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U.S. Department of Health and Human Services

522 Postmarket Surveillance Studies Database

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The FDA has the authority to require device manufacturers to perform postmarket surveillance under Section 522 of the Food, Drugs and Cosmetics (FD&C) Act, when questions are identified for devices that meet the statutory criteria. This database contains information about 522 Postmarket Surveillance Studies that have been required. This database allows you to search information about the postmarket surveillance requirements by manufacturer or device.

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  To search for Manufacturer beginning with a specific letter, select that letter

MISHA Post-Market Clinical Study

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Study Status Ongoing
522 Number / Requirement Number PS230002 / PSS001
Date Original Plan Accepted 07/28/2023
Date Current Plan Accepted 03/12/2024
Study Name MISHA Post-Market Clinical Study
Device Name Misha knee system
Root Document Number DEN220033 
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group Historical Control
Analysis Type Descriptive
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Objectives Study Design: The MISHA Post-Market Study is a prospective, single-arm, observational, multicenter, post-market clinical study.
Study Objective(s): Prospective evaluation of the safety and effectiveness of the MISHA Knee System. The study will collect data on the procedural and long-term adverse events, WOMAC pain and function scores, KSS satisfaction, subsequent surgical interventions (SSIs), BMI levels, range of motion (ROM), UCLA activity level of the subjects, and perform radiographic/x-ray evaluations at clinical visits through 5 years post- procedure. This study will assess device performance in subjects with intact and retained devices and subjects with devices removed prior to study termination and freedom from conversion to arthroplasty through 5 years. Study subjects will be followed over a five-year post-implant period.
Study Population The subject population for this study will include male or female subjects aged 25 to 65 years, with a diagnosis of medial knee osteoarthritis and study knee pain with an overall WOMAC pain score greater than or equal to 40 (scale 0 -100).
A Diversity Plan will also be followed for the post-market study to support inclusion of a diverse patient population with respect to age, sex, ethnicity, and race.
Sample Size Number of subjects: 120 subjects
Number of sites: Up to 10 US sites
Key Study Endpoints Primary Endpoint: Freedom from device- and procedure -related subsequent surgical interventions (SSIs) at 5 years post-implantation.
Secondary Endpoints
5 – Year WOMAC Pain and Function
Percent of subjects meeting clinically meaningful improvement of WOMAC Pain at 5 years (defined as greater than or equal to 10 – point change from baseline
Percent of subjects meeting clinically meaningful improvement of WOMAC Function at 5 years (defined as greater than or equal to 10 – point change from baseline
Additional Observations
The following procedural and long-term assessments will be measured at post-op (within 6
weeks), 3 months, 6 months, and annually through 5 years.
WOMAC pain questions derived from the KOOS Knee questionnaire
WOMAC function questions derived from the KOOS Knee questionnaire
KSS subject satisfaction
UCLA activity score
Range of motion (ROM)
Radiographic assessments (Implant Integrity)
Subsequent surgical interventions by type of surgical intervention (revision, removal, re-operation, supplemental fixation, conversion to arthroplasty, other intervention)
AEs by type over time and relatedness. AEs will be tabulated and summarized as counts and percentages. AEs will also be cross tabulated according to
-Unanticipated Adverse Device Effect (UADE);
-Serious Adverse Event (SAE)
-Device _ Relatedness
-Procedure – Relatedness
The study will continue to collect data on subjects who have the device removed to determine if they maintain the benefits post-removal. AEs and WOMAC pain & function scores will be compared for removal subjects and subjects that still have the device implanted. A sub-analysis will be performed among high-risk subgroups including subjects with high BMI and subjects with high levels of activity.
Follow-up Visits and Length of Follow-up All subjects included in this study will return for follow-up visits within six (6) weeks post-index procedure and at three (3), six (6) and twelve (12) months, then annually through five (5) years.
Interim or Final Data Summary
Actual Number of Patients Enrolled 2
Actual Number of Sites Enrolled 2
Patient Followup Rate N/A. The study has not progressed far enough to provide this information.
Final Safety Findings One adverse event
Final Effectiveness Findings N/A. The study has not progressed far enough to obtain findings.

MISHA Post-Market Clinical Study Reporting Schedule

Reporting Schedule
Date Due
FDA Receipt
Applicant's Reporting Status
6 month report 01/28/2024 01/26/2024 On Time
1 year report 07/28/2024    
18 month report 01/28/2025    
2 year report 07/28/2025    
3 year report 07/28/2026    

Contact Us

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

Additional Resources