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The ARTAS System from Restoration Robotics is indicated for harvesting hair follicles from the scalp in men diagnosed with androgenic alopecia (male pattern hair loss) who have black or brown straight hair. The ARTAS System from Restoration Robotics is intended to assist physicians in identifying and extracting hair follicular units from the scalp during hair transplantation; creating recipient sites; and implanting harvested hair follicles.

The ARTAS System is used under the control of a physician to assist with the harvesting of follicular units and recipient site creation steps of the hair transplantation process. Follicular units are harvested from the patient's scalp, and then implanted into the patient's scalp in the recipient sites created by the physician or the ARTAS System. Additionally, the modified ARTAS System has the capability to assist the physician with the implantation step of the hair transplantation procedure. The ARTAS System is an interactive, image-guided, computer assisted system consisting of several main subsystems. These include a robotic arm, imaging, needle mechanism, safety, computer, accessory kits and patient chair. The ARTAS System Cart houses the Robotic Arm, the Needle Mechanism, the Imaging subsystems and the Computer. The Needle Mechanism houses the Accessory Kits required for harvesting, recipient site creation, and implantation. The Needle Mechanism is mounted on the Robotic Arm which is mounted on the System Cart. The robotic arm controller is built into the cart and controls the robot and is connected to the computer for communications and transmission of movement instructions. The Accessory Kits contain components necessary to complete the hair transplantation procedure, including the accessories for harvesting, site-making, and implantation. The Accessory Kits used with the ARTAS System and Procedures include Disposable and Reusable Accessory Kits. For Implantation, the Implant Accessory Kits are used with the modified ARTAS System. The ARTAS Mechanism holds equivalent commercially available components of the predicate device. The Implantation Needle Assembly is inserted into the ARTAS Needle Mechanism with a pre-loaded 'Linear Cartridge' with hair follicles prior to implantation. Restoration Robotics has also incorporated an 'Index Cam-Obturator Assembly' which facilitates the progression of the Linear Cartridge to the next available hair follicle. The Fiducial Platform provides a location for fiducial markings used to track target locations during the Site Making and Implantation Procedures. All items must be sterilized prior to use.