Welcome to our product page for the Changmei KB0120S1 kyphoplasty balloon catheter. This medical device is designed for minimally invasive vertebral augmentation, offering a 20mm balloon diameter, 6cc maximum volume, and high-pressure reliability for effective fracture reduction and cavity creation.
Key Features
High-Pressure Capability: Constrained burst pressure ≥400 PSI ensures reliable inflation during cavity creation, minimizing the risk of balloon rupture.
Generous Inflation Volume: Maximum volume of 6 cc allows for effective vertebral height restoration and kyphotic deformity correction.
Optimal Marker Distance: Two radiopaque markers spaced 20 mm provide precise radiographic localization.
Single-Use Sterile: EO-sterilized for single use, ensuring patient safety and eliminating cross-contamination.
Regulatory Compliance: CE-MDR marked, ISO 13485 certified, and FDA 510(k) cleared (K223709).
Technical Specifications
Parameter
Value
Model
KB0120S1
Marker Distance
20 mm
Channel ID
≥3.10 mm
Overall Length
280 mm
Maximum Volume
6 cc
Constrained Burst Pressure
≥400 PSI
Size/Type
11G
Models and Options
This catheter is part of a family of 11G balloon catheters with different balloon diameters: KB0210S1 (10 mm), KB0115S1 (15 mm), and KB0120S1 (20 mm). The 20mm variant is ideal for larger vertebral bodies or when greater height restoration is required.
Materials and Structure
The balloon film is made of medical-grade thermoplastic polyurethane (TPU) with a four-wing pleating design, mounted on a PU shaft. Radiopaque markers are made of tantalum, and a stainless-steel stylet (06Cr19Ni10) provides pushability and fluoroscopic visibility.
Applications
This device is indicated for percutaneous balloon kyphoplasty (PKP) to treat painful vertebral compression fractures caused by osteoporosis, trauma, or neoplasia. It creates a cavity in cancellous bone for PMMA cement injection, restores vertebral height, and corrects kyphotic deformity.
Customization
Customization options are available for OEM/ODM partners, including custom packaging, labeling, and sterile barrier systems. Minimum order quantities for standard products are 10 sets.
Case Study
Our product has been used in VCFs with egg shell technique in Kuwait, achieving height restoration and pain relief. Clinical studies demonstrate significant VAS score reduction within 24-48 hours and restoration of 30-50% of lost height.
FAQ
What is the shelf life of the KB0120S1?
The product has a 3-year validated shelf life.
Is it supplied sterile?
Yes, it is EO-sterilized and intended for single use.
What certifications does it hold?
It holds CE-MDR, ISO 13485, and FDA 510(k) (K223709) clearances.
Can it be used with other brands' kits?
It is designed to pair with the Changmei KT-00-05 11G tool kit and BI-20A-10 inflator, but compatibility with other systems is not guaranteed.
What is the minimum order quantity?
MOQ for standard in-stock products is 10 sets.
What are the payment and delivery terms?
We accept full T/T before shipping; delivery under EXW/FOB/CIF terms.
Inquiry Information
For pricing and availability, contact us at cyz@czmed.com or via WhatsApp: +86 138-1368-7682.
