Designation:TA1, TA2，TA3，TA4,ASTM F67，Grade 1，Grade 2，Grade 3，Grade 4，Ti-6Al-4V (ELI) ，TC4 ELI，ASTM F136，Grade 5 ELI

Standard:ASTM F67，ASTM F136，ISO 5832-2，ISO 5832-3，ISO 5832-11，GB/T 13810-2017

Overview:Titanium plate for bone plate is a biomedical grade titanium metal plate designed, produced, and controlled specifically for the manufacture of internal fixation instruments for human fractures. Its function is to serve
 

Medical Titanium Plate | Core Technical Requirements

- Meet the standards of orthopedic implant devices and establish a solid clinical safety foundation for fracture repair

As the core implant material for orthopedic fracture internal fixation, maxillofacial defect repair, and spinal fusion fixation, medical titanium plates need to consider biocompatibility, mechanical adaptability, and molding precision The three core characteristics directly determine the clinical efficacy and patient rehabilitation process of terminal devices based on their quality.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 "porous adaptation, high ductility, and batch stability" of medical titanium plates, it has clarified the key technical requirements for TA3G pure titanium/TC4 titanium alloy medical titanium plates, making procurement decisions more accurate, production more efficient, and products more compliant.

1. Compliance requirements: Implant level security measures to eliminate registration barriers

Medical titanium plates are directly implanted into human bone tissue and come into long-term contact with bodily fluids. Biosafety and compliance with standards are the "first line of defense" for medical device manufacturers in procurement, directly determining whether the product can enter clinical applications.

1. Full coverage of authoritative standards

Strictly following the international standards of GB/T 13810-2017 "Titanium and Titanium Alloy Processing Materials for Surgical Implants", ISO 5832-2/3 "Metallic Materials for Surgical Implants", and ASTM F67 (TA3G pure titanium)/F136 (TC4 alloy), the product has passed the ISO 13485 medical device quality management system certification and meets the registration and application requirements of domestic and foreign orthopedic implant devices such as NMPA, FDA, CE, etc., to avoid delaying the market cycle due to non-compliance with material standards.

2. Implant level biosafety assurance

-TA3G pure titanium plate purity ≥ 99.5%, strict control of impurity elements, especially reducing iron and carbon content, and improving biological affinity; TC4 titanium alloy plate uses high-purity sponge titanium with a purity of ≥ 99.7% as raw material, and implements high standard impurity control technology - interstitial element oxygen ≤ 0.13% (TC4)/0.15% (TA3G), nitrogen ≤ 0.01%, hydrogen ≤ 0.001%, to eliminate bone tissue inflammation and rejection reactions caused by impurity precipitation from the root;

-Through ISO 10993 series biocompatibility testing (cytotoxicity, sensitization, local reactions after implantation, blood compatibility), third-party authoritative institutions issue qualified reports to meet the long-term implantation needs of orthopedics and maxillofacial surgery, especially suitable for osteoporosis patients and children with fracture fixation.

3. Full chain traceability is available for inspection

Establish a full process traceability file for "raw material batch → melting furnace number → rolling process → heat treatment parameters → finished product testing". Each titanium plate is equipped with an exclusive traceability code, complete testing reports and production records, which fully comply with the quality system audit of medical device manufacturers and the full life cycle supervision requirements of implanted devices.
 

2. Mechanical adaptability requirements: Match bone tissue characteristics to ensure repair safety

Medical titanium plates need to adapt to the mechanical requirements of different parts of bones - maxillofacial titanium plates need high ductility, limb titanium plates need high strength, spinal titanium plates need to balance elasticity and stability, and TA3G and TC4 models have precise performance matching clinical scenarios.

Additional guarantee: The strength and hardness fluctuation within the entire surface range is ≤ 3%, and the grain size reaches ASTM grade 5 or above (TA3G)/grade 6 or above (TC4). There is no problem of component segregation or uneven thickness, ensuring consistent performance of all parts of the titanium plate after drilling and bending, and avoiding titanium plate fracture caused by local stress concentration.

3. Processing adaptability requirements: Meet precision molding and improve production efficiency

Medical titanium plates need to be processed into terminal devices through complex processes such as porous drilling, bending and shaping, and surface spraying. Their dimensional accuracy and surface quality directly affect the production loss and yield of medical device manufacturers.

