510(k) · Cleared
ClearedSpineassist Device
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 Jan 7, 2004 as substantially equivalent to K963256 (Integrated Surgical Systems, S.A., 1997) and 5 other predicates after a 72-day review. Its family tree reaches back 4 generations to 1994. 35 later devices descend from it.
- Decided
- Jan 7, 2004
- Review
- 72 days
- Class
- Class II
- Product code
- HAW
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 4 generations to K911783 (1994). 17 ancestors in all, the oldest K811452 (1981). 35 later devices descend from it, 3 citing it directly.
- Root · 4 generations backK911783 Allegro Viewing WandI.S.G. Technologies, Inc. · 1994
- 3 generations backK960714 Isg Viewing WandI.S.G. Technologies, Inc. · 1996
- 2 generations backK964229 Regulus NavigatorCompass Intl., Inc. · 1997
- 1 generation backK981315 NavitrackOrthosoft, Inc. · 1998
- This deviceK033413 Spineassist DeviceMazor Surgical Technologies, Ltd. · 2004
- Descendant · cites it directly · 34 of its ownK051676 Spineassist Device with Additional AccessoriesMazor Surgical Technologies, Ltd. · 2005
- Descendant · cites it directly · 33 of its ownK063607 Spineassist SystemMazor Surgical Technologies, Ltd. · 2007
- Descendant · cites it directly · 32 of its ownK073467 Spineassist SystemMazor Surgical Technologies, Ltd. · 2008
- Descendant · 2 generations on · 31 of its ownK102130 Tenzing SystemMazor Surgical Technologies, Ltd. · 2010
- Descendant · 3 generations on · 24 of its ownK110911 Renaissance SystemMazor Robotics, Ltd. · 2011
Showing 5 of 35 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 35 · See all- K051676Spineassist Device with Additional AccessoriesMazor Surgical Technologies, Ltd. · 2005 · cites it directly34descendants
- K063607Spineassist SystemMazor Surgical Technologies, Ltd. · 2007 · cites it directly33descendants
- K073467Spineassist SystemMazor Surgical Technologies, Ltd. · 2008 · cites it directly32descendants
- K102130Tenzing SystemMazor Surgical Technologies, Ltd. · 2010 · 2 generations on31descendants
- K110911Renaissance SystemMazor Robotics, Ltd. · 2011 · 3 generations on24descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K911783 | Allegro Viewing Wand | I.S.G. Technologies, Inc. | 1994 | — |
| −3 | K960714 | Isg Viewing Wand | I.S.G. Technologies, Inc. | 1996 | — |
| −2 | K964229 | Regulus Navigator | Compass Intl., Inc. | 1997 | — |
| −1 | K981315 | Navitrack | Orthosoft, Inc. | 1998 | — |
| 0 (this device) | K033413 | Spineassist Device | Mazor Surgical Technologies, Ltd. | 2004 | — |
| +1 | K051676 | Spineassist Device with Additional Accessories | Mazor Surgical Technologies, Ltd. | 2005 | — |
| +1 | K063607 | Spineassist System | Mazor Surgical Technologies, Ltd. | 2007 | — |
| +1 | K073467 | Spineassist System | Mazor Surgical Technologies, Ltd. | 2008 | — |
| +2 | K102130 | Tenzing System | Mazor Surgical Technologies, Ltd. | 2010 | — |
| +3 | K110911 | Renaissance System | Mazor Robotics, Ltd. | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1987 | 1 | 0 |
| 1995 | 3 | 0 |
| 1997 | 2 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (6)
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 |
|---|---|---|---|
| * | K963256 | Neuromate Stereotactic SystemSummary page 2…following table. Device Manufacturer Type of Device 510(k) Number Neuromate Brainlab AG Stereotaxic Instrument K963256, K991081 Vector Vision Integrated Surgical Stereotaxic Instrument K010968, K021306 Systems Inc.… | 1997 |
| * | K991081 | Frameless NeuromateSummary page 2…g table. Device Manufacturer Type of Device 510(k) Number Neuromate Brainlab AG Stereotaxic Instrument K963256, K991081 Vector Vision Integrated Surgical Stereotaxic Instrument K010968, K021306 Systems Inc. Navit… | 1999 |
| * | K010968 | Vectorvision CT/FluoroSummary page 2…510(k) Number Neuromate Brainlab AG Stereotaxic Instrument K963256, K991081 Vector Vision Integrated Surgical Stereotaxic Instrument K010968, K021306 Systems Inc. Navitrack OrthoSoft Inc. Stereotaxic Instrument K981315, K031156… | 2001 |
| * | K021306 | Vectorvision CT-Free KneeSummary page 2…umber Neuromate Brainlab AG Stereotaxic Instrument K963256, K991081 Vector Vision Integrated Surgical Stereotaxic Instrument K010968, K021306 Systems Inc. Navitrack OrthoSoft Inc. Stereotaxic Instrument K981315, K031156… | 2002 |
| * | K981315 | NavitrackSummary page 2…Integrated Surgical Stereotaxic Instrument K010968, K021306 Systems Inc. Navitrack OrthoSoft Inc. Stereotaxic Instrument K981315, K031156 445 2 C Technological Char… | 1998 |
| * | K031156 | Navitrack System-Fluorospine, Model 900.005Summary page 2…ted Surgical Stereotaxic Instrument K010968, K021306 Systems Inc. Navitrack OrthoSoft Inc. Stereotaxic Instrument K981315, K031156 445 2 C Technological Characteristi… | 2003 |
What descends from it? (35)
See all 353 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 10 years and passes through 4 companies; a new generation was cleared every 2.1 years on median.
- None of the 17 ancestors has a recall.
- Of its descendants, K051676 (Mazor Surgical Technologies, Ltd., 2005) has gone furthest, with 34 descendants of its own.
- 2 other devices also cite its predicate K963256.
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 SpineAssist is indicated for precise positioning of surgical instruments during spinal fusion stabilization surgery. The device enables pre-operative planning of the surgical procedure and subsequent spatial positioning and orientation of the surgical tool during intra-operative procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K033413 · printed Nov 5, 2026
Cite this page
510(k) Report. “K033413: Spineassist Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K033413
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