As a leading China-based medical titanium alloy manufacturer with over 20 years of experience, we supply precision-manufactured titanium products fully certified to ISO 13485, ASTM F67 and ASTM F136 standards. From orthopedic implants to dental devices and surgical instruments, our medical-grade titanium alloys deliver reliable performance that meets the demanding safety requirements of the global healthcare industry.
| Item | Details |
|---|---|
| Executive Standards | 1. Medical Material Standards: ASTM F67 (Pure Titanium), ASTM F136 (Ti-6Al-4V ELI), ISO 5832-2, ISO 5832-3
2. Quality Management Standards: ISO 13485, FDA 21 CFR Part 820 3. Testing Standards: ASTM E8, ASTM G31 (Corrosion), ASTM F1295 (Biocompatibility) 4. Surface Finish Standards: ASTM B600, Ra 0.2-0.8 μm for implant applications |
| Material Grades | 1. Titanium Grade 2 (UNS R50400): Commercially pure titanium, excellent formability and biocompatibility
2. Titanium Grade 4 (UNS R50700): Highest strength pure titanium, good corrosion resistance 3. Titanium Grade 5 (UNS R56400): Ti-6Al-4V, high strength alloy for non-implantable medical devices 4. Titanium Grade 7 (UNS R52400): Ti-0.2Pd, superior crevice corrosion resistance for dental implants 5. Titanium Grade 23 (UNS R56407): Ti-6Al-4V ELI (Extra Low Interstitial), highest biocompatibility for long-term implants |
| Chemical Composition (Weight %) | Grade 2: Ti≥99.2, O≤0.25, Fe≤0.30, C≤0.08, N≤0.03, H≤0.015
Grade 4: Ti≥98.6, O≤0.40, Fe≤0.50, C≤0.08, N≤0.05, H≤0.015 Grade 5: Ti=Balance, Al5.5-6.75, V3.5-4.5, Fe≤0.30, O≤0.20, C≤0.08, N≤0.05, H≤0.015 Grade 7: Ti=Balance, Pd0.12-0.25, O≤0.25, Fe≤0.30, C≤0.08, N≤0.03, H≤0.015 Grade 23: Ti=Balance, Al5.5-6.5, V3.5-4.5, Fe≤0.25, O≤0.13, C≤0.08, N≤0.05, H≤0.0125 Note: Lower interstitial elements in Gr.23 provide superior biocompatibility and fatigue resistance |
| Mechanical Properties (Annealed State) | Grade 2: Tensile≥345MPa, Yield≥275MPa, Elongation≥20%, HB≤120
Grade 4: Tensile≥550MPa, Yield≥485MPa, Elongation≥15%, HB≤160 Grade 5: Tensile≥895MPa, Yield≥825MPa, Elongation≥10%, HB≤300 Grade 7: Tensile≥345MPa, Yield≥275MPa, Elongation≥20%, HB≤120 Grade 23: Tensile≥860MPa, Yield≥795MPa, Elongation≥10%, HB≤290 Modulus of Elasticity: 110 GPa (matches human bone closely) |
| Dimensional Tolerance | 1. Seamless Tubes: OD0.5-50mm ±0.05mm; Wall thickness ±0.03-0.08mm
2. Round Bars/Rods: Ø0.8-50mm ±0.05mm; Ø50-150mm ±0.1mm 3. Precision Ground Bars: Ø1-30mm ±0.01mm; Straightness ≤0.1mm/m 4. Length Tolerance: ±0.5mm (0.1-3m); custom lengths up to 6m available 5. Surface Finish: Ra 0.2-0.8 μm for implant applications; Ra 1.6-3.2 μm for general use |
| Why These Materials Are Used in Healthcare Industry | 1. Exceptional Biocompatibility:
– Non-toxic, non-allergenic and non-carcinogenic to human tissue – Osseointegrative, allowing bone to grow directly onto the implant surface – No adverse immune reactions or inflammatory responses – The only material approved by FDA for long-term implantation in the human body 2. Superior Corrosion Resistance: – Forms a stable, self-healing titanium oxide layer that protects against body fluids – Immune to corrosion from blood, saliva, urine and other bodily secretions – Eliminates metal ion release that can cause tissue damage and allergic reactions – Gr.7 provides additional crevice corrosion resistance for dental implants 3. Optimal Mechanical Properties: – Excellent strength-to-weight ratio, 40% lighter than stainless steel – Low modulus of elasticity (110 GPa) that matches human bone (10-30 GPa) – Reduces stress shielding, a common cause of implant failure – Excellent fatigue resistance for long-term implant performance 4. Excellent Fabricability: – Good formability for complex implant shapes – Excellent machinability for precision surgical instruments – Compatible with all common surface treatments including anodization and coating – Can be sterilized by all standard methods without degradation |
| Application Scenarios and Corresponding Customers | 1. Orthopedic Implants:
– Applications: Hip and knee replacements, spinal fusion devices, bone plates, screws, nails, rods – Customers: Johnson & Johnson, Medtronic, Stryker, Zimmer Biomet, Smith & Nephew 2. Dental Implants and Devices: – Applications: Dental implants, abutments, crowns, bridges, orthodontic brackets, surgical instruments – Customers: Nobel Biocare, Straumann, Dentsply Sirona, Zimmer Biomet Dental, 3M Oral Care 3. Surgical Instruments: – Applications: Forceps, scissors, retractors, clamps, needle holders, laparoscopic instruments – Customers: B. Braun, Aesculap, Ethicon, Medline, Integra LifeSciences 4. Cardiovascular Devices: – Applications: Stents, pacemaker cases, defibrillator components, heart valve parts – Customers: Boston Scientific, Medtronic, Abbott, Edwards Lifesciences, Siemens Healthineers 5. Medical Equipment: – Applications: Surgical tables, MRI components, X-ray equipment, sterilization trays, instrument cases – Customers: Siemens Healthineers, GE Healthcare, Philips Healthcare, Hill-Rom, Stryker Medical |
