SOLENDOS Inc.

Solendos Inc. specializes in reusable orthopaedic and arthroscopic surgical instruments. Their products include rigid optical arthroscopes for joint visualization, hand-held surgical retractors to hold back tissue, bone curettes for smoothing bone surfaces, and endoscopic-access dilators to expand tissue pathways. They also produce orthopaedic chisels for bone shaping, bone-coring punches for extracting bone samples, endoscope sheaths for protecting scopes, and spinal rongeurs for removing bone fragments. These instruments are designed for both minimally invasive and open surgical procedures.

Solendos Inc. is headquartered in the United States. The company’s location is relevant for understanding its regulatory framework, as it operates under FDA guidelines for device classification and compliance.

Solendos Inc.’s devices are listed in the FDA’s Unique Device Identification (UDI) system. This registry ensures traceability and transparency in the supply chain, allowing healthcare providers and regulators to identify and track specific devices by their unique identifiers.

Solendos Inc.’s devices fall under FDA’s Class I and Class II categories. Class I devices generally pose the lowest risk and may require general controls, while Class II devices involve moderate risk and require special controls to ensure safety and effectiveness. The classification depends on factors like the device’s intended use, potential risks, and the body part it interacts with.

The FDA categorizes devices based on their risk level and intended use. For example, reusable orthopaedic instruments like bone curettes or chisels may be classified as Class II due to their direct interaction with bone and potential for tissue trauma, requiring additional controls to mitigate risks. In contrast, simpler tools like certain retractors might qualify as Class I if they pose minimal risk when used as intended. The classification ensures appropriate regulatory oversight tailored to the device’s purpose.