Polyaxial Pedicle Screw System
Featuring a 360-degree dynamic friction head with up to 50° angular freedom, facilitating effortless rod insertion and reducing surgical contouring strain in multi-level thoracolumbar fusion.
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ASTM F1717 dynamic fatigue cycles verified
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Maximum polyaxial tulip articulation angle
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Full lot traceability via micro-laser marking
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Turnaround on tender engineering queries
Product Recommendation & System Selection
Pedicle Screw System Solutions for Thoracolumbar Fixation
Designed to address degenerative spine conditions, trauma fractures, spondylolisthesis, and complex deformities. Orthomanufacturer Medical Co., Ltd provides high-precision implant configurations with matching ergonomically validated surgical instrumentation.
Monoaxial & Sagittal Screws
Engineered for maximum rigidity in trauma cases and sagittal alignment correction. Rigid tulip head design ensures optimal load transfer across unstable spinal segments.
Reduction Pedicle Screws
Integrated extended tabs allow up to 20mm of gradual reduction force for spondylolisthesis and burst fracture reduction without demanding separate reduction instruments.
Percutaneous MIS Screws
Fully cannulated design optimized for K-wire guided minimally invasive spine procedures. Reduces operative trauma, soft-tissue disruption, and intraoperative blood loss.
Fenestrated Cement Screws
Side-port fenestrations enable polymethylmethacrylate (PMMA) bone cement injection directly through the screw core, drastically increasing pull-out strength in osteoporotic bone.
Spinal Surgical Instrument Set
Comprehensive reusable surgical trays containing quick-connect drivers, polyaxial benders, torque-limiting handles, pedicle probes, and rod benders in anodized sterilization cases.
Precision ManufacturingSwiss Machining · Passivation · CMM Inspection
Engineering Depth & Information Gain
Biomechanical Rigor in Pedicle Screw System Architecture
Global procurement teams evaluating pedicle screw systems must look beyond basic dimensions. The clinical performance of a spine construct relies on three vital factors: thread pitch taper dynamics, tulip head friction stability, and cross-thread resistance in the locking set screw.
At Orthomanufacturer Medical Co., Ltd, our pedicle screw systems are engineered with a dual-lead thread design that cuts insertion time in half while maximizing cortical purchase. The buttress or reverse angle set screw thread eliminates tulip splay under high tightening torque, securing 5.5mm or 6.0mm titanium rods with consistent clamping force.
- ASTM F136 Ti-6Al-4V ELI: Premium medical-grade titanium alloy providing high yield strength and exceptional biocompatibility.
- Dynamic Friction Polyaxial Saddle: Retains tulip orientation during rod placement, preventing annoying floppiness during surgery.
- Anti-Cross Threading Set Screws: Reverse-angle thread profile redirects radial forces inward, suppressing head expansion.
- Validated ASTM F1717 Testing: Exceeds 10 million cycles under cyclic bending fatigue without dynamic construct failure.
Global Market Insights
Future Procurement & Development Trends in Pedicle Screw Systems
As spine surgery transitions toward minimally invasive techniques, digital navigation, and cost-efficient supply chains, orthopedic distributors must adapt their sourcing strategies.
1. Surgical Robotics & AI Navigation
Modern operating rooms require pedicle screws engineered with high-precision reference geometries and tight instrument tolerances that pair seamlessly with optical and electromagnetic surgical robotic arrays.
2. Shift Toward Outpatient MIS (ASC)
Ambulatory Surgery Centers (ASCs) favor single-pass MIS cannulated pedicle screw kits with streamlined instrumentation that shorten operative time, reduce sterilization processing, and minimize tissue disruption.
3. Bioactive & Porous Modifications
Next-generation pedicle screws utilize 3D-printed porous titanium tips, hydroxyapatite (HA) plasma coatings, or surface micro-texturing to promote early osseointegration and combat pull-out in osteopenic bone.
4. Modular Private-Label OEM Sourcing
Distributors are consolidating vendors in favor of qualified OEM manufacturers like Orthomanufacturer Medical Co., Ltd capable of delivering full regulatory technical files, custom color coding, and localized packaging.
Manufacturing & OEM Excellence
Pedicle Screw System Precision Manufacturing
Every pedicle screw, rod, cross-link, and set screw produced at Orthomanufacturer Medical Co., Ltd follows rigorous quality control workflows to guarantee zero-defect surgery.
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ASTM F136 Material Verification
Raw bar stock of Ti-6Al-4V ELI titanium alloy is verified through optical emission spectroscopy and chemical analysis against mill certs.
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5-Axis CNC Swiss Turning
High-speed Swiss-type lathes machine dual-lead threads, internal drive hexalobe recesses, and cannulated channels with sub-micron precision.
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Anodizing & Surface Finishing
Controlled anodic oxidation creates durable color-coded size identification while electropolishing eliminates microscopic surface stress points.
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CMM & Optical Thread Inspection
Automated coordinate measuring machines (CMM) and optical comparators verify pitch, major/minor diameter, and tulip articulation torque.
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Micro-Laser Marking & UDI
Part numbers, lot identifiers, diameters, and lengths are laser-marked on each screw tulip for complete traceability from raw material to implantation.
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Class 100,000 Cleanroom Packaging
Cleaned in multi-stage ultrasonic baths with purified RO water, then packaged in double-sterile blister pouches ready for global distribution.
