K2M Gets U.S., European OK for Cascadia Lateral Interbody System
By K2M Group Holdings Inc. | January 8, 2016
Advanced 3-D printing creates complex structure well suited to bone growth activity.
Leesburg Va.-based K2M Group Holdings Inc., a medical device company that makes complex spine technologies, has earned 501(k) clearance from the U.S. Food and Drug Administration for its Cascadia Lateral Interbody System featuring Lamellar Titanium Technology, the company’s innovative and proprietary technology that uses 3-D printing with the goal of allowing for bony integration throughout an implant. In addition to U.S. regulatory clearance, K2M also received a CE mark for the system, which allows the company to expand the global availability of the product.
K2M’s Lamellar Titanium Technology uses an advanced 3-D printing method to create structures that 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.
“By incorporating the porosity and rough surfaces of the Lamellar Titanium Technology into the Cascadia Lateral interbodies, an alternative now exists to the traditional PEEK and Titanium cages commonly used in direct lateral fusion procedures,” said Pierce Nunley, M.D., director of the Spine Institute of Louisiana, who completed the first surgical case using Cascadia Lateral in December 2015. “The design of the Cascadia Lateral implant offers me a greater bone graft volume than my normal Aleutian PEEK implant, while increasing the endplate contact surface area and still allowing me the ability to radiographically evaluate the fusion.”
K2M’s Lamellar Titanium Technology incorporates titanium with a surface roughness of 3-5 microns and is designed to allow for direct bony ongrowth. The technology also incorporates 500 micron longitudinal channels throughout the implant which, in conjunction with traverse windows, create an interconnected lattice designed to allow for bony integration. Lamellar Titanium Technology exploits the material properties of titanium in conjunction with a product design that incorporates an approximately 70 percent porosity to mitigate the device’s radiographic signature.
The Cascadia Lateral Interbody System features a reverse hourglass implant design that allows for increased endplate contact compared to an ALEUTIAN implant and without sacrificing internal bone graft volume. The system includes a full range of implant sizes and is designed to work in conjunction with the Ravine Lateral Access System, offering a full line of instrumentation for the far lateral transpsoas approach.
“We are pleased to receive FDA 510(k) clearance and a CE Mark for the Cascadia Lateral Interbody System, further expanding the offering of our proprietary Lamellar Titanium Technology, which uses 3-D printing and is designed to allow for bony ongrowth and ingrowth,” said Eric Major, K2M’s president and CEO. “These regulatory milestones, coupled with the successful completion of the first surgical case late last year, underscore our commitment to expanding our minimally invasive spine portfolio by bringing innovative and differentiated technologies and products to the global spine market.”
Cascadia Lateral is K2M’s third product to feature its Lamellar Titanium Technology. The Company also received 510(k) clearance and a CE mark for the Cascadia AN and TL Interbody Systems in 2015.