1Department of Orthopedic Surgery, Mayo Clinic, Rochester, Minnesota

2Setting Scoliosis Straight Foundation, El Cajon, California

3Department of Population Health Sciences, Duke University School of Medicine, Durham, North Carolina

4Division of Orthopedics, Rady Children’s Hospital, San Diego, California

5Office of Product Evaluation and Quality, Office of Health Technology-6: Orthopedic Devices, Center for Devices and Radiological Health, Food and Drug Administration, Silver Spring, Maryland

6Office of Strategic Partnerships and Technology Innovation, Center for Devices and Radiological Health, Food and Drug Administration, Silver Spring, Maryland

7Division of Orthopedic Surgery, Children’s Hospital of Philadelphia, Philadelphia, Pennsylvania

8Department of Orthopaedic Surgery, Nemours Children’s Hospital, Wilmington, Delaware

9Department of Pediatric Orthopedic Surgery, Shriners Children’s Philadelphia, Philadelphia, Pennsylvania

10Department of Orthopedic Surgery, University of Virginia, Charlottesville, Virginia

11Department of Orthopaedic Surgery, Mount Sinai Hospital, New York, NY

aEmail for corresponding author: [email protected]

*A list of the Harms Study Group members is included in a note at the end of the article.

Disclosure: The Disclosure of Potential Conflicts of Interest forms are provided with the online version of the article (https://links.lww.com/JBJS/H751).