Biocompatibility benchmark | medical titanium cable orthopedic fixation
In orthopedic clinical fixation operations such as spinal fusion, joint replacement and long bone fracture, the medical titanium cable is a "stable link for bone reduction", which needs to meet the three core requirements of "biological safety without exclusion, strength suitable for bearing gravity and corrosion resistance for long-term retention". Traditional stainless steel cables have hidden dangers such as poor biocompatibility and easy electrolytic corrosion. The TA2 pure titanium and TC4 titanium alloy medical titanium cables developed by Baoji Dingding titanium, relying on the advantages of medical grade materials and precision processing technology of "China Titanium Valley", strictly follow the standards of GB 4234 and ASTM F136, and achieve tensile strength ≥ 800MPa and surface roughness Ra ≤ 0.2 μ m through the "cold drawing strengthening+polishing passivation" process. They have passed the NMP medical device registration certification, and serve the orthopedic centers of more than 500 class A hospitals nationwide.
1、 Core performance advantage: titanium alloy remodeling medical fixation safety standard
In view of the high demand for titanium cables in orthopedic clinic for "biological safety, mechanical stability and long-term tolerance", TA2 pure titanium and TC4 titanium alloy form a complementary system, which achieves a qualitative breakthrough compared with traditional metal cables:
TA2 pure titanium cable: strong compatibility
Purity ≥ 99.6%, in line with GB 4234.2 medical pure titanium standard, biocompatibility reached ISO 10993-4 level; No nickel, chromium and other sensitizing elements were precipitated, and the postoperative abnormal rate was ≤ 0.1%, which was suitable for children, patients with allergic constitution and long-term needs.
TC4 titanium alloy cable: strong and tough fit
Ti-6Al-4V Eli low gap element composition, tensile strength ≥ 960mpa, elongation at break ≥ 10%; The elastic modulus is 110GPa, which is highly compatible with human bone mechanics and avoids bone atrophy caused by stress shielding. It is the preferred weight-bearing part for adults.
Long term corrosion resistance
The surface passivation treatment forms an oxide film with a density of 99.9%, and the corrosion rate in human body fluid is ≤ 0.00001mm/year; It can be retained in the body for a long time (≥ 15 years) without degradation, avoiding the risk of secondary surgery and reducing the pain of patients.
Clinical ease of use
It is flexible and easy to shape, and can accurately fit the bone contour during operation; The supporting titanium alloy lock catch/collet is easy to install, the locking force is ≥ 500N, there is no looseness after fixation, and the X-ray can penetrate, without affecting the postoperative image review.
2、 Precise specification system: suitable for general orthopedic clinical scene
According to the surgical site (spine/joint/long bone), the patient's age and bearing capacity requirements, provide standardized medical titanium cables and supporting components, covering the full range of 0.5mm-3.0mm diameter:
| Clinical application scenarios | Selected material | Precise specification parameters | Major parameter(conforming to NMP requirements) | The matching components are compatible with the surgery |
| (Children) | Surface Ra≤0.2μm | Force ≥600N | The technique is compatible with the nail-stick system | |
| Joint replacement and fixation (hip/knee) | TC4 Eli | Diameter: 1.5-2.5mm, 7-strand twisted (high flexibility), length: 800-1500mm, elongation at break: ≥12% | The elastic modulus is 110GPa, which is compatible with bone mechanics. There is no stress shielding after the operation, and the corrosion resistance is ≥15 years | Anti-slip chucks and tensioners, suitable for artificial joint prosthesis fixation and tendon insertion point reconstruction |
| Binding and fixation for long bone fractures | TC4(Adults), TA2(Teenagers) | Diameter: 2.0-3.0mm, 19 strands twisted together (high strength), length: 1000-2000mm, tensile strength ≥1000MPa | After locking, the anti-slip force is ≥800N. There is no loosening during the fracture healing period (6-12 months), and X-rays can penetrate | High-strength locking fasteners and dedicated tensioners are suitable for binding comminuted fractures of the femur/tibia |
| The small joints are fixed to the bone blocks | TA2(Fine), TC4(Micro) | Diameter: 0.5-1.0mm, single-strand / 3-strand twisted, length: 300-500mm, surface polished Ra≤0.1μm | It is flexible and easy to shape, with a fixation accuracy of ±0.1mm, and is suitable for hand and foot surgery and maxillofacial surgery | Micro chuck and positioning needle, suitable for carpal bone/tarsal bone fractures and jawbone deformity correction |
| Fixation for osteoporosis patients | TC4(Low Elasticity) | Diameter 1.2-1.8mm, 7-strand twisted, elastic modulus optimized to 90GPa, length 600-1000mm | Reduce stress occlusion, promote bone integration, the postoperative bone density loss rate is ≤5%, and the fixation stability is ≥12 months | Buffer washers and anti-loosening lock buckles are suitable for osteoporotic fractures and spinal compression fractures in the elderly |
3、 Core clinical application: full scene guard from spine to joints
1. spinal surgery: stable support of fusion fixation
Spinal surgery has high requirements for fixation stability and biological safety, and titanium alloy titanium cable is accurately adapted:
-TC4 titanium cable is used for lumbar spondylolisthesis fusion, with a 1.8mm diameter 7-Strand stranded design and a tensile strength of 980mpa. After fixation with the screw rod system, the patient can get out of bed 3 months after operation, which is 50% shorter than that of the stainless steel cable, and there is no vertebral bone atrophy caused by stress shielding;
-TA2 pure titanium cable was used for cervical fracture fixation in 5-year-old children, and no sensitizing elements were precipitated. The rejection rate was 0 one year after operation. The titanium cable and bone grew together to avoid secondary surgery and reduce the trauma of children.
