Providence Medical Technology has received FDA 510(k) clearance for its CORUS Posterior Cervical Stabilization System 3D-T, a 3D-printed titanium implant designed to support posterior cervical fusion.
The device is indicated to stabilize spinal segments in patients with cervical degenerative disc disease. It retains the indications and surgical technique of the previous CORUS PCSS system while incorporating a porous titanium structure designed to support bone ingrowth, according to an Oct. 13 news release.
The updated implant has 1.5 times the surface area and eight times the surface roughness of its predecessor, according to the company.
A randomized trial of the previous-generation device found higher fusion rates at 12 and 24 months and a lower two-year revision rate when combined with multilevel anterior fusion, compared with anterior fusion alone. The findings do not apply directly to the newly cleared implant.
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