Yingnuoke's Magnesium Alloy Hollow Bone Screw Secures FDA Breakthrough Device Designation with High-Quality Submission Supported by HiRegen Medical

Recently, the FDA's actions regarding breakthrough medical devices from ChinaReview standards are becoming increasingly stringent,Some Chinese enterprises have failed to meet the quality standards for submitted materials or have engaged low-quality partner agencies to handle submissions, resulting inApplication Rejected, even undermining the company's credibility with the FDA. Against this backdrop,MDCE CROOn January 1, 2025, once again by virtue of its outstanding global medical device registration servicesSuccessfully Facilitated InnoCare’s Self-Developed Controllably Degradable Magnesium Alloy Bone Screws in Obtaining U.S. FDA Breakthrough Device Designation(Breakthrough Device Designation, BDD). This achievement signifies that the product’s innovation and clinical value have received high recognition from international authoritative bodies, further demonstrating MDCE CRO’s professional expertise in high-quality submissions and global regulatory services. This approval sets a technical benchmark for InnoCare in the field of orthopedic implants globally, and furthermoreChinese Orthopedic Medical DevicesIndustryBreakthrough into the International High-End Marketprovided strongDemonstration Effect, propelling Chinese innovative technologies to occupy a more prominent position on the global healthcare stage.

Official Letter from the U.S. Food and Drug Administration (FDA)

As Chinese innovative medical device companies accelerate their global market expansion, the U.S. Food and Drug Administration (FDA) has adopted stricter review standards for Breakthrough Device designation applications submitted by Chinese firms. Some Chinese companies have had their applications rejected due to insufficient quality of submitted materials, inadequate data support, or insufficient communication with the FDA, thereby adversely affecting their corporate reputation.The FDA is gradually lowering its tolerance for low-quality submissions,The review process is also becoming increasingly stringent, whichChinese enterprises are required to place greater emphasis on the quality of their submission materials, regulatory compliance, and effective communication with the FDA when filing applications.

As a CRO company specializing in global medical device registration and clinical trial services, MDCE CRO has always adhered to the principles of high quality and high standards, helping clients meet the stringent review requirements of the FDA. The successful certification of InnoCo’s magnesium alloy hollow screw is another testament to MDCE CRO’s excellence in high-quality submissions and global registration services.

The FDA’s Breakthrough Device Designation is designed to accelerate the development and approval process for innovative medical devices that provide more effective treatment for serious or life-threatening diseases. Devices granted this designation benefit from priority review, more frequent interactive communication and guidance, and a more flexible review process, thereby significantly reducing the time to market.

InnoCore’s magnesium alloy hollow screws have successfully obtained this certification, thanks to their superior performance and innovative design in orthopedic surgery.

This product adopts industry-leadingControllable Degradable Coating Technology, achieving precise synchronization between bone healing and implant degradation through breakthrough biocompatibility and controlled degradation, effectively addressing multiple pain points associated with traditional metal implants. The product featuresSuperior Mechanical Properties, with tensile strength exceeding that of pure titanium, providing stronger support for fractures; meanwhile, itsPrecision Degradation TechnologyEnsure stable degradation of the implant during the critical period of bone healing to effectively avoid complications. Furthermore, magnesium, as an essential element for bone tissue, exhibits high biocompatibility,Gradually Degradable, significantly reducing the risk of postoperative infection.

Product Illustration

As a CRO company specializing in global clinical trials and registration services for pharmaceuticals and medical devices, MDCE CRO is committed to providing comprehensive regulatory solutions for innovative enterprises. From regulatory consulting and dossier preparation to communication and coordination with the FDA, MDCE CRO leverages its extensive experience and professional team to help clients efficiently navigate the complex regulatory landscape of global markets.

In this project, MDCE CRO collaborated closely with Innoco to ensure that the submission materials for its magnesium alloy hollow screws fully complied with the FDA’s stringent requirements. Leveraging its extensive global resources and professional in-house local team, MDCE CRO provided robust support to help Innoco successfully obtain Breakthrough Device designation.

In this project, due to the United StatesMagnesium alloy products for the same indications are already on the market., this application was highly challenging. MDCE CRO was involved in every stage of the project, from strategy formulation to submission of materials, with its main responsibilities including:

▶ Strategy Formulation: MDCE CRO, through in-depth analysis of U.S. regulations and clinical literature searches,Systematic ReviewConducted a comparative analysis of the technical advantages and clinical benefits of the submitted product against other standard-of-care (SOC) treatment regimens, and provided well-substantiated arguments demonstrating the product’s advantages to assist InnocoDeveloped a regulatory submission strategy compliant with FDA requirements.

▶ Global Registration Services: MDCE CRO provided multi-faceted overseas regulatory services to Innoco, particularly assisting with preparation prior to FDA submission.Key Technical Documents, the rigor and sufficiency of the data effectively accelerated the approval process, enabling the deviceSuccessfully completed the certification without being requested to provide supplementary information.

▶ Compliance and Regulation: In terms of compliance, MDCE CRO ensures that all submitted documents meet the high standards of the U.S. FDA, helping Innoco address regulatory challenges during the review process.

The approval of this Breakthrough Device designation will accelerate the future regulatory and review process for InnoCo’s magnesium alloy bone screws at the FDA, effectively shortening the time to market. Meanwhile, this approval alsohighlighting InnoCare's technological leadership and market competitiveness in the global orthopedic implant sector with its magnesium alloy bone screws,This marks a significant milestone for InnoCare as it steps onto the global stage and implements its worldwide strategic layout, and alsoA Key Benchmark for Chinese Innovative Medical Device Companies Going Global.In the future, MDCE CRO will continueSupporting more Chinese innovative technology enterprises in achieving international expansion through high-quality overseas clinical trial and registration services, thereby contributing to the globalization of China’s medical technology.

Suzhou InnoCare Medical Technology Co., Ltd. is a high-tech enterprise possessing innovative technologies and independent intellectual property rights,Focused on the R&D and industrial translation of absorbable magnesium alloy materials and orthopedic devices,Achieving multiple breakthroughs within just two years of establishment, InnoCare has currently developed a portfolio coveringMultiple innovative medical devices in fields such as trauma orthopedics and sports medicine,Holds over 20 core patented technologies and has established in-depth collaborations with numerous universities and research institutions both domestically and internationally.

MDCE CRO is a pharmaceutical and medical device R&D outsourcing company with global clinical trials as its core business. Leveraging Harvard University’s global medical research resources and academic influence, MDCE CRO has established a comprehensive overseas service value chain, providing customized global expansion solutions for Chinese biopharmaceutical and medical device enterprises. Its services encompass overseas clinical development strategy and design, management and operations of overseas clinical trials, overseas product registration, and international commercialization layout. Since its inception, MDCE CRO has successfully facilitated the overseas launch of more than 60 biopharmaceutical and medical device projects, generating cumulative overseas profits exceeding RMB 20 billion for its clients. Currently, MDCE CRO boasts an in-house overseas clinical trial team of over 100 professionals, collaborates with more than 2,000 experts, and has partnered with over 100 renowned overseas hospitals, covering regions including the European Union, North America, Australia and New Zealand, Southeast Asia, Japan and South Korea, the Middle East, and Africa.

For inquiries regarding overseas clinical trials and regulatory affairs, please contact us via the information below:
Tel: +86 18611648819
Email: ask@mdcecro.com