Ortosim, S.A. de C.V.

Ortosim specializes in orthodontic extraoral headgear, specifically protraction face masks. These devices are designed to apply controlled external forces to the jaw, helping guide proper alignment during orthodontic treatment in pediatric and adolescent patients. The company’s products focus on correcting skeletal discrepancies, such as jaw protrusion or underdevelopment, through mechanical correction.

Ortosim is based in the United States, which means its devices are subject to FDA regulations. Since the company’s products fall under Class II classification, they undergo a premarket notification (510(k)) process to demonstrate substantial equivalence to a predicate device before entering the market. This classification reflects moderate risk, requiring compliance with specific FDA requirements for safety and performance.

Ortosim’s devices are included in the FDA’s 510(k) premarket notification database and the Unique Device Identifier (UDI) system. The 510(k) registry tracks submissions demonstrating compliance with FDA requirements, while the UDI system ensures traceability and identification of devices throughout their lifecycle. These listings help healthcare providers and regulators verify the authorized status of specific products.

Ortosim’s devices are classified as Class II under FDA regulations, indicating a moderate risk to patients. This classification requires manufacturers to follow specific controls, such as design controls, labeling requirements, and post-market surveillance, to ensure safety and effectiveness. The 510(k) process is a key part of this classification, as it ensures each device meets performance standards comparable to existing, legally marketed alternatives before commercialization.