SIGNEX

SIGNEX is a bone fixation system composed of plates and screws made from pure titanium or titanium alloy used to stabilize fractures, fusions, osteotomies, non-unions, malunions, and reconstructions across multiple anatomical sites including the hand, wrist, forearm, elbow, humerus, foot, fibula, tibia, femur, and clavicle. The device is supplied non-sterile and single-use only.

SIGNEX plates are made of pure titanium (ASTM F67) or Ti-6Al-4V ELI titanium alloy (ASTM F136), while screws are made of Ti-6Al-4V ELI alloy. Plates range from 6.9–438.0 mm in length and 0.6–6.0 mm thickness; screws range from 10.0–90.0 mm in length and 2.4–5.0 mm diameter. Both plates and screws are available with anodized or non-anodized surface treatments and include various anatomical shapes (straight, Y-, T-, square) and cannulated/non-cannulated designs.

Biocompatibility testing per ISO 10993-5 (cytotoxicity), ISO 10993-10 (sensitization and irritation), ISO 10993-11 (systemic toxicity and implantation), ISO 10993-3 (genotoxicity), and ISO 10993-6 (pyrogen testing). Mechanical testing per ASTM F543 (torsion, axial pullout, and driving torque), ASTM F382 (4-point bending).

SIGNEX is substantially equivalent to its primary predicate (K230546, also SIGNEX by OSTEONIC) and additional predicates (Synthes and other devices) because it has identical indications for use, anatomical sites, materials (titanium alloys), sterilization status (non-sterile), and single-use design. Although SIGNEX has slight differences in plate and screw size ranges compared to predicates, comparative testing with legally marketed devices demonstrated equivalent safety and effectiveness, confirming the size differences do not raise questions about safety or effectiveness.