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This month’s round-up of recent FDA clearances focuses on BlueOcean Global and Toetal Solutions, both of which received their first clearances for products in the trauma space. Let’s take a look at the new solutions and the backgrounds of each company.
BlueOcean Global | Excelsior System, K253291
Submitted September 2025, granted January 2026
FYI: Next-gen circular external fixation platform designed to support bone reconstruction and soft tissue management within a single system. Excelsior was developed to address 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.
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.
Excelsior is designed to allow surgeons to construct and modify circular frames for deformity correction, reconstruction and limb salvage using a single, modular platform. Its versatility may be particularly relevant in complex clinical scenarios such as Charcot reconstruction, infection, trauma and non-healing wounds.
BlueOcean was founded in 2021 and is headquartered in Miami, Florida. Leadership and staff bring experience from entitles such as FDA and Arthrex, Biomimetic Therapeutics, Bioventus, CONMED, Medtronic, Misonix, Orchid, Small Bone Innovations and Smith+Nephew.
Toetal Solutions | ZipToe Hammertoe Fusion System, K253325
Submitted September 2025, granted December 2026
Primary predicate: Stryker Smart Toe II, K201715
FYI: ZipToe Hammertoe Fusion was developed to deliver consistent fixation while supporting efficient, repeatable surgical workflow in proximal interphalangeal joint arthrodesis. It addresses common challenges of implant handling, alignment and procedural simplicity by incorporating a pre-loaded titanium and nitinol intramedullary implant into a fully disposable surgical kit.
The insertion tool includes two “ripcords” that are pulled to deploy the implant’s claws. The ripcord is a suture that is connected to the claws through a loop; once the implant is in place, the cords are pulled. Once deployed, the claws assist in initial fixation by providing opposing compression into the bone. Ziptoe comes sterile-packed with all necessary disposable instrumentation to perform the procedure in any surgical setting.
Toetal was founded in 2021 and is located in Malvern, Pennsylvania. The company is in the portfolio of Runway Healthcare, a medical device venture studio investing in early-stage technologies.
Members of Toetal’s leadership also helm other Runway companies, like Pace Surgical and Waypoint Orthopedics, and bring experience from entities like DePuy Synthes, Globus, SeaSpine and Trice Medical. Toetal has raised a total of $3.9 million over five rounds of funding since 2021.
