Medical Plate Special Titanium Plate TA3G/TC4 Precision Polishing Label Plate Biocompatibility Benchmark
 

As the core product of our deep cultivation in the medical field, medical bone plate specialized titanium plate relies on the full chain advantage of medical grade titanium material processing in "China Titanium Valley", focusing on mass production of two main grades of TA3G pure titanium and TC4 titanium alloy, covering all categories of precision polished plates and standard plates. With the three core characteristics of "superior biocompatibility, ultra-high processing accuracy, and stable mechanical performance", it has passed the NMPA medical device registration certification and ISO 13485 quality management system certification, becoming a strategic supplier for top enterprises such as Dabo Medical. Its annual production capacity exceeds 120 tons, and its products are applied in more than 500 tertiary hospitals across the country, helping to upgrade the precision of orthopedic clinical treatment.

1. Core competitive advantage: Exclusive genes of medical grade titanium materials

Excellent biocompatibility

TA3G pure titanium purity is ≥ 99.6%, TC4 titanium alloy element ratio is precise, there are no sensitizing elements such as nickel and chromium, and the tissue rejection rate after implantation is ≤ 0.03%, far below the industry average of 0.1%. The surface oxide film is stable and forms a good bone bond with the human skeleton. The bone integration time is reduced by 15% -20% compared to traditional materials, which meets the GB/T13810-2017 standard for medical titanium and titanium alloy processing materials.

Precision mechanical matching

TA3G tensile strength ≥ 580MPa, elongation ≥ 20%, suitable for cancellous bone repair; TC4 has a tensile strength of ≥ 930MPa, a yield strength of ≥ 865MPa, and an elastic modulus of approximately 110GPa. It is highly compatible with the mechanical properties of human cortical bone, effectively avoiding the "stress shielding effect", reducing the risk of secondary fractures after surgery, and meeting the bone joining needs of different parts such as limbs and spine.

Ultra high machining precision

Adopting the "multi pass cold rolling+precision leveling" process, the thickness tolerance of the standard plate is controlled within ± 0.02mm, and the flatness is ≤ 0.1mm/m; The surface roughness Ra of the precision polished plate is ≤ 0.3 μ m, and the mirror effect reaches 8K level. There are no defects such as scratches or pockmarks, providing a perfect substrate for laser cutting and bending of bone plates. The processing qualification rate has been increased to 99.5%.

II. Detailed explanation of main brand names and product specifications

Medical grade customized services: 1. Material selection: Professional engineers recommend the optimal grade TA3G/TC4 based on the application site of the bone plate (spine/limbs/jaw); 2. Customization of specifications: Supports unconventional thickness (0.5-10mm), width (30-500mm), and special size cutting; 3. Value added services: providing supporting services such as surface passivation, sterile packaging, third-party testing (such as biocompatibility testing), etc; 4. Delivery guarantee: Regular specifications can be delivered within 7-10 days, customized specifications can be delivered within 15-20 days, and each batch comes with a complete material list, performance testing report, and sterility certificate.

III. Advantages of Precision Polishing Process and Standard Plate Characteristics

Precision polishing board: mirror quality, suitable for high-end medical needs

-Multi pass polishing process: After four processes of rough polishing, medium polishing, precision polishing, and mirror polishing, medical grade polishing solution is used to avoid surface contamination and ensure the integrity of the oxide film;

-Excellent surface performance: The ultra smooth surface with Ra ≤ 0.1 μ m reduces bacterial adhesion, lowers the risk of postoperative infection, and enhances the aesthetics of the bone plate;

-Customized service: Support pre cutting according to the size of the bone plate, reduce material waste for customers, and provide single-sided/double-sided precision polishing to meet different processing needs.

Standard board: precise and stable, ensuring consistency in processing

-Strict control of dimensional accuracy: Real time monitoring with laser thickness gauge, thickness tolerance ± 0.02-0.03mm, flatness ≤ 0.1mm/m, ensuring accurate size of bone plate forming;

-Good organizational uniformity: Through isothermal annealing process, the grain size is refined to 10-15 μ m, avoiding cracking and deformation during processing and improving product qualification rate;

-High batch stability: The fluctuation error of mechanical properties of titanium plates in the same batch is ≤ 3%, meeting the consistency requirements for mass production of medical devices.

Medical grade customized services: 1 Material selection: Professional engineers recommend TA3G/TC4 preferred grades based on the application site of the bone plate (spine/limbs/jaw); 2. Customization of specifications: Supports unconventional thickness (0.5-10mm), width (30-500mm), and special size cutting; 3. Value added services: providing supporting services such as surface passivation, sterile packaging, third-party testing (such as biocompatibility testing), etc; 4. Delivery guarantee: Regular specifications can be delivered within 7-10 days, customized specifications can be delivered within 15-20 days, and each batch comes with a complete material list, performance testing report, and sterility certificate.

4. Full chain medical grade quality control system

1. Raw material side: Exclusive procurement of medical grade titanium materials: Medical grade sponge titanium that meets the GB 2524-2019 standard is used, with a purity of ≥ 99.7% and strict control of impurity elements (Fe, O, N, etc.) content. Each batch of raw materials is accompanied by an ICP-MS full element analysis report, and a raw material traceability file is established to ensure source safety.

2. Production end: equipped with specialized medical titanium processing equipment to avoid cross contamination with industrial grade titanium materials; Process parameters such as rolling and annealing are precisely controlled by computer systems, and production data is recorded in real-time to achieve product quality traceability.

3. Testing end: Multi dimensional medical grade testing: Establish a "raw material semi-finished product finished product" full process testing system, equipped with a direct reading spectrometer (component analysis)< span style="color:rgba(0, 0, 0, 0.85);font-family:Inter, -apple-system, BlinkMacSystemFont, "font-size:16px;background-color:#FFFFFF;"> High end instruments such as universal material testing machines (mechanical properties), surface roughness meters (precision polishing quality), and sterile testing equipment focus on performing biocompatibility testing (cytotoxicity, allergenicity, irritancy), mechanical performance testing, and corrosion performance testing to ensure that each batch of products meets medical grade requirements.

4. Certification end: Full system qualification guarantee: The product has passed ISO 13485 medical device quality management system certification and complies with medical standards in multiple regions such as China GB, the United States ASTM, and the European Union EN. It can be exported to major global medical markets.