Nevro Gains FDA Approval for Standalone SI Joint Fusion Technology—No Lateral Screw Required

Revolutionary Nevro System Achieves FDA Clearance with Integrated Transfixing Architecture

In a significant development for the sacroiliac joint treatment market, Nevro Corp. (NYSE: NVRO) has secured FDA 510(k) authorization for its new Nevro1 fusion system—marking a transformative moment for SI joint stabilization. The approval distinguishes itself by eliminating the requirement for a separate lateral screw component, positioning the Nevro system as a genuinely unified solution within the minimally invasive SI fusion landscape.

Technical Innovation Driving Market Differentiation

The Nevro1 represents an engineering breakthrough centered on integrated transfixation technology. The device employs self-deployed titanium anchors to simultaneously engage both the sacrum and ilium, creating enhanced axial and rotational joint stability. A defining feature lies in its proprietary instrumentation suite, engineered to facilitate precise intra-articular joint preparation—a prerequisite for durable fusion outcomes.

The system incorporates 3D-printed, osteogenic-enhanced surfaces designed to accelerate bone cell proliferation and subsequent osseous fusion. This biological integration strategy addresses a core challenge in SI fusion procedures: achieving stable, long-term fusion without external hardware complexity.

Clinical Validation and Physician Perspective

Orthopedic surgeons evaluating the Nevro system have highlighted its safety profile and procedural efficiency. According to clinical feedback, the standalone Nevro architecture delivers superior performance compared to existing alternatives, combining true fusion capabilities with straightforward deployment mechanics. The device’s integrated design eliminates the technical challenges and tissue trauma associated with multi-component fixation approaches.

Kevin Thornal, Chief Executive Officer of Nevro Corp., underscored the strategic importance: “The Nevro system now anchors our SI joint portfolio as our primary offering. This approval enables us to serve diverse physician preferences while addressing varied patient presentations—ultimately advancing clinical outcomes and patient quality of life.”

Market Expansion Following Vyrsa Acquisition

This clearance represents the first major regulatory approval since Nevro’s acquisition of Vyrsa Technologies in November 2023. The Vyrsa portfolio had previously established itself through minimally invasive chronic SI pain solutions. The approval transfer from Camber Spine to Nevro positions the company to scale manufacturing and distribution across its existing medical device infrastructure.

Broad Portfolio Strength in SI Joint Treatment

Nevro now commands one of the sector’s most extensive SI fusion product lineups. Alongside its core 10 kHz Therapy spinal cord stimulation platform—which includes the Senza SCS system and related support services for chronic trunk and limb pain—the Nevro system complements this comprehensive chronic pain ecosystem. With over 100,000 patients globally benefiting from proprietary 10 kHz technology, the company’s expansion into SI joint fusion reinforces its position as a multi-modality chronic pain treatment leader.

The integration of both spinal cord stimulation and structural joint fusion options allows Nevro to meet complex patient populations whose conditions may span multiple pain pathways and require flexible treatment sequencing.