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NuVasive announces expanded 510(k) clearance for TLX interbody system
NuVasive Inc. announced the FDA approved an expanded 510(k) clearance for the TLX interbody system for spine fusion surgery.
According to a company press release, the recent clearance includes a 20° expandable interbody, as well as additional indications for use with allogeneic bone graft comprised of cancellous or corticocancellous bone graft to facilitate fusion. The release noted surgeons can also use the TLX interbody system in the thoracic spine and at the thoracolumbar junction for treatment of disc degeneration disease or degenerative spondylolisthesis at one or two adjacent levels. The FDA also cleared use of the TLX interbody system as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis.
A low profile, bulleted design allows the TLX implants to be placed seamlessly into the disc space, according to the release. Inserted through a conventional transforaminal lumber interbody fusion (TLIF) approach, the TLX system’s size offerings provide multiple options for various patient sizes and anatomic considerations. Designed to induce lordosis in an anatomical fashion, the release noted the TLX interbody system provides restoration of sagittal alignment with customizable degrees of lordosis.
“With the additional clearance for our latest TLX system, we now provide the leading tools for TLIF procedures with our MAS TLIF solution, validating out commitment to improving spine solutions,” Matt Link, executive vice president of strategy, technology and corporate development at NuVasive, said in the release. “This clearance highlights our persistent investment in transforming spine outcomes by developing spine’s leading procedures, materials, expandables, systems and services.”
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