Obtaining accurate percutaneous renal access when treating intrarenal disease requires substantial skill. Robotic devices have been used in a variety of surgical applications and have been successful in facilitating percutaneous puncture while improving accuracy. Laboratory models of robotic devices for percutaneous renal access have also been developed. However, several technical hurdles need to be addressed. One relates to the device-patient interface. As a first step in creating a complete robotic system, a mechanical arm (PAKY) with active translational motion for percutaneous renal access has been developed and clinically assessed. The PAKY consists of a passive mechanical arm mounted on the operating table and a radiolucent needle driver that uses a novel active translational mechanism for needle advancement. The system utilizes real-time fluoroscopic images provided by a C-arm to align and monitor active needle placement. In vitro experiments to test needle placement accuracy were conducted using a porcine kidney suspended in agarose gel. Seven copper balls 3 to 12.5 mm diameter were placed in the collecting system as targets, and successful access was confirmed by electrical contact with the ball. The PAKY was then used clinically in nine patients. The number of attempts, target calix location, calix size, and time elapsed were evaluated. In the in vitro study, successful needle-ball contact occurred the first time in all 70 attempts, including 10 attempts at the 3-mm balls. Clinically, percutaneous access to the desired calix was attained on the first attempt in each case. The mean target calix diameter was 14.7 mm (range 7-40 mm). The mean time elapsed while attempting access was 8.2 minutes. No perioperative complications attributable to needle access occurred. Early experience indicates that the PAKY provides a steady needle holder and an effective and safe end-effector for percutaneous renal access. This device may provide the mechanical platform for the development of a complete robotic system capable of creating percutaneous renal access.