Research & Development
Theradaptive's Osteo-Adapt SP Spinal Fusion implant receives US FDA Breakthrough Medical Device designation
22 November 2021 -

Theradaptive, a US-based privately held biopharmaceutical company, announced on Friday that it has received Breakthrough Medical Device designation from the United States Food and Drug Administration (FDA) for its Osteo-Adapt SP Spinal Fusion implant intended for transforaminal lumbar interbody spinal fusion aimed at the treatment of degenerative disc disease, spondylolisthesis, or retrolisthesis.

The Breakthrough Devices Program is a program designed for certain medical devices that offer more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. According to the program, the US FDA is to offer Theradaptive a priority review and interactive communication related to device development and clinical trial protocols during the premarket review process.

Dr George Muschler of the Cleveland Clinic, said, 'Theradaptive has developed a technology that may provide several significant advantages over the current state-of-the-art in spinal fusion and musculoskeletal repair, including greater safety and more consistent outcomes. This is an exciting development in the field and having a Breakthrough Designation from the FDA is strong validation of the approach. The potential for patients is enormous.'

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