The US Food and Drug Administration (FDA) has granted 510(k) clearance to Providence Medical Technology for its CORUS Posterior Cervical Stabilization System 3D-T.
The device is indicated to stabilise and immobilise spinal segments alongside posterior cervical fusion in patients with cervical degenerative disc disease.
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Manufactured with a 3D porous titanium structure, the bilateral implant incorporates integrated screw fixation as a nonsegmental posterior instrumentation tool.
Supplied in a single-use, sterile-packaged kit, the device features an internal lattice engineered to replicate cancellous bone and facilitate bone ingrowth, while holding internal bone graft and distributing mechanical load evenly across variable patient anatomy.
Providence Medical Technology president and CEO Lane Major said: “Clearance of CORUS PCSS 3D-T is an important milestone for Providence and for the surgeons who rely on our platform.
“CORUS is backed by Level 1 evidence that’s rare in spine, and 3D-T brings the porous titanium surgeons increasingly expect to that proven foundation.
“It’s the next step in our commitment to Total Segmental Fusion and to helping surgeons deliver predictable fusion with fewer revision surgeries for their patients.”
The regulatory clearance builds on clinical data from the earlier-generation CORUS PCSS device.
A Level 1 randomised clinical trial showed that combining the posterior device with multilevel anterior fusion resulted in higher fusion rates at 12 and 24 months, as well as a lower surgical revision rate at two years, compared with anterior fusion alone.
Providence Medical Technology co-founder Bruce McCormack said: “Posterior cervical fusion depends on what happens at the bone-implant interface, and every detail of the implant matters in that small, demanding space.
“With CORUS PCSS 3D-T, we kept the technique surgeons already trust and gave bone a porous lattice to grow into, with 1.5 times the surface area and eight times the surface roughness of the original machined implant, plus room to pack graft inside the device.”
Providence Medical Technology focuses on supplemental posterior fixation and fusion systems.
The company pairs posterior instrumentation with anterior surgical approaches in its Total Segmental Fusion technique to raise fusion rates and decrease subsequent surgical revisions.
