510(k) · Cleared
ClearedNavitrack
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Orthosoft, Inc. · HAW Neurological Stereotaxic Instrument
Cleared on Jul 9, 1998 as substantially equivalent to K964229 (Compass Intl., Inc., 1997) and 1 other predicate after a 90-day review. Its family tree reaches back 3 generations to 1994. 36 later devices descend from it.
- Decided
- Jul 9, 1998
- Review
- 90 days
- Class
- Class II
- Product code
- HAW
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K911783 (1994). 8 ancestors in all, the oldest K871046 (1987). 36 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK911783 Allegro Viewing WandI.S.G. Technologies, Inc. · 1994
- 2 generations backK960714 Isg Viewing WandI.S.G. Technologies, Inc. · 1996
- 1 generation backK964229 Regulus NavigatorCompass Intl., Inc. · 1997
- This deviceK981315 NavitrackOrthosoft, Inc. · 1998
- Descendant · cites it directly · 35 of its ownK033413 Spineassist DeviceMazor Surgical Technologies, Ltd. · 2004
- Descendant · 2 generations on · 34 of its ownK051676 Spineassist Device with Additional AccessoriesMazor Surgical Technologies, Ltd. · 2005
- Descendant · 2 generations on · 33 of its ownK063607 Spineassist SystemMazor Surgical Technologies, Ltd. · 2007
- Descendant · 2 generations on · 32 of its ownK073467 Spineassist SystemMazor Surgical Technologies, Ltd. · 2008
- Descendant · 3 generations on · 31 of its ownK102130 Tenzing SystemMazor Surgical Technologies, Ltd. · 2010
Showing 5 of 36 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 36 · See all- K033413Spineassist DeviceMazor Surgical Technologies, Ltd. · 2004 · cites it directly35descendants
- K051676Spineassist Device with Additional AccessoriesMazor Surgical Technologies, Ltd. · 2005 · 2 generations on34descendants
- K063607Spineassist SystemMazor Surgical Technologies, Ltd. · 2007 · 2 generations on33descendants
- K073467Spineassist SystemMazor Surgical Technologies, Ltd. · 2008 · 2 generations on32descendants
- K102130Tenzing SystemMazor Surgical Technologies, Ltd. · 2010 · 3 generations on31descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K911783 | Allegro Viewing Wand | I.S.G. Technologies, Inc. | 1994 | — |
| −2 | K960714 | Isg Viewing Wand | I.S.G. Technologies, Inc. | 1996 | — |
| −1 | K964229 | Regulus Navigator | Compass Intl., Inc. | 1997 | — |
| 0 (this device) | K981315 | Navitrack | Orthosoft, Inc. | 1998 | — |
| +1 | K033413 | Spineassist Device | Mazor Surgical Technologies, Ltd. | 2004 | — |
| +2 | K051676 | Spineassist Device with Additional Accessories | Mazor Surgical Technologies, Ltd. | 2005 | — |
| +2 | K063607 | Spineassist System | Mazor Surgical Technologies, Ltd. | 2007 | — |
| +2 | K073467 | Spineassist System | Mazor Surgical Technologies, Ltd. | 2008 | — |
| +3 | K102130 | Tenzing System | Mazor Surgical Technologies, Ltd. | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1995 | 3 | 0 |
| 1997 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 3 | 0 |
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 5 | 0 |
| 2020 | 3 | 0 |
| 2021 | 1 | 0 |
| 2023 | 4 | 0 |
| 2024 | 1 | 0 |
| 2025 | 3 | 0 |
| 2026 | 6 | 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? (2)
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 |
|---|---|---|---|
| * | K964229 | Regulus NavigatorSummary page 1…ATE DEVICES The Navitrack™ System is substantially equivalent to the following legally*marketed devices : - e The Regulus™ Navigator from COMPASS International Inc. (K964229), determined to be substantially equivalent to a legally marketed device on August 19, 1997. e The Surgical Microscope Navigator… | 1997 |
| * | K965139 | Surgical Microscope Navigator (SMN) System/Surgical Tool Navigator (STN) SystemSummary page 1…tional Inc. (K964229), determined to be substantially equivalent to a legally marketed device on August 19, 1997. e The Surgical Microscope Navigator System from Zeiss (K965139), determined to be substantially equivalent to a legally marketed device on April 23, 1997. 00019 ORIGINAL 510K… | 1997 |
What descends from it? (36)
See all 361 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K033413 | Spineassist Device | 2004 | 35 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 4 years and passes through 3 companies; a new generation was cleared every 1.2 years on median.
- None of the 8 ancestors has a recall.
- Of its descendants, K033413 (Mazor Surgical Technologies, Ltd., 2004) has gone furthest, with 35 descendants of its own.
- 1 other device also cites its predicate K964229.
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 Navitrack™ System is a stereotaxic instrument indicated for use in precisely positioning instruments or implants during orthopedic surgery, such as operation perform within spinal structures.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K981315 · printed Nov 4, 2026
Cite this page
510(k) Report. “K981315: Navitrack.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K981315
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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