Search Results

The Stryker OrthoMap Express Knee system, which is comprised of the OrthoMap Express Knee 2.0 Software and a platform of the NAV31 platform family, is intended as a planning and intra-operative guidance system to enable open or percutaneous image-guided surgery. The system can be used for intraoperative guidance where a rigid anatomical structure can be identified. The system is indicated for conditions of the knee joint in which the use of computer assisted surgery may be appropriate.

The Stryker OrthoMap Express Knee system is intended to be used as a planning and intraoperative guidance system to enable open or percutaneous image guided knee surgery. The system uses wireless optical tracking technology to display to the surgeon the intraoperative location of navigated surgical instruments relative to a computed anatomical model of the patient's leg (femur and tibia). The computed model is based on an intra-operative anatomy survey of the leg. The system consists of a Stryker surqical software application (software), which runs on a platform, consisting of a Stryker computer, a navigation camera, an IO-Tablet and a monitor. The Stryker surgical software application interfaces with smart instruments (e.g. patient trackers, instrument trackers or pointers) and several accessories enabling the tracking of surgical instruments. The Stryker OrthoMap Express Knee 2.0 software is compatible with the NAV3i Platform Family. The NAV3i platform family is a family of platforms that. when used with a surgical software application, displays patient specific images and/or patient specific anatomical landmark information and tracks the position and movement of surgical instruments in relation to a target anatomical site on a patient. The NAV3i platform family consists of the following three platforms that have been previously cleared independently or with other Stryker surgical software applications: - . Stryker NAV3 Platform (K141551) - Stryker NAV3i Platform (K130874) ● - Stryker NAVSuite3 Kit (K150301) ● The platforms consist of the following components: - Stryker computer - Navigation camera ● - IO-Tablet - Monitor ● - Mobile cart (if applicable) ●

The Stryker Xia 4.5 Polyaxial Screwdriver is a Stryker Navigated Manual Surgical Instrument. Stryker Navigated Manual Surgical Instruments are intended to be used as accessories to the Stryker Spine Navigation System, when used with the SpineMap 3D Navigation software. They are manual surgical instruments intended to be used in spine surgery to facilitate placement of Stryker Spine implants. Stryker Navigated Spine Instruments may be used as part of the Stryker Spine Navigation System, which is indicated for any medical condition in which the use of computer assisted planning and surgery may be appropriate. The system can be used for intraoperative guidance where a reference to a rigid anatomical structure can be identified. Stryker Navigated Spine Instruments are intended for exclusive use with the Rotational Adaptor and associated Trackers to facilitate the placement of the Stryker Spine XIA® 3, XIA® 4.5, MANTIS®, MANTIS® Redux, and ES2® Spinal Fixation Systems using the STRYKER SpineMap® 3D Navigation System. The surgeon must also refer to the Stryker Spine XIA® 3, XIA® 4.5, MANTIS®, MANTIS® Redux, or ES2® package insert/instructions for use, product label, and surgical technique guide to obtain detailed product information and recommended surgical procedure.

The Navigated XIA® 4.5 Polyaxial Screwdriver, a Stryker Navigated Spine Instrument, is a manual tool for bone screw placement, insertion, and removal. The tip of the navigated screwdriver inserts into the screw head to turn it. The screwdriver also has an interface to allow a connection to the Rotational Navigation Adapter, a Stryker Spine Navigation System accessory, and to a handle.

The Stryker SpineMap® 3D Navigation System, when used with a Stryker computer workstation, is intended as a planning and intraoperative guidance system to enable open or percutaneous computer assisted surgery. The system is indicated for any medical condition in which the use of computer-assisted planning and surgery may be appropriate. The system can be used for intraoperative guidance where a rigid anatomical structure can be identified. The Stryker SpineMap® 3D Navigation System assists in precise positioning of instruments for procedures on the spine, including: · Pedicle screw placement The Stryker SpineMask™ Tracker is intended to be used as an accessory to the Stryker SpineMap® 3D Navigation System. It is placed onto the patient's skin dorsal to the spine. - · In combination with intraoperative imaging devices, it enables automatic patient registration for open or percutaneous computer assisted surgery. - · When used for patient tracking, the Stryker SpineMask™ Tracker supports minimally invasive procedures on the lumbar and thoracic spine.

The Stryker SpineMap® 3D Navigation System is an image guided surgery system to enable open or percutaneous computer-assisted spinal surgery. The system uses wireless optical tracking technology to display to the surgeon the intraoperative location of navigated surgical instruments relative to a CT image. The system consists of a software application, smart instruments (e.g. patient/instrument trackers, pointers, navigated surgical instruments), and several accessories to enable the tracking of surgical instruments. The system also includes the SpineMask™ Tracker, a new patient tracking device. The software application runs on a Stryker computer platform, consisting of a Stryker computer, a navigation camera and an IO-Tablet.

