Premia Spine’s TOPS Granted Breakthrough Device Designation

By Julie A. Vetalice

Premia Spine’s TOPS Granted Breakthrough Device Designation

The TOPS™ facet arthroplasty system from Premia Spine received Breakthrough Device Designation from FDA. TOPS is the first and only facet joint replacement system for the lumbar spine.

Developed to treat spinal stenosis or spondylolisthesis, the system is designed to relieve debilitating lower back and leg pain while enabling long-term mobility, stability and durability after decompression. TOPS is currently the subject of a pivotal clinical trial under an Investigational Device Exemption from FDA.

“The TOPS System is designed to relieve debilitating lower back and leg pain while enabling long-term mobility, stability, and durability for patients,” said Premia Spine CEO Ron Sacher. “We are gratified that the FDA recognizes TOPS’s potential to advance the standard of care for patients with spinal stenosis and spondylolisthesis.”

Product Labels: Dynamic Stabilization, Lumbar Spine

Tags: 510(k) Clearance, Regulatory