Explore our export-grade medical devices, custom pedicle screw assemblies, instrument trays, and arthroplasty systems manufactured under stringent ISO 13485 cleanroom conditions.
In contemporary spinal surgery, pedicle screw fixation represents the gold standard for stabilizing degenerate, traumatized, or deformed vertebral segments. As a global OEM pedicle screw spinal systems factory and exporter, our engineering paradigm is built upon optimizing the mechanical interface between high-grade implant metals and human bone pathology. Pedicle screws function under extreme cyclic fatigue loads, requiring precise thread geometry, superior tensile strength, and modular polyaxial articulation.
The choice of raw material dictates the stress-shielding characteristics, artifact signature during MRI/CT imaging, and long-term fatigue resistance of spinal construct assemblies. We utilize ultra-low interstitial Grade 5 Titanium (Ti-6Al-4V ELI / ASTM F136) as the foundational material for our pedicle screw shanks and tulip housings. ELI titanium provides an optimal balance of lower elastic modulus (closer to human cortical bone) and exceptional ultimate tensile strength (>860 MPa).
A primary failure mode in lumbar stabilization is pedicle screw loosening or axial pullout, particularly in osteoporotic patients. Our custom OEM manufacturing capabilities integrate dual-lead, variable-pitch, and dual-outer thread designs:
Information Gain Insight: Modern clinical data indicates that dual-lead threads cut surgical insertion time in half, reducing operating room exposure while doubling the threads engaged in the pedicle walls per millimeter of advancement.
As a full-spectrum contract manufacturer, we offer complete modular flexibility across monoaxial, polyaxial, cannulated MIS, and reduction pedicle screw designs tailored for global OEM branding partners.
| Screw Variant | Diameter Range (mm) | Length Range (mm) | Angular Deflection | Primary Clinical Application |
|---|---|---|---|---|
| Monoaxial Pedicle Screw | 4.5, 5.5, 6.5, 7.5 | 25mm – 55mm (5mm steps) | Rigid 0° (Fixed Axis) | Trauma, Spondylolisthesis, Rigid Deformity Correction |
| Polyaxial Pedicle Screw | 4.5, 5.5, 6.5, 7.5, 8.5 | 25mm – 60mm | ±30° (60° Total Cone) | Degenerative Disc Disease, Multi-level Fusion |
| Cannulated MIS Screw | 5.5, 6.5, 7.5 | 30mm – 55mm | ±28° Friction Fit | Percutaneous Minimally Invasive Surgery over K-wire |
| Reduction Pedicle Screw | 5.5, 6.5, 7.5 | 30mm – 55mm | Breakaway Extended Tabs | High-grade Spondylolisthesis & Lumbar Reduction |
| Cement-Injectable Screw | 6.5, 7.5, 8.5 | 35mm – 55mm | Fenestrated Distal Ports | Severe Osteoporosis & Pathological Bone Fixation |
Operating out of our 62,391 sq. ft. modern facility in Vadodara, Gujarat, India, Sharma Orthopedic represents the convergence of high-volume manufacturing capacity and micron-level precision engineering. Producing over 10,000 product SKUs, our plant is fully equipped with advanced Swiss-type lathe machining, multi-axis CNC milling centers, and automated passivation lines.
Pedicle screw tulips and threaded shanks require complex geometrical cuts, micro-locking grooves, and internal hex/torx drives. We utilize 5-axis CNC machining centers and Citizen Swiss Lathes capable of maintaining dimensional tolerances within ±0.005mm (5 microns). This ultra-precise tolerance ensures that the internal collet and set screw friction-fit perfectly around 5.5mm or 6.0mm spinal rods, preventing set screw back-out and post-operative construct slippage.
ISO Class 7 and Class 8 environmental cleanrooms guarantee zero particulate contamination during double-blister sterile packaging operations.
Color-coded electrolytic titanium anodization (Blue, Gold, Green, Magenta) for immediate intraoperative identification of screw diameters.
Zeiss 3D Coordinate Measuring Machines (CMM) and optical comparators verify 100% of critical dimensions against OEM blueprints.
