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news.Inion has received 510(k) marketing clearance from the FDA for its biodegradable graft containment systems for spinal fusion procedures.
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The US marketing clearance has been received for the Inion S-1 anterior cervical fusion system, the Inion S-1 double-level plate and the Inion S-2 anterior thoraco-lumbar fusion system.
Inion’s new graft containment systems also incorporate a radiographic marker to the edges of the plates and to the tips of screws. These markers enable surgeons to view the position of the implants in post-operative x-ray without interfering with their assessment of the site of surgery and its healing progress.
According to the company, the biodegradable implants also offer significant clinical benefits over traditional metal materials, primarily in that they slowly and completely degrade over time into carbon dioxide and water, which are absorbed into the body.
Chris Lee, CEO of Inion, said: “Our aim now is to push these new biodegradable products aggressively into the US spine market where we believe it will make an attractive alternative to traditional metal plates and a strong driver of value for the company.”