Theradaptive Secures Third FDA Breakthrough Designation

By Julie A. Vetalice

Theradaptive Secures Third FDA Breakthrough Designation

Theradaptive was granted Breakthrough Medical Device designation by FDA for the use of OsteoAdapt SP in Anterior Lumbar Interbody Fusion. This is 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.

Theradaptive is developing a therapeutic delivery platform technology for targeted tissue regeneration. Its regenerative implants are designed to permit precise and directed tissue regeneration for a variety of tissue types and clinical indications. This technology may enable superior outcomes and safety as well as greatly improved ease of use.

"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 orthopedic manufacturer has achieved this," said John Greenbaum, Senior Vice President of Clinical & Regulatory Affairs at Theradaptive.

Source: Theradaptive

Product Labels: PRP/Cell-Based/Osteoinductive Materials

Tags: Regulatory