US FDA clearance for Atlas Spine’s HiJAK SA system

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Atlas Spine has announced US Food and Drug Administration (FDA) clearance for the HiJAK SA expandable standalone cervical interbody system.

HiJAK SA joins first-to-market HiJAK AC and the V3 segmental plating system as the latest technology in Atlas Spine’s disruptive design portfolio, the company said in a press release.

“It was our goal from the onset to develop the most comprehensive and innovative offerings for treating complex cervical pathologies,” said Matt Baynham, CEO and co-founder of Atlas Spine. “With the addition of the standalone variant to our expandable cervical interbody and guided segmental plating system, we can now address broader patient conditions and surgical preferences,” said Baynham.

The HiJAK SA device leverages the design and clinical success of Atlas’s HiJAK AC expandable interbody platform, which Atlas describes as the market’s only cervical implant that provides surgeons the intra-operative ability to customize height and lordosis specific to their patient’s anatomy and surgical needs.

Along with its expandable capability, HiJAK SA incorporates an integrated low-profile plate that significantly improves screw access during minimally invasive applications and screw-to-bone integrity, something current stand-alone devices struggle with, Atlas Spine said in its press release.

“We, along with significant surgeon input, carefully studied the standalone market and product designs as we moved through our development process. Focusing on the clinical history of stand-alone devices, we identified opportunities to further improve positive attributes and eliminate drawbacks. Our final product gives surgeons and their patients the best of both worlds, the clinical benefits of a customisable interbody with enhanced structural integrity, and the ease of integrated fixation,” stated Brett Zarda, vice president of product development for Atlas Spine.

“I had the opportunity to implant and evaluate this technology in a cadaver lab, and I have to say, it doesn’t get much easier than this,” Patrick B Senatus, medical director, minimal invasive and functional spine surgery, Hartford Healthcare (Hartford, USA) said.


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