| Customer Requirements in This Industry | 1. Performance Requirements:
– Biocompatibility: Must meet ISO 10993 and FDA biocompatibility standards – Corrosion Resistance: Must resist corrosion in body fluids for the lifetime of the implant – Mechanical Strength: Must withstand physiological loads and cyclic fatigue – Surface Quality: Must have a smooth, defect-free surface to prevent bacterial adhesion – Sterilizability: Must withstand repeated sterilization cycles without degradation 2. Quality and Compliance Requirements: – Medical Certification: Must meet ISO 13485, ASTM F67, ASTM F136 and FDA requirements – Full Traceability: Must provide complete traceability from titanium sponge to finished product – Material Certification: Must provide comprehensive MTRs including chemical analysis and mechanical properties – Cleanliness Requirements: Must meet strict cleanliness standards for medical devices – Third-Party Inspection: Must allow inspection by authorized medical device auditors 3. Manufacturing Requirements: – Precision Dimensional Tolerances: Must meet tight tolerances for proper fit and function – Surface Finish Control: Must provide consistent surface finishes for implant applications – Internal Quality: Must be free from inclusions, porosity and segregation (100% UT verified) – Consistent Quality: Must have uniform chemical composition and mechanical properties across all batches – Customization: Must produce custom sizes and shapes per customer drawings |
| Common Related Products in This Industry | 1. Medical Titanium Seamless Tubes: For cardiovascular stents, catheters and surgical instruments
2. Medical Titanium Round Bars/Rods: For implant blanks, screws, nails and surgical instruments 3. Precision Ground Titanium Bars: For high-precision implant components 4. Titanium Forgings: Custom forgings for hip and knee implants, spinal devices 5. Titanium Wire: For sutures, orthodontic wires and springs 6. Titanium Sheets and Plates: For bone plates, cranial plates and medical equipment 7. Titanium Machined Components: Precision-machined implant parts and surgical instruments 8. Titanium Fasteners: Screws, nuts and bolts for medical devices 9. Titanium Dental Implant Blanks: Pre-machined blanks for dental implants 10. Custom Fabricated Assemblies: Pre-fabricated medical device components |
| Why Choose Us (Emily PIPE) | 1. 20+ Years of Medical Titanium Expertise: We have supplied titanium products to over 100 medical device manufacturers worldwide
2. Full Medical Certification: Our production facility is certified to ISO 13485 and meets FDA requirements 3. Complete Grade Range: We offer all five medical titanium grades in one place, simplifying your supply chain 4. Full-Process Quality Control: We implement comprehensive quality control from melting to final inspection 5. Advanced Manufacturing Capabilities: We use state-of-the-art equipment to produce precision medical titanium products 6. Clean Room Production: We have dedicated clean room facilities for medical product packaging 7. Professional Technical Support: Our team of metallurgical engineers provides expert material selection guidance 8. One-Stop Solution: We provide complete solutions from raw material supply to finished machined components |
| Supplementary Industry Information | 1. Comprehensive Test Reports: Each batch comes with a full MTR including chemical analysis, mechanical properties and NDT results. Biocompatibility test reports available upon request
2. Full Material Traceability: Every product has a unique heat number and complete traceability documentation 3. Value-Added Processing: We offer precision cutting, CNC machining, surface finishing and clean room packaging services 4. Prototype Development Support: We support small batch prototype orders with fast turnaround times 5. Market Growth: The global medical titanium market is projected to grow at a CAGR of over 8% through 2030, driven by aging populations and increasing demand for implantable devices 6. Sustainability Commitment: All our titanium products are manufactured using sustainable practices and are 100% recyclable |
| Packaging | 1. Plastic Caps: All tube/bar ends are protected with medical-grade polyethylene caps
2. Vacuum Sealing: Each product is individually vacuum-sealed in medical-grade packaging 3. Clean Room Packaging: Medical-grade products are packaged in Class 1000 clean rooms 4. Bundle Packing: Products of the same size are bundled with medical-grade straps 5. Wooden Case: Bundles are packed in sturdy fumigated wooden cases with steel reinforcement 6. Export Standard Packing: All packaging complies with international export standards and medical device regulations 7. Marking: Each package is clearly marked with product specifications, heat number, batch number and sterilization status |
Looking for medical-grade titanium bar or tube? Send us your size, quantity and application requirements. We will provide a suitable solution and competitive quotation.