Forcyte Autograft Harvest Kit

The Forcyte Autograft Harvest Kit is a manual bone and marrow harvesting system composed of a harvesting needle, collection jar, suction tubing, drill-tip guide pin, and hydration chamber. It is intended to harvest autologous cancellous bone and bone marrow for combination with commercially available allograft or bone void fillers to fill bony voids or gaps that are not critical to bone stability.

The subject device and predicate device share similar technological characteristics as manual autograft harvesting instrumentation. Both are manual systems designed to harvest bone and marrow for use as bone void fillers, with comparable operational design and function.

Not stated in this summary. The document indicates that there are no specific applicable test standards for this device class, though bench testing including simulated use, tensile, compression, torque, flexural, and vacuum testing were performed.

The device is substantially equivalent because it employs identical technology and methodology as the predicate device (Avitus Precision Autograft Delivery, K210631) for the same intended use of manual autograft harvesting. Bench testing, biocompatibility, and sterilization/shelf-life testing all demonstrated that the subject device is safe, effective, and performs as well as the predicate, establishing technological and functional equivalence despite minor wording differences in labeling.