Designation:TA2, TA3, TA4, TC4 ELI ( Grade 2, Grade 3, Grade 4. Grade 5 ELl )

Standard:GB/T13810，1S05832-2，ASTMF136

Overview:This product is made of TA1G pure titanium plate, with a thickness of 0.4mm and an ultra-thin design. The material is soft and easy to shape during surgery, perfectly fitting the complex craniofacial bone structure, prov
 

Titanium plate for human maxillofacial repair | TA3G/TC4 ultra-thin specification (0.1-0.4mm)

- Ultra thin adaptation and shape following, building a safe foundation for repairing maxillofacial defects

The anatomical structure of the human maxillofacial region is complex, involving the coordination of bones, nerves, and soft tissues. The titanium plate for maxillofacial repair needs to have the characteristics of "ultra-thin bone adhesion, high extensibility, and minimally invasive adaptation", which not only supports bone reduction but also ensures a natural appearance after surgery. We are based on the advantages of "China Titanium Valley" and aims to meet the needs of "precise repair and personalized shaping" in maxillofacial surgery. We have created TA3G pure titanium/TC4 alloy ultra-thin titanium plates with customized specifications of thickness 0.1-0.4mm, width within 300mm, and length within 1000mm, which are perfectly suitable for jawbone fracture, defect repair, and contour shaping scenarios, enabling medical device manufacturers to purchase more accurately and produce more efficiently.

1. Compliance Core: Maxillofacial Implant Level Safety, Clearing Registration Barriers

Maxillofacial titanium plates are directly attached to the surface of the jawbone and come into long-term contact with oral fluids and mucous membranes. Biosafety and compliance with standards are the "lifeline" for medical device manufacturers to purchase, directly determining whether the product can enter clinical practice.

1. Full coverage of authoritative standards: Strictly following 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)/F136 (TC4) international standards, the product has passed ISO 13485 medical device quality management system certification and can be directly used for NMPA, FDA, CE registration and application of maxillofacial titanium plates, avoiding delays in the market cycle due to non-compliance with material standards.

2. Maxillofacial exclusive biosafety: TA3G pure titanium plate purity ≥ 99.5%, strict control of impurities such as iron and carbon; TC4 alloy plate adopts high-purity sponge titanium with a purity of ≥ 99.7%, and implements maxillofacial level impurity control technology - oxygen ≤ 0.15% (TA3G)/0.13% (TC4), nitrogen ≤ 0.01%, hydrogen ≤ 0.001%, to fundamentally eliminate oral mucosal irritation and bone tissue inflammation caused by impurities; Through ISO 10993 series biocompatibility testing (cytotoxicity, allergenicity, oral mucosal irritation test), supported by third-party authoritative reports, it is suitable for long-term implantation.

3. Full chain traceability: Establish a full process traceability system of "raw material batch → melting furnace number → rolling parameters → finished product testing", with each titanium plate equipped with an exclusive traceability code and complete files, fully complying with the quality system audit of medical device manufacturers and the full life cycle supervision requirements of maxillofacial implants.

2. Core Performance: Adapt to maxillofacial characteristics, balancing support and shaping

Maxillofacial repair requires titanium plates that adhere to the bone without protruding or deforming, with ultra-thin specifications of 0.1-0.4mm to ensure minimally invasive implantation. TA3G/TC4 features accurately match different repair needs, balancing support strength and adaptability.

1. Ultra thin specifications and precise matching of mechanical indicators

2. Customized specifications adapted to different scenarios

Support customization within a width of 300mm and a length of 1000mm, and can be prefabricated according to commonly used sizes for maxillofacial repair (such as cheekbone titanium plate 100 × 50mm, mandible titanium plate 150 × 80mm) to reduce cutting waste for medical device manufacturers; 0.1mm ultra-thin specification is suitable for children's maxillofacial repair, and 0.3-0.4mm specification is suitable for adult jawbone fracture fixation, meeting differentiated clinical needs.

