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Kyphoplasty Balloon Catheter KB0210 8G 10mm Radiopaque Markers

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SKU: 4459663643
Model: KB0210

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CHANGMEI Kyphoplasty
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Product Details

Kyphoplasty Balloon Catheter KB0210 – 8G, 10mm Marker Distance

Product Summary

The Changmei Kyphoplasty Balloon Catheter KB0210 (8G) is a single-use, CE-MDR certified and FDA 510(k) cleared inflatable bone tamp designed for percutaneous balloon kyphoplasty (PKP). With a distance of two radiopaque markers of 10 mm, a channel inner diameter ≥3.65 mm, overall length 315 mm, and a constrained burst pressure ≥400 PSI, it ensures reliable cavity creation and vertebral height restoration.

Key Features

  • 10mm Marker Distance: Facilitates accurate fluoroscopic positioning of the balloon within the vertebral body.
  • Constrained Burst Pressure ≥400 PSI: Ensures reliable radial expansion, supporting effective cavity creation and height restoration.
  • Medical-Grade TPU Balloon: Biocompatible, with four-wing pleating for uniform expansion and smooth passage through the trocar.
  • Stainless-Steel Stylet: 06Cr19Ni10 stainless-steel stylet provides enhanced pushability during insertion.
  • EO Sterilized: Each unit is ethylene-oxide sterilized with a validated 3-year shelf life, minimizing infection risk.

Technical Specifications

Model KB0210
Distance of Radiopaque Markers 10 mm
Channel ID ≥3.65 mm
Overall Length 315 mm
Maximum Inflation Volume 4 cc
Constrained Burst Pressure ≥400 PSI
Size/Type 8G

Models and Options

This product is part of the Changmei 8G PKP catheter family. Other models include KB0115 (15 mm) and KB0120 (20 mm) balloon catheters, which differ in marker distance and inflation volume. The KB0210 is the 10 mm variant.

Materials and Structure

The balloon is constructed from medical-grade thermoplastic polyurethane (TPU), mounted on a PU shaft. Radiopaque markers are made of tantalum (Ta) for fluoroscopic visibility, and a 06Cr19Ni10 stainless-steel stylet provides reinforcement. Handle components use polycarbonate. The device is EO-sterilized for single use.

Applications

Indicated for balloon kyphoplasty (PKP) to reduce and fix vertebral fractures, create a void in cancellous bone, and restore vertebral height. Suitable for treating painful vertebral compression fractures (VCFs) caused by osteoporosis, trauma, or neoplasia. Used in orthopedic surgery, spine surgery, pain management, and interventional pain clinics.

Customization

Changmei offers OEM/ODM services for compatible kyphoplasty systems, including tool kits and inflators. Customization options may be available upon request.

Case Study

Changmei supplied its PKP systems to a hospital in Kuwait for treating vertebral compression fractures using the eggshell technique. The procedure involved balloon inflation to restore height and PMMA augmentation, resulting in successful fracture stabilization and patient mobilization.

FAQ

Q1: What is the shelf life of the KB0210 balloon catheter?

A1: The device has a validated shelf life of 3 years, ensuring long-term storage capability.

Q2: Is the KB0210 compatible with a specific tool kit?

A2: Yes, it is designed to pair with the Changmei KT-00-01 8G tool kit and BI-20A-10 balloon inflator.

Q3: What certifications does the KB0210 hold?

A3: It is CE-MDR marked and ISO 13485 certified, and has FDA 510(k) clearance (K223709, Product Code HRX).

Q4: What is the maximum inflation volume?

A4: The maximum inflation volume is 4 cc.

Q5: How is the device sterilized?

A5: The device is ethylene-oxide (EO) sterilized.

Q6: What is the burst pressure rating?

A6: The constrained burst pressure is ≥400 PSI, ensuring reliability during inflation.

Q7: Can the KB0210 be used for kyphoplasty in osteoporotic fractures?

A7: Yes, it is indicated for vertebral compression fractures caused by osteoporosis, trauma, or neoplasia.

Q8: What is the MOQ for this product?

A8: The MOQ for standard in-stock products is 10 sets.

Inquiry Information

For pricing and ordering, contact Mark at cyz@czmed.com or +86 138-1368-7682. MOQ: 10 sets. Delivery terms: EXW/FOB/CIF. Payment: Full T/T before shipping.

Product Images

Kyphoplasty Balloon Catheter KB0210 10mm marker distance, 8G

Kyphoplasty Balloon Catheter KB0210 8G 10mm Radiopaque Markers

kb0210-10mm-8g