250 |
| Device name | Minuteman® G6 MIS Fusion Plate |
| Applicant | Spinal Simplicity, LLC |
| Product code | PEK |
| Device class | Class II |
| Decision date | Dec 1, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 888.3050 |
The Minuteman G6 MIS Fusion Plate is a minimally invasive spinal fusion device composed of titanium alloy coated with hydroxyapatite. It attaches to the posterior spinous processes of the non-cervical spine (L1-S1) and is used with bone graft material to achieve spinal fusion for conditions including lumbar spinal stenosis, degenerative disc disease, and spondylolisthesis.
The Minuteman G6 has the same technological characteristics as the predicate device (Minuteman G5). It is made of Ti-6Al-4V ELI titanium alloy per ASTM F136 and coated with hydroxyapatite per ASTM F1185, designed for attachment through two sets of wings at the spinous processes and allowing controlled distraction with varied sizes for anatomical fit.
ASTM F1717 Static Compression Testing, ASTM F1717 Static Torsion Testing, ASTM F1717 Dynamic Compression Testing, Custom Pull Off Testing, and Cadaver Testing.
The Minuteman G6 is substantially equivalent to the predicate device because it has identical intended use and indications for use, the same technological characteristics, and non-clinical performance testing (bench and cadaver) demonstrates it performs safely and effectively as the legally marketed predicate device.
View the full FDA submission: accessdata.fda.gov