| K-number | K253291 |
| Device name | Excelsior System |
| Applicant | Blue Ocean Global |
| Product code | KTT |
| Device class | Class II |
| Decision date | Jan 20, 2026 |
| Decision | Substantially Equivalent |
| Regulation | 888.3030 |
The Excelsior System is a modular external fixation device consisting of implantable half pins, fixation wires, rings, struts, rods, hinges, and connectors made from stainless steel, aluminum, and titanium. It is indicated for treatment of fractures, limb lengthening, deformity correction, and various orthopedic conditions in pediatric and adult patients.
The device is designed as a modular, ring-based external fixation system matching predicate devices in intended use and technological characteristics. Additional components compared to the primary predicate are substantially equivalent to those in secondary predicates, with the same materials and assembly methodology.
Standard Specification and Test Methods for External Skeletal Fixation Devices per ASTM F1541. Additional testing included sterilization validation, dry time validation, and cleaning and disinfection validation.
The Excelsior System is substantially equivalent because it has the same intended use and technological characteristics as the predicate devices, the additional components raise no different safety or effectiveness questions, and performance testing demonstrates it meets all specifications met by predicates without raising different issues of safety or efficacy.
View the full FDA submission: accessdata.fda.gov