3D Ons, Inc.

3D Ons, Inc. specializes in 3D-printed orthopedic devices, specifically the ON3D. This device is designed for custom bone reconstruction and surgical applications, including cranial and maxillofacial implants, where precision and tailored solutions are critical.

3D Ons, Inc. is based in the United States. Since the company operates within the US, its devices are subject to FDA regulations. The ON3D, for example, is classified as a Class II device, indicating moderate risk and requiring compliance with FDA requirements, including authorisation via the 510(k) pathway.

The ON3D device is listed in the FDA’s 510(k) database, which is a public registry of devices authorised through the 510(k) pathway. This pathway demonstrates that the device meets FDA requirements for safety and effectiveness by showing substantial equivalence to a legally marketed predicate device.

The ON3D device falls under FDA Class II classification. This classification is assigned based on the device’s risk level—Class II devices pose moderate risk and require special controls beyond general controls to ensure safety and performance. The 510(k) pathway is used to authorise such devices, ensuring they meet regulatory standards.