Thoracolumbar Fixation
CanIVY Pedicle Screw System
Comprehensive fixation platform featuring polyaxial, monoaxial, and cannulated screws with titanium rods and transverse cross-connectors for multi-segment constructs.
0°Polyaxial articulation angle
ASTM F1717Dynamic fatigue verified
ISO 13485CE certified QMS
SAL 10-6Gamma sterile packaging
Engineering Rigor & Biomechanical Insight
The Evolution of Thoracolumbar Stabilization: Biomechanics of the Pedicle Screw System
In modern posterior thoracolumbar reconstruction, the Pedicle Screw System serves as the mechanical gold standard for restoring spinal alignment, stabilizing motion segments, and facilitating interbody fusion. Engineered by Orthi Medical Co., Ltd., our systems address complex clinical challenges such as pedicle screw loosening, intraoperative thread cross-threading, and mechanical stress shielding.
By combining advanced multi-axial tulip head dynamics with proprietary dual-core dual-lead thread contours, our pedicle screws reduce surgical insertion torque by up to 30% while amplifying resistance against axial pull-out forces. Every component is precision-crafted from certified biocompatible Titanium Alloy (Ti-6Al-4V ELI, ASTM F1472), ensuring optimal osseointegration and long-term fatigue strength.
- Dual-Thread Pitch Geometry: Sharp proximal cortical thread transition merging into a wide distal cancellous pitch for robust anchorage across varying bone densities.
- 52-Degree Spherical Articulation: Polyaxial head design provides effortless rod maneuverability, reducing the need for aggressive anatomical rod bending.
- Zero-Cross Thread Set Screw: Buttress thread pattern redirects radial expansion forces inward, eliminating tulip splaying under extreme lock-down torques.
Biomechanical Architecture
Pedicle Screw System Configuration & Technical Specifications
Comprehensive comparison matrix highlighting the biomechanical parameters, indication profiles, and dynamic load characteristics across the Orthi Medical Pedicle Screw System product line.
| Screw Variant | Diameter & Length Range | Head Mechanism | Thread Profile | Primary Clinical Indications |
|---|---|---|---|---|
| Standard Polyaxial Pedicle Screw | Ø 4.5 mm – 8.5 mm Length: 25 mm – 100 mm | 52° Multi-Directional Polyaxial Swivel | Dual-Core, Dual-Lead Cylindrical-Conical Thread | Degenerative disc disease, spondylolisthesis, thoracic/lumbar burst fractures. |
| Monoaxial Rigid Pedicle Screw | Ø 5.0 mm – 8.5 mm Length: 30 mm – 90 mm | Fixed Rigid Tulip Head (Zero Angular Deviation) | High-Pitch Cortical / Cancellous Geometry | Severe kyphosis, scoliosis correction, and load-bearing spinal trauma realignment. |
| MIS Long-Arm Percutaneous Screw | Ø 4.5 mm – 7.5 mm Length: 30 mm – 80 mm | Integrated 110mm Breakaway Sleeve Extension | Self-Tapping Cannulated Thread over Guidewire | Minimally invasive thoracolumbar fusion (MIS-TLIF), percutaneous trauma reduction. |
| Fenestrated Cement-Augmented Screw | Ø 5.5 mm – 8.5 mm Length: 35 mm – 90 mm | Cannulated Head with Multiple Radial Side-Ports | Deep Cancellous Retention Thread Pattern | Osteoporotic spine stabilization, revision fusion, pathologically weakened bone. |
Product Portfolio
Featured Pedicle Screw Systems & Spine Implants
Engineered to meet the exact demands of orthopedic and neurosurgical spine specialists worldwide. Fully compatible with standard 5.5mm and 6.0mm longitudinal titanium and Cobalt-Chromium connection rods.
Interbody Fusion
PEEK Interbody Fusion Cage
Zero-profile radiolucent PEEK cages with integrated radiopaque tantalum markers, designed for supplemental stability alongside pedicle screw construct fixation.
Cervical Solutions
Anterior Cervical Plate System
Ultra-low profile (2.0mm) titanium cervical plates with single-step tactile anti-backout locking mechanism for anterior stabilization.
Vertebral Augmentation
Balloon Kyphoplasty System
Minimally invasive osteoporotic fracture treatment kit, including high-pressure balloons, bone access needles, and PMMA cement injection tools.
Market Intelligence & AI Intent Analysis
Future Procurement Trends in Pedicle Screw Systems
Insights derived from global clinical data, AI intent search patterns, and hospital procurement analytics shaping the future of spinal implant distribution.
