Eden Spine receives FDA clearance for lumbar titanium implant: 5 things to know

Shayna Korol -   Print  |

Eden Spine received FDA 510(k) clearance for its titanium Sphynx implant.

Here are five things to know:

1. The Sphynx is implanted through the anterolateral approach to treat thoracolumbar instabilities. 

2. Indications for the implant include:

  • Spinal fractures
  • Vertebral tumors
  • Secondary thoracic and thoracolumbar spine instabilities 
  • An anterior stabilization low profile

3. The Sphynx is designed to complement the Giza, Eden Spine's proprietary expandable titanium vertebral body replacement implant with rotatable endplates. The Giza is designed to replace and fuse a collapsed, damaged or unstable vertebral body due to a tumor or fracture.

4. According to Eden Spine President Ben Mokhtar, the company developed an "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."

5. The Sphynx received CE Mark approval in 2016.

More articles on surface technology:

Nanovis completes $5.5M funding round to meet spinal implant demands: 3 details

4 things to know about Emerging Implant Technologies

Titanium fiber plates show potential for bone repair: 3 study insights

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