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U.S. Department of Health and Human Services

522 Postmarket Surveillance Studies

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CENTER FOR DEVICES AND RADIOLOGICAL HEALTH

DIVISION OF EPIDEMIOLOGY

"PROTECTING & PROMOTING PUBLIC HEALTH THROUGH DEVICE SURVEILLANCE AND RESEARCH"



WELCOME TO THE 522 POSTMARKET SURVEILLANCE STUDIES WEBPAGE

 

 

 

 

            

Fusion, AEs, Surg Procedures


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General
522 Number / Requirement Number PS090015 / PSS001
Current Plan Approved 05/21/2013
Study Name Fusion, AEs, Surg Procedures
Root Document Number K073143 
General Study Protocol Parameters
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description "Prospective single-arm multi-center (up to 6 sites) cohort study with literature control. Investigational patients will be enrolled in consecutive fashion. The performance of the investigational device, Silverbolt® Spinal System with Dynabolt® Rods, will be compared

to the rate of fusion, as described in published scientific literature."

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Study Population Description Patients with the device for bilateral (left and right) posterolateral fusions of the thoracic, thoracolumbar, lumbar, or lumbosacral spine using autogenous bone only.
Sample Size 171 patients, 6 sites

Data Collection Fusion, Adverse events, surgical procedures
Follow-up Visits and Length of Follow-up At 12 and 24 months post-treatment; the recruitment period is estimated to be 12 months with anticipated clinical investigation duration of 36 months.


Fusion, AEs, Surg Procedures Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
1 Yr Report 02/16/2013 02/22/2013 Overdue/Received
18 month report - revised timeline 08/17/2013 08/21/2013 Overdue/Received
2 year report 02/16/2014 03/13/2014 Overdue/Received
3 year report 02/16/2015 02/12/2015 Overdue/Received
4 year report 04/12/2016    


  • The 522 Postmarket Surveillance Studies Program encompasses design, tracking, oversight, and review responsibilities for studies mandated under section 522 of the Federal Food, Drug and Cosmetic Act. The program helps ensure that well-designed 522 postmarket surveillance (PS) studies are conducted effectively and efficiently and in the least burdensome manner.
  • In May 2008, the oversight responsibility of the 522 Postmarket Surveillance Studies Program was transferred to the Division of Epidemiology (DEPI) of the Office of Surveillance and Biometrics (OSB)/Center for Devices and Radiological Health (CDRH). DEPI continues to build the 522 program.
  • CDRH has established an automated internal tracking system that efficiently identifies the reporting status of active 522 PS studies based on study timelines incorporated in study protocols and agreed upon by the CDRH and applicants. This system represents CDRH's effort to ensure that all 522 PS commitments are fulfilled in a timely manner.
  • In addition, CDRH launched this publicly available webpage to keep all stakeholders informed of the progress of each 522 PS study. The webpage displays general information regarding each study, as well as the overall study status (based on protocol-driven timelines and adequacy of the data) and the applicant's reporting status for each submission due.

Links

Contact Information

Cheryl Reynolds
Project Manager, 522 Postmarket Surveillance (PS) Studies Program
Food and Drug Administration
10903 New Hampshire Ave
WO66-4108
Silver Spring, MD 20993-0002

Phone: (301) 796-7033
Fax: (301) 847-8140
Cheryl.Reynolds@fda.hhs.gov
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