Titanium Ti-6Al-4V ELI implant component

1. Product Overview
The Titanium Ti-6Al-4V ELI (Extra Low Interstitial) implant component is a high-purity, biomedical-grade machined or forged part engineered for permanent surgical implantation. It is primarily used in orthopedic and spinal fixation devices, dental implants, and maxillofacial prostheses where exceptional fatigue resistance and biocompatibility are non-negotiable. Its key value proposition lies in eliminating cytotoxic elements while offering a 30% higher strength-to-weight ratio than stainless steel alternatives. Strategically, this product is critical for manufacturers navigating tightening global medical device regulations (FDA, MDR), as its certified ELI chemistry directly reduces implant rejection risk and litigation exposure.

2. Key Specifications & Technical Characteristics

• Material Composition: Ti-6Al-4V ELI per ASTM F136 (Al: 5.5–6.5%, V: 3.5–4.5%, Fe ≤ 0.25%, O ≤ 0.13%, N ≤ 0.03%, C ≤ 0.08%, H ≤ 0.012%, Ti balance)

• Purity / Grade: Medical Grade 23 ELI; oxygen content ≤ 0.13% (maximizes ductility & fracture toughness)

• Physical Form: Precision-machined component (or near-net forged blank) – matte metallic finish

• Density: 4.43 g/cm³

• Tensile Strength: ≥ 860 MPa (yield ≥ 760 MPa)

• Elongation: ≥ 10% (ensures structural resilience under cyclic load)

• Surface Condition: As-machined, polished (Ra ≤ 0.8 µm), or textured for osseointegration

• Packaging Options: Double sterile-sealed medical-grade polymer pouches + vacuum-sealed aluminum moisture barrier; ETO or Gamma sterilized upon request

• Shelf Life: 5 years from date of manufacture when stored in original, unopened packaging at 15–25°C

3. Core Industrial Applications

• Orthopedic & Spine (Primary): Used in pedicle screws, interbody cages, plates, and intramedullary nails. Outperforms stainless steel due to MRI compatibility and lower modulus (110 GPa vs. 210 GPa), reducing stress shielding.

• Dental Implant Systems: Component-level use in abutments, screws, and healing caps. Ti-6Al-4V ELI delivers superior torque resistance over pure titanium (Grade 4), reducing prosthetic screw fracture in high-masticatory-load zones.

• Maxillofacial & Cranial Plates: Preferred for cranioplasty and mandibular reconstruction because ELI grade permits cold forming and thinning without microcracking, improving patient anatomical fit.

• Cardiovascular & Prosthetic Housings: Used in pacemaker enclosures and LVAD connectors – non-ferromagnetic properties eliminate interference with electromagnetic guidance systems.

4. Competitive Advantages

• Quality Consistency: 100% traceability from mill lot to final component; each batch includes certified ASTM F136, ISO 5832-3, and raw material test reports (MTRs).

• Supply Reliability: Dual-sourced virgin sponge from certified US/EU suppliers; buffer stock of semi-finished billet ensures lead times ≤ 6 weeks for standard geometries.

• Logistics Capability: Climate-controlled global distribution hubs (Americas, EMEA, APAC) with real-time cold-chain tracking for sterile products.

• Price Competitiveness: Lower total landed cost vs. European and Japanese ELI suppliers due to optimized near-net forging (reduces machining waste by 35%).

• Environmental & Compliance: 92% of machining scrap recycled into non-implant alloys; full REACH, RoHS 3, and China RoHS declarations provided.

• Technical Support: Dedicated regulatory affairs team assists with 510(k) and CE Mark technical file submissions including biocompatibility (ISO 10993) data packages.

5. Commercial & Supply Information

• Minimum Order Quantity (MOQ): BULK 20 metric tons (mixed geometries permitted)

• Loading Capacity: 22 metric tons per 20-ft dry container (standard palletized sterile packaging)