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MARCH 1, 2024

FDA 510(k) Clearance Allows Use of SI Fixation System Without Need for Screw

The FDA has granted 510(k) clearance to a sacroiliac (SI) joint fusion device called Nevro1 (Nevro), which is designed without the need to include the screw.

Nevro1, an integrated transfixing technology, is proven to immediately transfix the SI joint to enable long-term fusion, according to Nevro in a press release. Self-contained, deployable titanium anchors transfix the sacrum and ilium to enhance axial and rotational stability of the joint. 

In addition, “Nevro's proprietary


The FDA has granted 510(k) clearance to a sacroiliac (SI) joint fusion device called Nevro1 (Nevro), which is designed without the need to include the screw.

Nevro1, an integrated transfixing technology, is proven to immediately transfix the SI joint to enable long-term fusion, according to Nevro in a press release. Self-contained, deployable titanium anchors transfix the sacrum and ilium to enhance axial and rotational stability of the joint. 

In addition, “Nevro's proprietary instrumentation allows for optimal intra-articular SI joint preparation which is critical to achieve joint fusion,” according to the press release. 

 Nevro1 comes with 3D-printed, bone growth?enhancing technology, which helps promote bone cell growth and, as a result, fusion, according to the company. 

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

Based on a press release from Nevro. 

Related Keywords
FDA   SI Joint