III. Processing Adaptability: Meets the precision technology of maxillofacial region, improves the yield rate

Maxillofacial titanium plates require precision processing such as laser cutting, porous drilling, and personalized bending. The processing stability of 0.1-0.4mm ultra-thin titanium plates directly affects production efficiency and end product quality.

1. Micro level precision ensures convenient processing

Width tolerance ± 0.1mm, length tolerance ± 0.2mm, straightness error ≤ 0.02mm/m - when laser cutting into irregular titanium plates, there is no need for secondary calibration, directly ensuring precise matching with the anatomical shape of the jawbone; When drilling porous holes (with a diameter of 1.5-2.0mm), the positioning is precise, and the nail hole tolerance is ± 0.01mm, ensuring a perfect fit with the titanium nail and avoiding loosening.

2. Double excellence in surface quality and formability

-Surface characteristics: No scratches, oxide skin, pinhole defects, polished to a mirror effect, reducing tool wear and providing a good adhesion foundation for subsequent hydroxyapatite (HA) coating spraying, improving bone integration ability;

-Forming advantages: TA3G pure titanium plate can achieve 180 ° bending without cracks, suitable for the "on-site shaping" needs in maxillofacial surgery; TC4 alloy plate has no burrs on the edges after laser cutting, reducing the polishing process and improving batch production efficiency;

-Welding performance: TA3G titanium plate has excellent welding performance and can be spliced into large-area repair titanium plates, suitable for large-scale jawbone defect scenarios. The strength attenuation at the welding point is ≤ 5%, ensuring overall support.

Fourth, quality stability: batch consistency ensures clinical reliability

Maxillofacial repair requires extremely high consistency in appearance and performance of titanium plates, and quality fluctuations directly affect postoperative outcomes and patient reputation. Our company has established a full process quality control system.

1. Strict control of batch consistency: The fluctuation of composition, thickness, and surface quality of titanium plates in the same batch is ≤ 2%, and the difference between different batches is ≤ 4% - medical device manufacturers do not need to frequently adjust laser cutting and bending parameters to ensure the uniformity of size and appearance in the mass production of maxillofacial titanium plates.

2. Zero release for full inspection: Each batch undergoes spectral composition analysis, ultrasonic non-destructive testing (internal defects ≤ Φ 0.3mm), tensile testing, and an additional "bending fatigue test" for ultra-thin titanium plates (simulating chewing actions for 10 times without fracture), resulting in zero defective products entering the market.

3. Long term performance guarantee: TA3G undergoes vacuum annealing at 350-450 ℃, while TC4 undergoes "950 ℃ solid solution+600 ℃ aging" treatment, resulting in stable microstructure; Corrosion rate in oral saliva (pH 5.5-7.5) environment ≤ 0.0005mm/year, long-term service (≥ 15 years) without deformation or corrosion, meeting the long-term needs of maxillofacial implantation.

Preferred Partner for Maxillofacial Titanium Plate Procurement!

Based on the foundation of the "China Titanium Valley" industry and focusing on the segmented scenarios of maxillofacial repair, we provide exclusive services:

Ultra thin production capacity guarantee: Exclusive ultra-thin titanium plate production line, with an annual production capacity of 80 tons for 0.1-0.4mm specifications, and customized plates within 300 × 1000mm can be delivered within 7 days.

Qualification Assistance Registration: Equipped with a comprehensive testing report for maxillofacial implant level, it helps to quickly complete product registration.

Technical support: Our 24-hour team provides specialized technical advice on bending processes, coating adaptation, and other maxillofacial specialties.

Choose TA3G/TC4 Maxillofacial Special Ultra Thin Titanium Plate, with precise specifications of 0.1-0.4mm and the advantage of shaping according to shape, to build a strong safety and reputation barrier for your maxillofacial repair equipment, and help upgrade clinical repair effects!