• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

522 Postmarket Surveillance Studies

  • Print
  • Share
  • E-mail







Time to Revision and Explant Analysis

Suggest Enhancement / Report Issue | export reports to excelExport to Excel
Study Status Progress Adequate
522 Number / Requirement Number PS110003 / PSS001
Date Current Plan Accepted 11/08/2019
Study Name Time to Revision and Explant Analysis
Root Document Number P980052 
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source Sponsor Registry
Comparison Group No Control
Analysis Type Analytical
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description Objective 1: Survival Analysis- Prospective Cohort. To determine the survival rate for revision and/or removal of TMJ Concepts implants and use this data to determine factors that affect this survival during three years of follow-up. This will answer questions 1-3 and question 5b. Objective 2: Reason for Failure Analysis-cross-sectional study. To determine the reasons for TMJ implant revisions and removals among patients who have had TMJ Concepts implants. This will answer question 4. Objective 3: Explant Analysis. To determine the specific modes and causes of failure based on an analysis of all reasonably available explanted retrieved TMJ Concepts devices. This will answer question 5a.

Study Population Description 18 to 21 yrs; Adult 21+

Sample Size 672 patients

Data Collection 1. Survival Analysis: Revision or removal at three years of follow-up; Revision or removal for subgroups of patients. 2. Reason for failure analysis: Reasons for initial and subsequent revision or removal. 3. Explant Analysis; TMJ implant failure.

Follow-up Visits and Length of Follow-up FU Visits: Annually; Length of FU: 3 years

Time to Revision and Explant Analysis Schedule

Report Schedule
Date Due
FDA Receipt
Applicant's Reporting Status
6 month report 10/01/2013 11/13/2013 Overdue/Received
12 month report 04/01/2014 03/31/2014 On Time
18 month report 09/30/2014 09/30/2014 On Time
2 year report 04/01/2015 04/02/2015 Overdue/Received
3 year report 04/01/2016 04/04/2016 Overdue/Received
4 year report 04/03/2017 06/12/2017 Overdue/Received
5 year report 04/01/2018 03/12/2019 On Time
Final Report 01/20/2020 01/21/2020 Overdue/Received

  • 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.
  • CDRH 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

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