đź“‹ FDA Reference
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 ?
510(k)
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.
FDA-Cleared Indications
- Used for pneumatic cutting or shaping of bone during orthopedic surgical procedures.
- Intended for use by trained surgical personnel in an operating-room or comparable surgical setting.
Clinical Applications
- Bone cutting during orthopedic surgery
- Bone shaping during joint reconstruction or replacement procedures
- Bone preparation during fracture repair
- Other orthopedic procedures requiring controlled pneumatic bone cutting
Practical Considerations
- The device requires a compatible pneumatic power source and appropriate operating-room accessories.
- Available size, cutting attachments, and configuration should be confirmed from the applicable manufacturer instructions for use.
- Use requires training in pneumatic surgical instruments, bone-cutting technique, cleaning, sterilization, and maintenance.
- MRI safety is not established by the information provided; do not bring the device into an MRI environment unless its specific labeling confirms that it is MR Safe or MR Conditional.
- Contraindications, warnings, sterilization requirements, and service intervals should be taken from the current manufacturer labeling.
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.