Vortex5 Tailor's Bunion Correction System

The Vortex5 Tailor's Bunion Correction System is a single-use, permanently implanted bone fixation device consisting of an additively manufactured titanium alloy plate and machined screws. It is indicated for stabilization and fixation of fresh fractures, revision procedures, joint fusion, and reconstruction of small bones of the toes, specifically for 5th metatarsal osteotomies to correct Tailor's Bunion in adults and adolescents (13-21 years of age).

The subject device has similar design, dimensions, and materials as the predicate devices (K202657, K182949, K171558). Both the plates and screws incorporate equivalent features such as screw-receiving holes, tapered ends, and locking screws. Subject implant dimensions fall within the predicate ranges in diameter, thickness, width, and length.

The device mechanical performance was tested in accordance with recognized consensus standards and current industry practice. Testing included static and dynamic bending, static torsion, pullout and shear tests, and engineering analysis.

The Vortex5 is substantially equivalent because it has the same indications for use, similar technological characteristics, and equivalent performance to the predicate devices. Engineering analysis and mechanical testing demonstrate the subject device does not raise new issues of safety or efficacy and does not create a worst-case relative to the predicates, thus confirming substantial equivalence with respect to mechanical performance.