K2M Group Holdings, a global medical device company focused on designing, developing and commercializing innovative and proprietary complex spine technologies, techniques and minimally invasive procedures, today announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market the NILE™ Alternative Fixation Spinal System, the Company’s latest offering for addressing the most complex spinal deformity cases. K2M also received a CE Mark for NILE, which allows the Company to expand the global availability of the product.
NILE features low-profile, robust implants and intuitive and light ergonomic instruments, intended to provide stabilization between the spine and the rod, and to allow for reduction, translation, compression and distraction while sparing the anatomy. The NILE implants are comprised of bands, clamps and set screws designed to attach to titanium or cobalt chrome rods of various sizes and are also compatible with K2M’s MESA Rail™.
“We are excited to have received our 510(k) clearance and CE Mark for the NILE Alternative Fixation Spinal System, a truly differentiated technology designed specifically for simplicity and ease of use, while also providing versatility and adaptability for usage in a wide range of complex deformity cases,” stated Eric Major, K2M's President and CEO. “These regulatory milestones, coupled with the successful completion of the first surgical cases in the United States and abroad, reaffirm our commitment of developing novel technologies that improve patient outcomes and strengthen our position in the global spine surgery market.”
The color-coded NILE Band is woven to provide strength and maintain structure, with exposed metal leaders attached on both sides. The low-profile NILE Clamps allow for compression and distraction along the rod, and provide versatility with independent band and rod locking mechanisms. The intuitive and user-friendly NILE Tensioner, inspired by K2M's patented Cricket® technology, requires no assembly and also provides adjustable travel distance to allow for large reduction, as well as controlled, sequential reduction.
The first surgical case globally using this system was performed Jan. 7 by Dr. Brian Hsu, an orthopedic spine surgeon, at Westmeade Children’s Hospital in Sydney, Australia, and the first surgical case in the United States using NILE was completed March 10 by Dr. Burt Yaszay, a pediatric orthopedic surgeon, at Rady Children’s Hospital in San Diego.
Dr. Hsu stated:
The NILE Alternative Fixation Spinal System offers improvements compared to what is currently in the market, by providing smaller, lighter weight, and controlled reduction instruments
Dr. Yaszay added, “[NILE is] simple to use and offers very powerful correction capabilities. It is nice to have a new tool in the tool box.”
For more information on the NILE Alternative Fixation Spinal System and K2M's complete product portfolio, visit www.K2M.com