POINT Kinguide Agile Robotic Arm Surgical Stereotactic System

The POINT Kinguide Agile Robotic Arm Surgical Stereotactic System is a robotic accessory to the Kinguide Agile navigation platform designed to help surgeons achieve pre-planned surgical trajectories during neurosurgical and orthopedic procedures. It is specifically indicated for pedicle screw entry point alignment and angular orientation in spinal surgery (T12-S1 vertebrae, or T1-S1 when using the robotic arm) using intraoperative 3D imaging.

The system features a 6-degree-of-freedom RobotArm Station with 5 kg maximum payload and 900 mm working range; infrared passive marker-based tracking compatible with the Kinguide Agile navigation software; system accuracy of ≤2.0 mm positional error and ≤2.0° trajectory angle error; and integration with the Kinguide Agile Hybrid Navigation System for real-time surgical guidance.

IEC 60601-1 (Edition 3.2), IEC 60601-1-2 (Edition 4.1), IEC 60601-1-8 (Edition 2.2), IEC 80601-2-77 (Edition 1.1), ASTM F2554-22 for positional accuracy, ISO 14971:2019 for risk management, IEC 62304:2006 for software validation, ISO 10993-1:2018 for biocompatibility, and AAMI/ANSI standards for reprocessing and sterilization.

The Kinguide RobotArm is substantially equivalent to predicate devices K241130 (Kinguide Agile Hybrid Navigation System) and K202320 (CIRQ Robotic Alignment Module) because it shares identical intended use, indications, tracking technology, system accuracy specifications, intended use environment, and operator profiles. Both the subject device and predicates are intraoperative image-guided stereotactic systems for spinal surgery using infrared passive marker-based tracking with comparable performance metrics.