Anteralign™ LS Spinal System with Titan nanoLOCK™ Surface Technology MAZORX Stealth(TM) Edition

Medtronic Surgical Instruments are intended to be used during preparation and placement of Medtronic implants during spinal surgery to assist in precisely locating anatomical structures in either open, or minimally invasive, procedures. Medtronic Surgical Instruments are specifically designed for use with the Mazor X Stealth™ Edition, which is indicated for medical conditions in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as a skull, a long bone, or vertebra can be identified relative to a CT or MR-based model, fluoroscopy images, or digitized landmarks of the anatomy. Medtronic Surgical Instruments can be navigated or non-navigated manual instruments that may or may not be guided through the Mazor X Stealth™ Edition Arm Guide. Medtronic surgical drills shall only be used through the Mazor X Stealth™ Edition arm guides, Medtronic cannulas, and Medtronic drill guides. Some of the Medtronic Surgical Instruments are also compatible with the IPC™ Powerease™ System or AO* style quick connect drilling motors. An instrument may incorporate a measuring function which has uses as described on the label and the instrument. Medtronic cannulas may or may not be used with Midas Rex™ attachments and tools.

Medtronic Surgical Instruments are intended to be used during preparation and placement of Medtronic implants during spinal surgery to assist in precisely locating anatomical structures in either open, or minimally invasive, procedures. Medtronic Surgical Instruments are specifically designed for use with the Mazor X Stealth™ Edition, which is indicated for medical conditions in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as a skull, a long bone, or vertebra can be identified relative to a CT or MR-based model, fluoroscopy images, or digitized landmarks of the anatomy.

The Anteralign™ LS Navigated Reusable Surgical Instruments are spine preparation instruments made of high‐grade stainless steel. The subject navigated instruments consist of existing navigated trials and a navigated interbody inserter, which were recently cleared in K221180, S.E. 5/25/22 for use in Anteralign Interbody System procedures where the use of stereotaxic surgery may be appropriate with the StealthStation™ System. Per this 510(k) submission, Medtronic is seeking clearance of the navigated instruments to also be compatible with the MAZOR X™ Stealth Edition. The instruments are compatible with NavLock trackers and Medtronic single‐use sterile spheres to allow the Medtronic computer‐assisted surgery system, such as the Stealth Station System and MAZOR X™ System (Stealth™ Edition), to track the instruments in the surgical field.