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# Theradaptive Breakthrough Status for Spinal Device
- URL: https://www.fdaweb.com/theradaptive-breakthrough-status-for-spinal-device/
- Published: 2021-11-22T12:00:00.000Z
- Updated: 2026-09-14T17:23:07.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5150627

FDA has granted Theradaptive a breakthrough medical device designation for its Osteo-Adapt SP Spinal Fusion implant indicated for transforaminal lumbar interbody spinal fusion to treat degenerative disc disease, spondylolisthesis, or retrolisthesis. The company says the implant is designed to permit precise tissue regeneration for a variety of tissue types and clinical indications. “The new technology enables superior outcomes and safety, and greatly improved ease of use,” the company says.