đź“‹ FDA Reference
alpha orthopaedics at3 system
Alpha Orthopaedics
Summary: The Alpha Orthopaedics AT3 System is a Class 2 medical device used primarily in orthopedic procedures. It is designed for use by orthopedic surgeons in settings such as hospitals and surgical centers.
FDA Clearance Information
Pathway
510K
Number
K094041 ↗
Decision Date
April 7, 2010
Product Code
GEI
Device Class
Class 2
Evidence
0 studies
The Alpha Orthopaedics AT3 System was cleared through the FDA 510k pathway on April 7, 2010. It is manufactured by Alpha Orthopaedics and classified as a Class 2 device under product code GEI.
What It Is
The Alpha Orthopaedics AT3 System is an orthopedic device designed to assist in surgical procedures involving the knee, particularly total knee arthroplasty. It provides tools and guidance for precise bone cutting and alignment, which are crucial for successful knee replacement surgeries. The system aims to improve surgical outcomes by enhancing accuracy and reducing operative time.
Clinical Applications
This device is commonly used in orthopedic surgeries, specifically total knee arthroplasty. It is utilized in hospital operating rooms and surgical centers by orthopedic surgeons. The system is particularly beneficial for patients requiring knee replacement due to conditions such as osteoarthritis or rheumatoid arthritis, where accurate bone alignment is critical for the success of the procedure.
Indications for Use
The FDA-cleared indications for the Alpha Orthopaedics AT3 System involve its use in procedures requiring precise bone alignment and cutting, such as total knee arthroplasty. It is intended for patients undergoing knee replacement surgery to improve joint function and reduce pain.
Practical Considerations
The Alpha Orthopaedics AT3 System typically includes various sizing options to accommodate different patient anatomies. It is compatible with standard surgical instruments and requires familiarity with orthopedic surgical techniques. Surgeons should be trained in the use of navigation systems to maximize the benefits of this device.
Related Literature
The linked study examined the impact of tibial cutting techniques in total knee arthroplasty, comparing accelerated navigation to extramedullary targeting. Although the abstract is not available, the study likely focused on surgical precision and outcomes. Limitations may include a lack of detailed results and potential variability in surgical skill and patient anatomy.
Frequently Asked Questions
What is the Alpha Orthopaedics AT3 System used for?
It is used in total knee arthroplasty to assist with precise bone cutting and alignment.
What specialties typically use this device?
Orthopedic surgeons specializing in knee replacement surgeries use this device.
What are the FDA-cleared indications?
The device is indicated for use in procedures requiring precise bone alignment and cutting, such as total knee arthroplasty.
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.