Kyphoplasty systems
Kyphon Element
by Medtronic Sofamor Danek, Inc.
A catheter-like device with an inflatable balloon at the distal end used for the reduction of fractures and/or creation of a void in cancellous bone [e.g., in the spine for a vertebral compression fracture (VCF), hand, tibia, radius, and calcaneus]. It is commonly used for kyphoplasty, which involves its insertion into a patient's back to reduce a vertebral body fracture by compression of cancellous bone and/or movement of the endplates as the balloon is inflated. After the device is removed, orthopaedic bone cement is introduced into the created void to stabilize the vertebra. This is a single-use device.
Where to buy Kyphon Element
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Kyphon Element models and sizes
From the FDA Global Unique Device Identification Database. Confirm with the manufacturer's instructions for use.
| Model / catalog no. | Size | MRI | Status |
|---|---|---|---|
| KR153 | Outer Diameter 3.0 mm; Length 15.0 mm | Not stated | Available |
| KR153 | Length 15.0 mm; Outer Diameter 3.0 mm | Not stated | Available |
FDA clearances
- 510(k) K151532 July 2015
Procedures that use kyphoplasty systems
Frequently asked questions
What is Kyphon Element used for?
A catheter-like device with an inflatable balloon at the distal end used for the reduction of fractures and/or creation of a void in cancellous bone [e.g., in the spine for a vertebral compression fracture (VCF), hand, tibia, radius, and calcaneus]. It is commonly used for kyphoplasty, which involves its insertion into a patient's back to reduce a vertebral body fracture by compression of cancellous bone and/or movement of the endplates as the balloon is inflated. After the device is removed, orthopaedic bone cement is introduced into the created void to stabilize the vertebra. This is a single-use device.
Who makes Kyphon Element?
Kyphon Element is made by Medtronic Sofamor Danek, Inc.. It is listed under vertebral augmentation systems (kyphoplasty and vertebroplasty) in our device library.
What sizes does Kyphon Element come in?
Sizes listed for Kyphon Element: Outer Diameter: 3 mm; Length: 15 mm. Confirm availability with the manufacturer's instructions for use.
Is Kyphon Element MRI safe?
The FDA device database entry for Kyphon Element does not state its MRI safety status. Check the labeling before MRI.
Is Kyphon Element FDA cleared?
Kyphon Element is covered by FDA submission K151532.
How do I contact a Medtronic Sofamor Danek, Inc. sales representative?
Medtronic Sofamor Danek, Inc. has not listed representatives on LA Vascular yet. Visit the Medtronic Sofamor Danek, Inc. company page for contact details.
Models, sizes and MRI status come from the FDA Global Unique Device Identification Database (GUDID); descriptions marked "provided by the manufacturer" are reviewed before publishing. Not an endorsement; follow the manufacturer's instructions for use.