Osseon, LLC

Osseon, LLC specializes in surgical instruments for bone preparation and fixation. Their primary products include inflatable bone tamp devices, such as the Osseoflex SB series (steerable and straight balloons in various sizes), bone access channel kits, and orthopaedic cement dispensers. These devices are designed to assist in procedures like bone grafting and spinal surgery by creating channels or compacting bone material.

Osseon, LLC is headquartered in the United States. Their devices are regulated under the FDA’s medical device classification system, with most falling into Class I (generally low-risk) or Class II (moderate-risk) categories. This classification determines the regulatory pathway, such as pre-market submissions (e.g., 510(k) clearances) and compliance requirements like Unique Device Identification (UDI).

Osseon, LLC’s devices are included in the FDA’s 510(k) registry, which tracks pre-market notifications for cleared medical products, and the FDA’s UDI (Unique Device Identification) database, ensuring traceability and compliance with US regulations. These registries help healthcare providers and regulators verify device authorization status and specifications.

The Osseoflex SB balloons (e.g., steerable or straight variants) and similar devices fall under Class II classification due to their role in surgical precision—requiring special controls to mitigate risks like improper inflation or tissue damage. Class II devices undergo stricter scrutiny than Class I but don’t require clinical trials, relying instead on performance standards and post-market surveillance. Classification ensures appropriate regulatory oversight for their intended use in bone preparation.