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overtureti knee resurfacing systemtm
Overture Orthopaedics
Summary: The Overtureti Knee Resurfacing System is a medical device used for knee resurfacing procedures, primarily by orthopedic surgeons. It is designed to treat patients with knee joint issues, offering an alternative to total knee replacement.
FDA Clearance Information
Pathway
510K
Number
K242746 ↗
Decision Date
October 7, 2024
Product Code
HSX
Device Class
Class 2
Evidence
0 studies
The Overtureti Knee Resurfacing System was cleared through the FDA 510(k) pathway on October 7, 2024. Manufactured by Overture Orthopaedics, it is classified as a Class 2 device under product code HSX.
What It Is
The Overtureti Knee Resurfacing System is a specialized orthopedic device designed to resurface the knee joint. It involves the use of precision instruments and implants to restore joint function while preserving as much of the patient's natural bone and tissue as possible. This system is particularly useful for patients with localized cartilage damage or early-stage osteoarthritis, providing a less invasive alternative to total knee replacement.
Clinical Applications
This device is commonly used in orthopedic surgical settings, particularly for patients who are not yet candidates for total knee replacement but suffer from significant knee pain or dysfunction. It is ideal for younger, active patients with localized cartilage damage. The system is typically used in outpatient or inpatient surgical centers specializing in joint preservation and sports medicine.
Indications for Use
The FDA-cleared indications for the Overtureti Knee Resurfacing System include treatment of patients with knee joint issues such as localized cartilage damage or early-stage osteoarthritis. It is intended for patients who require relief from pain and improved joint function.
Practical Considerations
The Overtureti system is available in various sizes to accommodate different patient anatomies, ensuring a customized fit. It is compatible with standard orthopedic surgical techniques and instruments. Surgeons should be familiar with knee anatomy and resurfacing techniques to optimize outcomes.
Frequently Asked Questions
What is the Overtureti Knee Resurfacing System used for?
The device is used for knee resurfacing procedures to treat localized cartilage damage or early-stage osteoarthritis, offering an alternative to total knee replacement.
What specialties typically use this device?
Orthopedic surgeons, particularly those specializing in joint preservation and sports medicine, typically use this device.
What are the FDA-cleared indications?
The device is indicated for patients with knee joint issues such as localized cartilage damage or early-stage osteoarthritis, aiming to relieve pain and improve joint function.
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.