Titanium Intramedullary Nail is a precision-manufactured tibialfemoral intramedullary nail component designed for Tibial/femoral intramedullary nail with locking holes. 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 Intramedullary Nail
| Technical Parameter | Specification |
|---|---|
| Component SKU | TI-MD-TRA-TITANI |
| Standards & Specifications | ISO 2768-mMIL-STD-810H |
| Surface Finish | Electropolishing Ra <0.4um + passivation |
Titanium Intramedullary Nail
Tibial/femoral intramedullary nail with locking holes
| Technical Parameter | Specification Value |
|---|---|
| International Compliance | ISO 2768-m, MIL-STD-810H |
| Surface Finish & Max Temp | Electropolishing Ra <0.4um + passivation |
- • 100% Traceability: Mill Test Certificate (EN 10204 3.1) with heat analysis & mechanical testing.
- • Compliance: REACH, RoHS 3 certified. FAI AS9102 available.
- • Process: CNC milling, secondary deburring, bead blast finish, final CMM 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 material traceability is provided with Titanium Intramedullary Nail? ▼
Each Titanium Intramedullary Nail shipment includes full material traceability from ingot to finished component with EN 10204 Type 3.1 mill test certificates documenting heat analysis and mechanical properties. Process traceability covers all manufacturing steps with batch records, inspection results, and device history records — compliant with FDA 21 CFR Part 820 and ISO 13485 requirements.
Q: What is the typical lead time for Titanium Intramedullary Nail orders? ▼
Standard lead time for Titanium Intramedullary Nail 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 Intramedullary Nail? ▼
Each Titanium Intramedullary Nail 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 tibialfemoral intramedullary nail.
§ Why Ti-6Al-4V ELI for tibialfemoral intramedullary nail
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 Trauma Fixation configuration.
Specifications
- SKU: TI-MD-TRA-TITANI
- Category: Trauma Fixation
- Industry: Medical Device
- Material: Ti-6Al-4V ELI (ASTM F136)
- Process: CNC milling, secondary deburring, bead blast finish, final CMM inspection
- Weight: Up to 55% weight savings compared to stainless steel alternatives
§ Biocompatibility & Dimensional Inspection
Quality Management
Quality system compliant with ISO 9001:2015. Each Titanium Intramedullary Nail batch includes full material traceability, dimensional inspection results, and a Certificate of Conformity (CoC).
Inspection & NDT
Vision-based optical inspection for surface defects; helium leak testing for sealed interfaces; eddy current surface crack detection on high-stress areas
§ Surgical-Grade Manufacturing Process
Titanium Intramedullary Nail is manufactured using cnc milling, secondary deburring, bead blast finish, final cmm 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 Intramedullary Nail are batch-dependent. Contact our supply chain team for volume-based tiered pricing.
Regulatory & Quality Assurance Ledger
Verifiable certifications for Titanium Intramedullary Nail
Material Test Certificate (MTC)
EN 10204 3.1
Environmental Compliance
REACH (EC No 1907/2006)
Restricted Substances
RoHS 3 Directive (2015/863/EU)
Quality Management System
AS9100D
Dimensional Tolerances
ISO 2768-m
Standard: MIL-STD-810H
MIL-STD-810H
Systems Interconnectivity & Topology
Cross-functional integration matrix for Tier-1 supply chains and assembly orchestration.
- ▸ Device Enclosure Subassembly
- ▸ Internal Frame Structure
Titanium Intramedullary Nail
Material: Ti-6Al-4V ELI (ASTM F136)
SKU: TI-MD-TRA-TITANI
Industry: Medical Device / System: Medical Implants
- ▸ Assembly Hardware Pack
- ▸ Alignment Dowel Set
- ▸ Locking Mechanism
定制钛组件
Ready to manufacture Titanium Intramedullary Nail (SKU: TI-MD-TRA-TITANI)? 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.