We work directly with international orthopedic brands, hospital networks, and medical device distributors to deliver full-cycle custom manufacturing:
The global spinal implants market is undergoing a seismic shift driven by value-based healthcare, robotic-assisted navigation, and advanced material science. As a forward-looking exporter, we track and engineer solutions aligned with these major global procurement trends:
Additive manufacturing (Selective Laser Melting - SLM) is revolutionizing pedicle screw design. Future pedicle screws feature 3D trabecular porous coatings along the non-structural thread valleys. This porous architecture (300–500 micron pore sizes) encourages direct bone ingrowth (osseointegration) rather than mere mechanical apposition, virtually eliminating late-stage screw loosening in complex spinal reconstructions.
Hospital purchasing committees are aggressively expanding MIS inventory. Extended-tab pedicle screws feature integrated breakaway sleeves (sleek extended tulips) that allow percutaneous rod insertion without requiring bulky external towers. Once the set screw is torqued, the extended tabs are cleanly snapped off, reducing patient tissue trauma, surgical blood loss, and recovery duration.
Healthcare procurement managers are rapidly shifting from single-source manufacturing dependency toward high-capacity, certified OEM partners in India. India's robust metallurgical infrastructure, skilled engineering workforce, and cost-efficient production models offer global medical brands a 30% to 45% reduction in total manufacturing costs while maintaining strict compliance with US FDA and EU MDR standards.
Founded in 1992, Sharma Orthopedic India Limited has established itself among the top tier of international orthopedic manufacturers. When you choose us as your OEM factory and exporter, you gain access to an integrated enterprise ecosystem built on compliance, scale, and clinical performance.
Our quality management system is certified under ISO 13485:2016 and CE directives. Every batch of titanium and stainless steel is traceable from raw melt to sterile dispatch, supported by complete material test reports (MTRs).
From initial CAD drawings to final customized sterile box packaging, we deliver complete turnkey OEM solutions designed to match your brand’s exact regulatory filing specifications.
Trusted by distributors, government health ministries, and private hospital chains across 50+ countries in Latin America, Europe, Africa, the Middle East, and Southeast Asia.
We manufacture dedicated ergonomic surgical instrument sets designed specifically for our pedicle screw lines, ensuring smooth intraoperative workflow for spine surgeons.
Below are detailed answers to key technical, regulatory, and commercial questions asked by international procurement managers evaluating OEM pedicle screw manufacturing partners.
Our pedicle screws are exclusively crafted from medical-grade Titanium Alloy (Ti-6Al-4V ELI) conforming to ASTM F136 / ISO 5832-3 specifications. For select trauma and dynamic system lines, we also offer high-purity Stainless Steel 316LVM (ASTM F138) and Cobalt-Chromium-Molybdenum alloys (CoCrMo ASTM F1537).
Yes. As a contract OEM/ODM factory, our in-house R&D team works from your 2D engineering drawings or 3D STEP models. We can customize screw diameter (3.5mm to 8.5mm), thread pitch (single, double, or progressive dual-lead), tulip drive interface (Internal Hex, Torx, Star), and surface anodization colors.
Sharma Orthopedic operates under an ISO 13485:2016 quality management system certified by international notified bodies. We provide complete technical dossiers including ISO compliance documentation, CE certificate technical files, material raw certificates, passivation validation, cleanroom monitoring logs, and ASTM F1717 dynamic fatigue test reports.
Our standard production runs accommodate both small-batch specialized implant lines and high-volume commercial contracts. Standard OEM laser-marking and customized packaging generally start at 100 to 500 units per size SKU, with scalable volume discounts for annual contract supply agreements.
We provide both options. Non-sterile implants are delivered passivated, ultrasonically cleaned, and packaged in protective protective blister enclosures suitable for autoclave sterilization at the hospital. Cleanroom gamma-sterilized double-blister packaging (EO or Gamma Irradiation with 5-year shelf-life validation) is available upon request.
Our tulips and set screws utilize reverse-buttress or square thread geometry. This design directs set screw tightening forces downward into the rod rather than pushing the tulip walls outward. This prevents tulip splaying and eliminates cross-threading during high-torque intraoperative locking (typically calibrated to 12 Nm).
For standard catalog inventory, export orders are dispatched within 10 to 15 business days. For custom OEM/ODM contract manufacturing requiring new CNC tooling setups and customized graphic trays, standard lead times range from 30 to 45 days from sample sign-off.
Elevate your medical device brand with precision-engineered spinal fixation systems, rigorous regulatory compliance, and direct factory pricing from India's leader in orthopedic manufacturing.