Pterygoid Indication for GM Helix Implants

The Neodent GM Helix Implant System comprises dental implants and abutments intended for surgical placement in the upper or lower jaw to support prosthetic teeth and restore chewing function. This 510(k) expands the indications to include placement in the pterygoid region (upper jaw) for patients with severe jaw resorption, using 3.75–4.0 mm diameter implants with 45° angulated abutments in splinted multi-unit restorations.

The subject devices are threaded root-form implants with Grand Morse (GM) internal taper connection, made of titanium grade 4 (implants) and titanium alloy (abutments). Diameters are 3.75–4.0 mm; lengths are 18 mm for GM Helix and 20–25 mm for GM Helix LG. Abutment angles are 45° with gingival heights of 1.5–2.5 mm. Surface finish is Neoporos or Acqua; sterilization is gamma irradiation for implants and ethylene oxide for abutments.

ISO 14801 (dynamic loading test for endosseous dental implants), ISO 10993-1, ISO 10993-5, ISO 10993-18 (biocompatibility), ISO 11137-1 and ISO 11137-2 (sterilization validation), ISO 11135:2014 (ethylene oxide sterilization), and ISO 10993-7 (ethylene oxide residuals). FDA Guidance for Class II Special Controls for Root-form Endosseous Dental Implants and Abutments was also cited.

The subject devices are substantially equivalent to the primary predicate (K212785 Blue Sky Bio Dental Implant System) because they share identical design, materials, dimensions, and sterilization methods, with equivalent indications for pterygoid placement using 45° abutments in severe jaw resorption cases. Clinical literature demonstrates high survival rates (88.2–100%) for similar implants in the pterygoid region, and bench testing confirms performance equal to or better than the predicate device.