K2M announces 510(k) clearance of the Nile alternative fixation spinal system

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K2M has received 510(k) clearance from the US Food and Drug Administration (FDA) to market the Nile alternative fixation spinal system, the company’s latest offering for 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 implants and light ergonomic instruments intended to provide stabilisation 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 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 chief executive officer.

The color-coded Nile band is woven to provide strength and maintain structure, with exposed metal leaders attached on both sides. The low-profile clamps aim to assist compression and distraction along the rod, and provide versatility with independent band and rod locking mechanisms. The 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 by Brian Hsu, an orthopaedic spine surgeon, at Westmeade Children’s Hospital in Sydney, Australia, and the first surgical case in the USA using Nile was completed by Burt Yaszay, a paediatric orthopaedic surgeon, at Rady Children’s Hospital in San Diego.

“The Nile system offers improvements compared to what is currently in the market, by providing smaller, lighter weight, and controlled reduction instruments,” stated Hsu. 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.”

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