AxiEM™ 9733534

• FDA 510(k) K001284 decided 12 Jun 2000 Active
• FDA GUDID UDI-DI 00763000588359 listed 30 Dec 2021 Listed

• 2 recalls, same reason

  • Terminated Z-2317-2016 FDA Class II ·initiated 18 Jul 2016
  • Terminated Z-2319-2016 FDA Class II ·initiated 18 Jul 2016

  Medtronic Navigation, Inc. announces a voluntary field action for the Medtronic Navigation StealthStation Software applications affected by Neurologica BodyTom/CereTom floor-based scanners.

• 25 recalls, same reason

  • Terminated Z-1587-2014 FDA Class II ·initiated 24 Apr 2014
  • Terminated Z-1581-2014 FDA Class II ·initiated 24 Apr 2014
  • Terminated Z-1582-2014 FDA Class II ·initiated 24 Apr 2014
  • Terminated Z-1600-2014 FDA Class II ·initiated 24 Apr 2014
  • Terminated Z-1584-2014 FDA Class II ·initiated 24 Apr 2014
  • Terminated Z-1601-2014 FDA Class II ·initiated 24 Apr 2014
  • Terminated Z-1578-2014 FDA Class II ·initiated 24 Apr 2014
  • Terminated Z-1580-2014 FDA Class II ·initiated 24 Apr 2014
  • Terminated Z-1591-2014 FDA Class II ·initiated 24 Apr 2014
  • Terminated Z-1590-2014 FDA Class II ·initiated 24 Apr 2014
  • Terminated Z-1595-2014 FDA Class II ·initiated 24 Apr 2014
  • Terminated Z-1594-2014 FDA Class II ·initiated 24 Apr 2014
  • Terminated Z-1593-2014 FDA Class II ·initiated 24 Apr 2014
  • Terminated Z-1596-2014 FDA Class II ·initiated 24 Apr 2014
  • Terminated Z-1598-2014 FDA Class II ·initiated 24 Apr 2014
  • Terminated Z-1592-2014 FDA Class II ·initiated 24 Apr 2014
  • Terminated Z-1589-2014 FDA Class II ·initiated 24 Apr 2014
  • Terminated Z-1585-2014 FDA Class II ·initiated 24 Apr 2014
  • Terminated Z-1579-2014 FDA Class II ·initiated 24 Apr 2014
  • Terminated Z-1602-2014 FDA Class II ·initiated 24 Apr 2014
  • Terminated Z-1583-2014 FDA Class II ·initiated 24 Apr 2014 ·on shared 510(k) K001284
  • Terminated Z-1599-2014 FDA Class II ·initiated 24 Apr 2014
  • Terminated Z-1588-2014 FDA Class II ·initiated 24 Apr 2014 ·on shared 510(k) K001284
  • Terminated Z-1597-2014 FDA Class II ·initiated 24 Apr 2014
  • Terminated Z-1586-2014 FDA Class II ·initiated 24 Apr 2014

  Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package damage to ensure sterility.

• • Terminated Z-0718-06 FDA Unclassified (pre-2012) ·initiated 1 Feb 2006

  Knee Navigation Disposable Kits were programmed with an incorrect identification number on the tracker ROM chip which would not permit navigation during surgery.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

1. 24 Apr 2014 Recall initiated FDA recalls Z-1579-2014
2. 24 Apr 2014 Recall initiated FDA recalls Z-1602-2014
3. 24 Apr 2014 Recall initiated FDA recalls Z-1583-2014
4. 24 Apr 2014 Recall initiated FDA recalls Z-1599-2014
5. 24 Apr 2014 Recall initiated FDA recalls Z-1588-2014
6. 24 Apr 2014 Recall initiated FDA recalls Z-1597-2014
7. 24 Apr 2014 Recall initiated FDA recalls Z-1586-2014
8. 18 Jul 2016 Recall initiated FDA recalls Z-2317-2016
9. 18 Jul 2016 Recall initiated FDA recalls Z-2319-2016
10. 30 Dec 2021 Listed FDA GUDID 00763000588359

20 earlier events are in the sections above.

Trade name

AxiEM™

Generic name

Stereotactic surgery system probe, single-use

Model / reference

9733534

Primary DI / UDI-DI

00763000588359

510(k) Number

K001284 ↗

FDA product code

HAW

GMDN term

Stereotactic surgery system probe, single-use

Device class

Class II

Regulation number

882.4560

GUDID distribution status

In Commercial Distribution

Category: Stereotactic surgery system probe, single-use

Other devices filed under FDA product code HAW (Neurological stereotaxic Instrument).

• Instrument Adaptor (6.4 mm) COIH030E by BRAIN NAVI BIOTECHNOLOGY CO., LTD.
• IPLAN! DIGITAL TEMPLATING by Brainlab AG
• AQrate Robotic Assistance System by GLOBUS MEDICAL, INC.
• NAVIGUS PASSIVE PROBE, MODEL NP-1000 by Image-Guided Neurologics, Inc.
• MODIFICATION TO STEATHSTATION TREATMENT GUIDANCE PLATFORM by Medtronic Surgical Navigation
• ELEKTA STEREOTACTIC GUIDE by Elekta Instrument AB
• SURGETICS ORTHO KNEELOGICS NAVIGATION SYSTEM by Praxim
• STEALTHSTATION SYSTEM by Surgical Navigation Technologies, Inc.
• TRAJECTORY GUIDE, MODEL # TGX-XXX by Image-Guided Neurologics, Inc.
• MEDTRONIC SNT STEALTHSTATION AXIEM IMAGELESS KNEE MODULE by Medtronic Surgical Navigation Technologies

• Non-Invasive Patient Tracker

  Class I

  CE/MDR

• Autoguide System

  Class I

  CE/MDR

• Tactile Probe

  Class I

  CE/MDR

• Universal Drill Guides

  Class I

  CE/MDR

See all devices from Medtronic Navigation Inc. →