RTI Surgical Has Full U.S. Rollout of Two New Spinal Implant Systems

Both systems are designed for use in spine fusion.

RTI Surgical Inc. has made the full-market launch of its MaxFuse Vertebral Body Replacement System and the Aspect Anterior Cervical Plate System. Both systems are designed for use in spine fusion and are currently available for U.S. distribution.

“The MaxFuse VBR System and the Aspect Anterior Cervical Plate System are two exciting new additions to our spine portfolio,” said Brian K. Hutchison, RTI Surgical president and CEO. “These systems are manufactured in our world-class Marquette, Mich., facility and address important clinical needs in spine fusion.”

The MaxFuse System is used to replace a diseased vertebral body, resected or excised for the treatment of tumors, to achieve anterior decompression of the spinal cord and neural tissues in the thoracolumbar spine. The device also aids in restoring the height of a collapsed vertebral body. The system is made from PEEK-Optima that, due to its strength, helps maximize the volume of bone graft that can be placed inside the implant, as well as the graft-endplate apposition which supports the goal of a solid fusion.

The system is designed to allow surgeons to address a wide range of patient pathologies by offering a number of size options in footprints and heights and is designed to optimize fit with the adjacent vertebral bodies, as well as to restore a more normal sagittal balance. RTI received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the system in December.

The Aspect System is a simple, yet versatile anterior cervical plate system designed to meet the varying clinical needs of surgeons performing anterior cervical discectomy and fusion procedures, according to the company. The system is used for anterior cervical fixation for degenerative disc disease, spondylolisthesis, trauma, spinal stenosis, deformities or curvatures, tumor, pseudoarthrosis and failed previous fusion indications. RTI received 510(k) clearance from the FDA for the Aspect system in June last year.

Aspect temporarily provides resistance to flexion, extension, lateral bending and axial rotation with strength and stiffness in the cervical spine in order to support cervical fusion. The system is able to accommodate semi-constrained, constrained and hybrid constructs in a single set. It offers one through four-level plates, all with large graft visualization windows and a “zero-step” locking mechanism. The locking mechanism is a nitinol spring that has shape-retaining memory, allowing the screw to pass easily without the need for an additional step to engage the locking mechanism. Once the screw is fully seated, the nitinol spring is designed to resist screw back-out. The drive mechanism design helps ensure the screw is rigid and on-axis during insertion.

Alachua, Fla.-based RTI Surgical makes biologic, metal and synthetic implants. The company’s implants are used in sports medicine, general surgery, spine, orthopedic, trauma and cardiothoracic procedures and are distributed in nearly 50 countries. RTI company has four manufacturing facilities throughout the United States and Europe.

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