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The Avitus® DragonWing Large Volume Autograft Delivery System is intended to be used for the delivery of autograft or hydrated allograft bone graft material to an orthopaedic surgical site.

The Avitus® Dragonwing™ Large Volume Autograft Delivery System is designed to deliver bone autograft or hydrated allograft material to an orthopaedic surgical site. The device delivers approximately up to 5cc of bone graft material per each reloadable five-channel cartridge. Each system comes with the following: - · 2 x Graft Cartridge Features 5 graft channels, a latching lid, and connection points to the Delivery Cannula. - · 1 x Bone Scoop Accessory Used to add graft to the Graft Cartridge channels. - · 1 x Pack Tool Accessory Used to compress graft into the Graft Cartridge channels. - · 1 x Delivery Cannula Features a handle frame which connects to a loaded Graft Cartridge and a straight-tipped cannula through which graft material is delivered to the orthopaedic surgical site. - · 1 x Delivery Plunger Features a plunger rod and handle. During graft delivery, the Delivery Plunger is pushed through a Graft Cartridge channel to deploy graft material to the orthopaedic surgical site.

The Avitus® Precision Autograft Delivery System is intended to be used for the delivery of autograft or hydrated allograft bone graft material to an orthopaedic surgical site.

The Avitus Precision Autograft Delivery System is designed to deliver bone autograft or hydrated allograft material to an orthopaedic surgical site. The device delivers approximately up to 0.5cc of bone graft material per reloadable cartridge. Each system comes with the following: - · 2 x Graft Cartridge Features a graft channel, latching lid, and connection points to the Delivery Cannula and Threaded Delivery Plunger. - · 1 x Bone Loading Scoop Accessory Used to add graft to the Graft Cartridge channel. - · 1 x Bone Packer Accessory Used to compress graft into the Graft Cartridge channel. - · 1 x Straight Delivery Cannula Features a hub, which connects to a loaded Graft Cartridge, and straight-tipped cannula, through which graft material is delivered to the orthopaedic surgical site. - · 1 x Angled Delivery Cannula Features a hub, which connects a loaded Graft Cartridge, and angle-tipped cannula, through which graft material is delivered laterally to the orthopaedic surgical site. - · 1 x Threaded Delivery Plunger Features a plunger rod, knob, and threads. During graft delivery, the rod is depressed into the Graft Cartridge until the Plunger's threads engage with the Cartridge. This action transfers graft material into the Cannula. With the threads engaged, the user twists the Plunger knob to deliver a controlled volume of graft to the orthopaedic surgical site.

The Avitus® Bone Harvester is intended to harvest cancellous bone and marrow; to debride and capture infected, necrotic or diseased cancellous bone (e.g. osteomyelitis, cancellous bone tumors).

The proposed device is a minimally invasive manual non-powered cancellous bone and marrow graft harvester that can also be used for the removal of infected, necrotic, and diseased cancellous bone. The proposed changes described in this submission add to the types of materials to be collected to include infected, necrotic, or diseased cancellous bone. The Avitus® Bone Harvester consists of a metal cutting tip and shaft with transparent plastic handle, filter, collection chamber, and a threaded plastic cap. The principles of action for the proposed device with revised indications for use are identical to the predicate device. The Avitus® Bone Harvester is a manual surgical instrument that harvests cancellous bone and marrow, and debrides infected, necrotic, or diseased cancellous bone by manual actuation of the cutting tip. The Cap contains a barbed nozzle that connects to standard sized suction tubing to connect to a vacuum source. With the device connected to a vacuum source, when actuated in bone the cutting tip carves, scrapes, cuts, and collects the material into the reservoir filter insert inside the Handle. The Cap has a filter feature that prevents material from escaping the handle into the suction system by utilizing a physical sieve to keep bone particulate in the handle.

The Avitus® Bone Harvester is intended to harvest cancellous bone and marrow.

The proposed device is a manual surgical instrument that cuts cancellous bone by manual actuation of the cutting tip. The Cap contains a barbed nozzle that connects to standard sized suction tubing connect to a vacuum source. The proposed device can be connected to a waste canister that leads to standard operating room wall suction or to an external pump. With the device connected to a vacuum source, when actuated in bone the cutting tip carves, scrapes and cuts cancellous bone and collects the bone graft inside the handle. The suction pulls the bone and bone marrow from the cutting tip and into the bone reservoir inside the handle. The Cap has a filter feature that prevents material from escaping the handle into the suction system by utilizing a physical sieve. After harvesting, the bone graft can be retrieved from the handle. The proposed device includes a Filter Insert accessory that can assist the user to scoop the bone out from within the Handle after harvesting.