FDA Clearance and CE Mark for K2M NILE® Proximal Fixation Spinal System

Complex spine and minimally invasive solutions company, K2M has received U.S. FDA 510(k) clearance and CE Marking for its NILE® Proximal Fixation Spinal System, a spinal system specifically designed for proximal construct augmentation.

Background

K2M Group Holdings, Inc. is a self-styled global leader in complex spine and minimally invasive solutions focused on achieving three-dimensional Total Body Balance. Its NILE Proximal Fixation addresses complex spinal deformity cases and consists of bands and connectors that may be used in conjunction with spinal rod constructs for attachment to the posterior vertebral structures at the proximal end of the construct. The CE Mark for NILE Proximal Fixation also includes the use of anchors, which are not cleared for use in the United States.

The system has a versatile application in complex procedures, from scoliosis to adult degenerative. The NILE bands are manufactured from polyethylene terephthalate and can be used to provide additional fixation in a MESA®, MESA 2, EVEREST®, or DENALI® Spinal System construct through sublaminar passage or attachment to an anchor (OUS only). The band can then be integrated into the construct using the NILE transverse or medial offset connectors.

Physician comments

“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,” said Greg Mundis, MD, a surgeon specializing in pediatric and adult spinal deformity surgery in the Department of Orthopedics at Scripps Clinic Medical Group in La Jolla, California. “K2M has made it elegant and efficient to place the connectors and tension the bands in a predictable fashion.”

“I am excited about this addition to the NILE product family,” said John Ferguson, MD, an orthopedic spine surgeon in Auckland, New Zealand. “The implants are straightforward and easy to use. I think this product will be a very useful addition to many of my complex procedures.”

Company comments

“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,” stated K2M President and CEO Eric Major. “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.”

 

Source: Globe Newswire

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