Leesburg, Virginia – K2M Group Holdings Inc. officials announced the company 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.”
