OrthoCircle Spine

OrthoCircle Spine specializes in spinal fixation hardware, primarily focusing on devices used for stabilizing the spine. Their portfolio includes non-bioabsorbable pedicle screws, metallic interbody fusion cages, and internal spinal fixation rod systems. Additionally, they produce reusable orthopaedic instruments like positioning tools, trial-implant holders, depth limiters, and rod reducers, as well as reprocessed bone taps for surgical preparation. These devices are designed to aid in spinal surgeries and long-term stabilization.

OrthoCircle Spine is based in the United States. Their devices are authorised for use in the US, where they undergo regulatory pathways such as 510(k) submissions and Unique Device Identification (UDI) compliance. This ensures their products meet the necessary standards for safety and effectiveness in the US market.

OrthoCircle Spine’s devices are listed in the FDA’s 510(k) registry and the FDA’s Unique Device Identifier (UDI) database. These registries track devices that have undergone the 510(k) clearance process or are required to carry a UDI, ensuring transparency and compliance with US regulatory requirements.

All of OrthoCircle Spine’s devices fall under FDA Class II classification. This classification applies to devices that generally pose moderate risk and require special controls—such as performance standards or post-market surveillance—to ensure their safety and effectiveness. Class II devices like those offered by OrthoCircle Spine are typically cleared through the 510(k) pathway, demonstrating substantial equivalence to a legally marketed predicate device.