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Promimic, developer of nano surface treatments for improved osseointegration, announced a special FDA 510(k) clearance for Acuity Surgical Devices. This is the second special 510(k) clearance of a medical device with Promimic’s HAnano Surface, indicating validation that 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, Oblique Lumbar Interbody Fusion and Lateral Lumbar Interbody Fusion. 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 Promimic’s super-hydrophilic HAnano Surface that has been shown to promote faster and stronger osseointegration in pre-clinical studies with roughened titanium implants.
“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,” said Magnus Larsson, Promimic CEO.
Source: Promimic AB
