Regenerative spinal fusion implant lands 2nd FDA breakthrough designation

Theradaptive’s OsteoAdapt SP spinal implant received FDA breakthrough designation for posterolateral spinal fusion.

Advertisement

The device was indicated to treat degenerative disc disease, spondylolisthesis or retrolisthesis, according to a Feb. 15 news release. In November, the device got breakthrough designation for transforaminal lumbar interbody spinal fusion for degenerative disc disease, spondylolisthesis or retrolisthesis.

Breakthrough designation allows Theradaptive priority review and interactive communications with the FDA during the premarket review process.

At the Becker's 23rd Annual Spine, Orthopedic and Pain Management-Driven ASC + The Future of Spine Conference, taking place June 11-13 in Chicago, spine surgeons, orthopedic leaders and ASC executives will come together to explore minimally invasive techniques, ASC growth strategies and innovations shaping the future of outpatient spine care. Apply for complimentary registration now.

Advertisement

Next Up in Biologics

Advertisement

Comments are closed.