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edwards orthopaedics arthroscopes and accessories
Baxter Healthcare
Summary: The Edwards Orthopaedics Arthroscopes are medical devices used primarily in minimally invasive surgical procedures to visualize joints. They are typically used by orthopedic surgeons in hospital or outpatient settings.
FDA Clearance Information
Pathway
510K
Number
K880205 ↗
Decision Date
February 4, 1988
Product Code
HRX
Device Class
Class 2
Evidence
0 studies
The Edwards Orthopaedics Arthroscopes and Accessories were cleared through the FDA 510(k) pathway on February 4, 1988. Manufactured by Baxter Healthcare, this device is classified as Class 2 under product code HRX.
What It Is
The Edwards Orthopaedics Arthroscopes are specialized instruments designed for arthroscopic procedures, allowing surgeons to view the interior of joints through a small incision. These devices consist of a thin, flexible tube equipped with a camera and light source, providing high-resolution images to aid in diagnosis and treatment. They are essential tools in minimally invasive orthopedic surgeries, reducing recovery time and improving patient outcomes.
Clinical Applications
These arthroscopes are commonly used in procedures involving the knee, shoulder, elbow, and other joints. Orthopedic surgeons utilize them in both diagnostic and therapeutic interventions, such as repairing torn ligaments or removing loose cartilage. They are primarily used in hospital operating rooms and outpatient surgical centers, catering to patients with joint injuries or degenerative conditions.
Indications for Use
The FDA indications suggest that these arthroscopes are intended for use in visualizing and treating joint conditions. They are suitable for patients requiring minimally invasive surgery for joint issues, such as tears, inflammation, or degenerative diseases.
Practical Considerations
These devices come in various sizes to accommodate different joints and patient anatomies. They are compatible with standard surgical instruments and require careful handling to maintain sterility and functionality. Clinicians should be trained in arthroscopic techniques to ensure optimal outcomes.
Frequently Asked Questions
What is Edwards Orthopaedics Arthroscopes used for?
They are used for visualizing and treating conditions within joints during minimally invasive surgeries.
What specialties typically use this device?
Orthopedic surgeons primarily use these devices in surgical settings.
What are the FDA-cleared indications?
These devices are indicated for use in minimally invasive procedures to diagnose and treat joint conditions.
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.