Inion receives 510k for biodegradable graft Containment systems


Inion has announced it has received 510k marketing clearance from the FDA for its biodegradable graft containment systems for spinal fusion procedures.

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. These systems consist of biodegradable plates and screws, which are designed for bone graft containment in spinal fusion procedures. Such procedures are carried out as a treatment for a range of spinal conditions including ruptures and displacement of inter-vertebral discs. Inion’s S-1 and Inion S-2 graft containment systems include implants intended for use along the entire length of the spine in conjunction with traditional rigid fixation.

These 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. The biodegradable implants slowly and completely degrade over time into carbon dioxide and water, which are absorbed into the body.