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Theradaptive announced today that it received FDA breakthrough device designation for its Osteo-Adapt SP spinal fusion implant.

Frederick, Maryland–based Theradaptive designed the Osteo Adapt SP implant for transforaminal lumbar interbody spinal fusion to treat degenerative disc disease, spondylolisthesis or retrolisthesis.

According to a news release, the company touts its regenerative implants as best-in-class with designs to permit precise tissue regeneration for a variety of tissue types and clinical indications.

Cleveland Clinic’s Dr. George Muschler said in the release that the technology may provide “several significant advantages” over current state-of-the-art offerings in spinal fusion and musculoskeletal repair, including improved safety and more consistent outcomes.

“This designation is a major milestone for Theradaptive as we aspire to change the practice of medicine by enabling precise tissue regeneration in a way that was not previously possible,” Theradaptive SVP of Clinical & Regulatory Operations John Greenbaum said. “This opens the door to entirely new treatments for conditions that currently have very few options.”

Filed Under: Food & Drug Administration (FDA), Implants, Orthopedics, Regenerative Medicine, Regulatory/Compliance, Spine Tagged With: FDA, Theradaptive

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