K2M win FDA 510(k), CE Mark for Nile proximal fixation device

K2M (NSDQ:KTWO) said today it won FDA 510(k) clearance and CE Mark approval in the European Union for its Nile proximal fixation spinal system designed for proximal construct augmentation.

The Nile system is designed to address complex spinal deformities and consists of bands and connectors to be used in conjunction with spinal rod constructs to attach to the posterior vertebral structures at the proximal end of the construct, the Leesburg, Va.-based company said.

“I have used many band technologies for proximal construct augmentation from different companies and Nile Proximal is a huge leap forward in simplifying the design to achieve this goal. K2M has made it elegant and efficient to place the connectors and tension the bands in a predictable fashion,” Dr. Greg Mundis of La Jolla, Calif.’s Scripps Clinic Medical Group said in a prepared statement.

“I am excited about this addition to the Nile product family. The implants are straightforward and easy to use. I think this product will be a very useful addition to many of my complex procedures,” Dr. John Ferguson said in a prepared release.

K2M said that the CE Mark approval also covered the use of anchors, which were not included in the FDA clearance.

“Similar to our recent announcements around Mojave PL 3D Expandable, Sahara AL Expandable, and Capri Small 3D Static, we are incredibly proud to announce yet another innovative technology in Nile proximal fixation. This regulatory milestone—coupled with the recent launch of our Balance ACS platform—further emphasizes our focus on achieving three-dimensional spinal balance, and ultimately Total Body Balance, for patients,” K2M President and CEO Eric Major said in a press release.

Last month, K2M said it won FDA 510(k) clearance for its Capri small 3D static corpectomy cage system, touing it as the 1st-to-market 3D-printed, FDA-cleared device of its kind.

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