510(k) · Cleared
ClearedSpineassist Device with Additional Accessories
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 Sep 8, 2005 as substantially equivalent to K033413 (Mazor Surgical Technologies, Ltd., 2004) after a 77-day review. Its family tree reaches back 5 generations to 1994. 34 later devices descend from it.
- Decided
- Sep 8, 2005
- Review
- 77 days
- Class
- Class II
- Product code
- HAW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K911783 (1994). 18 ancestors in all, the oldest K811452 (1981). 34 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK911783 Allegro Viewing WandI.S.G. Technologies, Inc. · 1994
- 4 generations backK960714 Isg Viewing WandI.S.G. Technologies, Inc. · 1996
- 3 generations backK964229 Regulus NavigatorCompass Intl., Inc. · 1997
- 2 generations backK981315 NavitrackOrthosoft, Inc. · 1998
- 1 generation backK033413 Spineassist DeviceMazor Surgical Technologies, Ltd. · 2004
- This deviceK051676 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
- Descendant · 4 generations on · 23 of its ownK113228 Renaissance SystemMazor Robotics, Ltd. · 2011
Showing 5 of 34 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 34 · See all- 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
- K113228Renaissance SystemMazor Robotics, Ltd. · 2011 · 4 generations on23descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K911783 | Allegro Viewing Wand | I.S.G. Technologies, Inc. | 1994 | — |
| −4 | K960714 | Isg Viewing Wand | I.S.G. Technologies, Inc. | 1996 | — |
| −3 | K964229 | Regulus Navigator | Compass Intl., Inc. | 1997 | — |
| −2 | K981315 | Navitrack | Orthosoft, Inc. | 1998 | — |
| −1 | K033413 | Spineassist Device | Mazor Surgical Technologies, Ltd. | 2004 | — |
| 0 (this device) | 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 | — |
| +4 | K113228 | 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 |
|---|---|---|
| 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? (1)
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 1…e: Device Manufacturer 510(k) No. SpineAssistM orSriaTehooesLd K033413 4. Intended Use The SpineAssist System is indicated for precise positioning of surgical instruments during spina… | 2004 |
What descends from it? (34)
See all 342 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 11 years and passes through 4 companies; a new generation was cleared every 1.7 years on median.
- None of the 18 ancestors has a recall.
- Of its descendants, K063607 (Mazor Surgical Technologies, Ltd., 2007) has gone furthest, with 33 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.
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.
The Hover-T Bridge accessory used in conjunction with the SpineAssist device for minimally invasive surgical procedures, is intended for use for lumbar spinal fusion stabilization surgery.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K051676 · printed Nov 5, 2026
Cite this page
510(k) Report. “K051676: Spineassist Device with Additional Accessories.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K051676
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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