PEDILUX™ - X-Line PEDICLE SCREW SYSTEM

PEDILUX™ Polyaxial X – Line Pedicle Screw – Titanium
Polyaxial X – Line Pedicle Screw
PEDILUX™ Polyaxial X – Line Pedicle Screw – Titanium
PEDILUX™ Polyaxial X – Line Reduction Pedicle Screw – Titanium
PEDILUX™ Monoaxial X – Line Pedicle Screw – Titanium
PEDILUX™ Monoaxial X – Line Reduction Pedicle Screw – Titanium
Graphic Aluminium Implant Box for Pedicle Screw System
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Product Overview
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An X-LINE Pedicle Screw System is a specialized spinal fixation implant used in fusion procedures to stabilize the vertebral column. Pedicle screws are inserted into the vertebral pedicles and connected with rods to provide rigid fixation. This construct helps restore spinal alignment, correct deformities, and promote solid bony fusion between adjacent vertebrae.

X-LINE pedicle screw systems are often used in combination with interbody cages (such as PLIF or TLIF cages) to provide immediate mechanical stability and support long-term fusion success. Designed for reliable performance and procedural efficiency, the system is available in a wide range of diameters and lengths, with options for polyaxial, monoaxial, and reduction screws, offering versatility to accommodate diverse surgical requirements.

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PEDILUX™ - X-Line PEDICLE SCREW SYSTEM product image
Product DESCRIPTION

The PEDILUX™ X-LINE Pedicle Screw Fixation System by Siora Surgicals Pvt. Ltd. is a precision-engineered spinal fixation solution featuring an advanced single helical-lead thread design for improved insertion efficiency and enhanced fixation. It is designed to stabilize the thoracic and lumbar spine in a wide range of spinal fusion procedures.

Manufactured from high-quality, biocompatible Titanium (Ti-6Al-4V ELI), the PEDILUX™ X-LINE system combines strength, durability, and excellent imaging compatibility. Its streamlined, low-profile design is optimized for efficient handling and reduced soft tissue irritation, while ensuring reliable implant performance.

The pedicle screws are available in diameters of 5.5 mm, 6.5 mm, and 7.5 mm, with lengths ranging from 25 mm to 120 mm in 5 mm increments. The screws feature a tapered shaft design with a proximal cancellous (coarse pitch) thread and a distal cortical (fine pitch) thread, ensuring optimized insertion and fixation. The system also offers self-tapping screw options, enabling efficient insertion and secure fixation within the vertebral pedicles.

The X-LINE system also includes a comprehensive range of spinal fixation components such as cross-link connectors, iliac screws, lateral connectors, parallel connectors, domino connectors, lamina hooks, pedicle hooks, and staples. Rod options include 5.5 mm Titanium rods, CoCr rods, and tapered rods, providing enhanced construct stability and versatility across different spinal indications.

Designed for ease of application and consistent performance, the PEDILUX™ X-LINE Pedicle Screw Fixation System helps restore spinal alignment, correct deformities, and promote solid bony fusion. Backed by stringent manufacturing standards, Siora Surgicals Pvt. Ltd. ensures consistent quality, dependable performance, and reliable clinical outcomes.

PRODUCT FEATURES

Core Features

1. Low-Profile Tulip Design

  • Compact tulip profile minimizes implant prominence, reduces soft tissue irritation, and improves surgical access and handling.

2. Optimized Rod Seating & Fixation

  • Precision groove with lateral set screw mechanism ensures secure rod seating, accurate engagement, and rigid fixation, preventing construct loosening.

3. Advanced Locking & Drive Interface

  • Acme thread locking cap with TORX® 30 profile prevents cross-threading, ensures smooth engagement, reduces insertion torque, and provides reliable torque transmission with minimal slippage.

4. Self-Tapping Configuration

  • Specialized tip design enables efficient insertion without pre-tapping, reducing surgical steps while ensuring secure fixation within the pedicle.

5. Wide Angulation Capability

  • 45° cone of angulation provides a broad range of motion, supporting precise screw placement and adaptability in complex anatomical conditions.

X-LINE System-Specific Features

1. Single Helical-Lead Thread Design

  • Single helical-lead thread enables controlled insertion with consistent thread engagement, ensuring reliable bone purchase and stable fixation.

