Futurtec（鑫君特）has received European Union Medical Device Regulation certification for its ORTHBOT X knee-replacement surgical navigation and positioning system, according to a company announcement reported by MedChina in August.
The certification adds a joint-replacement product to Futurtec’s CE MDR-certified orthopedic-robotics portfolio. Its earlier ORTHBOT spinal surgical robot obtained CE MDR certification in 2023, while ORTHBOT X is designed for knee-replacement procedures, integrating pre-operative planning, surgical navigation and intraoperative positioning assistance.
Futurtec operates research, development and production facilities in Shenzhen and Suzhou. Its Suzhou entity is Futurtec (Suzhou) Medical Co., Ltd. The company’s public materials identify ORTHBOT X as a navigation and positioning system for total knee arthroplasty.
The CE MDR milestone is a regulatory prerequisite for placing the certified device on the EU market. It does not, however, establish completed sales, hospital adoption, reimbursement coverage or clinical utilisation in individual European countries. Public materials reviewed did not disclose the ORTHBOT X certificate number, notified body, validity period, distribution partners or a European launch timetable.
A separate August development involved Sinomed Neurovita Technology Inc.（赛诺神畅医疗科技有限公司）, a subsidiary of Shanghai STAR Market-listed SINOMED（赛诺医疗, 688108.SH）. The company said its COMETIU self-expanding intracranial drug-coated stent system received CE MDR certification on Aug. 6 from notified body DEKRA Certification B.V., with the certificate valid until Aug. 1, 2031.
SINOMED said COMETIU is intended for certain patients with intracranial atherosclerotic stenosis and that the certification allows the product to enter the EU and European Economic Area market. The company also cautioned that country-level post-market registration, distribution, hospital access and reimbursement processes remain necessary, and that it could not predict the impact on future sales.
Taken together, the two developments show China-based medtech developers pursuing European regulatory access in distinct high-risk device categories: orthopedic surgical robotics and neurovascular intervention. They should not be presented as evidence that either product has already achieved commercial scale overseas. The next meaningful milestones are country-level market-entry steps, distributor appointments, hospital procurement, reimbursement decisions and reported clinical use.
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