Pedicle Screw System

The Pedicle Screw System is an advanced posterior spinal fixation construct engineered to rigidify and stabilize spinal segments as an adjunct to fusion. By anchoring securely into the vertebral pedicles, the system transfers mechanical loads to connecting rods, maintaining correct anatomical alignment and providing an optimized biomechanical environment for bone graft incorporation.

Multidirectional Polyaxial Head Technology: The friction-fit polyaxial head design allows for a generous angulation range, significantly easing the insertion of the connecting rod in complex or deformed spinal alignments. This minimizes the need for aggressive rod contouring, reduces stress concentrations at the bone-screw interface, and shortens overall surgical time.

Optimized Dual-Lead Thread Geometry: Featuring an advanced thread profile, the screws provide high initial purchase and excellent pull-out resistance in both cortical and cancellous bone. The self-tapping tip allows for controlled insertion, preserving bone density around the thread tracks for enhanced immediate post-operative stability.

Secure Buttress-Thread Locking Mechanism: The set screw incorporates an optimized thread profile designed to eliminate head splay and prevent cross-threading during final tightening. This ensures a reliable mechanical lock that maintains long-term structural stability under cyclical physiological loading.

A standard clinical construct consists of the following precision-engineered components:

Pedicle Screws: The foundational anchors available in multiple functional designs to grip the vertebral body.

Polyaxial Screws: Offers multidirectional head mobility for versatile rod capturing.

Monoaxial Screws: Provides rigid, uni-directional stability ideal for targeted deformity correction.

Reduction Screws: Features extended break-away tabs to facilitate easier reduction of displaced vertebrae or rods.

Cannulated Screws: Designed with a central lumen to enable precise guide-wire guided insertion, optimized for minimally invasive surgery.

Longitudinal Connecting Rods: Biomechanical bridges that link multiple segments to redistribute corrective forces. Offered in pre-cut, pre-curved anatomical geometries or straight configurations.

Set Screws / Locking Caps: High-torque closure mechanisms that lock the rod into the screw head permanently, ensuring reliable construct integrity.

Cross Connectors & Offset Connectors: Transverse links applied to increase torsional rigidity across long-segment constructs, particularly critical in multi-level spinal reconstructions.

Surgical Instrumentation: A matching system of reamers, taps, drivers, and persuaders ensuring exact implant insertion and seamless intraoperative workflow.

Uncompromising Compliance with International Standards: Our production infrastructure is built upon a foundation of rigorous quality management systems dedicated to medical device manufacturing. Every implant and instrument produced complies fully with strict international regulatory expectations.

Precision Machining Infrastructure: Utilizing advanced multi-axis CNC Swiss-type turning centers and high-speed milling machines, we achieve dimensional tolerances within microscopic thresholds. This guarantees absolute interchangeability between screws, rods, and surgical drivers, preventing intraoperative mismatch.

Validated Quality Control Protocols:

• Material Certification: Every batch of raw titanium alloy is fully traceable with material test reports confirming compliance with ASTM F136 implant-grade standards.
• Biocompatibility Verification: Production processes adhere to cleaning and passivation protocols validated under ISO 10993 standards to guarantee residue-free, biocompatible implants.
• Mechanical Testing Laboratory: Regular fatigue, pull-out, and torsion testing are executed on specialized simulators to verify construct endurance against long-term cyclical stress.
• Cleanroom Packaging: Final cleaning and packaging processes are conducted within validated cleanrooms, allowing for the delivery of sterile-ready or pre-sterilized products.

Professional Contract Manufacturing (OEM/ODM): We offer extensive capabilities to support international medical device supply chains, including custom laser etching, bespoke sizing configurations, custom-designed instrument trays, and specialized packaging structures to match regional regulatory requirements.

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