đź“‹ FDA Reference
modification to miller galante precoat unicompartmental knee system 8 mm articular surface
Zimmer
Summary: The Miller Galante Precoat Unicompartmental Knee System is a knee implant used in partial knee replacement surgeries. It is primarily used by orthopedic surgeons to treat patients with unicompartmental knee arthritis.
FDA Clearance Information
Pathway
510K
Number
K010685 ↗
Decision Date
April 2, 2001
Product Code
HSX
Device Class
Class 2
Evidence
0 studies
The device was cleared through the FDA 510(k) pathway on April 2, 2001. It is manufactured by Zimmer and classified as a Class 2 medical device under product code HSX.
What It Is
The Miller Galante Precoat Unicompartmental Knee System is an orthopedic implant designed for partial knee replacement. It replaces only one compartment of the knee, typically the medial or lateral side, allowing for a less invasive procedure compared to total knee replacement. The system includes an 8 mm articular surface, which is designed to provide a smooth gliding surface for joint movement.
Clinical Applications
This device is commonly used in orthopedic surgery for patients with unicompartmental osteoarthritis of the knee. It is suitable for patients who have damage confined to a single compartment of the knee and who maintain good range of motion and ligament stability. The procedure is typically performed in hospital or outpatient surgical settings by orthopedic surgeons.
Indications for Use
The device is indicated for patients with unicompartmental knee arthritis, where only one part of the knee joint is affected. It is suitable for patients who do not require a total knee replacement and have sufficient bone stock and ligament integrity.
Practical Considerations
The system is available in various sizes to accommodate different patient anatomies. It is important to ensure proper alignment and fixation during the procedure to optimize outcomes. Compatibility with other Zimmer knee components may be beneficial for surgeons familiar with the brand.
Frequently Asked Questions
What is the Miller Galante Precoat Unicompartmental Knee System used for?
It is used for partial knee replacement in patients with unicompartmental knee arthritis.
What specialties typically use this device?
Orthopedic surgeons specializing in knee arthroplasty use this device.
What are the FDA-cleared indications?
The device is indicated for patients with unicompartmental knee arthritis affecting only one compartment of the knee joint.
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.