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The PathKeeper System is a stereotaxic image guidance system intended for the spationing and orientation of surgical instruments used by orthopedic surgeons and neurosurgeons during posterior approach spinal fusion surgeries when pre-operative CT imagery is available. The System, with PathKeeper spine surgery planning and navigation software and 3D optical camera, is intended as an aid for precisely locating anatomical structures in posterior approach open spine fusion surgery during pedicle screw placement in the thoraco-lumbo-sacral region. The device is indicated for posterior approach open spine fusion surgery during pedicle screw placement in the thoracolumbo-sacral region where reference to a rigid anatomical structure can be identified.

The PathKeeper System is an Orthopedic Surgical Navigation System. The system provides registration between preoperative computed tomography (CT) data and intraoperative Optical Topographic Image (OTI) data acquired using a proprietary OTI 3D camera. The system provides surgical guidance data by displaying the location of optically tracked Surgical Accessories relative to the patient anatomy, based on the calculated registration. Position and orientation data of PathKeeper's Tracked Surgical Accessories are linked to the preoperative scan data using the workstation. The PathKeeper System is designed for open spine surgery where reference to a rigid structure - Dynamic Reference Frame (DRF) - spine reference DRF - can be identified relative to the pre-operative image data of the anatomy. In open spine surgery the posterior elements of the operated vertebrae are exposed, either unilaterally or bilaterally. PathKeeper System's 3D image-processing capabilities provide co-registration of the topography of exposed bone structures obtained by the proprietary OTI 3D camera, to the pre-operative CT scan of the patient. The PathKeeper System is a portable console. The components of the PathKeeper System are, in arbitrary order: - . Workstation Cart with Articulated Arm ALSO referred to as Cart with Head (articulated arm and Camera) - A high-resolution proprietary Camera with OTI capabilities mounted to an articulated rigid metallic holding arm, computer (with PathKeeper software installed), monitor, keyboard, mouse, and DVD drive on a medicalgrade cart. The cart with its parts described above, is provided nonsterile with cleaning instructions in the User Manual. There is no patient contact. - . PathKeeper Software for pre-operative planning and intra-operative registration and navigation. The PathKeeper Software shall be installed on the workstation computer and displayed on the workstation monitor and will perform the bulk of the required computation for the system to operate. There is no patient contact. - . Surgical Accessories Kit including the following components: - · 6 Navigation Dynamic Reference Frames (DRFs) which are to be attached to common surgical tools (i.e., Awl, Pedicle probe, and Screwdriver). Note: Tools are not provided with the system and are not subject to this submission - Tool setun/calibration plate DRF - · Spine reference DRF - · Sterilization case (all DRFs above reside in this case) These tools are reusable, steam-sterilized accessories serving as spatial markers. - . Spheres - Single-use sterile standard navigation Retro-Reflective Spheres. Note: these are acquired off-the-shelf items and not provided with the system or the subject of this submission. - . Patient reference attachment mechanism - off-the-shelf attachment mechanism (Walton Cartilage Clamp, 8", Curved, Catalog # 270-170, manufactured by Integra LifeSciences) via which the Spine reference DRF (patient reference) is connected to the bony anatomy of the spine. Note: this is an acquired off-the-shelf item and not provided with the system or the subject of this submission. - . Sterile cover for handle - off-the-shelf single-use sterile cover (Universal Surgical Light Handle Cover, Catalog # LB82, manufactured by Steris Corporation) same as for OR lighting handles. Note: this is an off-the-shelf item and not provided with the system or the subject of this submission.