FDA Submission for a Humeral Head Cutting Guide
Honors Capstone Project
1
Advisor(s)
Dr. Joshua Gargac
Confirmation
1
Document Type
Paper
Location
ONU McIntosh Center; Ballroom
Start Date
18-4-2023 2:15 PM
End Date
18-4-2023 5:00 PM
Abstract
This Honors capstone enhancement project provides a model of required documentation for a 510k submission to the FDA to gain approval for a new medical device to be put on the market. This medical device is a humeral head cutting guide device to aid in shoulder replacement surgery. The cutting guide aims to facilitate the removal of the head of the humerus bone during surgery by providing a patient-specific solution that increases precision of the cut and accommodates surgeon preferences, therefore reducing the risk of patient complications. In order for such a device to be used and sold, it must first undergo a process to gain FDA approval, as demonstrated by the contents of project.
Recommended Citation
Ream, Courtney, "FDA Submission for a Humeral Head Cutting Guide" (2023). ONU Student Research Colloquium. 12.
https://digitalcommons.onu.edu/student_research_colloquium/2023/papers/12
Restricted
Available to ONU community via local IP address and ONU login.
FDA Submission for a Humeral Head Cutting Guide
ONU McIntosh Center; Ballroom
This Honors capstone enhancement project provides a model of required documentation for a 510k submission to the FDA to gain approval for a new medical device to be put on the market. This medical device is a humeral head cutting guide device to aid in shoulder replacement surgery. The cutting guide aims to facilitate the removal of the head of the humerus bone during surgery by providing a patient-specific solution that increases precision of the cut and accommodates surgeon preferences, therefore reducing the risk of patient complications. In order for such a device to be used and sold, it must first undergo a process to gain FDA approval, as demonstrated by the contents of project.