College - Author 1

College of Engineering

Department - Author 1

Biomedical Engineering Department

Degree Name - Author 1

BS in Biomedical Engineering

College - Author 2

College of Engineering

Department - Author 2

Biomedical Engineering Department

Degree - Author 2

BS in Biomedical Engineering

College - Author 3

College of Engineering

Department - Author 3

Biomedical Engineering Department

Degree - Author 3

BS in Biomedical Engineering

College - Author 4

College of Engineering

Department - Author 4

Biomedical Engineering Department

Degree - Author 4

BS in Biomedical Engineering

Date

3-2022

Primary Advisor

Britta Berg-Johansen, College of Engineering, Biomedical Engineering Department

Abstract/Summary

This document is an overview report of the Cal Poly Senior Project ASTM Test Fixture for SeaSpine orthopedic bone screws. The main application of orthopedic screws is to fasten implants directly to the bone structure, enhancing structural integrity. Testing for breaking angle, insertion torque, removal torque, axial pullout strength, and self-tapping force as specified in the ASTM F543 Annexes provides the FDA with vital screw mechanics and ensures manufacturing uniformity. The test system is comprised of custom and off the shelf components allowing for interchangeability, in case of part failure, and a low overall cost. It is mechanically capable of testing two of the four annexes to completion; future steps are included for remaining processes. Testing data validating the linear and rotational displacement of our system, as well as Annex data is incorporated into this report. Feasibility of the design showcased in the following documents present in this report: Intellectual Property Assessment, Technical Literature Review, Indications for Use, Project Budget, Customer Requirements, GANTT Chart, Network Diagram, House of Quality, Morphological Matrix, Concept Sketches, SOLIDWORKS Conceptual Model, System Detailed Design, Manufacturing Process Instructions, Device Testing Plans, Testing Data and Analyses, and an overall discussion and conclusion for the project.

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