Changmei Kyphoplasty Tool Kit KT-00-01
Complete 14-Piece Instrument Set for Balloon Kyphoplasty (PKP) and Vertebroplasty
Product Summary
The Changmei Kyphoplasty Tool Kit KT-00-01 is an 8G, CE-marked (CE 0123) and ISO 13485-certified PKP instrument set designed for percutaneous vertebral augmentation procedures. It enables orthopedic surgeons to establish a working channel for balloon inflation and bone cement delivery in balloon kyphoplasty (PKP) and vertebroplasty. This sterile, single-use kit contains a precisely configured 14-piece instrument complement, ensuring a reproducible and efficient procedure.
Key Features
- Complete 14-Piece Loadout: Includes 2 puncture devices (KT-01-01), 1 puncture expandor (KT-02-01), 2 expandors (KT-03-01), 1 bone drill (KT-05-01), 2 guide wires (KT-06-01), and 6 bone cement filling devices (KT-04-01) for a full PKP procedure.
- Medical-Grade Materials: Metal parts use 06Cr19Ni10 stainless steel; puncture stylet and cutting tips use 32Cr13Mo stainless steel for durability and precision.
- Certified Quality: CE 0123 marked and ISO 13485 certified, manufactured under TÜV SÜD-audited quality system; EO-sterilized for single-use safety.
- Interoperable System: Pairs seamlessly with Changmei KB0210 balloon catheter (8G, ≥400 PSI) and BI-20A-10 inflator (20cc, 30 atm) for a complete 8G system.
- OEM/ODM Customization: Gauge, length, and instrument configuration can be customized for global spine surgery centers.
Technical Specifications
| Model | KT-00-01 |
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| Gauge | 8G |
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| Components | 2× Puncture Device (KT-01-01), 1× Puncture Expandor (KT-02-01), 2× Expandor (KT-03-01), 1× Bone Drill (KT-05-01), 2× Guide Wire (KT-06-01), 6× Bone Cement Filling Device (KT-04-01) |
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| Material | 06Cr19Ni10 stainless steel; 32Cr13Mo stainless steel for cutting tips |
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| Certification | CE 0123, ISO 13485 |
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| Sterilization | EO-sterilized, single-use |
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Models and Options
Standard model: KT-00-01 (8G). OEM/ODM customization available for gauge, length, and instrument configuration. Please contact us for specific requirements.
Materials and Structure
The kit uses 06Cr19Ni10 medical-grade stainless steel for most metal parts (cannulas, expandor shafts, bone drill body, guide wire core) and 32Cr13Mo stainless steel for the puncture stylet and puncture expandor cutting tips. Handles are made of ABS/polymer. Joints are rated ≥100 N connection strength for reliable performance during pedicular navigation.
Applications
Indicated for minimally invasive treatment of 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. Suitable for orthopedic spine surgery, interventional radiology, pain management centers, and ambulatory surgery centers (ASCs).
Customization
Changmei supports OEM/ODM customization on gauge, length, and instrument configuration. MOQ for standard in-stock products: 10 sets. For OEM/ODM customized orders, minimum quantity is negotiable. Delivery terms: EXW/FOB/CIF. Payment: Full T/T before shipping. Pre-shipment test available.
FAQ
1. What is the KT-00-01 kit used for?
The KT-00-01 is designed for percutaneous vertebral augmentation procedures, specifically balloon kyphoplasty (PKP) and vertebroplasty, to treat painful vertebral compression fractures.
2. Is the kit sterile?
Yes, each KT-00-01 kit is EO-sterilized and intended for single-use only.
3. What certifications does the product have?
The kit is CE 0123 marked and manufactured under ISO 13485 certified quality management system, audited by TÜV SÜD.
4. Can I customize the kit configuration?
Yes, OEM/ODM customization is available for gauge, length, and instrument configuration. Please contact us to discuss your specific needs.
5. What is the MOQ?
The MOQ for standard in-stock products is 10 sets. For customized orders, MOQ is negotiable.
6. What are the main materials used?
Most metal parts use 06Cr19Ni10 medical-grade stainless steel, while the puncture stylet and cutting tips use 32Cr13Mo stainless steel.
7. Is the kit compatible with other Changmei products?
Yes, it pairs seamlessly with the Changmei 8G Kyphoplasty Balloon Catheter KB0210 and Balloon Inflator BI-20A-10 to form a complete 8G system.
8. What is the delivery method?
Delivery methods include EXW, FOB, and CIF.
Inquiry Information
For pricing, customization options, or to place an order, please contact:
Jiangsu Changmei Medtech Co., Ltd.
Contact: Mark
Email: cyz@czmed.com
Tel/WhatsApp: +86 138-1368-7682
Website: www.czmed.com
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