Search Results

The DigiMatch™ ROBODOC® Surgical System is intended for use as a device, which uses diagnostic images of the patient acquired specifically to assist the physician with presurgical planning and to provide orientation and reference information during intra-operative procedures, The robotic surgical tool, under the direction of the surgeon, precisely implements the presurgical software plan. The preoperative planning software and robotic surgical tool is used as an alternative to manual planning and broaching/reaming techniques for femoral canal preparation in primary total hip arthroplasty (THA). The DigiMatch ROBODOC Surgical System is indicated for Orthopedic procedures in which the broaching/reaming in primary total hip arthroplasty (THA) may be considered to be safe and effective and where references to rigid anatomical structures may be made.

The DigiMatch™ ROBODOC® Surgical System consists of the 510(k)-cleared (K960685) ORTHODOC® Preoperative Planning Workstation (ORTHODOC), and a Robot composed of an electromechanical arm, electronics control cabinet, display monitor and miscellaneous accessories (ROBODOC). The System (ORTHODOC and ROBODOC) is a threedimensional graphical preoperative planner and implementation tool and is indicated as an alternative to template planning and manual broaching for treatment of patients who require primary total hip arthroplasty (THA). The ORTHODOC component of the System allows a surgeon to preoperatively assess a patient's femoral anatomy and state of hip disease, select an optimally sized femoral stem implant from a library of prostheses, and determine where the implant should be positioned within the femur. Then ROBODOC component of the System, under direct control by the surgeon, will precisely implement the preoperative plan.

Stereotactic spatial positioning and orientation of an instrument holder or tool guide to be used by a surgeon to manually guide standard neurosurgical instruments.

A stereotactic system with an electromechanical, multijointed arm for spatial positioning and orientation of an instrument holder or tool guide. Guidance is based on a preoperative plan developed with three-dimensional imaging software and utilizes ultrasonic registration. The system is intended for use by neurosurgeous to guide standard neurosurgical instruments.

The ORTHODOC Preoperative Planner is a software device indicated for the planning of primary total hip arthroplasties on a personal computer. The software is intended to import computed tomography data, provide a constructed image of the data, and use computerized files, representing implant patterns of femoral components, to overlay the constructed image to aid surgeons in their selection and positioning of the femoral components.

This software is designed to run on a PentiumR-based personal computer. The device is a software-only product and is not intended to operate any other medical device or act directly on a patient. The application stores scaled graphic images of femoral stem components and provides a means for surgeons to superimpose these patterns on a CT image of the patient's femur. The implant patterns can be moved over the femur images to select what in the surgeon's judgement is the best stem size, position, neck length, and head diameter to achieve the physician's surgical goal. The library of implant patterns, called surface model files, is developed from computer-aided-design (CAD) geometric data supplied by the implant's manufacturer. The implant surface model file used by ORTHODOC contains implant identification information as well as geometric data which defines the shape and dimensions of the implant surface.