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FDA Clears First 3D Printed HAnano Surface Modified Implant

Promimic AB announced the first FDA 510(k) clearance of a 3D printed porous titanium implant modified with the company’s HAnano Surface.

Spine company Innovasis received the special 510(k) for its AxTiHA™ System, a standalone device for Anterior Lumbar Interbody Fusion, and TxTiHA™ System, a device for Transforaminal Lumbar Interbody Fusion. The micro porous 3D printed AxTiHA and TxTiHA offer up to 66% porosity and 61% porosity, respectively.

Through modification with HAnano Surface, the spinal devices maintain their micro porous properties, allow osseointegration, and are super hydrophilic, characteristics that can stimulate osteoconductive integration and promote faster and more direct bone on-growth to the implant.

“The product development efforts with Innovasis have been extremely positive and collaborative. Promimic is delighted that they chose our HAnano Surface technology to further differentiate their product portfolio. With them and our other spine, orthopedic, and dental corporate partners, we are excited to further our mission of making HAnano Surface the gold standard for osseointegration of surgical implants,” said Magnus Larsson, Promimic CEO.

HAnano Surface has been evaluated in more than 30 pre-clinical studies, which have shown that the technology:

  • Increases anchoring strength in surface-modified titanium implants by up to 35% in three weeks
  • Up-regulates important bone marker proteins
  • Improves new bone formation on titanium implant surface by 67% at four weeks.

Innovasis’ 510(k) is the fourth implant with HAnano Surface to receive FDA clearance.