9 spine devices granted breakthrough device designation

The FDA’s Breakthrough Devices Program is designed to accelerate the development, assessment and review of medical devices that provide effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions.

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Here are nine spine devices that received the designation this year:

1. Premia Spine’s Tops system: a facet joint replacement device for the lumbar spine

2. Theradaptive’s Osteo-Adapt SP: a regenerative implant indicated for transforaminal lumbar interbody spinal fusion

3. Amber Implants’ VCFix system: a 3D-printed device to treat vertebral fractures

4. Carlsmed’s Aprevo: s 3D-printed interbody designed for the treatment of adult spinal deformity

5. Auctus Surgical’s VBT system: a vertebral body tethering system that has a nonfusion approach to scoliosis treatment

6. Spino Modulation’s Miscoli system: a vertebral body tethering system to treat adolescent idiopathic scoliosis

7. Cerapedics’ P-15L: a bone graft for the treatment of degenerative disc disease

8. Spinal Stabilization Technologies’ PerQdisc: a lumbar nucleus replacement system

9. Intelligent Implants’ SmartFuse: a device used to remotely stimulate, control and monitor bone growth in lumbar spinal fusion patients

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