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U.S. Department of Health and Human Services

Post-Approval Studies (PAS)

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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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OSB Lead-Long Term PAS

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Study Status Progress Adequate
Application Number P110009 / PAS001
Current Plan Approved 05/08/2014
Study Name OSB Lead-Long Term PAS
General Study Protocol Parameters
Study Design Prospective Cohort Study
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 Design Description The primary objective of the study is to evaluate the long-term

overall success rate (see primary end-points for the definitions) of the investigational device as compared to the control in subjects enrolled in the pivotal IDE study of the Mobi-C (2- levels) device (IDE Number G050212).

Design-Prospective Cohort, a long term follow-up of the IDE

patients ( investigational and controls)

Study Population Description All eligible Mobi-C patients (n=221 -randomized and n=8 - training cases) treated at two contiguous levels All eligible fusion patients (n=99- randomized at 24-months) treated at two contiguous levels under the LDR-001 Pivotal Study (IDE G050212)
Sample Size Investigational¿n=221 -randomized and n=8 -training cases at treated at two contiguous levels. Control¿ all eligible fusion patients (n=99) treated at two contiguous levels
Data Collection For Mobi-C: Pain/Disability Improvement of at least 25% in the Neck Disability Index (NDI) at 5 years and 7 years; no device failures at the index level requiring revision, re-operation, removal, or supplemental fixation; absence of major complications defined as 1) neurologic deterioration, 2) radiologic failure and 3) adverse events determined to be major complications and related to the study

For Fusion ACDF: evidence of bridging trabecular bone and <2º

total angular motion (from flexion to extension) and <50% radiolucency along the graft/endplate interface and for Mobi- C® subjects radiologic failure is defined as evidence of continuous bridging bone and <2º total angular motion.

Follow-up Visits and Length of Follow-up 7 years at 7th year

OSB Lead-Long Term PAS Schedule

Report Schedule
Date Due
FDA Receipt
Applicant's Reporting Status
six month report 02/21/2014 02/21/2014 On Time
one year report 08/23/2014 08/21/2014 On Time
18 month report 02/21/2015 02/23/2015 Overdue/Received
two year report 08/23/2015 08/20/2015 On Time
Final Report 05/27/2016 05/31/2016 Overdue/Received

Contact Us

Julie Unger
Project Manager, Post-Approval Studies Program
Food and Drug Administration
10903 New Hampshire Ave
WO66-4206v Silver Spring, MD

Phone: (301) 796-6134
Fax: (301) 847-8140

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