ISO 13485 & CE Certified Manufacturing

Spine System Implants & Surgical Instrumentation

Precision-engineered spinal fixation, fusion cages, and pedicle screw systems for global hospital procurement and distributors.

CORE® Spinal Systems Portfolio

Engineered with medical-grade Titanium (Ti-6Al-4V ELI) and PEEK polymers, our spinal solutions provide exceptional mechanical stability, biocompatibility, and anatomical alignment for complex spine procedures.

CORE II Spine System
Pedicle & Rod System

CORE® II Spine System

Comprehensive polyaxial and monoaxial pedicle screw system with low-profile transverse connectors for thoracolumbar stabilization.

CORE Occipital System
Craniocervical Fixation

CORE® Occipital System

Occipital plates, multi-hole connectors, and laminar hooks designed for optimal occipitocervical junction reconstruction.

CORE Wedge Shaped Cage
Interbody Fusion

CORE® Wedge Shaped Cage

Anatomically contoured PEEK interbody fusion device engineered to restore lordosis and maximize bone graft packing area.

CORE Cervical System
Anterior Cervical

CORE® Cervical System

Low-profile anterior cervical plates (4-8 holes) with variable-angle locking screws for rigid cervical spine fusion.

CORE Pedicle Screws System
Thoracolumbar

CORE® Pedicle Screws System

Self-tapping titanium pedicle screws featuring friction-fit heads, dual lead threads, and ergonomics-focused insertion tools.

CORE Minimally Invasive MIS
MIS Technique

CORE® Minimally Invasive System

Percutaneous MIS pedicle screw and pre-bent connecting rod system engineered for reduced tissue trauma and rapid recovery.

CORE PLIF Cage System
Lumbar Fusion

CORE® PLIF Cage System

Posterior Lumbar Interbody Fusion cages with aggressive anti-migration ridges and integrated tantalum radiopaque markers.

CORE TLIF Cage System
Transforaminal Fusion

CORE® TLIF Cage System

Transforaminal Lumbar Interbody Fusion cages featuring a bullet-nosed lead edge for streamlined insertion via unilateral approach.

CORE Expandable Mesh Cage System
Vertebral Body Replacement

CORE® Expandable Mesh Cage System

Titanium mesh and expandable VBR cages engineered for structural reconstruction following corpectomy procedures.

Medical-Grade Spinal Implants for Advanced Surgical Reconstruction

At Sharma Orthopedic, we manufacture high-precision, result-oriented spinal implants designed to restore anatomical alignment, provide rigid biomechanical stability, and accelerate osseointegration. Over three decades of specialized clinical research and advanced manufacturing enable us to meet the strict quality standards demanded by spine surgeons, trauma centers, and healthcare buyers worldwide.

The CORE® Spine System is engineered for surgical versatility across cervical, thoracic, and lumbar procedures. Whether treating severe traumatic vertebral fractures, degenerative spinal disorders, or complex pediatric and adult deformities, our products offer uncompromised structural integrity.

Clinical Indications for Spinal Instrumentation

Spinal fixation systems and interbody devices are clinically indicated to achieve arthrodesis and stabilize the spinal column during bone graft healing. Key clinical applications include:

  • Degenerative Disc Disease (DDD): Restoring disc space height and eliminating painful segmental instability.
  • Spondylolisthesis: Grade I through IV vertebral slip reduction and posterior/anterior stabilization.
  • Spinal Deformity Correction: Multi-segmental stabilization for idiopathic scoliosis, kyphosis, and lordotic realignment.
  • Vertebral Fractures & Trauma: Immediate rigid internal fixation for burst fractures, dislocations, and spinal cord decompression.
  • Spinal Stenosis & Herniated Discs: Providing interbody support post-decompression laminectomy or discectomy.

Comprehensive System Components & Technical Specifications

Our complete spine portfolio is manufactured using 5-axis CNC machining, ultrasonic cleanroom processing, and 100% optical inspection to ensure sub-micron dimensional tolerance.

1. Thoracolumbar Pedicle Screw Systems

  • Screw Configurations: Polyaxial, Monoaxial, Reduction, and Cannulated MIS screws.
  • Diameters & Lengths: Diameters ranging from 4.5mm to 7.5mm; lengths from 25mm to 55mm.
  • Rod Options: Pre-bent and straight Titanium Alloy (Ti-6Al-4V ELI) rods in 5.5mm and 6.0mm diameters.
  • Cross-Connectors: Fixed and adjustable transverse connector rods for enhanced torsional rigidity.

2. Interbody Fusion Cages (PEEK & Titanium)

  • PLIF & TLIF Cages: Manufactured from biocompatible Polyetheretherketone (PEEK-OPTIMA®) with elastic modulus close to natural cortical bone.
  • Radiopaque Markers: Integrated Tantalum pins provide clear intraoperative imaging visualization under fluoroscopy.
  • Surface Micro-Texturing: Pyramid-shaped teeth prevent implant migration and expulsion under axial loading.

3. Anterior Cervical Fixation Systems

  • Cervical Plates: Ultra-low profile (2.0mm thickness) 1-level to 4-level pre-contoured plates with wide graft visualization windows.
  • Locking Mechanism: One-step tactile tactile-feedback blocking mechanism preventing screw back-out.

Global Regulatory Compliance & Quality Assurance

Sharma Orthopedic operates a state-of-the-art 62,000+ sq. ft. manufacturing campus in Gujarat, India, strictly adhering to international medical device regulations:

  • ISO 13485:2016 Certified: Comprehensive Quality Management System covering design, production, and final packaging.
  • CE Mark Certified: Full technical documentation dossiers matching European Medical Device Regulation (MDR) requirements.
  • Material Traceability: Raw materials sourced exclusively from certified suppliers with complete melt certificates and biocompatibility test reports.
  • Sterilization Ready: Offered in both non-sterile bulk packaging and validated gamma-sterilized cleanroom packaging.

Frequently Asked Questions for B2B Procurement

What certifications do your spine implant systems carry for international distribution?

All Sharma Orthopedic spine systems are manufactured under ISO 13485:2016 certified quality management. Products carry CE compliance and full technical dossiers (STED format) required for national health authority registrations across Europe, Asia, Latin America, Africa, and the Middle East.

What materials are utilized in your spinal cages and pedicle screws?

Our pedicle screws and cervical plates are manufactured from high-strength Titanium Alloy (Ti-6Al-4V ELI conforming to ASTM F136). Interbody fusion cages (PLIF/TLIF) are crafted from medical-grade PEEK polymer (ASTM F2026) embedded with X-ray visible Tantalum markers (ASTM F560).

Are spinal implants safe for postoperative MRI diagnostic scans?

Yes. Implants made from Titanium Alloy (Ti-6Al-4V) and PEEK are non-ferromagnetic. They are classified as MRI-Conditional, minimizing image artifacts and ensuring safe diagnostic imaging post-surgery.

Do you provide matching surgical instrument sets and trays for hospital trials?

We supply complete, dedicated ergonomic instrument sets—including benders, inserters, taps, reamers, and torque-limiting screwdrivers—housed in autoclavable aluminum sterilization containers designed for immediate operating theater utility.

What is the typical lead time for international bulk distributor orders?

Standard catalog items are available for dispatch within 2 to 3 weeks. Custom size configurations or private label (OEM) orders typically require 4 to 6 weeks depending on volume and packaging specifications.

Partner With a Reliable Global Spine Implant Manufacturer

Contact our international sales engineering team for technical catalogs, pricing quotes, and distributor partnership agreements.