Product Overview
The Minimally Invasive Spine Fixation System is an advanced spinal implant solution designed for minimally invasive spinal surgery (MISS). It provides surgeons with reliable spinal stabilization while reducing surgical trauma through smaller incisions and optimized instrumentation.
The system is widely used for posterior spinal fixation procedures, including thoracolumbar fractures, degenerative spinal diseases, spinal deformity correction, and other spinal stabilization surgeries.
Manufactured with high-quality medical-grade materials and precision machining technology, the system delivers excellent mechanical strength, corrosion resistance, and biocompatibility to meet the requirements of modern spinal surgery.
With comprehensive product configurations and flexible surgical options, our Minimally Invasive Spine Fixation System supports global orthopedic surgeons and healthcare providers with safe, efficient, and reliable spinal solutions.
Specifications & Sizing Chart
|
Diameter (mm) |
Length (mm) |
Type Options |
Material Standard |
|
4.5 |
25, 30, 35, 40, 45 |
Solid / Cannulated |
ASTM F136 / ISO 5832-3 |
|
5.5 |
30, 35, 40, 45, 50, 55 |
Solid / Cannulated |
ASTM F136 / ISO 5832-3 |
|
6.5 |
35, 40, 45, 50, 55, 60 |
Solid / Cannulated |
ASTM F136 / ISO 5832-3 |
|
7.5 |
40, 45, 50, 55, 60, 65 |
Solid / Cannulated |
ASTM F136 / ISO 5832-3 |
Key Features
Minimally Invasive Surgical Design
Designed specifically for minimally invasive spine procedures, the system enables surgeons to achieve spinal fixation through smaller surgical approaches, helping reduce muscle disruption and postoperative recovery time.
Reliable Mechanical Stability
The system provides excellent pull-out resistance, fatigue strength, and structural stability, ensuring dependable spinal support during the healing process.
Ergonomic Instrumentation Design
The specialized instrumentation system allows surgeons to perform implantation procedures efficiently with improved operational control and accuracy.
High Biocompatibility Materials
Manufactured using medical-grade titanium alloy materials, the implants provide excellent biocompatibility, corrosion resistance, and long-term implantation performance.
Comprehensive Product Portfolio
The system includes various implant components to meet different clinical requirements and surgical preferences.
Clinical Applications
The Minimally Invasive Spine Fixation System can be used for:
Thoracolumbar Fracture Treatment: Provides stabilization for spinal fractures caused by trauma.
Degenerative Spine Disease: Used in spinal stabilization procedures for degenerative conditions.
Spinal Deformity Correction: Supports correction and stabilization of spinal deformities.
Spinal Fusion Surgery: Provides fixation support during spinal fusion procedures.
Revision Spine Surgery: Suitable for selected revision fixation procedures.
Material Information
Implant Materials
- Titanium Alloy (Ti-6Al-4V ELI)
- Medical grade materials complying with international standards (ASTM F136 / ISO 5832-3)
Material Advantages
- Excellent biocompatibility to minimize adverse tissue reactions
- Lightweight structure reducing patient biological burden
- High corrosion resistance within the human body environment
- Long-term implantation reliability proven by clinical track records
Manufacturing & Quality Assurance
As a professional medical device manufacturer, we implement strict quality control throughout the entire manufacturing process.
Our quality management includes:
Incoming material inspection with material certificates
Precision machining control using multi-axis CNC machines
Surface treatment inspection and cleaning validation
Dimensional accuracy testing via advanced coordinate measuring machines
Mechanical performance testing including static and fatigue tests
Final product inspection and traceability code marking
Sterile packaging control in cleanrooms
We are committed to providing global customers with consistent product quality and reliable supply capability.
Packaging, Sterilization & Supply Chain Logistics
Supply & Packaging Configurations
- Sterile Packaging Option: Individually sealed in validated double-layer medical blister pouches and sterilized via Gamma radiation or Ethylene Oxide (EO). These components are delivered ready for direct surgical deployment.
- Non-Sterile Packaging Option: Enclosed within secure medical-grade protective bags. These configurations require appropriate sterilization protocols at the hospital or distributor facility prior to clinical application.
- Traceability Assurance: Every package incorporates a distinct batch tracking system, ensuring comprehensive traceability from raw material to the final destination.
Global Logistics & Contract Manufacturing Support
- Scalable Production Capacity: Utilizing advanced manufacturing facilities, our production output remains highly stable, ensuring reliable on-time delivery for both standardized inventory orders and volume-based procurement.
- Contract Customization Services: Full capabilities are available for specialized specification manufacturing derived from technical drawings. This includes customized product labeling and adapted outer packaging structures to comply with local regulatory import requirements.
- Flexible Transit Solutions: Shipments are dispatched using secure, flexible methods-including international air freight, express courier networks, and sea cargo-to strictly align with regional distribution timelines.
FAQ
Q: What material is used for the implants?
A: The implants are manufactured from premium medical-grade titanium alloy (Ti-6Al-4V ELI) that complies fully with ASTM F136 and ISO 5832-3 international standards, offering optimal biocompatibility and high mechanical strength.
Q: Can you provide contract manufacturing or customized specification services?
A: Yes, we provide comprehensive contract manufacturing services. We can customize component dimensions, thread profiles, surface treatments, and packaging formats based on your specific technical specifications and regional regulatory requirements.
Q: What certifications do your factory and spinal systems hold?
A: Our production infrastructure operates strictly under a certified ISO 13485 medical device quality management system. Product configurations adhere to international market requirements, with CE certification available for specified product ranges.
Q: Are the implants delivered sterile or non-sterile?
A: We support both options. Products can be supplied in validated sterile double-blister packs ready for direct surgical use, or in protective non-sterile bulk packaging depending on your local inventory management and distribution preferences.
Q: What is the typical lead time for international bulk shipments?
A: Lead times vary depending on the total order volume and the level of customization required. Standard product configurations can be dispatched promptly from inventory, while custom manufacturing runs are scheduled with definitive production timelines.
Q: How do you ensure batch-to-batch consistency and quality control?
A: Every single production lot undergoes comprehensive testing, including raw material chemical verification, online CNC dimensional audits, automated coordinate measuring machine checks, and final mechanical performance validation. Complete traceability records are permanently archived.
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