Kyphoplasty systems
Balloon Catheter
by Shanghai Kinetic Medical Co., Ltd.
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 Balloon Catheter
We do not have contact details for Shanghai Kinetic Medical Co., Ltd. yet. Send a request and we will route it to the right person for your country.
Balloon Catheter 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 |
|---|---|---|---|
| FA1110 | Length 10 mm | Not stated | Available |
| FA1115 | Balloon Length 15 mm | Not stated | Available |
| FA1120 | Balloon Length 20 mm | Not stated | Available |
| FG1001-10 | Length 10 mm | Not stated | Available |
| FG1001-15 | Length 15 mm | Not stated | Available |
| FG1001-20 | Length 20 mm | Not stated | Available |
FDA clearances
- 510(k) K113742 September 2012
Procedures that use kyphoplasty systems
Frequently asked questions
What is Balloon Catheter 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 Balloon Catheter?
Balloon Catheter is made by Shanghai Kinetic Medical Co., Ltd.. It is listed under vertebral augmentation systems (kyphoplasty and vertebroplasty) in our device library.
What sizes does Balloon Catheter come in?
Sizes listed for Balloon Catheter: Length: 10–20 mm; Balloon Length: 15–20 mm. Confirm availability with the manufacturer's instructions for use.
Is Balloon Catheter MRI safe?
The FDA device database entry for Balloon Catheter does not state its MRI safety status. Check the labeling before MRI.
Is Balloon Catheter FDA cleared?
Balloon Catheter is covered by FDA submission K113742.
How do I contact a Shanghai Kinetic Medical Co., Ltd. sales representative?
Shanghai Kinetic Medical Co., Ltd. has not listed representatives on LA Vascular yet. Visit the Shanghai Kinetic Medical Co., Ltd. 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.