# K141833: Stylet, 23CM, Skull-Mount Patient Tracker, Non-Invasive Patient Tracker, Tracer Pointer, Touch-N-GO Pointer, Navigation

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Navigation, Inc.
- Decided: Mar 25, 2015 after 261 days
- Product code: HAW (Neurological Stereotaxic Instrument)
- Device class: 2
- Regulation: 21 CFR 882.4560
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K001284 (2000). 3 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K001284: Stealthstation System Goldeneye Micro-Magnetic Tracking System, Medtronic Surgical Navigation Technologies (2000) Summary page 9.
- K022126: Catheter Introducer for the Stealthstation System, Medtronic Surgical Navigation Technologies (2003) Summary page 9.
- K050438: Stealthstation System Update, Medtronic Surgical Navigation Technologies (2005) Summary page 9.

## Most influential descendants
- K212194: Stryker Q Guidance System with Cranial Guidance Software, CranialMask Tracker and Microscope Tracker, Passive Optical Navigation Instruments, Mayfield Base with Articulating Arm, and Navigated Biopsy Needle, Electromagnetic Navigation Instruments, Precision Targeting System (2023), 1 descendant of its own
- K233542: Ortho Guidance Precision Knee Software; Ortho Guidance Express Knee Software; Ortho Guidance Versatile Hip Software; Q Guidance System (2024), 0 descendants of its own
- K163209: Fiagon Navigation System (2017), 0 descendants of its own

## Recalls of this device
- Dec 15, 2022 · Class II · Z-1039-2023: Due to increasing complaint trend for the Non-Invasive Patient Tracker system where complaints analysis indicates that users are unable to successfully verify their navigation instruments during image
- Dec 12, 2016 · Class II · Z-1007-2017: Medtronic Navigation, Inc. announces a voluntary field action for the AxIEM Touch N Go Pointer Probe because the patient registration accuracy may compromise navigation accuracy when using the Stealth

## Indications for use
The Non-Invasive Patient Tracker is indicated for use as a stereotactic reference frame to track the position of patient anatomy during navigated cranial and ENT procedures in adult and pediatric patients. It is indicated for use with Medtronic computer-assisted surgery systems using electromagnetic navigation and cranial and ENT software. The Medtronic computer assisted surgery system and its associated applications are intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. Their use is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the skull, can be identified relative to a CT-based or MR-based model, fluoroscopy images, or digitized landmarks of the anatomy. The Skull-Mount Patient Tracker is indicated for use as a stereotactic reference frame to track the position of patient anatomy during navigated cranial and ENT procedures. It is indicated for use with Medtronic computer-assisted surgery systems using electromagnetic navigation and cranial and ENT software. The Medtronic computer assisted surgery system and its associated applications are intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. Their use is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the skull, can be identified relative to a CT-based or MR-based model, fluoroscopy images, or digitized landmarks of the anatomy. The Stylet is indicated for use in precisely locating anatomical structures during navigated cranial procedures. It is indicated for use with Medtronic computer-assisted surgery systems using electromagnetic navigation and cranial software. The Medtronic computer assisted surgery system and its associated applications are intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. Their use is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the skull, can be identified relative to a CT-based or MR-based model, fluoroscopy images, or digitized landmarks of the anatomy. The Stylet is indicated for use in the following procedures: • General ventricular catheter placement • Pediatric ventricular catheter placement • Tumor resections • Skull base procedures • Craniotomies/craniectomies • Transsphenoidal procedures The Tracer® Pointer is indicated for use in registering patient anatomy and in precisely locating anatomical structures during navigated cranial procedures in adult and pediatric patients. It is indicated for use with Medtronic computer-assisted surgery systems using electromagnetic navigation and cranial software. The Medtronic computer assisted surgery system and its associated applications are intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. Their use is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the skull, can be identified relative to a CT-based or MR-based model, fluoroscopy images, or digitized landmarks of the anatomy. The Touch-n-Go Pointer is indicated for use in registering patient anatomy during navigated cranial procedures in adult and pediatric patients. It is indicated for use with Medtronic computer-assisted surgery systems using electromagnetic navigation and cranial software. The Medtronic computer assisted surgery system and its associated applications are intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. Their use is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the skull, can be identified relative to a CT-based or MR-based model, fluoroscopy images, or digitized landmarks of the anatomy. The Navigation Pointer is indicated for use in precisely locating anatomical structures during navigated cranial procedures. It is indicated for use with Medtronic computer-assisted surgery systems using electromagnetic navigation and cranial software. The Medtronic computer assisted surgery system and its associated applications are intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. Their use is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the skull, can be identified relative to a CT-based or MR-based model, fluoroscopy images, or digitized landmarks of the anatomy. The Navigation Pointer is indicated for use in the following procedures: • General tumor resections • Pediatric tumor resections • Skull base procedures • Craniotomies/craniectomies • Transsphenoidal procedures

Source page: https://510kreport.com/device/K141833
Methodology: https://510kreport.com/methodology