ADDITIVE ORTHOPAEDICS LLC

Additive Orthopaedics LLC specialises in metallic orthopaedic devices used primarily for foot and ankle procedures. Their portfolio includes non-customised metallic osteotomy fusion cages and non-bioabsorbable orthopaedic bone pins. Key examples are systems for hammertoe correction, such as the Hammertoe System, as well as bone wedge systems, MTP (metatarsophalangeal) cup and cone bone segments, locking lattice systems, and wedge osteotomy systems. These devices are designed to support bone fusion and alignment in surgical applications.

Additive Orthopaedics LLC is based in the United States. Their devices are classified under FDA Class II, which typically requires premarket notification (510(k)) clearance before they can be marketed. This classification is due to the moderate risk associated with these orthopaedic implants, which require validation of safety and performance through the regulatory process. The company’s devices are authorised through the 510(k) pathway, ensuring compliance with FDA requirements.

Additive Orthopaedics LLC’s devices are listed in the FDA’s official registries, specifically the 510(k) database and the Unique Device Identifier (UDI) system. The 510(k) registry documents premarket submissions demonstrating that the devices meet FDA safety and effectiveness standards, while the UDI system ensures traceability and identification of each device type in the market. These registries help healthcare providers and regulators track authorised products.

All of Additive Orthopaedics LLC’s devices fall under FDA Class II classification. This classification is assigned based on the level of risk associated with the device. Class II devices generally pose moderate risk and require special controls—such as performance standards or post-market surveillance—to ensure their safety and effectiveness. For orthopaedic implants like those produced by Additive Orthopaedics, this classification ensures rigorous evaluation through the 510(k) pathway before market authorisation.