Atlas Spine Receives FDA clearance for Expandable Stand-Alone Cervical Interbody System, Broadens Unique Expandable Cervical Offering
JUPITER, FL., March 10, 2020 — Atlas Spine Inc., a spinal implant company based in Jupiter Florida, announced today clearance from the Food and Drug Administration for their HiJAK SA Expandable Stand-Alone 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. “It was our goal from the onset to develop the most comprehensive and innovative offerings for treating complex cervical pathologies,” states Matt Baynham, CEO and co-founder of Atlas Spine. “With the addition of the stand-alone 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, 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. “We, along with significant surgeon input, carefully studied the stand-alone 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 customizable interbody with enhanced structural integrity, and the ease of integrated fixation,” stated Brett Zarda, Vice President of Product Development for Atlas Spine.
Surgeons concur that the customizable capability coupled with its ease of use will translate to a more efficient procedure and improved surgical results. “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,” stated spine specialist Patrick B. Senatus, M.D., PhD. Medical Director, Minimal Invasive and Functional Spine Surgery Hartford Healthcare.
Atlas Spine is currently welcoming inquiries for distribution of its growing product portfolio and hospital affiliations. For more information please contact us at (561) 741-1180 or Sales@atlasspine.com.
