Theradaptive has announced that the US Food and Drug Administration (FDA) has granted breakthrough medical device designation for the use of its OsteoAdapt SP spinal implant in anterior lumbar interbody fusion.
This marks the third breakthrough designation for Theradaptive in spinal fusion, along with transforaminal interbody and posterolateral fusion, allowing it to address over 90% of lumbar spinal fusion procedures.
Under the breakthrough devices program, the FDA will provide Theradaptive with priority review and interactive communication regarding device development and clinical trial protocols during the premarket review process. Expedited review of the premarket approval is included as a benefit.
Jay Jolley, the founder of Southeastern Spine, Brain and Joint and the Riverfront Surgery Center (Chattanooga, USA), said: “Evidenced by this being the third breakthrough designation awarded by the FDA to Theradaptive for this technology, there is a significant need for it in the bone grafting space.
“I see immense opportunity and advantages to the utility of OsteoAdapt SP in anterior lumbar interbody fusion indications. It is exciting to explore the potential advantages of this new product compared to current commercial offerings.”
John Greenbaum, senior vice president of clinical and regulatory affairs at Theradaptive, added: “This is Theradaptive’s third breakthrough designation from the FDA and broadens our portfolio of spinal fusion approaches. This significantly increases the number of patients who can potentially benefit from this game-changing technology. Theradaptive has now been granted breakthrough status on three indications for use. No other orthopaedic manufacturer has achieved this.”
