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 HA^nano 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 HA^nano 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 HA^nano 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 HA^nano Surface the gold standard for osseointegration of surgical implants,” said Magnus Larsson, Promimic CEO.

HA^nano 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 HA^nano Surface to receive FDA clearance.

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