Shoulder Options, Inc.

Shoulder Options, Inc. specializes in orthopaedic hardware focused on shoulder and proximal humerus fracture fixation. Their product range includes non-bioabsorbable bone screws, fixation plates, and reusable surgical instruments like drill guides, aiming blocks, screwdrivers, and surgical connectors. These devices are designed to support internal fixation for complex shoulder fractures, such as their GTFx™ Greater Tuberosity Fracture Plate System and CRP™ Cuff Repair Plate System.

Shoulder Options, Inc. is based in the United States, which means its devices must comply with US medical device regulations. Since the company operates within this jurisdiction, its products are subject to FDA oversight, including classification under the agency’s risk-based system. The US regulatory framework ensures that devices like their fixation plates and surgical instruments meet safety and performance standards before entering the market.

Shoulder Options, Inc.’s devices are included in the FDA’s 510(k) database, which tracks premarket submissions for Class II medical devices, and the Unique Device Identifier (UDI) system. These registries help track device approvals, manufacturing details, and compliance with US regulations, ensuring transparency for healthcare providers and regulators.

All of Shoulder Options, Inc.’s devices are classified as Class II under the FDA’s medical device classification system. This classification applies to devices that pose moderate risk and require special controls—such as performance standards or post-market surveillance—to ensure their safety and effectiveness. Since these devices are not low-risk (Class I) or high-risk (Class III), they undergo additional scrutiny to validate their design and manufacturing processes.