Pedicle Screw Systems
Polyaxial, monoaxial, and reduction pedicle screws with low-profile heads and friction-fit tulip design for thoracolumbar stabilization and deformity correction.
ISO-Certified Spine Implant Solutions for Global Healthcare
HCM Orthocare is an established spine implant manufacturer, supplier, and exporter based in Ahmedabad, Gujarat, India. Operating under strict ISO 13485:2016 quality management standards, we design and produce high-precision spinal fixation devices engineered to treat complex spinal fractures, degenerative disc diseases, scoliosis deformity, and interbody fusion cases.
Our medical-grade spinal implants are fabricated using premium Titanium Alloy (Ti6Al4V ELI conforming to ASTM F136) and PEEK-OPTIMA (conforming to ASTM F2026). Engineered for superior fatigue strength, optimum biomechanical load distribution, and high biocompatibility, HCM Orthocare spinal devices empower spine surgeons and orthopedists worldwide to achieve predictable clinical outcomes.
✔ ISO 13485:2016 Quality Assured
✔ CE Compliant Manufacturing
✔ Exported to 50+ Countries
Comprehensive Spinal Fixation Product Portfolio
HCM Orthocare offers a complete spectrum of thoracolumbar, cervical, and interbody spine implants tailored for hospital tenders, medical distributors, and surgical centers.
Spinal Mesh & Expandable Cages
Titanium mesh cages and height-expandable corpectomy cages designed to facilitate bone graft packing, restore anterior column height, and promote solid fusion.
PEEK Interbody Cages
Biocompatible PLIF, TLIF, and ALIF PEEK cages with radiolucent properties and integrated tantalum markers for precise post-operative imaging.
Cervical Plates & Spacers
Anterior cervical locking plates with zero-profile spacers, offering secure screw engagement and minimal esophageal irritation in ACDF procedures.
Spinal Hooks & Rod Systems
Laminar, pedicle, and transverse process hooks combined with high-tensile 5.5mm / 6.0mm titanium rods for hybrid spinal instrumentation.
Cross-Links & Connectors
Adjustable and fixed transverse cross-connectors, lateral offsets, and rod-to-rod connectors designed to increase rotational stability in long constructs.
Technical Parameters & Manufacturing Standards
Designed to withstand severe mechanical stresses in vivo, every HCM Orthocare spine implant is precision-machined via multi-axis CNC technology and audited against international clinical benchmarks.
| Technical Specification | Material & Compliance Details |
|---|---|
| Primary Raw Materials | Titanium Alloy Ti-6Al-4V ELI (ASTM F136 / ISO 5832-3), PEEK-OPTIMA (ASTM F2026) |
| Manufacturing Quality System | ISO 13485:2016 Certified Quality Management System |
| Regulatory & Directives | CE Marking Compliant (EU MDR 2017/745 standards) |
| Mechanical Testing Standards | Static & Dynamic Fatigue Tested per ASTM F1717 / ASTM F2193 protocols |
| Surface Treatment Options | Type II Anodization, Micro-blasted grit surface, Mirror-polished tulip heads |
| Imaging Compatibility | MRI & CT Compatible (Non-magnetic Ti6Al4V & Radiolucent PEEK) |
| Pedicle Screw Diameters | 4.0mm, 4.5mm, 5.0mm, 5.5mm, 6.5mm, 7.5mm (Lengths: 25mm to 55mm) |
| Rod Options & Diameters | Ø 5.5mm and Ø 6.0mm Titanium Grade 5 Rigid & Pre-bent Rods |
| Sterilization Compatibility | Gamma Irradiation, Ethylene Oxide (EO), Autoclave Steam Compatible |
| Packaging & Traceability | Double sterile-barrier blister pouch with GS1 compliant barcode tracking |
Special Features & Biomechanical Advantages
Spinal instrumentation requires exact anatomical contouring and fatigue-resistant locking mechanisms. HCM Orthocare spine implants feature optimized engineering solutions that assist surgeons during complex intraoperative maneuvers.
- ✔ Anatomical Load Sharing: Optimized thread pitch and dual-lead thread geometries enable rapid insertion and elevated pull-out resistance in osteoporotic bone.
- ✔ Friction-Head Locking: Polyaxial tulip heads retain intraoperative positioning, easing rod placement in multi-level construct alignments.
- ✔ Minimized Profile: Low-profile cervical plates and pedicle screw caps significantly reduce post-operative soft tissue impingement and dysphagia risks.
- ✔ Accelerated Fusion: Surface-engineered PEEK and porous titanium mesh cages promote vascular endplate contact and rapid osteointegration.
Global B2B Supply & OEM Contract Manufacturing
As a trusted OEM spine implant exporter in India, HCM Orthocare supports international healthcare brands, importers, and government hospital supply networks.
Custom OEM & Private Label
We provide contract manufacturing based on technical drawings, 3D CAD files, or custom surgical preferences with customized branding and laser etching.
Regulatory Dossier Support
Complete technical dossiers (CE documentation, material test certificates, biocompatibility reports) supplied for fast-track product registration overseas.
Sterile & Non-Sterile Supply
Available in bulk protective packaging or pre-sterilized cleanroom double blister packaging ready for direct surgical distribution.
Frequently Asked Questions
Professional insights regarding HCM Orthocare's spinal implants manufacturing standards and international order placement.
1. What quality standards govern HCM Orthocare spine implants?
All HCM Orthocare spinal implants are manufactured under ISO 13485:2016 quality management systems. Materials strictly conform to international biomaterial standards, including ASTM F136 for Titanium (Ti-6Al-4V ELI) and ASTM F2026 for implant-grade PEEK.
2. Are your pedicle screw systems compatible with standard spine instruments?
Yes. Our pedicle screw systems are supplied alongside dedicated, high-precision surgical instrument sets engineered for seamless intraoperative benders, reamers, taps, and screwdrivers.
3. Can international distributors request custom dimensions or private labeling?
Absolutely. We specialize in OEM contract manufacturing for global orthopedic brands. We can customize screw dimensions, rod profiles, laser-etched logos, and customized packaging based on your regional market requirements.
4. What is the lead time for export orders?
Standard inventory orders ship within 1 to 2 weeks. Custom OEM projects or large contract manufacturing orders depend on volume specifications and typically range from 3 to 5 weeks with expedited air freight capabilities worldwide.