510(k) · Cleared
ClearedSpineassist System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mazor Surgical Technologies, Ltd. · HAW Neurological Stereotaxic Instrument
Cleared on May 23, 2008 as substantially equivalent to K033413 (Mazor Surgical Technologies, Ltd., 2004) and 4 other predicates after a 165-day review. Its family tree reaches back 7 generations to 1994. 32 later devices descend from it.
- Decided
- May 23, 2008
- Review
- 165 days
- Class
- Class II
- Product code
- HAW
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 7 generations to K911783 (1994). 22 ancestors in all, the oldest K811452 (1981). 32 later devices descend from it, 1 citing it directly.
- Root · 7 generations backK911783 Allegro Viewing WandI.S.G. Technologies, Inc. · 1994
- 6 generations backK960714 Isg Viewing WandI.S.G. Technologies, Inc. · 1996
- 5 generations backK964229 Regulus NavigatorCompass Intl., Inc. · 1997
- 4 generations backK981315 NavitrackOrthosoft, Inc. · 1998
- 3 generations backK033413 Spineassist DeviceMazor Surgical Technologies, Ltd. · 2004
- 2 generations backK051676 Spineassist Device with Additional AccessoriesMazor Surgical Technologies, Ltd. · 2005
- 1 generation backK063607 Spineassist SystemMazor Surgical Technologies, Ltd. · 2007
- This deviceK073467 Spineassist SystemMazor Surgical Technologies, Ltd. · 2008
- Descendant · cites it directly · 31 of its ownK102130 Tenzing SystemMazor Surgical Technologies, Ltd. · 2010
- Descendant · 2 generations on · 24 of its ownK110911 Renaissance SystemMazor Robotics, Ltd. · 2011
- Descendant · 3 generations on · 23 of its ownK113228 Renaissance SystemMazor Robotics, Ltd. · 2011
- Descendant · 4 generations on · 21 of its ownK140167 Renaissance X SystemMazor Robotics, Ltd. · 2014
- Descendant · 3 generations on · 21 of its ownK120812 RenaissanceMazor Robotics, Ltd. · 2012 · Recalled
Showing 5 of 32 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 32 · See all- K102130Tenzing SystemMazor Surgical Technologies, Ltd. · 2010 · cites it directly31descendants
- K110911Renaissance SystemMazor Robotics, Ltd. · 2011 · 2 generations on24descendants
- K113228Renaissance SystemMazor Robotics, Ltd. · 2011 · 3 generations on23descendants
- K140167Renaissance X SystemMazor Robotics, Ltd. · 2014 · 4 generations on21descendants
- K120812RenaissanceMazor Robotics, Ltd. · 2012 · 3 generations on21descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K911783 | Allegro Viewing Wand | I.S.G. Technologies, Inc. | 1994 | — |
| −6 | K960714 | Isg Viewing Wand | I.S.G. Technologies, Inc. | 1996 | — |
| −5 | K964229 | Regulus Navigator | Compass Intl., Inc. | 1997 | — |
| −4 | K981315 | Navitrack | Orthosoft, Inc. | 1998 | — |
| −3 | K033413 | Spineassist Device | Mazor Surgical Technologies, Ltd. | 2004 | — |
| −2 | K051676 | Spineassist Device with Additional Accessories | Mazor Surgical Technologies, Ltd. | 2005 | — |
| −1 | K063607 | Spineassist System | Mazor Surgical Technologies, Ltd. | 2007 | — |
| 0 (this device) | K073467 | Spineassist System | Mazor Surgical Technologies, Ltd. | 2008 | — |
| +1 | K102130 | Tenzing System | Mazor Surgical Technologies, Ltd. | 2010 | — |
| +2 | K110911 | Renaissance System | Mazor Robotics, Ltd. | 2011 | — |
| +3 | K113228 | Renaissance System | Mazor Robotics, Ltd. | 2011 | — |
| +4 | K140167 | Renaissance X System | Mazor Robotics, Ltd. | 2014 | — |
| +3 | K120812 | Renaissance | Mazor Robotics, Ltd. | 2012 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1987 | 1 | 0 |
| 1995 | 3 | 0 |
| 1996 | 1 | 0 |
| 1997 | 2 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (5)
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 |
|---|---|---|---|
| * | K033413 | Spineassist DeviceSummary page 2…ssistTM system is substantially equivalent to the original SpineAssistTM system (manufactured by Mazor Surgical Technologies Ltd., and the subject of 510(k) document no. K033413, K051676 and K063607) and the StealthStation System (manufactured by Medtronic and the subject of 510(k) document nos. K954276 to… | 2004 |
| * | K051676 | Spineassist Device with Additional AccessoriesSummary page 2…ystem is substantially equivalent to the original SpineAssistTM system (manufactured by Mazor Surgical Technologies Ltd., and the subject of 510(k) document no. K033413, K051676 and K063607) and the StealthStation System (manufactured by Medtronic and the subject of 510(k) document nos. K954276 to K050438)… | 2005 |
| * | K063607 | Spineassist SystemSummary page 2…stantially equivalent to the original SpineAssistTM system (manufactured by Mazor Surgical Technologies Ltd., and the subject of 510(k) document no. K033413, K051676 and K063607) and the StealthStation System (manufactured by Medtronic and the subject of 510(k) document nos. K954276 to K050438). A comparis… | 2007 |
| * | K954276 | StealthstationSummary page 2…d., and the subject of 510(k) document no. K033413, K051676 and K063607) and the StealthStation System (manufactured by Medtronic and the subject of 510(k) document nos. K954276 to K050438). A comparison table and detailed discussion are presented in Section 12 of this application. Device Description: T… | 1996 |
| * | K050438 | Stealthstation System UpdateSummary page 2…subject of 510(k) document no. K033413, K051676 and K063607) and the StealthStation System (manufactured by Medtronic and the subject of 510(k) document nos. K954276 to K050438). A comparison table and detailed discussion are presented in Section 12 of this application. Device Description: The SpineAss… | 2005 |
What descends from it? (32)
See all 321 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K102130 | Tenzing System | 2010 | 31 |
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 14 years and passes through 4 companies; a new generation was cleared every 1.7 years on median.
- 2 of the 22 ancestors have a recall of any class.
- Of its descendants, K102130 (Mazor Surgical Technologies, Ltd., 2010) has gone furthest, with 31 descendants of its own.
- 2 other devices also cite its predicate K033413.
How does its category compare?
All HAW devicesHAW Neurological Stereotaxic Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
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 SpineAssistTM System is indicated for precise positioning of surgical instruments or implants (pedicle screws, plates and etc.) during general spinal surgery. The SpineAssistTM System may be used in either open or percutaneous procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K073467 · printed Nov 4, 2026
Cite this page
510(k) Report. “K073467: Spineassist System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K073467
Report an extraction error
Are you the manufacturer?
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