FDA grants market clearance for new Kleiner spinal fusion device

The FDA cleared Incline Village, Nev.-based Kleiner Device Labs’ new KG2 Surge flow-through interbody system for market use, the company said Sept. 22.

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The system’s interbody device is 3D-printed titanium featuring a diamond lattice porous structure designed to facilitate bone ingrowth. It will initially be available in footprints of 9×24 millimeters, 11×28 millimeters and 11×32 millimeters, with heights of 7 to 14 millimeters and lordosis of 0 and 6 degrees.

The system is designed to maximize bone graft delivery volume, distribute graft bilaterally into the intervertebral disc space, and streamline the implant, delivery, positioning and grafting process for transforaminal lumbar interbody fusion and posterior lumbar interbody fusion procedures, the company said.

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