KB0115S1 – 15 mm Radiopaque Marker, 11G PKP Balloon
The Changmei KB0115S1 Kyphoplasty Balloon Catheter is a single-use, 11G inflatable bone tamp engineered for percutaneous balloon kyphoplasty (PKP). It features a 15 mm distance between two radiopaque markers, a channel ID of ≥3.10 mm, and an overall length of 280 mm. With a maximum inflation volume of 4 cc and a constrained burst pressure of ≥400 PSI, it provides controlled cavity creation and vertebral height restoration. CE-MDR and ISO 13485 certified, FDA 510(k) cleared (K223709).
Key Selling Points
Precise 15 mm marker spacing: Facilitates accurate balloon positioning and inflation monitoring under fluoroscopy for reproducible outcomes.
High burst pressure ≥400 PSI: Allows sequential inflation to displace cancellous bone and create a well-defined cavity with minimal risk of rupture.
Medical-grade TPU balloon: Four-wing pleating delivers radial support, biocompatibility, and crack resistance for reliable performance.
Radiopaque tantalum markers: Enhanced visibility during the procedure ensures safe placement and controlled inflation.
Single-use EO sterilized: 3-year shelf life and validated sterilization minimize cross-contamination risk.
FDA cleared and CE marked: Regulatory approvals support global distribution and clinical adoption.
Technical Specifications
Parameter
Value
Model
KB0115S1
Size/Type
11G
Distance of Two Radiopaque Markers
15 mm
Channel ID
≥3.10 mm
Overall Length
280 mm
Maximum Volume
4 cc
Constrained Burst Pressure
≥400 PSI
Balloon Material
Medical-grade TPU
Shaft Material
PU
Stylet Material
06Cr19Ni10 stainless steel
Sterilization
EO sterilized
Shelf Life
3 years
Models and Options
The KB0115S1 is part of Changmei's 11G PKP catheter family. The 10 mm version (KB0210S1) and 20 mm version (KB0120S1) offer alternative balloon sizes. All models share the same shaft design and are compatible with the KT-00-05 11G tool kit and BI-20A-10 balloon inflator (20 cc, 30 atm). Choose the balloon size based on the vertebral body dimensions and the desired cavity size.
Materials and Structure
The balloon film is constructed from medical-grade thermoplastic polyurethane (TPU) using a standard four-wing pleating process. This design provides radial support, biocompatibility, environmental stress-crack resistance, and smooth passability through the trocar after deflation. The shaft is made of PU, reinforced with a 06Cr19Ni10 stainless-steel stylet for pushability. A tantalum (Ta) radiopaque marker band ensures fluoroscopic visibility. Handle components are made of polycarbonate. The device is EO-sterilized for single use.
Applications
The KB0115S1 is intended for balloon kyphoplasty (PKP) to treat painful vertebral compression fractures (VCFs) caused by osteoporosis, low-energy trauma, or neoplasia (including spinal metastases and multiple myeloma). It is also indicated for symptomatic vertebral hemangiomas. The procedure restores vertebral body height, corrects kyphotic deformity, and stabilizes the vertebra, enabling early mobilization.
Customization
Changmei offers OEM/ODM options for the KB0115S1, allowing customization of packaging, labeling, and possibly other specifications per agreement. Minimum order quantities for OEM/ODM are negotiable. Contact us to discuss your requirements.
Case Study
A clinical report (link: Dr. Tariq's Breakthrough) describes the use of Changmei PKP systems, including the 11G balloon, in VCFs with egg shell technique in Kuwait. The balloon inflation mechanism restored 30-50% of lost vertebral height on average and provided rapid pain relief.
FAQ
What is the maximum inflation pressure of the KB0115S1?
The constrained burst pressure is at least 400 PSI, ensuring reliable performance during sequential inflation.
Is the KB0115S1 compatible with existing PKP kits?
It is designed to pair with the Changmei KT-00-05 11G tool kit and BI-20A-10 balloon inflator, forming an interoperable system.
What regulatory approvals does the KB0115S1 have?
It is CE-MDR marked, ISO 13485 certified, and FDA 510(k) cleared (K223709).
What is the shelf life of the device?
The shelf life is 3 years when stored as recommended.
Can the KB0115S1 be used for osteoporotic vertebral fractures?
Yes, it is indicated for painful VCFs caused by osteoporosis, as well as traumatic and neoplastic fractures.
Is the balloon radiopaque?
Yes, it contains a tantalum radiopaque marker band for fluoroscopic visibility.
What is the minimum order quantity?
For standard in-stock products, the MOQ is 10 sets. For OEM/ODM, it is negotiable.
How is the device sterilized?
The device is ethylene-oxide sterilized for single use.
Inquiry Information
For pricing, availability, and OEM/ODM inquiries, please contact: Mark Email: cyz@czmed.com Tel/WhatsApp: +86 138-1368-7682 Address: No.27 Xinke West Road, Luoyang Town, Wujin District, Changzhou City, Jiangsu, China
Image: Kyphoplasty-9.jpg – KB0115S1 balloon catheter with 15mm markers
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