Shulou(Shulou.com)11/24 Report--

CTOnews.com March 6 news, recently, Shenzhen Lixin Science GAIABONE™ plastic absorbable bone repair material (referred to as "absorbable regenerative bone") has been approved by the US FDA 510 (K) for marketing, registration number is K220337, this product is the world's first artificial bone that can simultaneously meet the requirements of moldability, anti-liquid collapse and efficient induction regeneration.

CTOnews.com learned from Lixin Science Public Account that absorbable regenerated bone is mainly used in clinical bone defect repair surgery. With the development of medical technology, bone defect surgery is becoming more and more advanced, thus putting forward higher demand for materials. GAIABONE™ resorbable regenerative bone is plastic-like, can be shaped by hand or tool, and the filling effect is full. At the same time, the product meets the liquid phase collapse resistance, and can be stably applied in aqueous surgery environment, heavy bleeding or tissue fluid environment. Furthermore, GAIABONE™ has excellent osteoconductive and osteoinductive properties and bone regeneration can be completed 3-6 months after implantation.

Sun Yang, founder of Lixin Science, said,"We did not use any new materials to make this artificial bone, but through the combination of conventional materials and process innovation to achieve these three functions. This is unprecedented in the world, so we can say that this is a global first product. "

FDA approval means that the product has met international standards and can enter the US market. In the future, Lixin Science will continue to promote three product lines of absorbable internal fixator, bone filler and medical absorbable polymer. In terms of product research and development, this year the company will lay out more than 5 types of internal fixed products, which will be submitted to the State Food and Drug Administration for approval within this year.

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