FDA clearance for Stealth AXiS™, PMA approval for Infuse™ TLIF, and a strong Q3 earnings beat set the stage for what Medtronic’s cranial and spinal technologies chief calls a connected future for spine surgery.
February 23, 2026
TJ Halvorson, Orthopedics This Week
Friday, February 13th has a different meaning for Michael Carter now.
In the span of one week, Medtronic secured two major regulatory milestones: FDA 510(k) clearance for the Stealth AXiS™ Surgical System, the first fully integrated planning, navigation, and robotics platform for spine surgery, and FDA Premarket Approval (PMA) of Infuse™ Bone Graft for one- and two-level Transforaminal Lumbar Interbody Fusion (TLIF) procedures.
“It was a really exciting Friday,” Carter told Orthopedics This Week. “There are people on the team that have been working on the robotics platform since we acquired Mazor. And within 24 hours we also had the PMA approval for Infuse™ on TLIF.” That’s a positive Friday the 13th.
The regulatory wins arrived days before Medtronic reported its fiscal Q3 2026 earnings on February 17. Results showed the company’s Cranial & Spinal Technologies (CST) business delivering mid-single digit growth. Total company revenue reached $9.0 billion, up 6% organically, the highest enterprise growth rate in 10 quarters. The CST numbers reflect a business that has been quietly building momentum, and the two regulatory approvals signal that momentum is about to accelerate.
Stealth AXiS: Capturing The White Whale?
A major theme in the Stealth AXiS™ story is a capability called LiveAlign™ segmental tracking, a technology that allows surgeons to visualize anatomic motion, surgical adjustments, and patient alignment in real time during a procedure, without the need for repeated imaging.
Any claims about surgical time reduction will need real-world validation as expected. But the clinical value proposition goes well beyond efficiency. When surgeons can continuously track exactly where every spinal segment is moving and make decisions accordingly, they’re not just saving steps, they’re reducing radiation exposure from repeat confirmatory scans and executing the procedure with another level of confidence and precision.
Stealth AXiS™ was designed to extend from that installed base rather than disrupt it, combining familiar navigation workflows with a modular robotic design that lowers the adoption barrier for surgeons who haven’t yet moved to navigation (although recent statistics show approximately 70% of U.S. spine procedures utilize navigation technology).
For ambulatory surgery centers, Carter noted the modular design was a deliberate engineering decision from the start, with Medtronic specifically bringing in surgeons who work in ambulatory surgery centers (ASCs) during development. “That was all part of the arithmetic of how we’re going to make the transition from being very hospital-centric to really moving with the site of care.”
Perhaps the most underappreciated aspect of the launch, Carter suggested, is the seamless information flow that Stealth AXiS™ enables from preoperative planning through execution. Previously, planning software and intraoperative navigation existed as separate form factors with limited connectivity. With Stealth AXiS™, a surgeon’s preoperative plan is downloaded directly into the system and carried forward into the OR. “That’s going to save them time, reduce cognitive load, and the overall user experience is going to be the biggest thing people pick up on,” Carter said.
Infuse Approval for TLIF: Validating What Surgeons Already Knew
The PMA approval of Infuse™ Bone Graft for TLIF represents a different kind of milestone. Less a discovery than a validation. TLIF is one of the most commonly performed lumbar fusion procedures in the U.S. and Infuse™ is now the only PMA-approved growth factor bone graft for ALIF, OLIF, and TLIF, and the only growth factor bone graft approved for spine fusion including two-level constructs.
The clinical trial supporting the approval was a prospective, multicenter, randomized controlled study of 493 patients across three arms: Infuse™ at 2.1 mg/level, Infuse™ at 4.2 mg/level, and local bone autograft. Following the first interim analysis, the Independent Data Monitoring Committee determined that primary endpoints were met for both Infuse™ dose groups, triggering an early study stop for success. Fusion rates exceeded 90% in single-level TLIF, with comparably strong results in two-level constructs, and patients showed earlier radiographic evidence of fusion compared to autograft.
On this news, Carter spoke to this validation adding to the confidence and faith in Medtronic for doing the hard work to make sure they know what’s safe for their patients. He added that budget impact modeling across Medtronic’s biologic portfolio consistently supports the conclusion that the company’s products reduce the overall cost burden on health systems rather than adding to it.
The Bigger Picture: An Ecosystem Strategy
During the Q3 earnings call, CEO Geoff Martha called Stealth AXiS™ “meaningfully underappreciated” by the investment community. A pointed signal that Medtronic believes Wall Street hasn’t yet fully priced in what the platform means for the company’s spine growth trajectory. Carter’s view is simple: let the system speak for itself. When more surgeons use it and see segmental movement through LiveAlign™ in real time, the investment community will understand what the surgeons confirm.
In the Q3 earnings call, Medtronic management indicated that Stealth AXiS™ could begin contributing to CST revenue as soon as the fourth quarter of fiscal 2026, and that the platform’s architecture is designed to expand beyond spine into cranial and ENT indications, pending future 510(k) clearances. The Infuse™ TLIF approval, meanwhile, opens what is arguably the largest single addressable procedure market the biologic has ever been approved for.
For a business that posted 8% Core Spine growth in Q3 and now enters Q4 with two landmark regulatory wins and a 10,000-unit navigation installed base to build from, the next chapter of Medtronic’s spine story appears to be just beginning.
Michael Carter is Senior Vice President and President of Cranial & Spinal Technologies at Medtronic. This article includes comments from a discussion with OTW’s TJ Halvorson following Medtronic’s FY26 Q3 earnings release on February 17, 2026.
