Spinal Fixator/Pedicle Screw Special TC4/TC4 ELI Titanium Alloy Rod | Core Technical Requirements

- Meet the mass production standards of spinal instruments and establish a solid foundation for clinical safety of minimally invasive fixation
 

The pedicle screws of spinal fixators serve as the "core anchor" for spinal reduction and fixation, requiring precise fixation and long-term load-bearing in narrow vertebral spaces. Their performance depends entirely on the quality of the raw material titanium alloy rods. We are based on the advantages of the entire industry chain of "China Titanium Valley", closely following the core procurement demands of medical device manufacturers. In response to the characteristics of "precise size, minimally invasive adaptation, and strong fatigue resistance" of pedicle screws, we have clarified the key technical requirements for TC4/TC4 ELI titanium alloy rods, making procurement decisions more accurate, production more efficient, and products more compliant.

1. Compliance Requirements: Double certification as a backup to clear registration barriers

Spinal instruments are directly related to neurological safety, with strict registration and review processes. Material compliance is the "lifeline" of medical device manufacturers' procurement, which directly determines whether the product can enter clinical practice smoothly.

1. Full coverage of authoritative standards: Strictly follow GB/T 13810-2017 "Titanium and Titanium Alloy Processing Materials for Surgical Implants", ISO 5832-3 "Metallic Materials for Surgical Implants Part 2: Titanium 6 Aluminum 4 Vanadium Alloy" and ASTM F136 international standards. TC4 ELI low clearance models additionally comply with ASTM F136-13 special requirements, ensuring that the materials can be directly used for pedicle screw production and domestic and foreign registration applications such as NMPA, FDA, CE, etc., to avoid delays in the market cycle due to non-compliance with material standards.

2. Biosafety level biological guarantee: using high-purity sponge titanium with a purity of ≥ 99.7% as raw material, implementing high standard impurity control process - interstitial element oxygen TC4 ELI ≤ 0.13%, nitrogen ≤ 0.01%, hydrogen ≤ 0.001%, to fundamentally eliminate "hydrogen embrittlement" and intraspinal inflammation and nerve stimulation caused by impurity precipitation; Through ISO 10993 series biocompatibility testing (cytotoxicity, allergenicity, genotoxicity), third-party authoritative institutions issue qualified reports to meet the long-term implantation needs of the spine.

3. Full process traceability: Each batch of products comes with a complete file of "raw material testing report+melting record+forging and rolling process parameters+finished product testing report", establishing a full chain traceability system from raw material batch to melting furnace number to finished product number, fully meeting the quality system audit requirements of medical device manufacturers and the full life cycle supervision requirements of spinal instruments.

2. Mechanical adaptability requirements: Match spinal characteristics to ensure fixation safety

Pedicle screws need to withstand complex loads such as spinal flexion, extension, and rotation, and the implantation space is narrow. Titanium alloy rods need to balance high strength, fatigue resistance, and minimally invasive adaptability.

Additional guarantee: The strength and hardness fluctuation within the entire length range should be ≤ 5%, and the grain size should reach ASTM grade 6 or above, ensuring that the performance of key parts such as the pedicle screw body, threads, and connecting holes is uniform, and avoiding intraoperative fracture or postoperative failure due to local performance differences.

Third, processing adaptability requirements: conform to minimally invasive technology, improve production efficiency

Pedicle screws have precise dimensions (usually ranging from 3.5-6.5mm in diameter) and require precision threading, connecting hole drilling, and other processes. The processing stability of titanium alloy rods directly affects production losses and yield.

1. Micron level dimensional accuracy

The diameter tolerance is strictly controlled within ± 0.007mm, the straightness error is ≤ 0.03mm/m, and the diameter tolerance after centerless grinding reaches H7 level, perfectly adapting to precision thread processing of pedicle screws (pitch accuracy ± 0.01mm), connecting hole drilling (aperture tolerance ± 0.01mm) and other processes; The length and diameter can be customized according to the specifications of the nail body (such as commonly used diameters of φ 3.5- φ 12mm), reducing material cutting waste and lowering production costs.

2. Double excellence in surface quality and formability

-Surface requirements: No defects such as cracks, folds, scratches, etc. After mechanical polishing, the surface roughness Ra is ≤ 0.4 μ m, and the surface dense oxide film has a corrosion resistance rate of ≤ 0.001mm/year to body fluids. This not only reduces the wear of taps and drill bits, but also avoids the stimulation of vertebral tissue caused by surface defects after implantation;

-Molding performance: elongation rate ≥ 10%, cross-sectional shrinkage rate ≥ 30%, meeting the precision process requirements of pedicle screw head upsetting, thread rolling, etc. It is not easy to crack or collapse during the processing and is suitable for large-scale automated production lines.

Fourth, quality stability requirements: batch consistency, long-term reliability

Spinal instruments require extremely high batch consistency, and the quality stability of titanium alloy rods directly determines the efficiency and clinical reputation of the production line.

1. Strict control of batch consistency: The composition, mechanical properties, and dimensional accuracy of titanium alloy rods in the same batch fluctuate by ≤ 2%, and the difference between different batches is ≤ 4%, ensuring that medical device manufacturers do not need to frequently adjust the production process parameters of pedicle screws, ensuring the continuous and stable operation of the production line, especially suitable for the precision production needs of minimally invasive spinal instruments.

2. Long term performance stability: Through the heat treatment process of "950 ℃/1h solid solution water quenching+600 ℃/2h aging air cooling", a stable α+β biphasic tissue is formed, which can serve in the human body fluid environment for a long time (≥ 15 years) without degradation, deformation, corrosion, fatigue fracture risks, and meets the long-term support needs of spinal fixators.

3. Zero release for full inspection: Each batch of products undergoes spectral composition analysis, ultrasonic non-destructive testing (internal defects ≤ Φ 0.5mm equivalent flat bottom hole), tensile testing, hardness testing, fatigue strength testing, and additional thread strength testing for critical batches, with zero defective products entering the market.

Preferred partner for purchasing titanium alloy rods for spinal instruments!

Based on the industrial foundation of "China Titanium Valley", we provide one-stop services for medical device manufacturers with "physical guarantee+complete qualifications+technical customization+fast delivery" as the core:

Physical production capacity: Our own 8000 square meter production base has an annual production capacity of 300 tons. Standardized products can be delivered within 3 days, and customized specifications (such as ultra-fine diameter and special mechanical requirements) can be responded to within 25 days to ensure supply chain stability.

Fully qualified: certified by ISO 13485 medical quality management system, equipped with comprehensive testing reports, to assist customers in quickly completing the registration of spinal instrument products.

Technical Support: Our 24-hour technical team is online, providing specialized support such as processing parameters for ultra-fine titanium rods and optimization of thread forming processes to solve pain points in the production of minimally invasive spinal instruments.

Choose Spinal Fixator · Pedicle Screw Special Titanium Alloy Rod, allowing you to purchase without compliance concerns, production without process difficulties, and products without clinical risks, and jointly build a safety barrier in the field of minimally invasive spinal treatment!