Kyphoplasty Tool Kit KT-00-05
Product Summary
Designed for percutaneous vertebral augmentation, the Changmei Kyphoplasty Tool Kit KT-00-05 is an 11G, CE-marked (CE 0123) and ISO 13485-certified PKP instrument set. It enables orthopedic surgeons to establish a working channel for balloon inflation and bone cement delivery in balloon kyphoplasty (PKP) and vertebroplasty. Each sterile, single-use kit includes 2 puncture expandor modules (KT-07-01), 1 bone drill (KT-09-01), and 6 bone cement filling devices (KT-08-01) for controlled PMMA delivery.
Key Features
- Complete 9-piece loadout – 2 expandor modules, 1 bone drill, 6 cement filling devices provide everything needed for the PKP procedure (source: product params).
- Medical-grade materials – 06Cr19Ni10 stainless steel for cannulas and shafts, 32Cr13Mo for cutting tips, ensuring strength and reliability (source: material).
- CE 0123 and ISO 13485 certified – meets EU and international quality standards (source: product params and certifications).
- Sterile, single-use – EO-sterilized and designed for one-time use to reduce infection risk (source: selling_point).
- Pairs with 11G system – compatible with KB0210S1 balloon catheter and BI-20A-10 inflator for integrated workflow (source: product params).
- OEM/ODM customization – options for gauge, length, and instrument configuration (source: product params).
Technical Specifications
| Specification | Detail |
|---|
| Model | KT-00-05 |
| Gauge | 11G |
| Components | 2 puncture expandor (KT-07-01), 1 bone drill (KT-09-01), 6 bone cement filling devices (KT-08-01) |
| Material | 06Cr19Ni10, 32Cr13Mo stainless steel |
| Sterility | EO-sterilized, single-use |
| Certifications | CE 0123, ISO 13485 |
| Compatibility | KB0210S1 balloon catheter (11G, 10mm marker, 3cc, 280mm), BI-20A-10 inflator (20cc, 30atm) |
Models and Options
Available as KT-00-05 standard kit. Customization of gauge, length, and instrument configuration available via OEM/ODM.
Materials and Structure
Metal parts are manufactured from 06Cr19Ni10 medical-grade stainless steel for cannulas, expandor shafts, bone drill body, and guide wire core. The puncture stylet and cutting tips use 32Cr13Mo stainless steel for enhanced hardness and edge retention.
Applications
Suitable for balloon kyphoplasty (PKP) and vertebroplasty in treating vertebral compression fractures, including osteoporotic and neoplastic cases. Used in orthopedic spine surgery, interventional radiology, pain management centers, and ambulatory surgery centers.
Customization
Changmei supports OEM/ODM for gauge, length, and instrument configuration to meet specific clinical needs.
FAQ
1. What certifications does the KT-00-05 have?
It is CE-marked (CE 0123) and ISO 13485 certified.
2. Is the kit sterile?
Yes, it is EO-sterilized and intended for single use.
3. What components are included?
The kit includes 2 puncture expandor modules, 1 bone drill, and 6 bone cement filling devices.
4. Can the kit be customized?
Yes, OEM/ODM customization on gauge, length, and instrument configuration is available.
5. What is the compatibility with balloon catheters?
It is designed to work with Changmei's 11G Kyphoplasty Balloon Catheter KB0210S1 and Balloon Inflator BI-20A-10.
6. What materials are used?
Medical-grade stainless steel 06Cr19Ni10 and 32Cr13Mo are used.
7. What is the typical procedure time?
Procedures typically take 30-60 minutes under local or general anesthesia.
Inquiry Information
For pricing, availability, and customization inquiries, contact:
Mark | Email: cyz@czmed.com | Tel/WhatsApp: +86 138-1368-7682
MOQ: Standard in-stock products: 10 sets; OEM/ODM negotiable.
Delivery: EXW/FOB/CIF. Payment: Full T/T before shipping.
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Image Alt: Kyphoplasty Tool Kit KT-00-05 - 11G PKP instrument set components
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