FDA Clears Latest Spinal Product from K2M

K2M Inc. received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Santorini line of corpectomy cage systems, which is designed to replace collapsed, damaged or unstable vertebral bodies due to trauma or tumor and provide anterior spinal column support.

The cages are manufactured from biocompatible PEEK polymer and, according to the company, allow for an unobstructed view of the post-operative fusion. They will be available as solid and expandable options in different sizes. The solid version offers an enlarged graft space, while expandable cages allow for in-situ expansion with a locking clip to secure the desired height.

“FDA clearance for Santorini is an important expansion of our complex spine product offering, particularly in the areas of trauma and tumor spinal surgeries,” said Eric Major, K2M’s president and CEO. “As the first addition to K2M’s portfolio in 2012, we’re proud to offer surgeons and patients new products that continue to highlight our commitment to treating the full spectrum of spine pathologies.”

Based in Leesburg, Va., K2M devolps devices for the treatment of complex spinal pathologies and minimally invasive procedures—with a focus on the treatment of deformity, degenerative, trauma, and tumor spinal patients.