TC4 titanium alloy medical tube | intramedullary nail special substrate builds a solid foundation for orthopedic implant medical care

——Empowering precise treatment of orthopedic intramedullary fixation surgery with biocompatibility and mechanical adaptability
 

In orthopedic intramedullary nail implantation surgery, the biocompatibility, mechanical compatibility, and molding accuracy of the substrate directly determine the surgical effect and patient recovery process. We are deeply engaged in the field of medical titanium materials, strictly following the GB/T 13810-2007 standard "Titanium and Titanium Alloy Processing Materials for Surgical Implants", and creating TC4 titanium alloy medical tubes, specially customized for intramedullary nail implantation instruments. With excellent biological safety, biomimetic mechanical properties, and high-precision molding quality, it has become the core substrate supplier for orthopedic implant instrument manufacturers.

1、 Core advantage: Medical grade performance characteristics that are compatible with intramedullary nails

TC4 titanium alloy medical tube achieves three core breakthroughs in material characteristics and processing accuracy for the implantation scenario of intramedullary nails, fully meeting the strict requirements of surgical implant instruments:

1. Excellent biocompatibility

The pipe material is made of medical grade TC4 titanium alloy with low clearance impurities, which does not contain allergenic metal elements such as nickel and chromium. After implantation in the human body, there is no rejection reaction. After surface electrochemical polishing treatment, it can induce bone cell adhesion and growth, achieve the effect of "bone integration", reduce the risk of postoperative loosening, and meet the ISO 10993 biocompatibility certification standard. It has passed the medical implant material admission test of the National Medical Products Administration.

2. Matching degree of biomimetic mechanics

The elastic modulus of TC4 titanium alloy (about 110GPa) is closer to that of human bones (about 10-30GPa) and far superior to stainless steel (about 200GPa). When used as a base material for intramedullary nails, it can effectively avoid the "stress shielding" effect and prevent osteoporosis and secondary fractures caused by long-term insufficient stress on the bones after surgery; At the same time, the tensile strength of the pipe is ≥ 930MPa and the yield strength is ≥ 860MPa, which can provide stable support for the fracture site and have a certain degree of toughness, adapting to the changes in bone stress during human movement.

3. High precision molding quality

Adopting medical grade precision rolling and CNC boring technology, the outer diameter tolerance of the pipe is ≤± 0.03mm, the wall thickness uniformity error is ≤ 0.02mm, and the inner wall roughness Ra is ≤ 0.1 μ m. It can be directly processed into different specifications of intramedullary nails (such as femoral intramedullary nails and tibial intramedullary nails), and its precise dimensional accuracy ensures the fit between the intramedullary nail and the bone marrow cavity, reduces the stimulation of the inner wall of the bone marrow cavity, and lowers the probability of postoperative infection and pain. The forming pass rate is over 99.8%.

2、 Customized specifications: covering the production needs of all categories of intramedullary nails

TC4 titanium alloy medical tubes can provide multi-dimensional customized specifications to meet the intramedullary nail needs of patients in different parts and age groups, and are suitable for various orthopedic implantation scenarios

3、 Production and quality control: strict control over the entire medical grade process

1. Medical grade raw material control

Select medical TC4 titanium alloy castings that comply with ASTM F136 standards, and melt them at least 3 times in a vacuum consumable arc furnace to ensure uniform composition and impurity content (such as oxygen, nitrogen, hydrogen) below medical standard limits. Each batch of raw materials is accompanied by a third-party medical material testing report to achieve full process traceability.

2. Aseptic production process

The pipe processing is completed in a clean workshop, using medical grade processing materials throughout the process to avoid pollution such as oil stains and metal debris; The finished product is sterilized with ethylene oxide and provided with sterile packaging, which can be directly delivered to the equipment manufacturer for subsequent processing, reducing material damage in the secondary sterilization process.

3. Comprehensive medical testing

Each pipe passes through:

-Mechanical performance testing (including tensile, bending, and fatigue testing to ensure long-term stability after implantation);

-Non destructive testing (Level I acceptance standard, without internal defects such as pores and cracks);

-Surface cleanliness testing (compliant with the residual limit of particles on the surface of medical implants);

-Corrosion resistance test (simulating human body fluid environment, corrosion resistance rate ≤ 0.0001mm/year) to ensure that the product fully meets the requirements for medical implants.

4、 Application value: Empowering orthopedic surgery and patient rehabilitation

1. For device manufacturers: The high precision and consistency of TC4 titanium alloy medical tubes can significantly reduce the scrap rate of intramedullary nail processing and shorten the production cycle; Medical grade qualifications and complete testing reports help manufacturers quickly complete the registration and application of implanted devices, improving the efficiency of product market access.

2. For medical institutions: Based on the excellent performance of TC4 titanium alloy, intramedullary nail implantation has strong fixation stability and fewer postoperative complications, which can shorten patient hospitalization time and improve surgical cure rate, especially suitable for complex fractures, osteoporotic fractures and other difficult cases.

3. For patients: good biocompatibility, postoperative incidence of adverse reactions<0.5%; High mechanical compatibility can accelerate fracture healing, reduce the pain and cost of long-term postoperative rehabilitation, and the non-magnetic nature of titanium material does not affect postoperative magnetic resonance imaging (MRI) follow-up, ensuring the convenience of subsequent diagnosis and treatment.

Core Supplier of Medical Titanium Alloy Tubes!

Relying on the industrial advantages of "China Titanium Valley" and the specialized production line for medical titanium materials, the company has achieved large-scale and sterile production of TC4 medical titanium tubes, with an annual production capacity of 300 tons. It has served more than 30 well-known orthopedic instrument manufacturers in China, and its products are widely used in orthopedic intramedullary fixation surgeries in hospitals at all levels, becoming a reliable partner in the field of medical implantable titanium materials.

Choose TC4 Titanium Alloy Medical Tube to build a solid foundation for intramedullary nail implantation with medical grade quality, providing solid material support for orthopedic medicine and patient rehabilitation!