5 spine, orthopedic products granted ‘breakthrough device’ designation in 2021

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.

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By: Carly Behm

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.

At the Becker's 23rd Annual Spine, Orthopedic and Pain Management-Driven ASC + The Future of Spine Conference, taking place June 11-13 in Chicago, spine surgeons, orthopedic leaders and ASC executives will come together to explore minimally invasive techniques, ASC growth strategies and innovations shaping the future of outpatient spine care. Apply for complimentary registration now.

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