The Thoracolumbar Screw is a precision-engineered pedicle screw system designed for fixation in the thoracolumbar region. Constructed from medical-grade titanium alloy (Ti-6Al-4V ELI, ASTM F136 / ISO 5832-3), this screw provides exceptional strength, biocompatibility, and corrosion resistance. Available in 6.5mm diameter and multiple lengths (30mm to 50mm), it supports secure fixation during spinal stabilization procedures.

Technical Features & Specifications:

• Material: Titanium Alloy Ti-6Al-4V ELI (ASTM F136 / ISO 5832-3)
• Design: Threaded pedicle screw with optimized pitch for strong cortical & cancellous bone engagement
• Diameter: Ø6.5mm
• Lengths: 30mm – 50mm
• Head Geometry: Low-profile design, compatible with standard rod systems
• Manufacturing: CNC precision machining, surface anodized & passivated
• Certification: ISO 13485 & CE approved

Clinical Applications & Uses:

• Stabilization in thoracolumbar spinal fractures
• Correction of spinal deformities (scoliosis, kyphosis)
• Fixation in degenerative disc disease & spondylolisthesis
• Support in tumor or trauma-related resections

Advantages & Benefits:

• Rigid Fixation: Strong engagement in cortical & cancellous bone
• Durable Titanium: Corrosion-resistant, MRI compatible (ASTM F2503 conditional)
• Wide Range: Available in 5 lengths (30–50mm)
• Proven Safety: Tested to ASTM F543 (mechanical screw properties)
• Traceability: Laser-marked with batch/lot for UDI compliance

Available Sizes & Codes:

Additional Notes:

• Testing: ASTM F543 (screw pull-out, torsional, driving torque)
• Sterilization: Supplied non-sterile (to be sterilized by EO/Steam prior to surgery)
• Packaging: Individually packed with labeling compliant to MDR/UDI
• Compatibility: Designed for thoracolumbar fixation systems with 5.5mm rods
• Instrument Set: Compatible with standard pedicle screw drivers & torque-limiting handles