Single-Use 10mm Kyphoplasty Balloon Catheter KB0210S1 11G CE FDA 510(k)
Product Summary:
The Changmei Kyphoplasty Balloon Catheter KB0210S1 is a single-use, CE-MDR marked and ISO 13485-certified inflatable bone tamp designed for percutaneous balloon kyphoplasty (PKP). It features a 10 mm distance between two radiopaque markers, a channel ID of ≥3.10 mm, overall length of 280 mm, maximum inflation volume of 3 cc, and constrained burst pressure of ≥400 PSI. With 11G size, it is the core 10 mm balloon in Changmei's PKP catheter family, alongside 15 mm and 20 mm models. The device holds U.S. FDA 510(k) clearance (K223709, Product Code HRX, Class II, 21 CFR 888.1100) and is designed for reducing vertebral fractures and creating a void for bone cement injection.
Key Features
- 4-wing pleating design: Uniform radial expansion creates a well-defined cavity, enabling effective height restoration and kyphosis correction (source: selling_point).
- High burst pressure: Withstands ≥400 PSI, reducing intraoperative burst risk (source: selling_point).
- Radiopaque markers: Tantalum band provides fluoroscopic visibility for precise placement (source: selling_point).
- Biocompatible materials: Medical-grade TPU and PU shaft with stainless-steel stylet for pushability (source: material).
- Sterile and validated: EO-sterilized, 3-year shelf life, factory pressure and seal tested (source: selling_point).
Technical Specifications
| Parameter | Value |
|---|
| Model | KB0210S1 |
| Distance of Two Radiopaque Markers | 10 mm |
| Channel ID | ≥3.10 mm |
| Overall Length | 280 mm |
| Maximum Volume | 3 cc |
| Constrained Burst Pressure | ≥400 PSI |
| Size/Type | 11G |
Models and Options
This 10 mm balloon (KB0210S1) is part of a family that includes 15 mm (KB0115S1) and 20 mm (KB0120S1) options, allowing surgeons to select the appropriate size based on vertebral body dimensions and fracture morphology. All models use the same 11G access system and are compatible with Changmei's tool kit and inflator.
Materials and Structure
The balloon is made of medical-grade thermoplastic polyurethane (TPU) with a four-wing pleating structure, mounted on a PU shaft with a tantalum radiopaque marker band and a 06Cr19Ni10 stainless-steel stylet for reinforcement. The handle components use polycarbonate. The device is EO-sterilized for single use.
Applications
Indicated for percutaneous balloon kyphoplasty (PKP) to treat painful vertebral compression fractures (VCFs) caused by osteoporosis, low-energy trauma, or neoplasia (including spinal metastases and multiple myeloma). Also indicated for symptomatic vertebral hemangiomas. The procedure reduces pain, restores height, corrects kyphosis, and stabilizes the vertebra.
Customization
Changmei offers OEM/ODM support for customization based on specific requirements. MOQ for standard products is 10 sets; for customized orders, MOQ is negotiable. Delivery terms: EXW/FOB/CIF; payment: full T/T before shipping; pre-shipment testing available.
FAQ
Q: What is the shelf life of the KB0210S1?
A: The device has a validated 3-year shelf life from the date of manufacture.
Q: Is the catheter compatible with standard 11G trocars?
A: Yes, the 11G size ensures smooth passability through the trocar after deflation.
Q: What is the minimum order quantity?
A: For standard in-stock products, MOQ is 10 sets. For OEM/ODM customized orders, MOQ is negotiable.
Q: What certifications does this product hold?
A: It is CE-MDR marked, ISO 13485 certified, and has FDA 510(k) clearance (K223709).
Q: How is the product sterilized?
A: The device is ethylene-oxide (EO) sterilized and intended for single use.
Q: What is the annual production capacity?
A: Changmei has an annual production capacity of 1,000,000 balloon catheters.
Q: Are there any clinical studies supporting this device?
A: Clinical studies report significant VAS score reduction within 24-48 hours and average height restoration of 30%-50%.
Inquiry Information
For pricing, samples, and delivery, contact Mark at cyz@czmed.com or +86 138-1368-7682 (WhatsApp). Visit www.czmed.com for more details.
Image: Kyphoplasty balloon catheter KB0210S1 – product view (Alt: Kyphoplasty balloon catheter KB0210S1 with 10mm marker distance, 11G)