The Stryker PROFESS™ system is a navigation surgical software module that, when used with a specific Stryker computer workstation, is intended as an intraoperative guidance system to enable intranasal and sinus computer-assisted surgery. The system tracks and displays the intraoperative location of navigated surgical instruments relative to a CT image. The system can be used for intraoperative guidance where a reference to a rigid anatomical structure can be identified. The Stryker PROFESS™ system is indicated for intranasal and sinus surgery in which the use of computer-assisted surgery is appropriate and for which a CT image of the patient in accordance with the imaging protocol is available. The Stryker PROFESS™ system supports the following surgical procedures: • Endoscopic sinus surgery • Intranasal procedures

The PROFESS™ System, consisting of a computer platform, software and sterile single-use accessories, is designed to enable image guided surgery in intranasal and sinus surgery. Specifically, the system tracks and displays to the surgeon the intraoperative location of navigated surgical instruments, for example suction tools, relative to a CT image. The PROFESS™ System is based on the use of live video images captured by the miniature video camera mounted on the PROFESS™ Navigated Surgical Instruments. The captured images can be processed by the PROFESS™ Software for localization and tracking of the PROFESS™ Navigated Surgical Instrument relative to the PROFESS™ Patient Tracker as long as the PROFESS™ Patient Tracker is partially visible in the video image. The following are the PROFESS™ System components: - PROFESS™ Software - PROFESS™ Navigated Surgical Instruments: - PROFESS™ Straight Suction - PROFESS™ Curved 70°Suction - PROFESS™ Curved 90° Suction - PROFESS™ Frontal Sinus Seeker - PROFESS™ Registration Stickers - PROFESS™ Patient Tracker - PROFESS™ Adaptor Cable - Computer platform containing an SPC-3 Workstation and IO-Tablet, one of: - Stryker ADAPT® Platform - Stryker Nav3® Platform - Stryker Nav3i™ Platform

The Stryker Navigation System - CranialMap Neuro Module is a navigation surgical software module that, when used with a specific Stryker computer workstation, is intended as a planning and intraoperative guidance system to enable open or percutaneous computer assisted surgery. The system is indicated for any medical condition in which the use of computer assisted planning and surgery may be appropriate. The system can be used for intraoperative guidance where a reference to a rigid anatomical structure can be identified. The system should be operated only by trained personnel such as surgeons and clinic staff. The CranialMap Neuro Navigation system supports, but is not limited to, the following surgical procedures: - Cranial biopsies - Puncture of abscesses - Craniotomies - Craniectomies - Resection of tumors and other lesions - Removal of foreign objects - Skull base procedures - Transnasal neurosurgical procedures - Transphenoidal pituitary surgery - Shunt placement, including pediatric shunt placement - Placement of electrodes for recording, stimulation and lesion generation - Endoscopic Sinus Surgery (ESS) - Intranasal procedures - Ear implant procedures - Craniofacial procedures - Skull reconstruction procedures - Orbital cavity reconstruction procedures.

The Stryker Navigation System - CranialMap Neuro Module is intended as a planning and intraoperative guidance system to enable open or percutaneous computer assisted surgery. The system is indicated for any medical condition in which the use of computer assisted planning and surgery may be appropriate. The system can be used for intraoperative quidance where a reference to a rigid anatomical structure can be identified. The CranialMap Neuro Module is the Stryker Navigation System for cranial surgeries as described in the indications for use statement. The subject device is the Stryker Navigation Software - CranialMap Neuro which together with the Stryker Navigation Platform, Smart Instruments and Accessories forms the Stryker Navigation System - CranialMap Module. It is therefore regarded as a component of the Stryker Navigation System - CranialMap Neuro Module. The design modifications introduced with the Stryker Navigation Software CranialMap Neuro are intended to increase the user comfort, to enhance the look and feel of the software and to simplify and extend the provided functions using the latest system platform technology.

The NAV3i Platform is a computer workstation that, when used with specific Stryker Navigation surgical software, displays patient specific images and/or patient specific anatomical landmark information and tracks the position and movement of surgical instruments in relation to a target anatomical site on a patient. The clinical setting and target population for the NAV3i Platform is that of a patient undergoing a surgical procedure using stereotactic techniques.

The Stryker NAV3i Platform is a modular component of the Stryker Navigation System and is intended to run Stryker Navigation surgical software for surgical procedures using stereotactic techniques. The surgical navigation software used on this device is cleared as a separate 510(k). The Stryker Navigation System is a planning and intraoperative guidance system which assists in various surgical procedures. It allows for the localization of surgical instruments and visualization of their position relative to patient specific images and/or patient specific anatomical landmark information assisting the surgeon in performing the intervention at a high level of precision. For localization, active optical tracking based on infrared light is used. Using three linear sensors, the Navigation Camera detects signals from infrared light emitting diodes which are attached to the instruments to be localized. The NAV3i Platform consists of a mobile cart, a computer system, a monitor and a Navigation Camera. During surgery, the placed close to the operating room table but not within the sterile field. Articulated arms allow for the alignment of the Navigation Camera and the monitor to the operative field. The NAV3i Platform features for entering medical images such as CT images or microscope images which are required for navigation. The computer is used to install and run Stryker Navigation Software. while the monitor conveys navigation information to the user.