Titanium Spinal Pedicle Screw is a precision-manufactured polyaxial pedicle screw component designed for Polyaxial pedicle screw for spinal fixation. Fabricated from Ti-6Al-4V ELI, this component meets the stringent requirements of sterile surgical environments including corrosion resistance to bodily fluids, compatibility with repeated autoclave cycles, and non-magnetic properties for MRI compatibility.
Titanium Spinal Pedicle Screw
| Technical Parameter | Specification |
|---|---|
| Component SKU | TI-MD-SPI-SPINAL |
| Standards & Specifications | MIL-STD-810HASTM B117 |
| Surface Finish | PVD TiAlN coating (2-3um, HV2500) |
Titanium Spinal Pedicle Screw
Polyaxial pedicle screw for spinal fixation
| Technical Parameter | Specification Value |
|---|---|
| International Compliance | MIL-STD-810H, ASTM B117 |
| Surface Finish & Max Temp | PVD TiAlN coating (2-3um, HV2500) |
- • 100% Traceability: Mill Test Certificate (EN 10204 3.1) with heat analysis & mechanical testing.
- • Compliance: REACH, RoHS 3 certified. FAI AS9102 available.
- • Process: 5-axis CNC contouring, electropolishing, ultrasonic clean, vision inspection.
- • Thermal Stress Relief: Post-machining vacuum annealing (540-675°C under Argon) reduces distortion risk >70%.
- • Rolled Threads: Thread rolling (not cutting) increases fatigue limits by 30-50%.
Q: What biocompatibility standards does Titanium Spinal Pedicle Screw comply with? ▼
Titanium Spinal Pedicle Screw is manufactured from Ti-6Al-4V ELI which meets ISO 10993 biocompatibility requirements including cytotoxicity, sensitization, and irritation testing. The material's long clinical history in surgical and implantable devices provides documented biocompatibility data. All processing chemicals are selected to avoid leachables that could affect polyaxial pedicle screw performance.
Q: What is the typical lead time for Titanium Spinal Pedicle Screw orders? ▼
Standard lead time for Titanium Spinal Pedicle Screw is 15-25 business days depending on quantity and complexity. Rush orders (3-5 working days) are available for prototype evaluation. Sample evaluation (1-5 units) can be expedited to 5-7 business days. Volume pricing is available for production quantities above 100 units.
Q: What material certifications are provided with Titanium Spinal Pedicle Screw? ▼
Each Titanium Spinal Pedicle Screw shipment includes EN 10204 Type 3.1 mill test certificate with chemical analysis, mechanical properties, and heat identification. Dimensional inspection reports and Certificate of Conformance (CoC) are standard. First Article Inspection Reports (FAIR) per AS9102 are available on request for polyaxial pedicle screw.
§ Why Ti-6Al-4V ELI for polyaxial pedicle screw
Function
Designed for Medical Device applications, this component fulfills the role of . The use of Ti-6Al-4V ELI (ASTM F136) ensures long-term reliability in this Spine Fixation configuration.
Specifications
- SKU: TI-MD-SPI-SPINAL
- Category: Spine Fixation
- Industry: Medical Device
- Material: Ti-6Al-4V ELI (ASTM F136)
- Process: 5-axis CNC contouring, electropolishing, ultrasonic clean, vision inspection
- Weight: Weight optimized through topology analysis - 30% lighter than baseline
§ Biocompatibility & Dimensional Inspection
Quality Management
Manufactured under ISO 9001:2015 with full EN 10204 Type 3.1 material traceability from ingot to finished Titanium Spinal Pedicle Screw. All critical features are CMM-verified and documented in the First Article Inspection Report.
Inspection & NDT
100% CMM dimensional inspection per ISO 10360 on critical features; surface roughness verification per ISO 4287; material grade verification via PMI
§ Surgical-Grade Manufacturing Process
Titanium Spinal Pedicle Screw is manufactured using 5-axis cnc contouring, electropolishing, ultrasonic clean, vision inspection. Each operation is performed by certified machinists with real-time process monitoring and dimensional verification at critical stages. Heat code traceability is maintained throughout all production steps.
Commercial Logistics & Procurement Framework
Pricing and lead times for Titanium Spinal Pedicle Screw are batch-dependent. Contact our supply chain team for volume-based tiered pricing.
Regulatory & Quality Assurance Ledger
Verifiable certifications for Titanium Spinal Pedicle Screw
Material Test Certificate (MTC)
EN 10204 3.1
Environmental Compliance
REACH (EC No 1907/2006)
Restricted Substances
RoHS 3 Directive (2015/863/EU)
Dimensional Tolerances
ISO 2768-m
Standard: MIL-STD-810H
MIL-STD-810H
Standard: ASTM B117
ASTM B117
Systems Interconnectivity & Topology
Cross-functional integration matrix for Tier-1 supply chains and assembly orchestration.
- ▸ Platform Interface Plate
- ▸ System Integration Frame
Titanium Spinal Pedicle Screw
Material: Ti-6Al-4V ELI (ASTM F136)
SKU: TI-MD-SPI-SPINAL
Industry: Medical Device / System: Trauma & Spine Fixation Hardware
- ▸ Retention Clip Assembly
- ▸ Compression Spring Set
- ▸ Installation Tool
定制钛组件
Ready to manufacture Titanium Spinal Pedicle Screw (SKU: TI-MD-SPI-SPINAL)? Contact our engineering team for a custom solution.
定制钛组件Related Knowledge
One Metal. One Focus. Infinite Precision.
Founded in 2011 in Baoji's Titanium Valley, BOZE Metal is dedicated exclusively to titanium — from raw material to precision engineering. AS9100D, ISO 13485 & ISO 9001 certified with 500+ clients across Aerospace, Medical & Motorsport industries, we deliver end-to-end precision titanium CNC machining with full material traceability from source to component.
Boze Titanium Manufacturing Center is operated by Baoji Boze Metal Products Co., Ltd.