If Medtronic announced it was planning to spin off a business 10 years ago, most analysts’ money would’ve been on its then-lagging spine surgery unit.  

A lot changes in a decade, however. The company instead announced last year that it would spin off its Diabetes business, and according to the ODT Top 10 Orthopedic Device Firms report, spine revenue grew by a mid-single digit percentage in 2025 to reach sales near $5 billion.

Since the spine speculations began, Big Blue has ignored the noise and invested heavily in its spine portfolio. It grabbed Mazor Robotics and its robotic guidance systems in 2018, followed by Titan Spine and its surface-enhanced titanium interbody implants a year later. 2020 brought on Medicrea and AI capabilities with the UNiD ASI platform, and last year, the company enlisted Nanovis based on its nanotechnology for PEEK interbody fusion.

With Stryker, ZimVie, and Johnson & Johnson parting ways with their respective spine units in recent years (Stryker to VB Spine, ZimVie to Highridge Medical, and J&J’s prospective separation of Orthopaedics), surely analysts are wondering again if Medtronic is next. However, recent activity in the unit begs to differ—at least for the foreseeable future.

The company’s Stealth AXiS surgical system won U.S. Food and Drug Administration (FDA) clearance in February. The next-gen platform merges planning, navigation, and robotics into one intelligent system for spine surgery.

Stealth AXiS was designed for hospitals and ambulatory surgery centers (ASCs) and does not rely on multiple standalone technologies. It combines familiar navigation workflows with a modular robotic design so organizations can deploy what they need at the moment and expand over time as their clinical needs evolve.

Its LiveAlign segmental tracking helps to visualize anatomic motion, surgical adjustments, and patient alignment without the need for repeated imaging. Medtronic engineered the capability to reduce reliance on manual steps and support consistent execution of patient-specific plans.

Screw trajectory planning and alignment, as well as interbody, facet, and rod planning are automated using the platform. It uses AI-based algorithms to support confident construction design and it provides auto-segmentation, labeling, 3D measurements, over 30 alignment metrics, facet decortication, and integration with the UNiD system.

Stealth AXiS is a component of the company’s greater AiBLE smart ecosystem, which seeks to meaningfully connect devices, software, and data before, during, and after spine surgery.

“The Stealth AXiS system represents a meaningful step forward in how we think about navigation and robotics working together,” said Ronald A. Lehman Jr., M.D., tenured professor of Orthopaedic Surgery (Neurological Surgery) at Columbia University, division chief of Spine Surgery and spine medical director at The Spine Hospital at NewYork-Presbyterian/The Allen Hospital, and a paid consultant to Medtronic. “One of the biggest challenges in spine surgery has been understanding and responding to how the spine moves during a procedure. The Stealth AXiS system gives surgeons real-time visibility into that motion, helping us more consistently achieve our surgical plan without interrupting workflow.”

About a week after the AXiS clearance, Medtronic earned a new FDA approval for its Infuse bone graft. The agency nod now permits Infuse for use in transforaminal lumbar interbody fusion (TLIF) procedures at one or two levels from L2–S1, with both PEEK and titanium interbody cages.

The nod made the bone graft the only PMA-approved growth factor bone graft for anterior lumbar interbody fusion (ALIF), oblique lateral lumbar interbody fusion (OLIF), and now TLIF. It’s also the only growth factor bone graft product approved for spine fusion, including two-level constructs for TLIF—which is one of the most commonly performed lumbar fusion procedures for patients with degenerative disc disease, disc herniation, or spinal instability.

The TLIF indication earned FDA breakthrough status in April 2024, powering it to a panel-track PMA application in August 2025. The application was approved 180 days later on Feb. 13, 2026.

In the INFUSE TLIF study, fusion rates exceeding 90% were achieved in single-level TLIF, and comparable results were observed for two-level constructs.

“Every patient considering TLIF places tremendous trust in us during one of the most challenging moments of their lives, and they deserve the very best chance at healing and returning to the life they love,” said Joseph Smucker, M.D., Indiana Spine Group (Indianapolis, Ind.), and global investigator for the INFUSE TLIF study. “Expanding INFUSE Bone Graft to this widely used procedure brings a biologic solution that reliably supports the body’s natural healing process—an advancement grounded in years of rigorous study and a deep commitment to improving outcomes for patients and families everywhere.”