Theradaptive's OsteoAdapt SP implant received its third FDA breakthrough designation.
The new indication is for anterior lumbar interbody spinal fusion, according to a June 22 news release. It has two other breakthrough designations for transforaminal interbody and posterolateral fusion, allowing the implant to address more than 90 percent of spinal fusion procedures.
"This significantly increases the number of patients who can potentially benefit from this game-changing technology," John Greenbaum, senior vice president of clinical and regulatory affairs at Theradaptive said in the release. "Theradaptive has now been granted breakthrough status on three indications for use. No other orthopedic manufacturer has achieved this."
OsteoAdapt SP's second breakthrough designation was granted in February, and its first nod was given in November. Theradaptive's regenerative implants are designed to allow precise, directed tissue regeneration.