STEALTHSTATION SYSTEM UPDATE— 510(k) K050438

Clearance details

Applicant

Medtronic Surgical Navigation Technologies

Product code

Code HAW

Device class

Class 2

Regulation

21 CFR 882.4560

Advisory panel

Neurology

Date received

2005-02-22

Decision date

2005-06-02

Decision

Substantially Equivalent

Clearance type

Special

Location

Louisville, CO, US

• K253856 — Geniant Cranial (Navigated Neurosurgical Positioning Robot)2026-09-10
• K261932 — Leksell® Vantage Stereotactic System2026-08-05
• K253663 — Zeta Navigation System2026-05-01
• K253379 — Stealth AXiS Cranial clinical application2026-03-26
• K231897 — NeuroAlign software2025-10-21

• K043088 — MEDTRONIC SNT STEALTHSTATION AXIEM IMAGELESS KNEE MODULE2005-01-05
• K030552 — IMAGELESS KNEE MODULE FOR THE STEALTHSTATION SYSTEM2003-03-19
• K030106 — STEALTHSTATION SYSTEM ADVANCED CONTOUR REGISTRATION SOFTWARE MODULE2003-02-12
• K022126 — CATHETER INTRODUCER FOR THE STEALTHSTATION SYSTEM2003-01-03
• K021980 — HIP MODULE FOR THE STEALTHSTATION SYSTEM2002-11-19

Death

52

Injury

1,083

Malfunction

17,300

Total

18,435

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• Z-2746-2017 — Install CD, Spine tools, Plus and S7, Version 25. Model Number 9731958.Class II·Terminated·Medtronic Navigation, Inc.·20170510
• Z-2313-2016 — Synergy Cranial S7. The software application is sent in CD format with an IFU, wrapped in plastic with a label for shipping purposes. Product Usage: The StealthStation System is intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. The StealthStation System 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, a long bod, or vertebra can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.Class II·Terminated·Medtronic Navigation, Inc.·20160718
• Z-2318-2016 — MACH Cranial Treon. The software application is sent in CD format with an IFU, wrapped in plastic with a label for shipping purposes. Product Usage: The StealthStation System is intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. The StealthStation System 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, a long bod, or vertebra can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.Class II·Terminated·Medtronic Navigation, Inc.·20160718
• Z-2824-2015 — P/N: 9734856, SCREWDRIVER, 9734856, SOLERA STD MAST; P/N: 9734857, SCREWDRIVER, 9734857, SOLERA RDN MAST; P/N: 9734279, SCREWDRIVER 9734279 SOLERA STANDARD; and P/N: 9734373, SCREWDRIVER 9734373 SOLERA REDUCTION. The Medtronic Navigated Solera Screwdrivers are reusable devices that are designed for use in spine surgery to assist in the placement of screws during the surgery, using a Medtronic computer-assisted surgery system.Class II·Terminated·Medtronic Navigation, Inc.·20150914
• Z-0441-2013 — The Vertex Max Drill Tube is a component within the Navigated Vertex Max Drill Guide Set (item 9733370). The Navigated Vertex Max Drill Guide Set is intended to be used with a Medtronic Computer Assisted Surgery System to help assist with screw placement during spine surgical procedures. The device is reusable and requires sterilization according to product labeling. .Class II·Terminated·Medtronic Navigation, Inc.·20121113

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K050438.