GraftGun Universal Graft Delivery System (GDS)

The GraftGun Universal Graft Delivery System (GDS®) is a sterile, single-use, disposable device with non-sterile reusable adapter tips designed to deliver prepared allograft, autograft, or synthetic bone graft material to orthopedic surgical sites via direct visualization or minimally invasive approaches.

The subject device incorporates the same design, material composition, and principles of operation as the predicate devices (K170675 and K180937). Modifications include updated naming convention, improved loading device and adapter tips for ease of use, and revised packaging configuration for smaller size and easier transport.

ISO 11137 and ISO 17665 (sterilization validation), ISO 10993 (biocompatibility), ASTM D4169 (package performance), plus compatibility assessments, cleaning validations for reusable components, and shelf-life testing.

The subject device maintains identical intended use, materials, design principles, and function compared to the predicate devices. The modifications (updated naming, improved loading device and adapter tips, smaller packaging) represent design refinements rather than fundamental changes. All performance testing—including compatibility, sterilization, cleaning, biocompatibility, and package performance—confirms these improvements do not alter the device's safety or effectiveness profile, supporting substantial equivalence.