K2M receives USA FDA clearance and CE mark for Nile Proximal Fixation system


K2M has received 510(k) clearance from the US Food and Drug Administration (FDA) and CE marking for its Nile Proximal Fixation spinal system, a device specifically designed for proximal construct augmentation.

Nile Proximal Fixation is designed to address 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 also includes the use of anchors, which are not cleared for use in the USA.

“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,” says Greg Mundis, a surgeon specialising in paediatric and adult spinal deformity surgery in the Department of Orthopedics at Scripps Clinic Medical Group in La Jolla, USA. “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,” says John Ferguson an orthopaedic 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.”

Nile Proximal Fixation can be used to treat a number of spinal disorders, including scoliosis and adult degeneration. 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.