2. Dual-Zone Thread Design

  • Tapered shaft with proximal cancellous (coarse pitch) and distal cortical (fine pitch) threads ensures optimized insertion, enhanced bone purchase, and stable fixation across varying bone densities.

3. Precision Insertion Control

  • Optimized thread geometry and shaft profile provide controlled advancement, improved tactile feedback, and enhanced accuracy during screw placement.
CLINICAL INDICATIONS

The PEDILUX™ X‑LINE Pedicle Screw Fixation System is indicated for stabilization of the thoracic and lumbar spine in various spinal fusion procedures, including:

1. Degenerative Lumbar Conditions (e.g., Degenerative Disc Disease, Spondylolisthesis)

  • Progressive disc degeneration or vertebral slippage leading to chronic spinal instability, mechanical back pain, and reduced segmental function, requiring stabilization and fusion

2. Spinal Trauma (Thoracic and Lumbar Fractures)

  • Vertebral fractures or acute traumatic injuries resulting in loss of spinal stability and alignment, requiring urgent stabilization and reconstruction

3. Spinal Deformities (e.g., Scoliosis, Kyphosis, Lordosis)

  • Abnormal spinal curvatures or misalignment of the thoracic or lumbar spine requiring corrective stabilization and deformity correction

4. Revision Procedures and Failed Previous Surgery

  • Persistent or recurrent symptoms following prior spinal instrumentation or fusion procedures, requiring re-stabilization and surgical correction

5. Pseudarthrosis or Tumor- and Infection-Related Instability

  • Non-union following previous fusion or spinal instability due to tumor resection or infection, requiring rigid fixation and structural support
Available Sizes
Cat No. (Titanium)Dia (mm)Length (mm)
Ti.636.45.30 – Ti.636.45.504.530 -50
Ti.636.55.30 – Ti.636.55.505.530 -50
Ti.636.65.30 – Ti.636.65.506.530 -50
Ti.636.75.30 – Ti.636.75.507.530 -50
Cat No. (Titanium)Dia (mm)Length (mm)
Ti.637.55.30 – Ti.637.55.505.530 -50
Ti.637.65.30 – Ti.637.65.506.530 -50
Ti.637.75.30 – Ti.637.75.507.530 -50
Cat No. (Titanium)Dia (mm)Length (mm)
Ti.638.45.30 – Ti.638.45.504.530 -50 
Ti.638.55.30 – Ti.638.55.505.530 -50
Ti.638.65.30 – Ti.638.65.506.530 -50
Ti.638.75.30 – Ti.638.75.507.530 -50
Cat No. (Titanium)Dia (mm)Length (mm)
Ti.639.55.30 – Ti.639.55.505.530 -50
Ti.639.65.30 – Ti.639.65.506.530 -50
Ti.639.75.30 – Ti.639.75.507.530 -50

frequently asked questions

What is the PEDILUX™ X-LINE Pedicle Screw Fixation System used for?

The PEDILUX™ X-LINE system is used to stabilize the thoracic and lumbar spine in spinal fusion procedures, helping restore spinal alignment, correct deformities, and promote solid bony fusion between vertebrae.

The system is manufactured from high-quality, biocompatible Titanium (Ti-6Al-4V ELI) alloy, ensuring strength, durability, and excellent imaging compatibility. It is sterilized using gamma radiation (ISO 11137), ensuring residue-free sterility in sealed packaging.

Pedicle screws are available in diameters of 5.5 mm, 6.5 mm, and 7.5 mm, with lengths ranging from 25 mm to 120 mm in 5 mm increments. The system features an advanced single helical-lead thread design with a tapered shaft and dual-thread configuration for optimized fixation. Rod options include 5.5 mm Titanium rods, CoCr rods, and tapered rods, providing versatility across different surgical indications.

Yes. Siora Surgicals Pvt. Ltd. offers OEM/ODM services, supports global distribution, and partners with distributors worldwide for spinal fixation solutions.

The company provides complete export support, including sterile processing, documentation, packaging, and reliable logistics coordination to ensure timely global delivery.

Technical support, product training, and clinical guidance are provided to ensure proper usage and optimal surgical outcomes.

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