Nevro has received the US Food and Drug Administration (FDA) 510(k) clearance for its Nevro1 sacroiliac (SI) joint fusion device without the NevroFix lateral screw.

Nevro1 is an integrated transfixing device. It is said to transfix the sacroiliac joint immediately and provide the chance for long-term fusion.

The ilium and sacrum are transfixed with self-contained, deployable titanium anchors. This improves the joint’s axial and rotational stability, US-based Nevro claimed.

Additionally, Nevro’s proprietary instrumentation enables optimal intra-articular sacroiliac joint preparation, which is essential for achieving joint fusion.

Nevro, a medical device company focused on chronic pain treatment, said that Nevro1 aids in the growth and eventual fusion of bone cells using its 3D-printed bone-growth boosting technology.

Pennsylvania State College orthopedic surgeon Gregory Bailey said: “Nevro1 as a standalone device represents the most significant advancement in SI fusion in years. In my experience, it is the safest and most efficient and effective true fusion implant available.”

This is the first regulatory clearance that Nevro has received since November 2023, when it acquired Vyrsa Technologies.

The deal also included Vyrsa’s line of cutting-edge technologies that offer patients with persistent sacroiliac joint pain minimally invasive therapy alternatives.

Originally received by Camber Spine, the FDA clearance will be transferred to Nevro for marketing as well as distribution.

Nevro CEO and president Kevin Thornal said: “Nevro1 will be our flagship SI joint fusion product as there is no other device like it on the market.

“We now offer one of the most comprehensive portfolios of products in the SI joint space, and we can meet the preferences of different physicians and varying patient needs – ultimately helping to improve health outcomes and quality of life for patients.”

In August last year, Nevro announced 24-month positive data from the Senza painful diabetic neuropathy (PDN) trial of its spinal cord stimulation (SCS) device.