Additive Implants Announces FDA Clearance of the SureMAX Cervical Spacer System

Additive Implants, Inc., announces the FDA clearance of its first product, the 3D printed, titanium alloy SureMAXTM Cervical Spacer System.

Additive Implants is a medical device company focused on using the power of additive manufacturing to address unmet surgeon needs.

“Failure to achieve sagittal alignment due to hardware design limitations still exists in ACDF procedures,” said Bob Brosnahan, COO with Additive Implants.  “We’ve learned through extensive research with high volume cervical surgeons that stability at the bone-implant interface throughout the healing process may hold the key to better sagittal alignment and improved outcomes. The SureMAX Cervical Spacer was engineered with that stability in mind.”

The 3D printed, titanium alloy SureMAX Cervical Spacer offers a roughened porous surface with several unique features on the superior, inferior, and lateral aspects of the implant, designed to effectively engage bone on the vertebral endplates.  These features combine to provide an ideal environment for fusion while also helping to resist rotational forces throughout the healing process.

“Surgeons look to device manufacturers for solutions to help them achieve proper sagittal alignment in their ACDF procedures, but too often limited options result in a “one size fits all” portfolio that falls short of expectations,” said Jeff Horn, VP Commercialization with Additive Implants.  “We’ve achieved something special with the SureMAX spacer.  The system offers a comprehensive suite of footprints and heights available in 7° lordotic and 14° hyperlordotic options that will provide surgeons seeking sagittal balance a solution for any patient pathology.”

Additive Implants will be launching the SureMAX Cervical Spacer System to the US Market at The Annual Meeting of the AANS/CNS Section on Disorders of the Spine and Peripheral Nerves Spine Summit 2019 in Miami Beach, March 15-17, booth #410.

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