Eden Spine’s Sphynx plating system has won FDA clearance, the company said today.
Sphynx was designed to complement the company’s Giza titanium vertebral body replacement with rotatable endplates, introduced in 2012. The Giza is intended to replace and fuse a collapsed, damaged, or unstable vertebral body due to a tumor or a fracture and provides multiple angulation options by rotating the endplates.
Made of titanium, the low-profile Sphynx is designed to be implanted via the antero-lateral approach for the treatment of thoraco-lumbar instabilities. Indications include spinal fractures, vertebral tumors, secondary instabilities of the thoracic and thoraco-lumbar spine, and any other indication requiring an anterior stabilization low profile.
“The Sphynx is the latest innovation coming from our R&D department in Geneva, Switzerland,” said Ben Mokhtar, president of Eden Spine Europe, in a prepared statement. “Our goal was to develop a technology that was simple to use, intuitive, and worked with the anatomy. To achieve that goal we have developed a cutting-edge integrated locking system, minimized the thickness of the implant in an effort to respect the surrounding tissues, and maximized the range of precurved plates, to provide optimal adaptation to patient’s anatomy.”
The Sphynx was granted CE Mark approval in 2016.