Osteotomy Wedge System

The SiNAPTIC Osteotomy Wedge System is a sterile, single-use Silicon Nitride implant designed for internal bone fixation in foot and ankle osteotomies, including procedures for Hallux Valgus, Cotton osteotomies, lateral column lengthening, and hindfoot fusion. The wedges come in various shapes and sizes with a central open area for graft material or supplemental fixation.

The device is made of Silicon Nitride (Si3N4) material and features similar shapes, sizes, and design characteristics to predicate devices, with an insertion feature and central open area for graft packing or supplemental fixation. Although the material differs from some predicates, the physical design, mechanism of fixation, and principles of action are comparable to previously cleared devices.

Not stated in this summary. The document references bench performance testing including static compressive strength, dynamic compressive strength, static compression shear strength, and expulsion testing, but no specific FDA performance standards or consensus standards (ISO, IEC, ASTM) are cited.

The Osteotomy Wedge System is substantially equivalent because it has similar design and physical characteristics, identical indications for use, and comparable mechanism of fixation and principles of action to predicate devices (particularly Nvision Biomedical's Trigon HA Stand-Alone Wedge Fixation System). Performance testing and materials comparison support that no new safety or effectiveness concerns are raised despite the material difference.