TriALTIS Navigation Enabled Instruments

Navigation Enabled Instruments are reusable instruments indicated to be used during the preparation and placement of DePuy Synthes screws 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 Medtronic StealthStation® System. The Navigation Enabled Instruments are indicated for use in surgical spinal procedures, in which:
• the use of EXPEDIUM 4.5, EXPEDIUM 5.5, EXPEDIUM 6.35, VIPER 2, VIPER SAI, EXPEDIUM VERSE, VIPER PRIME (without stylet control), SYMPHONY OCT and the TriALTIS Spine System is indicated,
• 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.

Navigation Enabled Instruments are reusable instruments indicated to be used during the preparation and placement of DePuy Synthes screws 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 Medtronic StealthStation® System. The Navigation Enabled Instruments are indicated for use in surgical spinal procedures, in which: • the use of EXPEDIUM 4.5, EXPEDIUM 5.5, EXPEDIUM 6.35, VIPER 2, VIPER SAI, EXPEDIUM VERSE, VIPER PRIME (without stylet control), SYMPHONY OCT and the TriALTIS Spine System is indicated, • 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.

Navigation Enabled Instruments are reusable instruments used for the preparation and placement of DePuy Synthes EXPEDIUMTM 4.5, EXPEDIUMTM 5.5, EXPEDIUMTM 6.35, VIPERTM 2, VIPERTM SAI, VIPER PRIMETM, EXPEDIUM VERSETM, SYMPHONYTM OCT and TriALTISTM screws, in either open or percutaneous procedures. The Navigation Enabled Instruments include drills, taps and screwdrivers and can be operated manually or under power. These instruments are designed for navigated and non-navigated use. Navigation of these instruments is achieved using the Medtronic StealthStation navigation system and associated tracking arrays.