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First-in-Human Implantation of PI-Rod Performed Worldwide

June 26, 2026 By SPINEMarketGroup

Spinal Alignment Solutions marks the first surgical case of its pelvic-incidence-based rod system.

FORT WAYNE, IND. — June 9, 2026 — Spinal Alignment Solutions, Inc. (SAS) today announced the first-in-human implantation, worldwide, of its PI-Rod system, performed by spine surgeon Micah Smith, MD, in Fort Wayne, Indiana.

PI-Rod is a system of pre-contoured spinal rods matched to a patient’s pelvic incidence (PI) category, indicated for use with the Medtronic CD Horizon™ SOLERA™ Spinal System as an adjunct to lumbar and sacral fusion.

Dr. Smith, who performed the case, described his experience with the system:

“PI-ROD system facilitates the next step in patient-centered care. Using this technology, we can match the shape a patient’s spine should be based on their pelvic incidence. This system is uniquely designed with markings for the likely alignment of each level’s pedicle screws. It makes it extremely user-friendly. It facilitates ideal shaping of the spine and helps provide a template for where the apex of lordosis should be. Rods of every other screw set are simply bent in a general curve. That simply doesn’t make sense, because the curve changes throughout the lumbar spine and depends on the PI. The beauty of using my robotics is that we can now place pedicle screws in the ideal place and marry that with the markings on the rod to get appropriate spinal alignment.”

— Micah Smith, MD, Spine Surgeon, Fort Wayne, Indiana

“This is the moment we’ve been building toward. For decades, spine surgery has relied on generic, or hand-bent rods. PI-Rod was built to change that, and seeing it reach a patient for the first time tells us the era of the generic rod is ending. We’re just getting started.”

— Bassel G. Diebo, MD, Co-Founder & Chief Executive Officer, Spinal Alignment Solutions

About Spinal Alignment Solutions, Inc.

Spinal Alignment Solutions, Inc. is a medical device company developing pre-contoured, pelvic-incidence-based spinal fixation technology. Learn more at pi-rod.com.

The Spinal Alignment Solutions Pelvic Incidence (PI) Rod System is indicated for use with the Medtronic CD Horizon™ SOLERA™ Spinal System for posterior, lumbar and sacral fixation in skeletally mature patients as an adjunct to fusion. Indications include: degenerative disc disease (DDD), spondylolisthesis, trauma, spinal stenosis, curvatures, tumor, pseudarthrosis, and/or failed previous fusion. See Instructions for Use for complete indication, contraindication, warning, and precaution information. 510(k): K242350. Exclusively distributed by Medtronic and Spinal Alignment Solutions.

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Filed Under: NEWS Tagged With: 2026

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