K2M receives FDA clearance of CASCADIA™ systems

K2M Group Holdings, Inc., a medical device company focused on designing, developing and commercializing innovative and proprietary complex spine and minimally invasive spine technologies and techniques, has recently received 510(k) clearances from the U.S. Food and Drug Administration (FDA) to market the CASCADIA™ Cervical and the CASCADIA AN Lordotic Oblique Interbody Systems featuring Lamellar 3D Titanium Technology™, the Company’s innovative technology that uses 3D printing with the goal of allowing for bony integration throughout an implant.

K2M’s Lamellar 3D Titanium Technology uses an advanced 3D printing method to create structures that were once considered impractical with traditional manufacturing techniques. The CASCADIA Cervical Interbody System functions 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 CASCADIA AN Lordotic Oblique Interbody System provides surgeons with a full range of anatomically designed interbodies for oblique placement through a transforaminal-lumbar approach.

In conjunction with the two regulatory clearances, K2M also received clearance to market additional offerings of the CASCADIA TL and CASCADIA Cervical Interbody Systems. The complete CASCADIA portfolio also includes the CASCADIA Lateral and AN Interbody Systems, both of which received 510(k) clearance from the FDA within the past year.