Regulatory Clearance for the Align® Interbody System with HAnano Surface

October 19, 2022
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Acuity Surgical Devices, LLC has received regulatory clearance from the FDA through a special 510(k) application for their additively manufactured spinal interbody device portfolio with HAnano Surface, expanding the variety of spinal devices in clinical use with HAnano Surface.

GOTHENBURG, SWEDEN AND DALLS (PRWEB) OCTOBER 13, 2022

Promimic AB, the world’s leading innovator in nano surface treatments for improved osseointegration, is pleased to announce a special 510(k) clearance from the U.S. Food and Drug Administration (FDA) for Acuity Surgical Devices, LLC. This is the second special 510(k) FDA clearance of a medical device with HAnano Surface, validating that the regulatory pathway is allowing an expedited clearance process.

The Align® portfolio includes additively manufactured titanium devices intended for the following approaches: stand-alone Anterior Lumbar Interbody Fusion (ALIF), Oblique Lumbar Interbody Fusion (OLIF), and Lateral Lumbar Interbody Fusion (LLIF). Each Align® device features an enhanced porous structure designed to improve adhesion to the vertebral body endplates. With this special 510(k) clearance, Align® implants also integrate the super-hydrophilic HAnano Surface that has been shown to promote faster and stronger osseointegration in pre-clinical studies with roughened titanium implants.

Acuity Surgical Align® Implants Before and After HAnano Surface Treatment

“We are delighted that Acuity Surgical Devices chose our hydrophilic HAnano Surface to further differentiate their product portfolio. That the clearance came after an expedited special 510(k) further establishes a faster path to market for our customers, so that more implants with improved osseointegration can be used clinically”, says Magnus Larsson, Promimic CEO.

“We are very excited to augment our options within in the Align® product family. This collaboration is an example of how Acuity listens to its surgeon partners and continues to invest in total spine solutions to match surgeon needs with patient benefits. We believe the bioactive performance of the nano surface supplementing our enhanced porous structure will make Align® implants with HAnano Surface the new gold standard in stability”, says John Davidson, President of Acuity Surgical Devices.

HAnano Surface has been evaluated in more than thirty pre-clinical studies, testing a variety of implant materials and designs in different models. It has proven to increase anchoring strength for titanium implants by up to 35% in just three weeks. The studies also show that HAnano Surface up-regulates important bone marker proteins and improves new bone formation on titanium implant surface by 67% at four weeks.*

For more information about HAnano Surface, please visit https://www.promimic.com/. To learn more about Acuity Surgical Devices Align® portfolio, please visit https://www.acuitysurgical.com/.

*Data on file at Promimic AB.

About
Promimic is a growth company that develops and markets biomaterials for improved osseointegration to leading companies in the fields of dental and orthopedic implants. The main product HAnano Surface has been developed from cutting edge research at Chalmers University of Technology in Sweden. The technology is proven to improve osseointegration in over thirty scientific studies and with over 700,000 implants in clinical use. Promimic has offices in Mölndal, Sweden and Austin, Texas, USA.

Spine surgeons choose Acuity Surgical Devices for spinal implant solutions. They know they can count on Acuity’s unwavering commitment to world class customer support of its premier lumbar, cervical, and biologic evidenced-based systems.

Contact
Chris Whitfield E-mail: chris.whitfield@promimic.com
Bryan Cowan E-mail: bcowan@acuitysurgical.com

HAnano Surface is a registered trademark of Promimic AB, Mölndal, Sweden.
Align® is a registered trademark of Acuity Surgical Devices, LLC, Dallas, Texas, USA.