Theradaptive’s Spinal Fusion Implant Designated a Breakthrough Device

Frederick, Md.-based Theradaptive has received the FDA’s breakthrough device designation for its Osteo-Adapt SP spinal fusion implant.

The implant is intended to treat degenerative disc disease or when a vertebra slips either forward or backward out of position. Currently, there are no precision regenerative implants available to treat spinal fusion, orthopedic repair or craniomaxillofacial repair and the current state of the art is based on technology that is more than 20 years old, the company said.

Theradaptive hopes to “change the practice of medicine by enabling precise tissue regeneration in a way that was not previously possible,” said John Greenbaum, the company’s senior vice president of clinical & regulatory operations.