Medical Titanium Wire

Key Alloy Grades & Biomedical Properties

1. Ti-6Al-4V ELI (ASTM F136, GR23)

•  Biocompatibility: ISO 13485 and FDA 510(k) compliant for long-term implantation

•  Low Interstitial Content: Reduced O₂, N₂, H₂ to minimize tissue reaction

•  High Strength: Tensile strength 860–1030 MPa, ideal for load-bearing implants

2. Pure Titanium (ASTM F67, GR1)

•  99.5% Pure Ti: Excellent formability for delicate surgical wires

•  Corrosion Resistance: Passive TiO₂ film stable in body fluids (pH 7.4)

•  Biological Inertness: Ideal for dental fixtures and temporary implants

Mechanical Specifications

Dimensions & Sterilization Options

Wire Diameter Range

•  Micro-Fine: 0.05 mm to 0.5 mm (neurosurgical applications)

•  Standard: 0.5 mm to 5.0 mm (orthopedic wires)

•  Tolerance: ±0.002 mm for diameters ≤0.5 mm

•  Spool Configurations: Sterile blister packs (1 m/5 m/10 m) or bulk reels (up to 100 m)

Surface & Sterilization

Medical Applications

1. Orthopedic Implants

 Use Cases:

•  Bone fixation wires for fracture repair

•  Spinal fusion cables and rods

•  Joint replacement components (hip/knee)

•  Advantage: Osseointegrative surface promotes bone growth within 6–8 weeks.

2. Dental & Craniofacial

 Use Cases:

•  Dental implant abutments and anchors

•  Cranial fixation wires for trauma surgery

•  Maxillofacial reconstruction plates

•  Compliance: Meets ISO 14630 for medical device manufacturing.

3. Minimally Invasive Surgery

 Use Cases:

•  Endoscopic guide wires

•  Cardiovascular stents and embolization coils

•  Laparoscopic surgical sutures

•  Design Feature: Ultra-flexible wires with memory shape for precise placement.

Quality Assurance & Regulatory Compliance

 Biocompatibility Testing:

•  Cytotoxicity (ISO 10993-5)

•  Genotoxicity (ISO 10993-3)

•  Systemic toxicity (ISO 10993-11)

 Sterility Assurance:

•  SAL 10⁻⁶ (Sterility Assurance Level)

•  Validated sterilization records provided

 Regulatory Approvals:

•  CE Mark (MDR 2017/745)

•  FDA 510(k) clearance (GR23 products)

•  ISO 13485:2016 certified manufacturing

Custom Solutions for Medical Devices

 Tailored Services:

•  Custom alloy development (e.g., Ti-Nb-Zr for reduced modulus)

•  Nitride coating (TiN) for wear resistance in joint implants

•  Pre-formed shapes (hooks, loops) for surgical ease

 R&D Collaboration:

•  Material testing for new medical device prototypes

•  Surface modification for enhanced biocompatibility

•  Regulatory documentation support (DMF filing)

Packaging & Supply Chain

 Sterile Packaging:

•  ISO 11607-1 compliant peel pouches

•  Tamper-evident seals with sterility indicators

•  Lot number and expiration date traceability

 Logistics:

•  Cold chain distribution (2–8°C for sensitive products)

•  Lead times: 2–4 weeks for standard sizes, 6–8 weeks for custom

•  GMP-certified warehousing to maintain sterility

Why Choose BYC Ti for Medical Titanium Wire?

1. Biomedical Expertise: 15+ years supplying to top orthopedic and dental manufacturers

2. Purity Control: Vertical integration from titanium sponge to finished wire

3. Clinical Validation: Wires used in over 1 million successful implant procedures