1. Micron level dimensional accuracy control

-Thickness tolerance: Conventional titanium plate (0.5-4.0mm) tolerance ± 0.03mm, ultra-thin titanium plate (0.2-0.5mm) tolerance ± 0.01mm, width tolerance ± 0.1mm, straightness error ≤ 0.02mm/m;

-Adaptation process: Perfectly matched with precision processes such as porous drilling of orthopedic titanium plates (aperture tolerance ± 0.01mm), three-dimensional bending and forming of maxillofacial titanium plates, and tapping of spinal titanium plate nail holes, without the need for additional leveling or polishing, reducing material waste;

-Customized support: Sizes can be customized according to customer needs (width 50-300mm, length 100-1500mm), supporting the cutting and processing of irregular titanium plates, and adapting to the production of fracture fixation instruments in different parts.

2. Mirror level surface quality and process adaptation

-Surface requirements: No scratches, oxide skin, pinholes or other defects, surface roughness Ra ≤ 0.4 μ m after mechanical polishing, meeting medical hygiene standards; To provide a good adhesion foundation for subsequent hydroxyapatite (HA) coating spraying and enhance the bone integration ability between titanium plates and bone tissue;

-Molding performance: TA3G pure titanium plate can achieve 180 ° bending without cracks, suitable for personalized shaping of maxillofacial repair; TC4 alloy plate can withstand multiple punching and tapping processes without edge breakage, and is suitable for batch processing on automated production lines to improve the qualification rate of finished products;

-Welding performance: TA3G pure titanium plate has excellent welding performance and can be welded with medical stainless steel, cobalt chromium alloy and other dissimilar materials. It is suitable for the production of composite titanium plate instruments and meets special clinical needs.

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

Orthopedic implant devices require extremely high batch consistency of titanium plates, and quality fluctuations directly affect clinical safety and brand reputation. Our company has established a full process closed-loop quality control system.

1. Strict control of batch consistency

The fluctuation of composition, thickness, and surface quality of the same batch of titanium plates is ≤ 2%, and the difference between different batches is ≤ 4%, ensuring that medical device manufacturers do not need to frequently adjust processing parameters and guaranteeing the stability of batch production of orthopedic titanium plates and maxillofacial titanium plates.

2. Zero release for full item testing

Each batch of products undergoes spectral composition analysis, thickness accuracy testing, surface roughness testing, and tensile testing. Implanted grade titanium plates are additionally subjected to ultrasonic non-destructive testing (internal defects ≤ Φ 0.3mm equivalent flat bottom holes) and fatigue strength testing (simulating human activity load cycles ≥ 10 ⁷ times), with zero defective products entering the market.

3. Long term performance guarantee

TA3G pure titanium plate undergoes vacuum annealing treatment at 350-450 ℃ to enhance its formability; TC4 alloy plate undergoes a heat treatment of "950 ℃/1h solid solution water quenching+600 ℃/2h aging air cooling" to form a stable α+β biphasic structure. Both materials of titanium plate have long-term service (≥ 15 years) in human body fluid environment without degradation of performance, deformation, corrosion, or fracture risks, which meets the long life requirements of orthopedic implants.

Preferred Partner for Medical Titanium Plate Procurement!

Based on the industrial foundation of "China Titanium Valley" and the specialized technical accumulation of medical titanium materials, we provide one-stop services for medical device manufacturers:

-Physical production capacity guarantee: Our own 8000 square meter production base has an annual production capacity of 120 tons of medical titanium plates. Standardized products can be delivered within 3 days, and customized specifications (irregular, ultra-thin) can be responded to within 20 days to ensure supply chain stability;

-Complete qualifications to assist registration: Equipped with implant level comprehensive testing reports, helping customers quickly complete the registration of orthopedic implant devices and shorten the market cycle;

-Technical support throughout the process: Our 24-hour technical team is online to provide specialized optimization suggestions for titanium plate porous processing, bending processes, coating adhesion, etc., to solve production pain points.

Choose TA3G/TC4 Medical Titanium Plate, allowing you to purchase without compliance concerns, production without process difficulties, and products without clinical risks, building a safety barrier in the field of orthopedic repair together!