On March 6, 2023, SZLX Medical Device Technology Group announced that the plastic absorbable bone repair material developed by the company (hereinafter referred to as "absorbable and regenerated bone") was approved by FDA 510 (K) of the United States for listing.
This product is the world's first artificial bone that can simultaneously meet the requirements of shape-resistant, liquid-phase collapse resistance and efficient induction regeneration.
It is reported that this is another innovative product of SZLX after the absorbable interface screw was approved by the State Drug Administration of China in October 2022.
There are many artificial bone products in the world. Why is this artificial bone the first product in the world?
The CTO of SZLX explained, "Although the artificial bone launched this time does not use new materials, but uses the conventional material combination of polylactic acid (PLA)+hydroxyapatite (HA), but through the raw material combination technology and advanced technological innovation, the artificial bone has achieved the functions of plasticity, resistance to liquid phase collapse and efficient induction of regeneration. There is no such artificial bone product in the world before, so it is the first in the world!"
The product has been clinically applied in medical units such as Shanghai Sixth Hospital. In terms of operability, the product is in the shape of plasticine, which can be shaped by hand or tools at will, and the filling effect is full; The product meets the requirements of anti-liquid phase collapse, and can be stably applied in aqueous phase surgery environment, massive hemorrhage or tissue fluid environment; The product has excellent bone conduction and bone induction ability, and can complete bone regeneration within 3-6 months after implantation.
It is reported that the selection of materials plays a vital role in artificial bone. The ideal artificial bone substitute material should be similar to the autogenous bone graft, and can make up for the defects of autogenous bone, allogeneic bone and other materials. During the growth of new bone, the material should be gradually reconstructed and absorbed, and finally disappear from the implant site.
At present, China's orthopedic clinic has a strong demand for bone defect repair materials, and there is a huge gap in clinical demand. This time, SZLX has developed better innovative materials through the combination of conventional materials, and achieved product innovation in the global artificial bone field.
The world's first absorbable regenerated bone has completely independent intellectual property rights and has been approved by FDA. This is the recognition of SZLX's innovative ability, marking that the company's products have reached international standards and officially entered the international market.