FDA approves Sculptor Robotic Guidance Arm (Stanmore Implants) for Surgery

Stanmore Implants has received 510(k) clearance from the FDA to market its Sculptor Robotic Guidance Arm for precision implant placement in unicompartmental knee Surgery, also known as partial knee resurfacing. The Sculptor RGA system is a robotic guide to assist with bone preparation, performed by a high speed cutting burr attached to the robotic arm, which limits the surgeon's operation of the cutting burr to a safe area so that bone is only removed corresponding to the implant's planned position as determined both pre- and intra-operatively.

A second mechanical tracking arm is attached to the bone that is being sculpted to accurately track the location of the patient, providing real time dynamic referencing relative to both the position of the robotic arm and the surgical plan. This surgeon-controlled system features an interactive touch screen which the surgeon uses throughout the procedure.