# K051734: GE Healthcare Insta Trak 3500PLUS/ Fluoro Trak 9800 Plus System with Axcess Bone Pin, Model Part # 1006955

- Pathway: 510(k) (Traditional)
- Applicant: Ge Healthcare Technologies
- Decided: Nov 23, 2005 after 148 days
- Product code: HAW (Neurological Stereotaxic Instrument)
- Device class: 2
- Regulation: 21 CFR 882.4560
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K904283 (1990). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K992927: Stealthstation Treatment Guidance Platform, Surgical Navigation Technologies, Inc. (1999) Summary page 2.
- K022370: Framelock; Framelock Accessories, Medtronic Xomed, Inc. (2002) Summary page 2.
- K023651: Vectorvision Cranial/Ent, Brainlab AG (2004) Summary page 2.

## Recalls of this device
- Nov 8, 2006 · Class II · Z-1989-2012: GE Healthcare is aware of a few instances where the Axcess Cranial Screw has broken during insertion. There is a possibility that breaking of the screws could lead to a health hazard.

## Indications for use
The GE Healthcare Navigation and Visualization System [InstaTrak 3500 Plus System (K040050) or OEC FluoroTrak 9800 Plus (1K022069)] together with the Axass Bone Pin, is intended as an aid to the surgeon for precisely locating anatomical structures anywhere on the human body during either open or percutaneous procedures. It is indicated for any medical condition that may benefit from the use of stereotaxic surgery and which provides a reference to rigid structures such as sinus, skull, long bone or vertebra visible on medical images such as CT, MR or x-ray. The Axcss Bone Pin is intended to be used where rigid fixation of a tracking device to bone is required.

Source page: https://510kreport.com/device/K051734
Methodology: https://510kreport.com/methodology