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U.S. Department of Health and Human Services

522 Postmarket Surveillance Studies

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Fusion, AEs, Surg Procedures

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Study Status Terminated
522 Number / Requirement Number PS090008 / PSS001
Date Current Plan Accepted 04/18/2014
Study Name Fusion, AEs, Surg Procedures
Root Document Number K050809  K063670 
General Study Protocol Parameters
Study Design Retrospective Cohort Study
Data Source Other Data Source
Comparison Group Concurrent Control
Analysis Type Analytical
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description 2 arm- retrospective cohort study. The data for the study will be obtained from patient medical records after applying inclusion/exclusion criteria. The data for analysis will be extracted from 112 patient records with PEEK rods (investigational device) and 112 control patient records with titanium rods. The time frame for this retrospective review of records will include surgeries occurring between September 15, 2005 tp March 5, 2011.

Study Population Description Patients who have received PEEK or titanium rods for posterior non-cervical fixation as an adjunct to posterolateral fusion for spondyloslisthesis, trauma, spinal stenosis, or curvatures (i.e. scoliosis, kyphosis, and/or lordosis, tumor, pseudoarthrosis, and/or failed previous fusion.)
Sample Size "112 controls and 112 investigational. The total number of sites selected will depend on the number of subject cases that can be included per site in order to reach the 224 subjects

needed for the primary endpoint. There will be a minimum of 5 and up to 20 centers. "

Data Collection Fusion, adverse events, surgical procedures
Follow-up Visits and Length of Follow-up "Pre-operative assessments (60 days or less from sugery). The postoperative evaluations for the primary study endpoint will be reviewed from 6 months up to 24 months, if available, or until the last

observation on the subject, or until device failure, or until a subsequent surgical procedure is performed at the index level(s). All available postoperative safety data, regardless of time point, will be reviewed for each subject up to 24 months postsurgery. "

Interim or Final Data Summary
Interim Safety Information There are 2 sites enrolled

Fusion, AEs, Surg Procedures Schedule

Report Schedule
Date Due
FDA Receipt
Applicant's Reporting Status
6 month report 09/23/2011 09/26/2011 On Time
1 year report 03/22/2012 03/22/2012 On Time
18 month report 09/22/2012 09/17/2012 On Time
2 year report 03/23/2013 03/20/2013 On Time
3 year report 03/22/2014 03/19/2014 On Time
4 year report 03/21/2015 03/20/2015 On Time
5 year report 03/21/2016 03/18/2016 On Time

  • 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.


Contact Information

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

Phone: (301) 796-6068
Fax: (301) 847-8140