Bone Screw

The Bone Screw is a titanium alloy fixation screw with a 1.2 mm diameter and lengths of 3.0, 4.0, or 5.0 mm. It is used in oral cavity procedures to stabilize and fixate bone grafts, bone filling material, and barrier membranes during bone regeneration, particularly for fixing non-resorbable membranes or titanium membranes in dental implant applications.

The subject device has a smaller thread diameter (∅1.2 mm) compared to the primary predicate (∅1.4 and 1.95 mm), but matches the thread diameter of the reference device (∅1.2 mm). It shares the same material (Titanium Alloy ASTM F136), manufacturing process, surface treatment (machined), sterilization method (gamma irradiation), shelf-life (8 years), and length range (3/4/5 mm) as the primary predicate.

ASTM F543-17 was used for performance testing, including driving torque, axial pullout strength, and torsional strength. FDA Guidance Document ISO 10993-1 and the ISO 10993 suite of standards were followed for biocompatibility evaluation. FDA guidance on MR safety testing was referenced for magnetically induced displacement force and torque assessment.

The subject device demonstrates substantial equivalence through mechanical comparison testing with the reference device (K201210), which shares the identical 1.2 mm thread diameter. Although smaller than the primary predicate (K182881), the subject device maintains the same material, indications for use, manufacturer, manufacturing process, and comparable size ranges. Performance testing confirmed equivalence with the reference device, establishing that the smaller diameter does not raise new safety or effectiveness concerns. The device can leverage existing sterilization validation and shelf-life data from the primary predicate due to identical materials, packaging, and sterilization methods.