Pedicle Screw System

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ISO 13485 Certified Pedicle Screw System Manufacturer in India

HCM Orthocare is a globally recognized manufacturer, supplier, and exporter of high-precision Pedicle Screw Systems designed for thoracic and lumbar spinal stabilization. Engineered in our state-of-the-art facility in Ahmedabad, India, our spinal fixation systems provide optimal rigid anchorage and biomechanical stability during spinal fusion procedures.

Utilizing advanced 5-axis CNC Swiss machining and premium medical-grade materials—including Titanium Alloy (Ti6Al4V ELI per ASTM F136) and Stainless Steel 316L (ASTM F138)—our pedicle screws deliver superior fatigue resistance, biocompatibility, and tactile feedback for spine surgeons worldwide.

ISO 13485:2016 Certified CE Compliant MRI Safe Titanium Global B2B Supply
Pedicle Screw System — Spinal Fixation Implant by HCM Orthocare India

Engineering Excellence & System Configurations

Designed to address diverse surgical challenges in posterior spinal instrumentation, our pedicle screw portfolio offers versatility, ease of insertion, and intraoperative flexibility.

Polyaxial Pedicle Screws

Features a 52-degree multi-directional swivel head to facilitate seamless rod placement in complex anatomy, minimizing the need for extensive rod bending and intraoperative stress.

Monoaxial (Rigid) Screws

Engineered for rigid structural stability and maximum pullout strength. Ideal for deformity correction, trauma fixation, and spondylolisthesis reduction requiring high mechanical leverage.

Cannulated MIS Screws

Specifically designed for Minimally Invasive Spine (MIS) surgery. Integrates guide-wire compatibility and precise percutaneous delivery channels to reduce surgical trauma and patient recovery time.

Reduction Pedicle Screws

Equipped with extended break-away tabs that allow progressive, controlled reduction of vertebral bodies in high-grade spondylolisthesis and severe spinal deformities.

Dual-Thread Geometry

Designed with a dual-lead self-tapping thread profile for fast insertion speed, increased cortical bone purchase, and enhanced resistance against mechanical loosening.

Color Anodized Coding

Systematic color anodizing by screw diameter ensures immediate intraoperative identification and streamlined workflow for surgical scrub teams and distributors.

Technical Specifications & Matrix

Comprehensive technical parameters for HCM Orthocare's spinal pedicle screw fixation system, serving global hospital procurement managers and medical distributors.

Specification Parameter Technical Details & Standards
Material Composition Titanium Alloy Ti6Al4V ELI (ASTM F136 / ISO 5832-3) & Stainless Steel 316L (ASTM F138)
Screw Diameters 4.5mm, 5.5mm, 6.5mm, 7.5mm, 8.5mm (Color Coded)
Screw Lengths 25mm to 55mm (in 5mm increments)
Rod Compatibility Standard 5.5mm & 6.0mm Titanium / Stainless Steel Spinal Rods
System Types Polyaxial, Monoaxial, Cannulated MIS, Mono-Planar, and Reduction Screws
Head Angulation (Polyaxial) ≥ 52° conical range of motion for effortless rod engagement
Locking Mechanism Square-thread locking set screw engineered to eliminate cross-threading and head splay
Quality Assurance ISO 13485:2016 Certified, CE Marking, 100% Dimensional & Optical Inspection
Sterilization & Supply Available Non-Sterile (Autoclavable in Instrumentation Tray) or Gamma/EO Sterile Packaged
Global B2B Options Custom OEM, Private Labeling, Custom Size Fabrication & Distributor Support

Clinical Indications & Surgical Applications

HCM Orthocare Pedicle Screw Systems are indicated for posterior, non-cervical pedicle fixation in skeletally mature patients to treat acute and chronic spinal instability.

  • Degenerative Disc Disease (DDD): Provides rigid stabilization post-discectomy for lumbar interbody fusion (PLIF, TLIF).
  • Spondylolisthesis: Corrects sagittal alignment and immobilizes slipping vertebral segments (Grade I to IV).
  • Spinal Trauma & Fractures: Secures unstable thoracolumbar burst fractures and traumatic dislocations.
  • Spinal Deformities: Essential for multi-segment instrumentation in scoliosis, kyphosis, and revision surgeries.

Why Sourcing from HCM Orthocare Gives B2B Buyers an Advantage

As a direct manufacturer based in India, we deliver global-standard orthopaedic implants with exceptional cost competitiveness. Overseas importers, OEM partners, and medical distributors benefit from:

  • • Complete regulatory support dossier for fast local registration
  • • Flexible Minimum Order Quantities (MOQ) for market testing
  • • Precision surgical instrumentation sets supplied in custom trays
  • • Fast international lead times with major air freight logistics

Frequently Asked Questions

Key inquiries answered for medical procurement officers, spine surgeons, and international orthopaedic distributors.

What is a Pedicle Screw System and what are its main clinical indications? +
A Pedicle Screw System is an orthopaedic spinal fixation device designed to anchor rods into the pedicles of the thoracic and lumbar spine. It provides rigid immobilization to promote bone fusion in conditions such as degenerative disc disease, spondylolisthesis, spinal fractures, scoliosis, and spinal instability.
What materials are used in HCM Orthocare pedicle screws? +
We manufacture our pedicle screw systems using biocompatible Medical-Grade Titanium Alloy (Ti6Al4V ELI conforming to ASTM F136 / ISO 5832-3) and Implant-Grade Stainless Steel 316L (ASTM F138). Titanium screws offer excellent fatigue strength, MRI compatibility, and reduced artifact interference in post-operative scans.
What screw variations are available in your spinal fixation range? +
HCM Orthocare offers Polyaxial Pedicle Screws, Monoaxial Screws, Cannulated MIS Screws, Mono-planar Screws, and Reduction Screws in diameters from 4.5mm to 8.5mm and lengths from 25mm to 55mm. All screws are color-coded for rapid identification.
Does HCM Orthocare support OEM and custom private label branding? +
Yes. We specialize in contract manufacturing, custom OEM solutions, and private labeling for international orthopaedic brands. We can customize screw geometry, laser markings, anodization colors, surgical instrument sets, and packaging per your specific market regulations.
What certifications and quality standards do your pedicle screw systems hold? +
HCM Orthocare operates under ISO 13485:2016 quality management standards. Our pedicle screw systems comply with CE safety norms, undergo comprehensive mechanical testing (fatigue, static torque, pull-out strength), and carry complete batch traceability documentation.

Need Commercial Pricing or Technical Specs for Pedicle Screw Systems?

Connect directly with our international regulatory & sales engineering team for detailed product catalogs, volume quotations, and distributor partnerships.

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