đź“‹ FDA Reference
orthopaedic surgery planning software aijoint
Longwood Valley Medical
Summary: AIJoint is an orthopaedic surgery planning software used for personalized prosthesis selection in total hip arthroplasty. It is primarily used by orthopedic surgeons to enhance surgical planning and outcomes.
FDA Clearance Information
Pathway
510K
Number
K233761 ↗
Decision Date
August 5, 2024
Product Code
LLZ
Device Class
Class 2
Evidence
0 studies
AIJoint received FDA clearance through the 510(k) pathway on August 5, 2024. Manufactured by Longwood Valley Medical, it is classified as a Class 2 medical device.
What It Is
AIJoint is a software tool designed to assist orthopedic surgeons in planning surgeries, particularly total hip arthroplasty. It uses AI algorithms to analyze CT imaging data and generate 3D models that help in selecting the most suitable femoral prosthesis for individual patients. This personalized approach aims to improve surgical precision and patient outcomes.
Clinical Applications
AIJoint is commonly used in orthopedic settings, particularly for planning total hip arthroplasty procedures. It aids surgeons in pre-operative planning by providing detailed 3D models of the patient's anatomy, which can be crucial for complex cases or patients with unique anatomical considerations. This tool is especially beneficial in hospitals and specialized orthopedic centers.
Indications for Use
The FDA indications suggest that AIJoint is intended for use in planning orthopedic surgeries, specifically for selecting appropriate prostheses in hip replacement surgeries. It is designed for patients requiring personalized surgical planning to optimize outcomes.
Practical Considerations
AIJoint is compatible with standard CT imaging systems and integrates with existing surgical planning workflows. Surgeons should ensure that imaging data is of high quality for optimal software performance. Familiarity with 3D modeling software may enhance user experience.
Related Literature
The linked study explored the use of AIJoint in planning total hip arthroplasty by combining CT measurement parameters with AI-assisted 3D planning. The study found that this approach could enhance the selection of femoral prostheses, potentially improving surgical outcomes. However, the study's limitations include a small sample size and the need for further research to validate findings across diverse patient populations.
Frequently Asked Questions
What is AIJoint used for?
AIJoint is used for planning orthopedic surgeries, specifically to assist in selecting the appropriate prosthesis for total hip arthroplasty.
What specialties typically use this device?
Orthopedic surgeons, particularly those specializing in joint replacement surgeries, typically use AIJoint.
What are the FDA-cleared indications?
AIJoint is indicated for use in planning orthopedic surgeries, focusing on personalized prosthesis selection in hip replacement procedures.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.