Signature Osteosynthesis Plate System

The Signature Osteosynthesis Plate System is a bone fixation device using titanium alloy screws and plates to stabilize fractures, osteotomies, malunions, and non-unions in adult patients. Different plate designs target specific anatomical sites: tubular and small compression plates for the foot, hand, wrist, and forearm; narrow and broad compression plates for upper and lower extremities (excluding femur and proximal tibia); and clavicle plates for clavicular fractures in patients with fused growth plates.

The subject device has nearly identical technological characteristics to the predicate (K171320), sharing the same indications for use, materials of manufacture (medical-grade titanium alloy), structural support mechanism, principle of operation, and sizing. Implants are provided sterile (single-use) or non-sterile with steam sterilization instructions; instruments are non-sterile and reusable.

Static Four-point Bending per ASTM F382-99 (2008); Dynamic Four-point Bending per ASTM F382-99 (2008); Static Torsion per ASTM F543-13; Static Axial Pullout per ASTM F543-13.

The subject and predicate devices share identical indications for use, materials, design principle, and manufacturing/sterilization processes, with only minor differences that do not raise new safety or effectiveness concerns. Non-clinical testing demonstrated that the strength of the Signature system is sufficient for its intended use and substantially equivalent to the predicate device, establishing bioequivalence without the need for clinical data.