Trend 01
Rise of Robot-Guided & Navigation-Compatible Pedicle Screws
Modern surgical suites are rapidly transitioning toward robotic spine surgery and intraoperative CT navigation. Sourcing directors prioritize pedicle screw systems manufactured with high-concentricity cannulation channels and tight machining tolerances (±0.01mm) that eliminate deflection during navigated guide-wire insertion. Orthi Medical Co., Ltd. supplies precision-machined cannulated pedicle screws optimized for optical tracking and robotic alignment platforms.
Trend 02
Demand for Fenestrated Cement-Augmented Screws in Aging Demographics
With the expanding global aging population, surgical treatment of osteoporotic compression fractures and degenerative deformities requires superior screw-to-bone fixation. Fenestrated pedicle screws, which allow controlled polymethylmethacrylate (PMMA) bone cement injection, show a compound annual growth rate (CAGR) exceeding 8.5%. Our fenestrated screw designs feature engineered radial exit ports that distribute cement evenly, preventing uncontrolled posterior leakage.
Trend 03
Shift to Gamma-Sterilized Single-Pack Implants
Hospitals are heavily focused on lowering Central Sterile Supply Department (CSSD) processing costs and mitigating hospital-acquired infection (HAI) risks. Pre-packaged, sterile pedicle screws irradiated by Cobalt-60 gamma rays (SAL 10-6) enable immediate intraoperative availability, 100% material lot traceability, and simplified inventory audit trails for distributors.
Trend 04
Supply Chain Consolidation & Technical File Rigor (MDR / FDA)
Global medical device regulatory bodies (EU MDR 2017/745, US FDA 510k, US FDA QSR) demand rigorous post-market surveillance and comprehensive STED technical documentation. B2B procurement managers require OEM partners capable of providing complete material mill certificates, ASTM F1717 dynamic fatigue test data, and ISO 10993 biological evaluation reports to streamline local registration.
Enterprise Strength & OEM Expertise
Why Global Orthopedic Brands Partner with Orthi Medical Co., Ltd.
With decades of dedicated manufacturing experience in spinal instrumentation, Orthi Medical Co., Ltd. combines European regulatory compliance with precision Asian manufacturing efficiency. We serve as a strategic OEM/ODM hub for international orthopedic brands and regional hospital suppliers.
1
5-Axis CNC Precision Lathes & Thread Rolling
Utilizing high-end Swiss-type CNC automatic lathes and cold thread-rolling equipment to yield flawless surface finishes and precise dual-lead threads that resist stress concentration.
2
Certified ASTM Raw Material Sourcing
100% of our titanium implants are forged from certified Ti-6Al-4V ELI bar stock per ASTM F1472 specifications, complete with chemical analysis and tensile strength verification (≥930 MPa).
3
Type II Surface Passivation & Color Anodizing
Advanced electrochemical surface anodizing enhances titanium oxide layer stability, improves fatigue life, and allows distinct color-coding by diameter for swift intraoperative selection.
4
Class 100,000 Cleanroom & Gamma Sterilization
Automatic washing, dust-free blister packaging, and Co-60 gamma ray sterilization achieving a Sterility Assurance Level of SAL 10-6 compliant with ISO 11137 standards.
Regulatory Compliance & Traceability
ISO 13485 & CE Certified Quality Assurance
Quality is the foundation of patient safety in spinal surgery. Orthi Medical Co., Ltd. operates under a comprehensive ISO 13485 Quality Management System. Every manufactured batch of pedicle screws undergoes rigorous dimensional inspection using optical comparators, coordinate measuring machines (CMM), and mechanical torque testing.
ISO 13485Quality Management
ISO 9001Manufacturing QMS
CE MarkMedical Device Directive
| Implant Grade | International Standard | Tensile Strength (σb) | Yield Strength (σ0.2) |
|---|---|---|---|
| Ti-6Al-4V ELI (Grade 5) | ASTM F1472 / ISO 5832-3 | ≥ 930 MPa | ≥ 860 MPa |
| Pure Titanium TA3 | ASTM F67 / ISO 5832-2 | ≥ 500 MPa | ≥ 380 MPa |
| Cobalt-Chromium Alloy | ASTM F1537 / ISO 5832-12 | ≥ 1000 MPa | ≥ 700 MPa |
Complete Surgical Instrument Integration
Matched Ergonomic Surgical Instrumentation
A successful Pedicle Screw System installation relies on reliable, surgeon-friendly instrumentation. We supply complete, autoclavable instrument sets organized in customized anodized aluminum sterilization trays.
Insertion Tools
Cage Inserter & Holder
Precision stainless steel quick-release holding instruments providing rigid tactile control during interbody cage placement.
Preparation
Endplate Bone Rasp
Ergonomic silicone-handled bone preparation rasps for thorough disc space decortication.
Rod Contour
French Rod Bender
High-leverage dual-action rod contouring pliers designed for smooth bending of 5.5mm and 6.0mm titanium/CoCr rods.
