K2M receives FDA clearance for expansion of lateral interbody system

K2M Group Holdings Inc. announced it has received 510(k) clearance to expand its Cascadia Lateral Interbody System featuring Lamellar 3-D Titanium Technology.

The lateral interbody system is designed to promote an increase in endplate contact, without having to sacrifice internal bone graft volume and is intended to work alongside the Ravine Lateral Access System.

According to the release, K2M’s Lamellar 3-D Titanium Technology uses an advanced 3-D printing method to create structures that are impossible with traditional manufacturing techniques. Cascadia implants start with a titanium powder and are grown through the selective application of a high-energy laser beam, incorporating complex internal geometries and rough surface architecture that preclinical data have linked with bone growth activity, the release noted.

“K2M is proud to strengthen our industry-leading portfolio of FDA-cleared, 3-D-printed spinal solutions, thus reinforcing our market leadership and competitive advantage in this space,” Eric Major, K2M president and chief executive officer, said in the release. “[Minimally invasive surgery] MIS procedures and 3-D printing are core competencies for K2M, as indicated by the breadth and depth of our product offerings.”

Reference:

http://investors.k2m.com/releasedetail.cfm?ReleaseID=992440