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.
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