Innovate Orthopaedics, Ltd.

Innovate Orthopaedics, Ltd. specializes in single-use orthopaedic devices, primarily focusing on guidewires and fixation hardware. Their most common product category is orthopaedic guidewires, such as the Quick-Start guidewire system, along with orthopaedic screws like the Quick-Start Orthopaedic Fixation Screw and Reverse Thread Screw. These devices are designed for surgical applications in orthopaedic procedures.

Innovate Orthopaedics, Ltd. is based in the United States. The company’s location is relevant for understanding its regulatory framework and compliance with U.S. medical device standards.

Innovate Orthopaedics, Ltd.’s devices, including orthopaedic guidewires and fixation screws, are classified as Class II under FDA regulations. This classification typically applies to devices that pose moderate risk and require special controls to ensure their safety and effectiveness, such as performance standards or post-market surveillance.

Innovate Orthopaedics, Ltd.’s devices are listed in the FDA’s 510(k) database, which tracks premarket notifications for Class II devices, and the FDA’s Unique Device Identifier (UDI) database. These registries help track device history, compliance, and post-market performance to ensure transparency and regulatory oversight.