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U.S. Department of Health and Human Services

Post-Approval Studies (PAS) Database

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The FDA has the authority to require sponsors to perform a post-approval study (or studies) at the time of approval of a premarket approval (PMA), humanitarian device exemption (HDE), or product development protocol (PDP) application. Post-approval studies can provide patients, health care professionals, the device industry, the FDA and other stakeholders information on the continued safety and effectiveness (or continued probable benefit, in the case of an HDE) of approved medical devices. This database allows you to search Post-Approval Study information by applicant or device information.

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REFLECT Scoliosis Correction System Registry PAS

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Study Status Delayed
Application Number /
Requirement Number
H210002 / PAS001
Date Original Protocol Accepted 07/13/2023
Date Current Protocol Accepted  
Study Name REFLECT Scoliosis Correction System Registry PAS
Device Name REFLECT™ Scoliosis Correction System
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group No Control
Analysis Type Descriptive
Study Population Child: 2-12 yrs, Adolescent: 13-18 yrs, Transit. Adolescent B (as adults) : 18-21 yrs
Detailed Study Protocol Parameters
Study Objectives The purpose of this multi-center, prospective, single-arm registry study is to evaluate radiographic and clinical outcomes of patients with idiopathic scoliosis treated with the REFLECT™ Scoliosis Correction System.
Study Population Inclusion Criteria
Patients may be enrolled in the study if all of the following inclusion criteria are met:
Diagnosis of progressive idiopathic scoliosis
Preoperative major Cobb angle 30°-65°
Preoperative flexibility to less than or equal to 30° on side bending radiograph (left or right)
Skeletally immature at the time of surgery with Risser sign <5 or Sanders score <8
Osseous structure dimensionally adequate to accommodate screw fixation, as determined by radiographic imaging
Failed or intolerant to bracing
Signed informed consent and/or assent forms specific to this study
Exclusion Criteria
Patients cannot be enrolled in the study if any of the following exclusion criteria are met:
Prior spinal surgery at the level(s) to be treated
Documented poor bone quality, defined as a T-score of -1.5 or less
Presence of any systemic infection, local infection, or skin compromise at the surgical site
Any medical or surgical condition which would preclude the potential benefit of spinal surgery, such as coagulation disorders, allergies to the implant materials, and patient's unwillingness or inability to cooperate with post-operative care instructions
Unwillingness, inability, or living situation (e.g. custody arrangements, homelessness, detention) that would preclude ability to return to the study site for follow-up visits as described in protocol and Informed Consent
Active participation in a drug or device study that is more than minimal risk such that participation would confound the measurements of the present study
Sample Size Number of subjects: 100 patients
Assumptions for sample size estimation: N/A
Number of sites: 5
Sites location: U.S. sites
Key Study Endpoints Primary Endpoints
The primary endpoints are deformity correction and safety, evaluated at 60 months postoperative, using the following:
• Primary probable benefit: maintenance of major Cobb angle less than or equal to 40°
• Primary safety: serious adverse events (SAEs) and device- or procedure-related adverse events (AEs)
Secondary Outcomes:
Secondary outcome measures include the following evaluations at 60 months postoperative, compared to preoperative baseline where applicable:
• Curve progression no greater than 10° of any secondary curve above or below the implant, or development of a new curve equal to or greater than 40°
Device integrity failures including cord breakage and screw migration
Composite endpoint analysis (maintenance of major Cobb angle less than or equal to 40° AND freedom from Serious Adverse Events (SAEs) during the procedure and procedure/device related SAEs following surgery)
Analysis of the failure attributable to conversion to another spinal implant OR major Cobb angle that exceeded 40° at defined follow-up visit OR any progression of the major curve at defined follow-up compared to baseline OR death OR permanent disability
Mean score of Scoliosis Research Society 22r Patient Questionnaire
Follow-up Visits and Length of Follow-up Patients will be followed for 5 years with evaluations at the following timepoints: preoperative, intraoperative, immediate postoperative (first erect), 6 weeks, 6 months, 12 months, 24 months, and 60 months. The clinical evaluation schedule with follow-up windows (+/-2wk at 6wk; +/-1mo at 6mo; +/-2mo at 12; +/-4mo at 24 and 60mo) is provided in Appendix I.

REFLECT Scoliosis Correction System Registry PAS Reporting Schedule

Reporting Schedule
Date Due
FDA Receipt
Applicant's Reporting Status
6 month report 01/13/2024 01/10/2024 On Time
18 month report 01/14/2025    
2 year report 07/14/2025    
3 year report 07/14/2026    

Contact Us

Mandated Studies Program
Food and Drug Administration
10903 New Hampshire Ave.
Silver Spring, MD 20993-0002
Email: MandatedStudiesPrograms@fda.hhs.gov

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