Product Overview
The Cannulated Pedicle Screw System is a high-performance spinal fixation implant engineered for posterior spinal fusion procedures. Featuring an advanced hollow cannulated architecture, this system enables precise screw insertion over a guide wire, significantly enhancing surgical accuracy, minimizing placement deviation, and protecting critical neurological structures.
Forged from premium medical-grade titanium alloy, the system delivers superior mechanical strength, excellent fatigue resistance, and exceptional biocompatibility. It serves as a reliable solution for thoracolumbar fixation, spinal deformity corrections, traumatic reconstructions, and degenerative disc diseases, while being fully optimized for modern minimally invasive approaches.
Product Specifications
|
Specification |
Details |
|
Product Name |
Cannulated Pedicle Screw System |
|
Material |
Medical-Grade Titanium Alloy (ASTM F136 / ISO 5832-3) |
|
Application |
Posterior Thoracolumbar Spinal Fixation |
|
Design Type |
Cannulated, Polyaxial / Monoaxial Options |
|
Diameter Range |
4.5mm to 7.5mm (Standard and customized options) |
|
Length Range |
25mm to 60mm (Available in 5mm increments) |
|
Thread Profile |
Dual-lead / Cutting flutes for enhanced bone purchase |
|
Surface Treatment |
Type II Anodization / Customized Surface Processing |
|
Sterilization Status |
Available in Non-Sterile (Standard) or Sterile (EO/Gamma upon request) |
Key Product Features & Clinical Benefits
Cannulated Architecture for Guided Insertion: The central lumen allows seamless compatibility with guide wires, ensuring a controlled, predictable trajectory. This maximizes placement precision and shortens fluoroscopy time during percutaneous approaches.
Optimized Thread Profile & Dual-Lead Design: Engineered with self-tapping cutting flutes and a scientifically optimized thread pitch to maximize bone-to-screw contact. This provides exceptional initial purchase and high pull-out resistance even in compromised bone qualities.
Advanced Material Integrity: Manufactured using elite biocompatible medical titanium alloy designed to withstand long-term physiological stress. High fatigue strength prevents implant degradation, while excellent imaging compatibility reduces MRI/CT artifacts.
Instrumentation Integration: Designed to interface flawlessly with standard orthopedic surgical trays, including cannulated screwdrivers, taps, and parallel guide systems, ensuring seamless adoption into existing operating room workflows.
Primary Clinical Applications
The Cannulated Pedicle Screw System is highly indicated for rigid stabilization protocols across various spinal pathologies:
Degenerative Spinal Disorders: Advanced lumbar spondylolisthesis, spinal stenosis, and degenerative disc disease requiring instrumentation.
Spinal Trauma & Fracture Management: Thoracolumbar burst fractures and unstable spinal column injuries requiring anatomical reconstruction.
Deformity Correction: Complex scoliosis, kyphosis, and sagittal imbalance alignment protocols.
Minimally Invasive Spine Surgery (MISS): Percutaneous stabilization procedures aimed at reducing muscle trauma and accelerating patient recovery.
Product System Components
The Cannulated Pedicle Screw System provides a complete spinal fixation solution with compatible implants and instruments designed for efficient surgical application.
The system includes:
- Cannulated Pedicle Screws with polyaxial and monoaxial options
- Spinal rods and locking components
- Cross connectors for enhanced construct stability
- Compatible surgical instruments for implantation procedures
All components are precisely engineered to ensure reliable compatibility and smooth integration into existing surgical workflows.
OEM / ODM Customization Services
We provide flexible OEM and ODM solutions for orthopedic distributors, medical device companies, and healthcare brands worldwide.
Customization services include:
- Screw dimensions and structural modifications
- Thread and design optimization
- Surface treatment options
- Private labeling and packaging solutions
From prototype development to commercial production, we support partners with reliable manufacturing and technical assistance.
Manufacturing Quality & Regulatory Assurance
Every implant adheres to stringent international medical manufacturing protocols. Our production facility utilizes multi-axis CNC machining centers to guarantee micro-level dimensional consistency.
Our comprehensive quality control infrastructure encompasses:
- Material Traceability: Complete chemical and mechanical verification of incoming raw titanium stock.
- Optical Dimensional Inspection: Laser-measured tolerances ensuring exact thread pitch and lumen alignment.
- Mechanical Testing: Rigorous fatigue and static torsion testing simulating long-term physiological loads.
- Cleanroom Processing: Processing within controlled environments to meet strict bioburden and packaging requirements, supporting international distribution compliance.
Frequently Asked Questions
Q: What materials are utilized in the fabrication of these cannulated pedicle screws?
A: The implants are manufactured from medical-grade titanium alloy, which fully complies with ASTM F136 and ISO 5832-3 international standards. This specific alloy is selected for its superior strength-to-weight ratio, excellent fatigue limits, and proven long-term biocompatibility in orthopedic applications.
Q: Are these screws compatible with percutaneous and minimally invasive surgical techniques?
A: Yes, the hollow cannulated design is engineered specifically to accommodate standard guide wires. This makes the system ideal for percutaneous delivery and minimally invasive spine surgery approaches, helping to minimize soft tissue disruption.
Q: What options are available regarding sterilization and packaging for international delivery?
A: The products are standardly supplied in non-sterile packaging, cleanroom-processed and ready for hospital sterilization. However, pre-sterilized packaging utilizing Ethylene Oxide (EO) or Gamma irradiation can be arranged based on specific regulatory and institutional procurement requirements.
Q: Can the dimensions or thread configurations be modified for specific contract manufacturing needs?
A: Comprehensive manufacturing flexibility is available. The production line can adjust screw diameters, lengths, and thread profiles to meet specific technical portfolios, backed by complete technical documentation and material certificates.
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