Orthopedics This Week: Axis Spine’s Modular Interbody Device Cleared

Axis Spine Technologies, Ltd. was granted FDA 510(k) clearance on May 20, 2020 for its first device, a modular interbody fusion device for anterior lumbar interbody fusion (ALIF), the Axis-ALIF. The device was cleared just over three months after submission for single and contiguous 2-level use.

The company plans to have the device available for surgery by August or September of this year. Axis Spine, based in St. Albans, UK near London, decided to forego CE marking preferring to first enter the U.S. market. There, the company hopes to generate clinical data to support future clearances.

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Fundraising March 2020

Axis Spine Technologies – which is helping to develop the next generation of spinal implant technology – received £830,000 from investors Mercia Asset Management. The funding round was signed off despite the coronavirus pandemic, which has left many start-ups fearful about survival.

Axis founder Jonathan Arcos said: ‘The current trading environment is very challenging, but this investment will help take us to the next level. Thankfully we were at quite an advanced stage when the lockdown measures were first brought in. We are delighted to get it over the line.’ read more…