2. joint surgery: long term adaptation of prosthesis fixation
In artificial joint replacement, titanium cable should take into account the matching of fixation strength and mechanics. TC4 Eli material has outstanding advantages:
-TC4 Eli titanium cable was used in total hip arthroplasty. The 2.0mm diameter acetabular prosthesis was fixed. The elastic modulus was close to the bone tissue at 110GPa. After operation, the range of motion of the hip joint returned to 90% before operation, and the prosthesis loosening rate was only 0.8% in 5-year follow-up;
-In knee revision surgery, TC4 titanium cable was used to bind and fix the bone defect with a locking force ≥ 700n. The bone defect healing rate was 95% 6 months after surgery, and the healing time was 30% shorter than that of traditional wire fixation.
3. traumatic orthopedics: flexible and reliable fracture fixation
Long bone comminuted fractures need flexible fixation, and multi strand stranded titanium cable has strong adaptability:
-TC4 2.5mm diameter 19 strand titanium cable is used for the binding of femoral comminuted fractures, with a tensile strength of 1020mpa and an anti slip force of 850n. Patients can take early functional exercise after operation, the fracture healing time is shortened from 12 weeks to 8 weeks, and the excellent and good rate of joint function recovery is 98%;
-TA2 0.8mm micro titanium cable is used for fixation of carpal scaphoid fracture. It has good flexibility and can fit the contour of bone block. The fixation accuracy is ± 0.1mm. The fracture healed 3 months after operation, without limited wrist movement, and can meet the needs of patients' fine motion.
4. geriatric orthopedics: a safe choice for patients with osteoporosis
The bone bearing capacity of elderly patients with osteoporosis is weak, and low elastic titanium cable reduces the risk of fixation
-The low elastic TC4 titanium cable was used for the fixation of spinal compression fractures in 75 year old patients. The elastic modulus was optimized to 90GPa to reduce stress shielding. The bone mineral density loss rate was only 3% 6 months after operation, which was 60% lower than that of conventional titanium cable;
-When used with buffer washer, the compression injury rate of titanium cable on osteoporotic vertebral body was reduced from 15% to 1%, and the incidence of postoperative complications was significantly reduced, which improved the operation safety of elderly patients.
4、 Medical quality assurance: full chain control from raw materials to clinic
1. exclusive control of medical raw materials: medical grade sponge titanium (TA2 ≥ 99.6%, TC4 Eli in accordance with ASTM F136) is used, and ICP-MS composition report is attached to each batch of raw materials to ensure that there are no harmful impurities; Passed ISO 10993-4 biocompatibility test (cytotoxicity, sensitization, implantation test);
2. precision aseptic manufacturing: produced in a 100000 level clean workshop, the cold drawing process improves strength while maintaining flexibility, and multi pass polishing ensures that the surface RA ≤ 0.2 μ m; EO sterilization (residue ≤ 10 μ g/g) is adopted, aseptic packaging is used to avoid secondary pollution, and the sterilization batch number attached to each package is traceable;
3. all clinical tests: all passed the tensile strength test, elongation at break test, corrosion resistance test (immersion in simulated body fluid), and surface roughness test; The clinical trial was completed according to the requirements of NMP (300 patients, the effective rate was 99.2%);
4. clinical service guarantee: orthopedic clinical engineer team is provided to provide surgical operation training and on-site technical support; The postoperative follow-up system was established to track the long-term effect of titanium cable; Provide 24-hour medical emergency consulting services to respond to hospital needs.
the choice of clinical trust for medical titanium cable!
The company has been deeply engaged in the field of medical titanium alloy for 11 years, has 2 special production lines for medical titanium cables, with an annual production capacity of 5million sets, and has passed the ISO 13485 medical device quality management system certification. The products serve Beijing Jishuitan Hospital, Shanghai Sixth People's Hospital, West China Hospital and other domestic excellent orthopedic centers. With the three advantages of "biological safety, mechanical stability and clinical ease of use", they have become the preferred recommended brand of many orthopedic experts.
