Spinal Simplicity has received FDA 510(k) clearance for the Minuteman G6 MIS Fusion Device, a next-generation, minimally invasive platform designed to enhance procedural efficiency while preserving anatomy through a tissue-sparing, direct access approach. The Minuteman G6 expands the company's portfolio for aging spine care, with a phased U.S. commercial launch planned for Q1 2026.
OVERLAND PARK, Kan., Dec. 16, 2025 /PRNewswire-PRWeb/ -- Spinal Simplicity, a leading innovator in minimally invasive spine solutions, today announced that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for the Minuteman G6 MIS Fusion Device. The next-generation platform builds upon the proven clinical foundation of the Minuteman family with enhanced design features focused on procedural efficiency, paired with tissue-sparing direct access instrumentation, and robust segmental stabilization.
The Minuteman G6 is designed to address lumbar spinal instability through a minimally invasive, tissue-sparing approach with direct access that allows physicians to lift, balance, and stabilize the spinal segment while eliminating unnecessary anatomical disruption. The device and enhanced surgical instrumentation further expand Spinal Simplicity's portfolio of technologies, providing surgical solutionsfor aging spine care.
"The clearance of Minuteman G6 marks a significant milestone for our company and, more importantly, for the patients and physicians we serve," said Todd Moseley, Co-Founder & Chief Executive Officer of Spinal Simplicity. "Our mission has always been to deliver meaningful, minimally invasive, tissue-sparing solutions. G6 represents the next evolution of that mission—providing stabilization while preserving anatomy in today's ASC-driven healthcare environment."
Minuteman G6 incorporates design enhancements focused on streamlined deployment, controlled segmental distraction, and an optimized implant-to-bone interface—enabling physicians to treat patients with vertical and angular segmental instability while maintaining a tissue-sparing direct access procedural profile.
"From a clinical perspective, innovation matters only if it translates into better care for patients," said Tim Deer, MD, a nationally recognized interventional pain physician and researcher at the Spine and Nerve Centers of the Virginias. "Minuteman G6 reflects a thoughtful progression of technology—supporting stabilization through a minimally invasive, tissue-sparing, direct access approach. This is exactly the type of advancement physicians need as we continue to expand mechanical solutions within interventional spine."
Product availability for Minuteman G6 is expected to begin in Q1 of 2026 through a controlled, phased commercial launch.
About Spinal Simplicity
Spinal Simplicity is a medical device company dedicated to creating simple, innovative procedure solutions for our physician partners to help improve their patients' pain and quality of life. A life where pain no longer defines the day, that's the future we fight for. Chronic pain steals independence, freedom, and joy. At Spinal Simplicity, we believe patients deserve more—lasting relief, restored mobility, and renewed hope.
Media Contact
Parker Snedden, Spinal Simplicity, 1 (913) 451-4414, [email protected], https://spinalsimplicity.com
Jonathan Hess, Spinal Simplicity, 1 (913) 451-4414, [email protected], https://spinalsimplicity.com
SOURCE Spinal Simplicity
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