Meticuly Receives US FDA 510(k) for 3D Printed Patient-Specific Titanium Cranial Mesh and Craniofacial Mesh
Preceding the US FDA clearance, Meticuly, a personalised bone-implant provider, has been expanding internationally with its benchmark devices and gaining trust from surgeons in the Asia-pacific region. A relatively young startup with 4 years of experience, we have received recognition for our solutions in various surgery fields with over 500 successful cases.
Meticuly has received U.S. Food and Drug Administration (FDA) clearance for 3D printed Patient-specific titanium cranial mesh and craniofacial mesh in December 2021. This has marked another huge milestone achievement for Meticuly given the US FDA 510(k) product clearance is one of the highest acceptable international standards for implantable medical devices. Meticuly’s Patient-specific titanium implants are designed and manufactured under rigorous processes through collaboration between professional surgeons and engineers.
Meticuly’s Patient-specific titanium cranial mesh and craniofacial mesh use titanium 3D printing technology to tailor implants for each surgeon’s technique and patient-specific requirement, which further enhance recovery for patients. We thoroughly inspect our products to ensure zero residues from the manufacturing process, which could cause adverse effects inside the patients. Our products have been approved by relevant regulators with regard to safety and quality.
Following the US FDA clearance, we aim to expand our operation into India, Republic of Korea, Australia, the Middle East region, and the Greater China region in 2022 to further serve medical professionals. Through collaboration with distribution partners, we plan to serve patients and surgeons globally within the next 5 years. Our mission is to provide patients and surgeons with high-quality medical implants at affordable prices to create the best clinical outcomes, with patients’ wellbeing and surgeons’ needs fulfilment our top priorities.