Technical Reference
Pedicle Screw System Specifications & Material Matrix
Review standard sizing, material grades, and surgical indications for our thoracolumbar spinal fixation portfolio.
| Implant Variant | Material Standard | Diameter Options | Length Range | Surgical Indication |
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| Polyaxial Pedicle Screw | ASTM F136 Ti-6Al-4V ELI | 4.5mm / 5.5mm / 6.5mm / 7.5mm | 25mm – 55mm (5mm increments) | Thoracolumbar degenerative disc disease, spondylolisthesis, spinal stenosis |
| Monoaxial Pedicle Screw | ASTM F136 Ti-6Al-4V ELI | 5.5mm / 6.5mm / 7.5mm | 30mm – 55mm | Spinal trauma, vertebral burst fractures, rigid deformity reconstruction |
| Reduction Pedicle Screw | ASTM F136 Ti-6Al-4V ELI | 5.5mm / 6.5mm / 7.5mm | 35mm – 55mm | High-grade spondylolisthesis reduction, kyphosis correction |
| MIS Cannulated Pedicle Screw | ASTM F136 Ti-6Al-4V ELI | 4.5mm / 5.5mm / 6.5mm / 7.5mm | 30mm – 60mm | Percutaneous minimally invasive spine surgery (MIS TLIF) |
| Fenestrated Pedicle Screw | ASTM F136 Ti-6Al-4V ELI | 5.5mm / 6.5mm / 7.5mm | 35mm – 55mm | Severe osteoporotic bone fixation with PMMA bone cement augmentation |
| Spinal Fixation Rods | ASTM F136 Ti-6Al-4V ELI / CoCr | Ø 5.5mm / Ø 6.0mm | 40mm – 400mm (Pre-contoured/Straight) | Spinal construct stabilization across thoracolumbar levels |
* Customized diameter, special thread pitch, and private-label laser etching are available upon engineering review by Orthomanufacturer Medical Co., Ltd.
OEM Partner Journey
Turnkey OEM & Private Label Pedicle Screw Sourcing
From customized CAD modification to regulatory technical file compilation, we streamline every step of your private-label spine portfolio launch.
1. Engineering Review
Analysis of your target specifications, local regulatory rules, and volume goals.
2. CAD & Prototype
Rapid 3D drafting, prototype machining, and insertion torque testing.
3. Sample Validation
Evaluation of physical sample sets for tulip articulation, drive fit, and finish.
4. Batch CNC Production
Controlled batch machining, passivation, anodizing, and micro-laser marking.
5. Regulatory Dossier
Full ISO 13485 test dossiers, material certs, and sterile packaging delivery.
Search Intent & FAQ
Frequently Asked Questions on Pedicle Screw Sourcing
Answers to common engineering, regulatory, and procurement questions asked by global distributors and hospital purchasing leads.
How does Orthomanufacturer Medical ensure pedicle screw pull-out strength and structural stability?
We utilize high-grade Ti-6Al-4V ELI (ASTM F136) titanium alloy combined with dual-lead, tapered thread geometries. Dual-lead threads increase bone-implant contact area while doubling insertion speed. Furthermore, all pedicle screw configurations undergo rigorous ASTM F1717 static compression bending, torsion, and 10-million-cycle dynamic fatigue testing to guarantee structural endurance.
What are the primary differences between monoaxial, polyaxial, and reduction pedicle screws?
Monoaxial screws feature a fixed tulip head for maximal construct rigidity, ideal for trauma and deformity stabilization. Polyaxial screws feature a spherical saddle allowing up to 50° omnidirectional movement to accommodate anatomical rod placement. Reduction screws incorporate extended break-away tabs designed to pull slipped vertebrae back to the alignment rod in spondylolisthesis cases.
Can Orthomanufacturer Medical Co., Ltd support custom OEM and private-label projects?
Yes. We specialize in custom OEM and private-label pedicle screw production. Our engineering team supports custom laser marking (brand logos, UDI barcodes, size dimensions), specialized anodized color coding, custom tray configurations, and modifications to tulip profile or thread pitch tailored to your regional hospital preferences.
Are your MIS cannulated pedicle screws compatible with surgical navigation platforms?
Yes. Our percutaneous MIS pedicle screw systems feature standardized cannulated inner lumens compatible with standard 1.5mm/1.6mm K-wires. Tight machining tolerances across drivers, taps, and screw heads allow smooth integration with optical and electromagnetic surgical navigation arrays used in modern operating rooms.
What regulatory technical documentation is provided to support local product registration?
We provide complete registration support, including ISO 13485 system certificates, ASTM F136 raw material certificates, mechanical test reports (ASTM F1717), packaging validation, sterilizer processing IFUs, and technical dossiers required by health authorities across Europe, Latin America, the Middle East, and Asia.
How can global distributors request a sample kit for evaluation?
You can request a physical sample kit by contacting our export department at [email protected] or clicking the Inquire Now button on this page. Qualified distributors can test tactile driver engagement, tulip articulation friction, and surface quality firsthand prior to placing production orders.
Global Partner Portal
Start Your Pedicle Screw System Sourcing Today
Connect directly with our senior biomedical engineers and export specialists to obtain technical drawings, price lists, and OEM project quotes tailored to your region.
- Direct manufacturer pricing with no intermediate agent markups
- Full regulatory support dossier for rapid market authorization
- Sample kits available for technical and clinical evaluation
Contact Our Export Engineering Team
Send your product list and technical specifications for immediate review.
Email Direct[email protected]
- Provide requested screw diameters, lengths, and quantities
- Indicate market destination and registration timeline
- Specify private-label or OEM packaging requirements