CROSSNAV Navigation Enabled Instruments for Disc Preparation and Interbody

Navigation Enabled Instruments are reusable instruments indicated to be used during the preparation and placement of DePuy Synthes implants as well as discectomy and / or bony resection, during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or percutaneous procedures. The Navigation Enabled Instruments are designed for use with only the specific DePuy Synthes implant system(s) for which they are indicated and with the VELYS SPINE Navigation as well as with the Brainlab Navigation System and the Medtronic StealthStation Navigation System. The Navigation Enabled Instruments are indicated for use in surgical spinal procedures, in which:
• the use of EXPEDIUM™, VIPER™, SYMPHONY™ OCT, TriALTIS™, and the CONDUIT™ Spine System is indicated, if used for implant placement,
• the use of stereotactic surgery may be appropriate, and
• reference to a rigid anatomical structure, such as the pelvis or a vertebra, can be identified relative to the acquired image (CT, MR, 2D fluoroscopic image or 3D fluoroscopic image reconstruction) and/or an image data based model of the anatomy. These procedures include but are not limited to spinal fusion. The Navigation Enabled Instruments are also compatible with DePuy Synthes Power Systems and the Medtronic IPC™ POWEREASE System. The Navigation Enabled Instruments used in conjunction with the SYMPHONY™ OCT System are intended to support indicated cervical and thoracic polyaxial screw placement only. The Navigation Enabled Instruments indicated for discectomy and / or bony resection, as well as the CONDUIT implants placement are for use with Medtronic StealthStation System only.

Navigation Enabled Instruments are reusable instruments indicated to be used during the preparation and placement of DePuy Synthes implants as well as discectomy and / or bony resection, during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or percutaneous procedures. The Navigation Enabled Instruments are designed for use with only the specific DePuy Synthes implant system(s) for which they are indicated and with the VELYS SPINE Navigation as well as with the Brainlab Navigation System and the Medtronic StealthStation Navigation System. The Navigation Enabled Instruments are indicated for use in surgical spinal procedures, in which: • the use of EXPEDIUM™, VIPER™, SYMPHONY™ OCT, TriALTIS™, and the CONDUIT™ Spine System is indicated, if used for implant placement, • the use of stereotactic surgery may be appropriate, and • reference to a rigid anatomical structure, such as the pelvis or a vertebra, can be identified relative to the acquired image (CT, MR, 2D fluoroscopic image or 3D fluoroscopic image reconstruction) and/or an image data based model of the anatomy. These procedures include but are not limited to spinal fusion. The Navigation Enabled Instruments are also compatible with DePuy Synthes Power Systems and the Medtronic IPC™ POWEREASE System. The Navigation Enabled Instruments used in conjunction with the SYMPHONY™ OCT System are intended to support indicated cervical and thoracic polyaxial screw placement only. The Navigation Enabled Instruments indicated for discectomy and / or bony resection, as well as the CONDUIT implants placement are for use with Medtronic StealthStation System only.

Navigation Enabled Instruments (CROSSNAV™ Instruments) are reusable instruments used for the preparation and placement of DePuy Synthes EXPEDIUM™, VIPER™, SYMPHONY™ OCT, TriALTIS™, and CONDUIT™ implants, in either open or percutaneous procedures. The Navigation Enabled Instruments include drills, taps and screwdrivers and can be operated manually or under power. They also include manual tissue and bone removal / manipulation devices as well as interbody sizers and interbody implant inserters. These instruments are designed for navigated and non-navigated use. Navigation Enabled Instruments also include the CROSSNAV™ Adaptor to facilitate navigation of the Navigation Enabled Instruments with the VELYS™ SPINE Navigation as well as with the Brainlab Navigation System. Navigation of these instruments is achieved using the VELYS™ SPINE Navigation as well as the Brainlab Navigation System and the Medtronic StealthStation™ Navigation System and their associated tracking arrays.