The FDA provides "breakthrough device" designation to products that are deemed effective to treat certain diseases and conditions. The designation speeds up the development, assessment and review for products.
Five spine and orthopedic devices that earned the mark so far in 2021:
1. Premia Spine's Tops facet arthroplasty system.
2. Cerapedics' P-15L bone graft for the treatment of degenerative disc disease.
3. Spinal Stabilization Technologies' PerQdisc.
4. Intelligent Implants' remote orthopedics platform, SmartFuse.
5. Hyalex Orthopaedics' Hyalex Cartilage System.