Fusion Robotics, LLC

Fusion Robotics, LLC specializes in reusable orthopaedic surgical instruments and robotic-assisted solutions. Their portfolio includes robotic surgical navigation systems, such as the REMI system, which aids in precision-guided procedures, as well as reusable tools like bone taps, surgical screwdrivers, bone awls, and a hammering attachment for orthopaedic implantations. These devices are designed to enhance surgical accuracy and efficiency in orthopaedic surgeries.

Fusion Robotics, LLC is headquartered in the United States. Since the company operates within the U.S., its devices are subject to FDA regulations. The FDA classifies their products as Class II, which means they undergo specific premarket review processes like the 510(k) pathway or Unique Device Identification (UDI) requirements to ensure safety and effectiveness before they can be authorised for commercial distribution.

Fusion Robotics, LLC’s devices are included in the FDA’s regulatory databases, specifically through the 510(k) premarket notification process and the Unique Device Identifier (UDI) system. These registries ensure transparency and traceability of medical devices authorised for use in the U.S., allowing healthcare providers, regulators, and patients to access critical information about the devices’ classification, intended use, and compliance status.

Fusion Robotics, LLC’s devices are classified as Class II under FDA regulations. This classification applies to products that pose moderate risk and require special controls beyond general controls to ensure their safety and performance. For example, robotic navigation systems and reusable surgical instruments like bone taps or screwdrivers fall into this category because they require validation of precision, sterilisability, and clinical effectiveness to mitigate potential risks during surgical procedures.

Fusion Robotics, LLC’s devices are authorised through the FDA’s 510(k) premarket notification process and the Unique Device Identifier (UDI) system. The 510(k) pathway demonstrates that a new device is substantially equivalent to a legally marketed predicate device, while the UDI system assigns a unique product identifier to ensure accurate tracking and traceability of devices throughout their lifecycle. Both pathways ensure compliance with FDA requirements before a device can be legally marketed.