Theradaptive Gets Additional FDA Breakthrough Device Designation for Spinal Fusion

Theradaptive has received a Breakthrough Device designation from the FDA for its OsteoAdapt SP spinal fusion implant for use in posterolateral fusion procedures.

At present, there are no precision regenerative implants available to treat spinal fusion, orthopedic repair or craniomaxillofacial repair, the company said.  

This is the second Breakthrough Device designation the Frederick, Md.-based company has received for spinal fusion.

The FDA’s Breakthrough Device program includes a priority review and interactive communications with the agency during the premarket review process.