Kyphoplasty systems
Kyphoplasty Balloon Dilatation Catheters
by Shanghai Lange Medtech 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.
Kyphoplasty Balloon Dilatation Catheters 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 |
|---|---|---|---|
| S01-1610 | — | Not stated | Available |
| S01-1615 | — | Not stated | Available |
| S01-1620 | — | Not stated | Available |
FDA clearances
- 510(k) K252458 November 2025
Procedures that use kyphoplasty systems
Frequently asked questions
What is Kyphoplasty Balloon Dilatation Catheters 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 Kyphoplasty Balloon Dilatation Catheters?
Kyphoplasty Balloon Dilatation Catheters is made by Shanghai Lange Medtech Co., Ltd.. It is listed under vertebral augmentation systems (kyphoplasty and vertebroplasty) in our device library.
What sizes does Kyphoplasty Balloon Dilatation Catheters come in?
The FDA device database does not list sizes for Kyphoplasty Balloon Dilatation Catheters. Check the instructions for use or ask a Shanghai Lange Medtech Co., Ltd. representative.
Is Kyphoplasty Balloon Dilatation Catheters MRI safe?
The FDA device database entry for Kyphoplasty Balloon Dilatation Catheters does not state its MRI safety status. Check the labeling before MRI.
Is Kyphoplasty Balloon Dilatation Catheters FDA cleared?
Kyphoplasty Balloon Dilatation Catheters is covered by FDA submission K252458.
How do I contact a Shanghai Lange Medtech Co., Ltd. sales representative?
Shanghai Lange Medtech Co., Ltd. has not listed representatives on LA Vascular yet. Visit the Shanghai Lange Medtech 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.