Theradaptive Granted Breakthrough Device Designation

By Julie A. Vetalice

Theradaptive Granted Breakthrough Device Designation

Theradaptive was granted a second Breakthrough Medical Device designation from FDA for its OsteoAdapt SP Spinal Fusion implant. The device is indicated for posterolateral spinal fusion to treat degenerative disc disease, spondylolisthesis or retrolisthesis.

The company's first breakthrough designation was granted in late 2021.

Theradaptive's regenerative implants are designed to permit regeneration for a variety of tissue types and clinical indications.

"This is Theradaptive's second Breakthrough designation from FDA in four months and expands our portfolio into the posterolateral fusion approach. This significantly increases the number of patients who can potentially benefit from this game-changing device," said John Greenbaum, Senior Vice President of Clinical & Regulatory Affairs at Theradaptive.

Source: Theradaptive

Product Labels: PRP/Cell-Based/Osteoinductive Materials

Tags: 510(k) Clearance, Regulatory