Kyphoplasty systems
KYPHON Express II Inflatable Bone Tamp
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 Express II Inflatable Bone Tamp
We do not have contact details for Medtronic Sofamor Danek, Inc. yet. Send a request and we will route it to the right person for your country.
KYPHON Express II Inflatable Bone Tamp 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 |
|---|---|---|---|
| KE102 | — | Not stated | Available |
| KE102 | — | Not stated | Available |
| KE152 | — | Not stated | Available |
| KE152 | — | Not stated | Available |
| KE202 | — | Not stated | Available |
| KE202 | — | Not stated | Available |
FDA clearances
- 510(k) K123771 December 2012
Procedures that use kyphoplasty systems
Frequently asked questions
What is KYPHON Express II Inflatable Bone Tamp 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 Express II Inflatable Bone Tamp?
KYPHON Express II Inflatable Bone Tamp 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 Express II Inflatable Bone Tamp come in?
The FDA device database does not list sizes for KYPHON Express II Inflatable Bone Tamp. Check the instructions for use or ask a Medtronic Sofamor Danek, Inc. representative.
Is KYPHON Express II Inflatable Bone Tamp MRI safe?
The FDA device database entry for KYPHON Express II Inflatable Bone Tamp does not state its MRI safety status. Check the labeling before MRI.
Is KYPHON Express II Inflatable Bone Tamp FDA cleared?
KYPHON Express II Inflatable Bone Tamp is covered by FDA submission K123771.
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.