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U.S. Department of Health and Human Services

522 Postmarket Surveillance Studies Database
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The FDA has the authority to require device manufacturers to perform postmarket surveillance under Section 522 of the Food, Drugs and Cosmetics (FD&C) Act, when questions are identified for devices that meet the statutory criteria. This database contains information about 522 Postmarket Surveillance Studies that have been required. This database allows you to search information about the postmarket surveillance requirements by manufacturer or device.

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Fusion, AEs, Surg Procedures


 
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General
Study Status Terminated
522 Number / Requirement Number PS090007 / PSS001
Date Original Plan Accepted 05/04/2012
Date Current Plan Accepted 05/04/2012
Study Name Fusion, AEs, Surg Procedures
Device Name Transition stabilization system
Root Document Number K073439 
General Study Protocol Parameters
Study Design Randomized Clinical Trial
Data Source New Data Collection
Comparison Group Concurrent Control
Analysis Type Analytical
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Objectives This is a prospective randomized clinical trial to compare incident rates of certain events (see study endpoints section) in the treatment group to those of the control group. The treatment group will include patients treated with the TRANSITION Stabilization System at one or two levels of the thoracic, lumbar and/or sacral spine, with or without interbody fusion. The control group will include patients treated with the REVERE Stabilization System, at one or two levels of the thoracic, lumbar and/or sacral spine, with or without interbody fusion.
Study Population Patients with acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine in skeletally mature patients: degenerative spondylolisthesis with objective evidence of neurologic impairment, kyphosis, and failed previous fusion (pseudoarthrosis).
Sample Size 360 patients at 20 sites
Key Study Endpoints Fusion, Oswestry Disability Index scores, radiographic findings and device related adverse events
Follow-up Visits and Length of Follow-up Patients will be followed for 24 months: pre-op; discharge; 6 months; 12 months and 24 months.


Fusion, AEs, Surg Procedures Reporting Schedule

Reporting Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
6 month report due 11/02/2012 11/05/2012 Overdue/Received
1 yr report 05/03/2013 05/08/2013 Overdue/Received
18 month report 11/02/2013 11/05/2013 Overdue/Received
2 year report 05/04/2014 05/02/2014 On Time
3 year report 05/04/2015 05/04/2015 On Time
4 yr report 05/03/2016 05/03/2016 On Time


Contact Us

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

Additional Resources
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