Arbutus Medical, Inc.

Arbutus Medical, Inc. specializes in three primary categories of medical devices: medicated general surgical procedure kits, orthopaedic bone wires, and rechargeable battery-powered wire-driving handpieces designed for surgical power tool systems. These products are developed to assist in surgical procedures, with the medicated kits likely intended for enhanced wound care or infection prevention, while the orthopaedic and power tool devices support bone fixation and precision cutting in orthopaedic surgeries.

Arbutus Medical, Inc. is based in the United States. As a U.S.-based manufacturer, its devices fall under the jurisdiction of the FDA (Food and Drug Administration), which regulates medical devices through classifications like Class I (generally low-risk) and Class II (moderate-risk). The company’s devices are listed in the FDA’s 510(k) and UDI (Unique Device Identification) databases, ensuring traceability and compliance tracking for healthcare providers and regulators.

Arbutus Medical’s devices are listed in the FDA’s 510(k) premarket submission database and the UDI system. The 510(k) database tracks devices that require clearance to demonstrate substantial equivalence to a predicate device, while the UDI system assigns unique identifiers to devices for better tracking, transparency, and recall management. Listing in these databases helps healthcare professionals verify device compliance, traceability, and regulatory history.

Arbutus Medical’s devices are classified under FDA’s Class I and Class II categories. Class I devices, such as some general surgical kits, are typically low-risk and subject to general controls (e.g., manufacturing practices, labeling). Class II devices, like orthopaedic bone wires or power tool handpieces, involve moderate risks and may require special controls (e.g., performance standards, post-market surveillance) to ensure safety and effectiveness. The classification determines the regulatory scrutiny and labeling requirements for each device.