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FDA Clears Spinal Fixation Device from Spineology

Company claims its system's features offer industry firsts.

St. Paul, Minn.-based Spineology Inc. has fully released its Via Spinous Process Fixation System in the United States.

The company received clearance of its 510(k) from the U.S. Food and Drug Administration on Sept. 10.

According to the company, Via is the “first and only” spinous process plate with independently compressible superior and inferior plates that are contoured to maximize the fit between the implant and the spinous processes and associated laminae.

“Our goal in developing the Via Spinous Process Fixation System was to offer versatility beyond that of existing systems on the market,” said Karen Roche, vice president of R&D for Spineology. “The independently compressible plates accommodate varying spinous process widths and allow for fixation on each spinous process independent of fixation on the adjacent spinous process, maximizing teeth engagement. The anatomically contoured design allows the device to fit the contour of the spinous processes and laminae, utilizing the strength of the latter.”

Spineology develops spinal implants and instruments. The company’s goal, according to its leadership, is to develop tools that enable surgical techniques to conserve spinal bone, ligament and muscle tissue.

“VIA is the most recent addition to Spineology’s Anatomy Conserving Technology (ACT) product platform,” said John Booth, CEO for Spineology. “The implant and instrumentation help preserve patient anatomy and limit operating room time which follows Spineology’s anatomy conserving design philosophy. The system will be a great addition to our product line.”



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