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Metal Additive Manufacturing Thoracolumbar Fusion Matching Prosthesis System Approved for Marketing

CCFDIE| Updated: 2023-04-21

Recently, the innovative product Metal Additive Manufacturing Thoracolumbar Fusion Matching Prosthesis System of Beijing AK Medical Co., Ltd. is approved by China NMPA.

This product is composed of a thoracolumbar fusion matching prosthesis, and matching components such as buckles and screws. This product innovatively adopts polyethylene buckles as a flexible connection device, combined with the posterior screw-rod system, to achieve a "truss" structure of joint fixation of the anterior and posterior approach. For patients who require multi-segment thoracolumbar resection and reconstruction, this product adopts a porous structure and can realize matching design for patients (designed and manufactured based on patient CT data) and implant fixation, which can improve the postoperative quality of life and survival rate of patients to a certain extent.

This product is intended for structural reconstruction from upper thoracic vertebrae to lower lumbar vertebrae (T1-L5) after three or more consecutive vertebral resections due to tumors or other lesions. It needs to be matched with the spinal internal fixation system and achieve permanent implantation. The marketing of this product will provide a new treatment option for patients.

The NMPA will strengthen the post-marketing surveillance of the product to protect the safety of medical devices used by patients.