Post-Approval Studies (PAS) Database

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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4WEB Medical Talar Replacement Device PAS

General
Study Status	Hold
Application Number / Requirement Number	H240001 / PAS001
Date Original Protocol Accepted	03/20/2025
Date Current Protocol Accepted
Study Name	4WEB Medical Talar Replacement Device PAS
Device Name	4WEB Medical Talar Replacement Device
General Study Protocol Parameters
Study Design	Prospective Cohort Study
Data Source	New Data Collection
Comparison Group	No Control
Analysis Type	Descriptive
Study Population	Adult: >21
Detailed Study Protocol Parameters
Study Objectives	Study Design: Multi-center, Single-arm, Prospective, Post-Approval Study Study Objective: The primary objective of this clinical investigation is to assess the safety and probable benefit of 4WEB Medical Talar Replacement Device in a commercial use setting.
Study Population	Adults (=22 years of age) who have received the 4WEB Medical Talar Replacement Device under an approved HDE for one of the indications listed on the Instructions for Use (IFU) and who do not have a contraindication.
Sample Size	Number of subjects: 30 Number of sites: Minimum of 5 sites, with no more than 20 subjects enrolled per center. Sites location: USA
Key Study Endpoints	Primary Endpoint Safety: Absence of a subsequent secondary surgical intervention (SSSI) and a device-related serious adverse event (SAE) on the affected joint at five (5) years. • Probable Benefit: Device survivorship at 5 years Secondary Endpoints Safety: • The incidence of device or procedure related Adverse Events (AEs) • Serious Adverse Events (SAEs) Probable Benefit: • Improvement or maintenance of Ankle Range of Motion (ROM) measured at 5 years postop compared to preop (when available) • Improvement in American Orthopaedic Foot and Ankle Outcome Scores (AOFAOS) measured at 5 years postop compared to preop (when available) – Composite score and individual scores for the following subscales o Pain o Function o Alignment Exploratory Endpoints X-ray assessments: When available, x-rays will be used to evaluate the presence of adverse events, proper location of implant without migration, absence of subsidence into calcaneus, and health of surrounding soft tissue: • Tibiotalar Alignment • Talar Tilt Angle • Boehler’s Angle • Talar declination angle1 • Meary’s angle
Follow-up Visits and Length of Follow-up	Frequency of Follow-up Visits: Three (3) months, six (6) months, twelve months and annually thereafter Length of Follow-Up: 5 years

4WEB Medical Talar Replacement Device PAS Reporting Schedule

Reporting Schedule	Report Date Due	FDA Receipt Date	Applicant's Reporting Status
6 month report	06/27/2025	08/29/2025	Overdue/Received

Contact Us

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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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• Guidance Document: "Procedures for Handling Post-Approval Studies Imposed by PMA Order"
• PAS Program Background