Augmenix, Inc.

Augmenix, Inc. specializes in implantable medical devices primarily used in surgical and radiation therapy procedures. Their product line includes radiological image markers, such as the TraceIT and MARKIT series, which are liquid-filled and designed for precise anatomical identification during imaging. Additionally, they produce the SpaceOAR System and SpaceOAR Vue Hydrogel, which are hydrogel-based tissue spacers used to create separation between tissues, particularly in radiation therapy for prostate cancer.

Augmenix, Inc. is based in the United States, which means its devices fall under the regulatory jurisdiction of the U.S. Food and Drug Administration (FDA). Since the company’s products are classified as Class II devices, they are subject to FDA’s 510(k) premarket notification process and must comply with UDI (Unique Device Identifier) requirements. This classification indicates a moderate level of risk, requiring specific controls to ensure safety and effectiveness.

Augmenix, Inc.’s devices are listed in the FDA’s 510(k) database and the Unique Device Identifier (UDI) system. The 510(k) database records premarket submissions demonstrating that a device is substantially equivalent to a legally marketed predicate device, while the UDI system provides a standardized identification system for tracking devices throughout their lifecycle. This ensures traceability, reduces medical errors, and supports regulatory compliance.

Augmenix, Inc.’s devices are classified as Class II by the FDA, which indicates a moderate risk to the user. Class II devices require special controls in addition to general controls to ensure their safety and effectiveness. These controls may include performance standards, post-market surveillance, or labeling requirements. The classification helps regulators balance oversight with innovation while ensuring patient safety.

The TraceIT and MARKIT tissue markers, as well as the SpaceOAR System and SpaceOAR Vue Hydrogel, are listed in the FDA’s 510(k) database because they undergo a premarket notification process to demonstrate equivalence to a previously approved device. This ensures they meet FDA safety and performance standards before entering the market. Their inclusion in the UDI database allows for standardized tracking, reducing confusion in healthcare settings and improving patient safety by ensuring the correct device is used during procedures.