Additive Implants' 1st product receives FDA clearance

Shayna Korol -   Print  |

Additive Implants received FDA clearance for its first product, its 3D-printed titanium alloy SureMAX Cervical Spacer System.

Three things to know:

1. The spacer features a roughened porous surface with several novel features on the superior, inferior and lateral aspects of the implant, designed to engage bone on the vertebral endplates. These features are designed to facilitate fusion and help resist rotational forces throughout the healing process.

2. "Failure to achieve sagittal alignment due to hardware design limitations still exists in [anterior cervical discectomy and fusion] procedures," said Bob Brosnahan, COO of 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."

3. The system offers a suite of footprints and heights available in 7 degree lordotic and 14 degree hyperlordotic options. Additive Implants will launch the SureMAX Cervical Spacer System in the U.S. at the Annual Meeting of the American Association of Neurological Surgeons/Central Nervous System Section on Disorders of the Spine and Peripheral Nerves Spine Summit 2019 in Miami Beach, March 15-17.

More articles on surface technology:
3D-printed spine, orthopedic implant manufacturing facility expands: 3 things to know
Triangular titanium implant more effective than conservative care for sacroiliac joint pain – 4 study findings
1st cases performed with Amplify Surgical's dualX expanding interbody fusion system – 5 insights

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