Walter Eisner • Mon, July 10th, 2017
K2M Group Holdings, Inc. sandwiched two FDA 510(k) Clearances around the Fourth of July. One for a 3D printed corpectomy cage and, the other, for a spinal proximal fixation system.
On June 28, 2017, the company announced the clearance of the Capri Small 3D Static Corpectomy Cage System. Calling the clearance, a milestone for the company, the system is a first-to-market 3D-printed cleared corpectomy cage. It is also the company’s third product group to feature Lamellar 3D Titanium Technology.
The system, according to the company, provides a surgical solution for stabilizing the thoracolumbar spine (T1 to L5) in cases of vertebral body resections resulting from trauma or tumor. Its porous structure and rough surface architectures are designed to allow for bony integration throughout an implant. The system’s lordotic options help support the anterior spinal column with the goal of achieving sagittal balance.