Theradaptive's Osteo-Adapt SP spinal fusion implant received the FDA's breakthrough medical device designation, according to a Nov. 19 news release.
Osteo-Adapt SP is a regenerative implant indicated for transforaminal lumbar interbody spinal fusion. It's intended to treat degenerative disc disease, spondylolisthesis and retrolisthesis. Theradaptive's implants are designed to allow precise tissue regeneration.
"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," George Muschler, MD, of Cleveland Clinic, said in the release.
Under breakthrough designation, the product will receive priority review and interactive communications on device development from the FDA.