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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 ?
510(k)
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.
FDA-Cleared Indications
- Use during orthopedic procedures requiring accurate bone cutting, alignment, and sizing of the knee.
- Use in total knee arthroplasty according to the manufacturer's surgical technique and FDA-cleared labeling.
Clinical Applications
- Bone preparation during total knee replacement surgery.
- Femoral and tibial alignment and sizing during knee arthroplasty.
- Guidance for orthopedic surgeons performing knee replacement in hospitals or ambulatory surgical centers.
Practical Considerations
- The system should be used by orthopedic surgeons trained in knee arthroplasty and the device's surgical technique.
- Available component sizes and instrument compatibility should be confirmed before surgery and matched to the patient's anatomy.
- The record does not establish that the system is MRI safe or MRI conditional; MRI status should be confirmed in the current manufacturer labeling.
- Use requires standard sterile operating-room technique and appropriate orthopedic imaging, alignment, and bone-cutting equipment.
- Contraindications, warnings, and handling instructions should be obtained from the current FDA-cleared labeling and manufacturer instructions for use.
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.