Medical & Dental

K2M received 510(k) clearances from the U.S. FDA

New FDA clearances for CASCADIA Cervical & AN Lordotic Oblique Interbody Systems position K2M as the product offering leader in the 3D printing of spinal devices

LEESBURG, Va., June 01, 2016

K2M Group Holdings, Inc. (NASDAQ:KTWO) (the “Company” or “K2M”), a global medical device company focused on designing, developing and commercializing innovative and proprietary complex spine and minimally invasive spine technologies and techniques, today announced it has received 510(k) clearances from the U.S. Food and Drug Administration (FDA) to market theCASCADIA 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.

“I’m excited to have the Lamellar 3D Titanium Technology available for the cervical spine as it presents a balance of roughness and porosity that allows the potential for bone to grow into the implant,” said Tom Morrison, MD, a neurosurgeon at Polaris Spine & Neurosurgery Center in Atlanta, Georgia, who completed the first surgical case using CASCADIA Cervical Interbody System. “Additionally, the biomechanical stiffness of the CASCADIA implants are similar to PEEK and less than a more-traditional solid titanium design.”

K2M’s Lamellar 3D Titanium Technology uses an advanced 3D printing method to create structures that were once considered impractical with traditional manufacturing techniques. Starting with a titanium powder, CASCADIA 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.

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. All CASCADIA Interbody Systems 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, and we are excited to expand our portfolio to include the CASCADIA Cervical and CASCADIA AN Lordotic Oblique Interbody Systems featuring our innovative Lamellar 3D Titanium Technology,” stated 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.”

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.

About K2M

K2M Group Holdings, Inc. is a global medical device company focused on designing, developing and commercializing innovative complex spine and minimally invasive spine technologies and techniques used by spine surgeons to treat some of the most difficult and challenging spinal pathologies. K2M has leveraged these core competencies to bring to market an increasing number of products for patients suffering from degenerative spinal conditions. These technologies and techniques, in combination with a robust product pipeline, enable the Company to favorably compete in the global spinal surgery market. Additional information is available online atwww.K2M.com.

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