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Ti-6Al-4V ELI Titanium Pedicle Screw Spinal Fixation

High-strength spinal stabilization components engineered for maximum pull-out strength and dynamic fatigue resistance through micron-level 5-axis manufacturing.

Our Advantages：

Material Integrity: Grade 23 Ti-6Al-4V ELI per ASTM F136 standards.

Precision Class: Dimensional tolerances strictly maintained at ±0.01mm.

Thread Profile: 4H medical grade precision threads for maximum purchase.

Machining Logic: 5-axis simultaneous milling for superior concentricity.

System Compliance: ISO 13485:2016 certified medical production line.

Surface Standard: Controlled Ra 0.4 - 0.8 μm for direct bone contact.

Ti-6Al-4V ELI Titanium Pedicle Screws

Technical Specifications for Spinal Fixation Screws

Parameter	Technical Requirements
Material Grade	Ti-6Al-4V ELI (ASTM F136 / ISO 5832-3)
Machining Process	Simultaneous 5-Axis CNC Milling & Turning
Diameter Range	3.5mm, 4.0mm, 4.5mm, 5.0mm, 5.5mm, 6.0mm, 7.5mm
Length Range	10mm – 60mm (available in 2mm increments)
Dimensional Tolerance	±0.01mm (Critical fit zones ±0.005mm)
Thread Accuracy	Medical Grade 4H Precision Threads
Surface Roughness	Ra 0.4 - 0.8 μm (As machined or polished)
Certifications	ISO 13485:2016, full Material Test Reports (MTR)

Custom Titanium Pedicle Screws

Subtractive 5-Axis Milling for Fatigue Resistance

Our manufacturing process utilizes solid medical grade titanium bar stock, bypassing the structural risks associated with forged components. By leveraging the same high-precision technology used for 5-axis zygomatic implants, we maintain the longitudinal grain flow of the metal. This single-setup subtractive milling increases dynamic fatigue strength by 40%, preventing implant failure under the multi-axial stresses of spinal stabilization.

Precision Thread Geometry and Pull-out Strength

We utilize high-speed thread milling to achieve a 4H fit. The dual-lead thread design, combined with a tapered core, optimizes torque transmission and increases bone-to-implant contact (BIC), ensuring the orthopedic implants remain stable even in osteoporotic bone environments.

FDA Approved Titanium Pedicle Screws

Metrology and Regulatory Validation Protocols

All production follows a rigorous validation cycle to ensure 100% compliance with surgical requirements for medical grade titanium components.

Dimensional Verification via CMM and Vision Systems

Post-machining, every lot undergoes coordinate measuring machine (CMM) analysis. We verify critical drive interfaces (Torx/Hex) and thread crest diameters to ensure zero-slip engagement with surgical instrumentation and locking nuts.

Material Traceability and Laser Identification

Full traceability is documented from the raw titanium heat lot to the final packaged unit. Each screw is laser-marked with a Unique Device Identifier (UDI) to meet global regulatory standards for implant tracking.

Polyaxial Titanium Pedicle Screws

Industrial Applications in Orthopedic Implants

Our CNC machined pedicle screws are integral components for various orthopedic implants and spinal systems:

Degenerative Disc Disease

Rigid fixation for interbody fusion.

Scoliosis Correction

Multi-level stabilization for sagittal alignment.

Trauma Care

Posterior fixation for vertebral fractures.

Spinal Oncology

Structural support following tumor resection.

Get A Quote for Spinal Pedicle Screws

FAQs

5-Axis CNC Machined Polyaxial Titanium Pedicle Screw

01.Why is Ti-6Al-4V ELI required for spinal pedicle screws?

Ti-6Al-4V ELI (Grade 23) offers superior fracture toughness and lower oxygen content compared to standard Grade 5 titanium. In spinal fixation, this translates to better resistance against cyclic loading and higher biocompatibility, reducing the risk of long-term implant rejection.

02.Does your CNC process eliminate the need for secondary finishing?

While our 5-axis milling achieves Ra 0.8 finishes as-machined, we offer secondary SLA (Sandblasted, Large-grit, Acid-etched) treatments. This creates a micro-topography that is clinically proven to accelerate osseointegration and shorten patient recovery times.

03.How do you ensure the concentricity of polyaxial screw heads?

By using a single-setup 5-axis machining strategy, the screw shank and the spherical head are machined in the same coordinate system. This eliminates the run-out errors found in multi-stage production, ensuring smooth ±30° movement of the polyaxial housing.

04.Can you provide material certification for medical audits?

Yes. Every shipment includes a complete Material Test Report (MTR) confirming ASTM F136 compliance, alongside a Certificate of Conformance (CoC) and detailed CMM dimensional reports for your quality management records.

05.What surface treatments assist in osseointegration?

We provide SLA (Sandblasted, Large-grit, Acid-etched) finishes that create a micro-rough surface, which is clinically proven to accelerate bone-to-implant contact (BIC).

06.How does the ±0.01mm tolerance affect surgical outcomes?

High-precision tolerances ensure that the pedicle screw interfaces perfectly with rods and locking nuts. This prevents mechanical play within the spinal construct, significantly reducing the incidence of post-operative component loosening and "fretting" corrosion.

Optimize your spinal fixation system with ±0.01mm precision.
Upload your 2D/3D CAD files (STEP, IGS, or DXF) for an immediate DFM review and technical quote. Our engineering team provides feedback within 24 hours.

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