Innovasis Gains FDA 510(k) for Interbody Fusion Devices with HAnano Surface Technology

By Julie A. Vetalice

Innovasis Gains FDA 510(k) for Interbody Fusion Devices with HAnano Surface Technology

Innovasis received FDA 510(k) clearance to market bio-enhanced, 3D-printed titanium AxTiHA™ and TxTiHA™ Interbody Fusion Devices modified with Promimic's HAnano Surface® technology. Alpha launch is slated for 4Q20, with full release in 1Q21.

AxTiHA is a standalone device for Anterior Lumbar Interbody Fusion with up to 66% porosity. TxTiHA supports Transforaminal Lumbar Interbody Fusion with up to 61% porosity.

Both implants are modified with HAnano Surface, which offers features such as:

  • Significant acceleration and enhanced integration of implants using nano-sized crystalline hydroxyapatite particles
  • Faster and more direct bone on-growth to the implant through super hydrophilic properties
  • Early bone formation with faster fusion and stronger fixation
  • Minimal risk of HAnano Surface cracking or delamination

Mike Wheelock, Vice President of Sales at Innovasis, said, “We are excited about the partnership with Promimic. Their HAnano Surface technology is a perfect complement to our new 3D printed Tetracell line and has over 30 pre-clinical studies validating the benefits of HAnano Surface. This will build on the HA data and great outcomes Innovasis has from over 700+ patients enrolled in our HA Data Registry. The new 3D printed Tetracell interbodies will be a nice complement to our successful HA peek product line and cement our leadership position in the bioactive surface technology space. We believe our Peek and 3D printed HA platforms with give the surgeon the edge in the race to osseointegration and patient satisfaction.”

Product Labels: Spinal Fusion

Tags: 510(k) Clearance, Regulatory