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endotome pneumatic orthopaedic cut
Cabot Medical
Summary: The Endotome Pneumatic Orthopaedic Cut is a surgical device used primarily in orthopedic procedures. It is designed for use by orthopedic surgeons to perform precise bone cutting and shaping, particularly in procedures like prostate artery embolization.
FDA Clearance Information
Pathway
510K
Number
K840831 ↗
Decision Date
April 4, 1984
Product Code
HSZ
Device Class
Class 1
Evidence
0 studies
The Endotome Pneumatic Orthopaedic Cut was cleared through the FDA 510(k) pathway on April 4, 1984. Manufactured by Cabot Medical, it is classified as a Class 1 device under product code HSZ.
What It Is
The Endotome Pneumatic Orthopaedic Cut is a specialized surgical tool designed for precision cutting of bone during orthopedic procedures. It operates pneumatically, providing consistent power and control to the surgeon. This device is particularly useful in procedures requiring meticulous bone shaping, enhancing surgical outcomes by allowing for precise cuts.
Clinical Applications
Commonly used in orthopedic surgeries, the Endotome is ideal for procedures that involve bone cutting and shaping, such as joint replacements or fracture repairs. It is primarily used in hospital operating rooms and specialized surgical centers by orthopedic surgeons. The device is also applicable in prostate artery embolization, where precise bone access is necessary.
Indications for Use
The FDA indications suggest that the device is intended for use in procedures requiring bone cutting, such as orthopedic surgeries. It is suitable for patients undergoing surgeries that involve bone manipulation, including those with conditions requiring joint replacement or fracture repair.
Practical Considerations
The device is typically available in various sizes to accommodate different surgical needs and patient anatomies. It is compatible with standard pneumatic systems found in most surgical settings. Surgeons should be familiar with pneumatic device handling and maintenance to ensure optimal performance.
Frequently Asked Questions
What is the Endotome Pneumatic Orthopaedic Cut used for?
It is used for precise bone cutting and shaping in orthopedic surgeries, including joint replacements and fracture repairs.
What specialties typically use this device?
Orthopedic surgeons primarily use this device in hospital operating rooms and specialized surgical centers.
What are the FDA-cleared indications?
The device is indicated for use in orthopedic procedures requiring bone cutting, such as joint replacements and fracture repairs.
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.