510(k) · Cleared
Recalled · Class II · 2006GE Healthcare Insta Trak 3500PLUS/ Fluoro Trak 9800 Plus System with Axcess Bone Pin, Model Part # 1006955
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ge Healthcare Technologies · HAW Neurological Stereotaxic Instrument
Cleared on Nov 23, 2005 as substantially equivalent to K992927 (Surgical Navigation Technologies, Inc., 1999) and 2 other predicates after a 148-day review. Its family tree reaches back 2 generations to 1990. It has been recalled once.
- Decided
- Nov 23, 2005
- Review
- 148 days
- Class
- Class II
- Product code
- HAW
- Recalls
- 1
- Predicates
- 3
Its longest line of descent runs back 2 generations to K904283 (1990). 6 ancestors in all. No later device cites it as a predicate yet.
- Root · 2 generations backK904283 PS Medical Cranial Hand DrillPudenz-Schulte Medical Research Corp. · 1990
- 1 generation backK022370 Framelock; Framelock AccessoriesMedtronic Xomed, Inc. · 2002
- This deviceK051734 GE Healthcare Insta Trak 3500PLUS/ Fluoro Trak 9800 Plus System with…Ge Healthcare Technologies · 2005
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K904283 | PS Medical Cranial Hand Drill | Pudenz-Schulte Medical Research Corp. | 1990 | — |
| −1 | K022370 | Framelock; Framelock Accessories | Medtronic Xomed, Inc. | 2002 | — |
| 0 (this device) | K051734 | GE Healthcare Insta Trak 3500PLUS/ Fluoro Trak 9800 Plus System with Axcess… | Ge Healthcare Technologies | 2005 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 2 | 0 |
| 2001 | 1 | 0 |
| 2004 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in HAW? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new HAW device
- #1 K253856 Geniant Cranial (Navigated Neurosurgical…score 15.0 · 11 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K992927 | Stealthstation Treatment Guidance PlatformSummary page 2…The GE Healthcare InstaTrak 3500 Plus System with Axcess Bone Pin is substantially equivalent to the following: * LandmarXTM Image Guided Surgical System (K992927) when used with Framelock TM (K022370), the transmitter rigid fixation device - both manufactured by Medtronic Xomed, Inc… | 1999 |
| * | K022370 | Framelock; Framelock AccessoriesSummary page 2…em with Axcess Bone Pin is substantially equivalent to the following: * LandmarXTM Image Guided Surgical System (K992927) when used with Framelock TM (K022370), the transmitter rigid fixation device - both manufactured by Medtronic Xomed, Inc. * VectorVision Cranial/ENT (K023651) s… | 2002 |
| * | K023651 | Vectorvision Cranial/EntSummary page 2…2927) when used with Framelock TM (K022370), the transmitter rigid fixation device - both manufactured by Medtronic Xomed, Inc. * VectorVision Cranial/ENT (K023651) system, which contains a proprietary transmitter rigid fixation device (Skull Reference Array)- manufactured by BrainLAB… | 2004 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 8, 2006 | Class II | Z-1989-2012 | Device Design | 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. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 15 years and passes through 3 companies; a new generation was cleared every 12.0 years on median.
- 2 of the 6 ancestors have a recall of any class.
- 2 other devices also cite its predicate K992927.
How does its category compare?
All HAW devicesHAW Neurological Stereotaxic Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HAW
9in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HAW
163in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HAW
2in 2025
Class I (9 since 2007) Class II/III not classified
Adverse event reports per year · HAW
3,425in 2025
MAUDE reports naming product code HAW, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 15 | 107 | 2 | 49 |
| 2008 | 12 | 112 | 10 | 53 |
| 2009 | 8 | 221 | 6 | 96 |
| 2010 | 6 | 138 | 28 | 299 |
| 2011 | 4 | 66 | 5 | 1,725 |
| 2012 | 8 | 178 | 4 | 986 |
| 2013 | 3 | 172 | 6 (1) | 1,290 |
| 2014 | 5 | 238 | 5 | 1,606 |
| 2015 | 10 | 232 | 3 | 1,767 |
| 2016 | 9 | 175 | 5 | 1,828 |
| 2017 | 7 | 226 | 2 | 3,505 |
| 2018 | 6 | 112 | 2 (2) | 4,439 |
| 2019 | 10 | 147 | 4 (1) | 6,062 |
| 2020 | 5 | 88 | 1 | 3,480 |
| 2021 | 9 | 168 | 4 (2) | 2,827 |
| 2022 | 7 | 128 | 1 | 1,929 |
| 2023 | 14 | 142 | 4 (1) | 2,510 |
| 2024 | 7 | 107 | 2 (2) | 3,755 |
| 2025 | 9 | 163 | 2 | 3,425 |
| 2026 | 5 | 162 | 6 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K051734 · printed Nov 6, 2026
Cite this page
510(k) Report. “K051734: GE Healthcare Insta Trak 3500PLUS/ Fluoro Trak 9800 Plus System with Axcess Bone Pin, Model Part # 1006955.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051734
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026