K2M Receives 3D-Printed Cervical Systems Clearances

K2M Group Holdings, Inc., has received 510(k) clearances from the FDA to market the Cascadia Cervical and the Cascadia AN Lordotic Oblique Interbody Systems.

In a June 1, 2016 announcement the company said the clearances enhance the company’s 3D-printed spine portfolio and positions K2M as “the product offering leader in the 3D printing of spinal devices.”

The systems feature the company’s Lamellar 3D Titanium technology, which uses 3D printing with the goal of “allowing for bony integration throughout an implant.”

The technology uses an advanced 3D printing method to create structures that the company says were once considered impractical with traditional manufacturing techniques. Starting with a titanium powder, the implants are grown through the selective application of a high-energy laser beam, allowing for the incorporation of both a porosity and surface roughness that pre-clinical data have associated with bone growth activity.

Tom Morrison, M.D., a neurosurgeon at Polaris Spine & Neurosurgery Center in Atlanta, Georgia, completed the first surgical case using the system. He said the biomechanical stiffness of the implants are similar to PEEK and less than a more-traditional solid titanium design.

K2M’s Cascadia systems function as an intervertebral body fusion device to provide support and stabilization of the cervical segment of the spine for patients suffering from degenerative spinal disorders. The systems, according to the company, provide surgeons with a full range of anatomically designed interbodies for oblique placement through a transforaminal-lumbar approach and are cleared for use with both autologous and allogenic bone graft tissue in the treatment of patients with degenerative disc disease (DDD) and degenerative scoliosis.

“3D printing is a strategic priority for K2M, ” said K2M President and CEO Eric Major. “K2M was the first leading spine company to introduce a 3D-printed titanium interbody device and is now the only company to offer a complementary allograft solution in the United States. Through continued development efforts and subsequent product launches, K2M offers the most comprehensive portfolio of FDA-cleared 3D-printed spinal devices on the market, cementing K2M as the leader in the 3D printing of spinal devices.”