ORTHOGEM LTD

Orthogem Ltd specializes in synthetic bone graft materials, primarily used in orthopedic and spinal applications. These devices are designed as porous and bioactive scaffolds to support bone regeneration and fusion procedures, helping patients recover from fractures, joint replacements, or spinal surgeries.

Orthogem Ltd is based in the United States, which means its devices fall under the jurisdiction of the FDA. Since the company’s products are classified as Class II devices, they undergo premarket notification (510(k)) and unique device identification (UDI) requirements to ensure safety and effectiveness before entering the market.

Orthogem Ltd’s devices are listed in the FDA’s 510(k) and UDI registries. The 510(k) process demonstrates that a device is substantially equivalent to a legally marketed predicate, while the UDI system ensures accurate identification, tracking, and traceability of medical devices throughout their lifecycle, improving patient safety and regulatory compliance.

Orthogem Ltd’s devices are classified as FDA Class II, which means they pose moderate risk and require special controls beyond general controls to ensure their safety and effectiveness. This classification requires manufacturers to submit a 510(k) premarket submission to demonstrate compliance with regulatory requirements before commercial distribution.