Regenerative spinal fusion implant lands 2nd FDA breakthrough designation

Biologics

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

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.

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