Kyphoplasty systems
Synflate
by Synthes GmbH
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 Synflate
We do not have contact details for Synthes GmbH yet. Send a request and we will route it to the right person for your country.
Synflate 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 |
|---|---|---|---|
| 03.804.700S | — | Not stated | Available |
| 03.804.701S | — | Not stated | Available |
| 03.804.702S | — | Not stated | Available |
FDA clearances
- 510(k) K130146 May 2013
Procedures that use kyphoplasty systems
Frequently asked questions
What is Synflate 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 Synflate?
Synflate is made by Synthes GmbH. It is listed under vertebral augmentation systems (kyphoplasty and vertebroplasty) in our device library.
What sizes does Synflate come in?
The FDA device database does not list sizes for Synflate. Check the instructions for use or ask a Synthes GmbH representative.
Is Synflate MRI safe?
The FDA device database entry for Synflate does not state its MRI safety status. Check the labeling before MRI.
Is Synflate FDA cleared?
Synflate is covered by FDA submission K130146.
How do I contact a Synthes GmbH sales representative?
Synthes GmbH has not listed representatives on LA Vascular yet. Visit the Synthes GmbH 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.