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BlueOcean Global was granted FDA 510(k) clearance to market the Excelsior External Fixation System, a next-gen circular external fixation platform designed to support both bone reconstruction and soft tissue management within a single system. Phased rollout will commence through select centers, with broader availability planned in the coming months.
Excelsior was developed in response to the growing clinical complexity associated with diabetes, vascular disease, infection, trauma, and chronic non-healing wounds. These conditions often require coordinated management of skeletal stability and vulnerable soft tissue, a challenge not fully addressed by traditional external fixation systems.
Unlike legacy systems designed primarily around bone correction, Excelsior was conceived from the ground up to integrate osseous and soft tissue considerations throughout reconstruction. The system is guided by FASTR (Fixator Assisted Soft Tissue Repair), a procedural framework that incorporates soft tissue protection, offloading, and support directly into the external fixation construct rather than treating soft tissue management as a separate phase of care.
The Excelsior External Fixation System is designed to allow surgeons to construct and modify circular external fixation frames for deformity correction, reconstruction, and limb salvage using a single, modular platform. This versatility may be particularly relevant in complex clinical scenarios such as Charcot reconstruction, infection, trauma, and non-healing wounds.
“For decades, innovation in external fixation has focused on incremental changes,” said Scott Ludecker, President and Founder of BlueOcean Global. “Excelsior reflects a more integrated approach that aligns with the realities of modern limb salvage, where bone stability and soft tissue considerations must be addressed together.”
Source: BlueOcean Global
BlueOcean Global was granted FDA 510(k) clearance to market the Excelsior External Fixation System, a next-gen circular external fixation platform designed to support both bone reconstruction and soft tissue management within a single system. Phased rollout will commence through select centers, with broader availability planned in the coming...
BlueOcean Global was granted FDA 510(k) clearance to market the Excelsior External Fixation System, a next-gen circular external fixation platform designed to support both bone reconstruction and soft tissue management within a single system. Phased rollout will commence through select centers, with broader availability planned in the coming months.
Excelsior was developed in response to the growing clinical complexity associated with diabetes, vascular disease, infection, trauma, and chronic non-healing wounds. These conditions often require coordinated management of skeletal stability and vulnerable soft tissue, a challenge not fully addressed by traditional external fixation systems.
Unlike legacy systems designed primarily around bone correction, Excelsior was conceived from the ground up to integrate osseous and soft tissue considerations throughout reconstruction. The system is guided by FASTR (Fixator Assisted Soft Tissue Repair), a procedural framework that incorporates soft tissue protection, offloading, and support directly into the external fixation construct rather than treating soft tissue management as a separate phase of care.
The Excelsior External Fixation System is designed to allow surgeons to construct and modify circular external fixation frames for deformity correction, reconstruction, and limb salvage using a single, modular platform. This versatility may be particularly relevant in complex clinical scenarios such as Charcot reconstruction, infection, trauma, and non-healing wounds.
“For decades, innovation in external fixation has focused on incremental changes,” said Scott Ludecker, President and Founder of BlueOcean Global. “Excelsior reflects a more integrated approach that aligns with the realities of modern limb salvage, where bone stability and soft tissue considerations must be addressed together.”
Source: BlueOcean Global
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JV
Julie Vetalice is ORTHOWORLD's Editorial Assistant. She has covered the orthopedic industry for over 20 years, having joined the company in 1999.
