FDA 510(k) for Providence Medical CAVUX FFS-LX Lumbar Facet Fixation

Providence Medical Technology received FDA 510(k) clearance to market the CAVUX FFS-LX: Lumbar Facet Fixation system for use in lumbar spinal fusion.

The clearance marks the company’s expansion into the lumbar spine market. CAVUX FFS-LX was designed to offer increased stabilization following lumbar fusion to increase fusion rates and reduce future complications and reoperations.

Summary clinical study data reviewed by FDA in considering the clearance included:

• 57 patients were evaluated with a median follow-up of 30 months. The median age was 45, the median body mass index was 30, and 68% of subjects reported nicotine use as a risk factor.
• 96% of levels were determined to be fused as defined by a range of motion less than 5° on flexion/extension x-rays assessed by an independent core imaging lab.
• Clinically meaningful improvement in pain was achieved in 79% of subjects.

Jeff Smith, Co-founder and CEO of Providence Medical, said, “CAVUX FFS-LX builds off our successful cervical platform and applies the same principles to the lumbar spine where the challenge of treating high-risk patients is even more pronounced. We are excited to be launching into the lumbar market and provide high-risk patients a new option for a fusion success.”

Source: Providence Medical Technology, Inc.