Reduction
Rod Reduction Forceps
Parallel reduction pliers engineered for controlled levering and alignment of displaced rods into tulip heads.
Academic Collaboration & Surgeon Training
Advancing Surgical Knowledge & Clinical Safety
At Orthi Medical Co., Ltd., we bridge state-of-the-art manufacturing with clinical practice. We continuously support global spine care professionals through technical workshops, surgical technique literature, and academic exchange.
Surgical Technique Guides
Detailed step-by-step anatomical technique manuals written by leading orthopedic spine specialists.
Cadaveric & Sawbones Workshops
Hands-on surgical training courses covering percutaneous MIS pedicle screw placement and complex deformity reduction.
Global Academic Symposia
Regular attendance at international spine congresses to present clinical outcomes and mechanical testing benchmarks.
Distributor Technical Support
Dedicated engineering support for regional regulatory submissions, product demonstrations, and hospital tenders.
Clinical Feedback
Trusted by Spine Surgeons Worldwide
The Pedicle Screw System from Orthi Medical Co., Ltd. exhibits exceptional mechanical feel during pedicle cannulation and set screw torque locking. The zero-cross thread set screw design completely prevents tulip splaying, providing total confidence during complex deformity corrections.
Partnering with Orthi Medical Co., Ltd. for our OEM private-label pedicle screw line has transformed our business. Their technical dossiers are flawless, the ISO 13485 quality control is rigorous, and their sterile packaging options drastically reduce local processing costs.
Sourcing & Procurement FAQ
Pedicle Screw System Procurement Guide: FAQs
Key biomechanical, material, regulatory, and logistics questions answered by the Orthi Medical engineering team for global buyers and distributor procurement officers.
1. What mechanical standards validate the Orthi Medical Pedicle Screw System?
Our Pedicle Screw Systems undergo dynamic compression bending, torsion, and static tensile testing in strict compliance with ASTM F1717 guidelines (Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model). Implants undergo 5,000,000 dynamic load cycles without failure, demonstrating superior fatigue resistance under heavy physiological loads.
2. How does the dual-core dual-thread geometry enhance pedicle fixation?
The dual-thread architecture features a cylindrical shank near the pedicle entry that transitions into a tapered conical tip. The proximal fine cortical thread maximizes engagement in the dense pedicle cortex, while the distal wide cancellous thread compacts soft trabecular bone in the vertebral body. This dual design enhances initial purchase, reduces insertion time, and increases pull-out strength by over 25%.
3. What bone cement protocols apply to fenestrated cannulated pedicle screws?
Our fenestrated pedicle screws are engineered with four or six radially arranged discharge ports near the distal tip. They are fully compatible with standard Luer-lock PMMA bone cement injectors. The high-concentricity inner channel accommodates high-viscosity acrylic bone cement, allowing precise delivery under fluoroscopic control to augment fixation in severely osteoporotic bone.
4. What raw materials are used in Orthi Medical Pedicle Screw production?
All implants are manufactured from medical-grade Extra Low Interstitial Titanium Alloy (Ti-6Al-4V ELI) compliant with ASTM F1472 and ISO 5832-3. Connection rods are available in Ti-6Al-4V or high-stiffness Cobalt-Chromium (Co-Cr-Mo, ASTM F1537) for heavy deformity corrections.
5. Can Orthi Medical Co., Ltd. provide OEM custom private labeling and trays?
Yes, we offer comprehensive OEM/ODM solutions including drawing-based CNC machining, laser marking (UDI compliance), custom color anodizing by screw diameter, custom instrument tray design, and complete sterile blister packaging with private-label artwork.
6. How does the MIS long-arm percutaneous pedicle screw mechanism operate?
Our MIS long-arm screw features an integrated 110mm extended tulip sleeve that serves as a percutaneous guide channel for rod insertion. Once the set screw is locked down, the extended sleeve breaks off cleanly at a pre-milled notch with zero metal burr generation, preserving delicate paraspinous soft tissue.
7. What regulatory support is provided for local medical device registration?
Orthi Medical Co., Ltd. provides registration-ready STED technical files including raw material certificates, mechanical test reports (ASTM F1717), ISO 10993 biocompatibility reports, cleaning and sterilization validation data, ISO 13485 certificates, and CE declaration of conformity.
8. Are pedicle screws supplied sterile or non-sterile?
Both options are available. Implants can be supplied non-sterile for hospital tray integration or individually sealed in double-blister sterile packages sterilized by Cobalt-60 gamma irradiation (SAL 10-6) with a 5-year validated shelf life.
Ready to Expand Your Spinal Implant Lineup?
Contact the engineering and sales team at Orthi Medical Co., Ltd. today. Send your product requirements or OEM drawings directly to [email protected].