Monoaxial Pedicle Screw

The Monoaxial Pedicle Screw is a fundamental component of spinal fixation systems. It is implanted into the vertebral pedicle and connected with spinal rods and locking caps to stabilize spinal segments and support solid bone fusion.

Compared with polyaxial pedicle screws, monoaxial screws provide a fixed screw head orientation. This design significantly improves construct rigidity, resists shear forces, and eliminates unwanted movement between the screw head and the rod during complex de-rotation maneuvers.

The system is widely utilized in posterior thoracolumbar spinal fixation procedures, including spinal trauma, degenerative disc diseases, spondylolisthesis, deformity correction, and spinal reconstruction.

High-Strength Titanium Alloy Material: Made from premium medical-grade titanium alloy, the screw provides excellent biocompatibility, superior corrosion resistance, and high fatigue strength. The material complies strictly with international orthopedic implant standards, ensuring long-term stability in vivo.

Rigid Fixed-Angle Screw Head: The solid, monoaxial screw head maintains a rigid, non-flexible connection between the screw and the longitudinal rod. This enhances the overall construct stiffness, allowing for efficient load transmission and powerful corrective leverage during spinal deformity correction.

Biomechanically Optimized Thread Shaft: Features a tapered core and optimized thread profile to improve initial bone engagement and pull-out resistance. It ensures a secure grip in both cancellous and cortical bone while reducing insertion torque and cutting resistance.

Precision Internal Reverse Thread: The rod-receiving channel is engineered with a reverse angle thread for the locking cap. This specialized interface prevents cross-threading and eliminates outer wall splaying during final tightening.

To ensure seamless operating room workflow, we provide fully compatible surgical instrument kits.

We operate under strict international quality management standards to deliver safe, reliable, and high-quality orthopedic implants.

Certified Manufacturing: Facilities are certified under ISO 13485 quality management systems for medical devices.

Comprehensive Inspection: 100% dimensional inspection utilizing optical comparators, coordinate measuring machines (CMM), and surface roughness testers.

Full Process Control: Strict quality gates including Incoming Material Inspection, CNC Machining In-process Control, Surface Quality Inspection, and Packaging Integrity Validation.

Traceability Management: Full batch-to-batch traceability from raw material titanium bars to the finished, packaged product.

Technical Documentation Support: Complete technical files, material certificates, and cleanroom validation documentation are available to support local registration for international importers.

As a dedicated orthopedic manufacturing partner, we support global distributors and companies with flexible commercial solutions:

Contract Manufacturing (OEM/ODM): Custom sizing, thread modifications, and specific surface treatments based on your technical drawings.

Private Labeling & Packaging: Customized laser marking, labeling, and packaging configurations according to your market regulations.

Bulk Supply Chain: Scalable production capacity ensuring stable lead times and consistent volume supply for large-scale procurement.

Instrument Matching: Customizing or modifying instrument kits to align with your existing system preferences.

Each implant is handled with care to maintain sterility and structural integrity during international transit:

Sterile Double-Blister Packaging: ISO Class 5 cleanroom washed and packed, validated for a long shelf-life.

Non-Sterile Bulk Packaging: Securely packed in protective cases for clients who perform local sterilization.

International Logistics: Full support for global air freight, express shipping, and sea freight with complete customs clearance documentation.

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