Full market launch of two new spine systems

Aspect anterior cervical plate system and MaxFuse VBR system designed for use in spine fusion procedures and available for US distribution.

February 25, 2014
Manufacturing Group
Contract Manufacturing Design/Engineering Devices/Implants/Equipment Industry/Regulations Materials People/Facilities

Alachua, Fla. - RTI Surgical Inc., a leading global surgical implant company, announced the full market launch of the 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 chief executive officer. “These systems are manufactured in our world-class Marquette, Mich., facility and address important clinical needs in spine fusion.”

MaxFuse VBR system
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, a unique material selected for its strength, which 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 allows surgeons to address a wide range of patient pathologies by offering industry-leading 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 2013.

Aspect anterior cervical plate system
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 (ACDF) procedures. The system is used for anterior cervical fixation for degenerative disc disease (DDD), 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 2013.

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 self-drilling and self-tapping screw designs provide a quick start and excellent bone purchase. The industry-leading drive mechanism design helps ensure the screw is rigid and on-axis during insertion.

Source: RTI Surgical Inc.