510(k) · Cleared
ClearedTenzing 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 Aug 26, 2010 as substantially equivalent to K073467 (Mazor Surgical Technologies, Ltd., 2008) and 1 other predicate after a 28-day review. Its family tree reaches back 8 generations to 1994. 1 of the 63 devices in its family, counting itself, has a Class I recall. 31 later devices descend from it.
- Decided
- Aug 26, 2010
- Review
- 28 days
- Class
- Class II
- Product code
- HAW
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 8 generations to K911783 (1994). 31 ancestors in all, the oldest K811452 (1981). 31 later devices descend from it, 2 citing it directly. 1 of the 63 devices in this family, counting this one, has a Class I recall.
- Root · 8 generations backK911783 Allegro Viewing WandI.S.G. Technologies, Inc. · 1994
- 7 generations backK960714 Isg Viewing WandI.S.G. Technologies, Inc. · 1996
- 6 generations backK964229 Regulus NavigatorCompass Intl., Inc. · 1997
- 5 generations backK981315 NavitrackOrthosoft, Inc. · 1998
- 4 generations backK033413 Spineassist DeviceMazor Surgical Technologies, Ltd. · 2004
- 3 generations backK051676 Spineassist Device with Additional AccessoriesMazor Surgical Technologies, Ltd. · 2005
- 2 generations backK063607 Spineassist SystemMazor Surgical Technologies, Ltd. · 2007
- 1 generation backK073467 Spineassist SystemMazor Surgical Technologies, Ltd. · 2008
- This deviceK102130 Tenzing SystemMazor Surgical Technologies, Ltd. · 2010
- Descendant · cites it directly · 24 of its ownK110911 Renaissance SystemMazor Robotics, Ltd. · 2011
- Descendant · 2 generations on · 23 of its ownK113228 Renaissance SystemMazor Robotics, Ltd. · 2011
- Descendant · 3 generations on · 21 of its ownK140167 Renaissance X SystemMazor Robotics, Ltd. · 2014
- Descendant · 2 generations on · 21 of its ownK120812 RenaissanceMazor Robotics, Ltd. · 2012 · Recalled
- Descendant · 3 generations on · 20 of its ownK152041 Renaissance X SystemMazor Robotics, Ltd. · 2015
Showing 5 of 31 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K003837 Flexiview 8800 Digital Mobile Imaging System3 generations back · 2001
Most influential descendants
Showing 5 of 31 · See all- K110911Renaissance SystemMazor Robotics, Ltd. · 2011 · cites it directly24descendants
- K113228Renaissance SystemMazor Robotics, Ltd. · 2011 · 2 generations on23descendants
- K140167Renaissance X SystemMazor Robotics, Ltd. · 2014 · 3 generations on21descendants
- K120812RenaissanceMazor Robotics, Ltd. · 2012 · 2 generations on21descendants
- K152041Renaissance X SystemMazor Robotics, Ltd. · 2015 · 3 generations on20descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K911783 | Allegro Viewing Wand | I.S.G. Technologies, Inc. | 1994 | — |
| −7 | K960714 | Isg Viewing Wand | I.S.G. Technologies, Inc. | 1996 | — |
| −6 | K964229 | Regulus Navigator | Compass Intl., Inc. | 1997 | — |
| −5 | K981315 | Navitrack | Orthosoft, Inc. | 1998 | — |
| −4 | K033413 | Spineassist Device | Mazor Surgical Technologies, Ltd. | 2004 | — |
| −3 | K051676 | Spineassist Device with Additional Accessories | Mazor Surgical Technologies, Ltd. | 2005 | — |
| −2 | K063607 | Spineassist System | Mazor Surgical Technologies, Ltd. | 2007 | — |
| −1 | K073467 | Spineassist System | Mazor Surgical Technologies, Ltd. | 2008 | — |
| 0 (this device) | K102130 | Tenzing System | Mazor Surgical Technologies, Ltd. | 2010 | — |
| +1 | K110911 | Renaissance System | Mazor Robotics, Ltd. | 2011 | — |
| +2 | K113228 | Renaissance System | Mazor Robotics, Ltd. | 2011 | — |
| +3 | K140167 | Renaissance X System | Mazor Robotics, Ltd. | 2014 | — |
| +2 | K120812 | Renaissance | Mazor Robotics, Ltd. | 2012 | 1 |
| +3 | K152041 | Renaissance X System | Mazor Robotics, Ltd. | 2015 | — |
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 | 2 | 0 |
| 2001 | 4 | 1 |
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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.
1 device in this family has a Class I recall. 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 |
|---|---|---|---|
| * | K073467 | Spineassist SystemSummary page 1…and LLZ 4. Predicate Devices The TenZing System is substantially equivalent to the following devices Mazor Surgical Technologies SpineAssist K073467 05/23/2008 Mazor Surgical Technologies C-InSight K081672 08/15/2008… | 2008 |
| * | K081672 | C-InsightSummary page 1…lent to the following devices Mazor Surgical Technologies SpineAssist K073467 05/23/2008 Mazor Surgical Technologies C-InSight K081672 08/15/2008 469 5. Device Description The T… | 2008 |
What descends from it? (31)
See all 312 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K003837Flexiview 8800 Digital Mobile Imaging SystemGe Oec Medical Systems · 2001 · 3 generations back · ◆ in the 2001 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 16 years and passes through 4 companies; a new generation was cleared every 2.0 years on median.
- 7 of the 31 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K110911 (Mazor Robotics, Ltd., 2011) has gone furthest, with 24 descendants of its own.
How does its category compare?
All HAW devicesHAW Neurological Stereotaxic Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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 TenZing System is a combination of the SpineAssist System and C-InSight System, allowing the C-InSight application to run on the SpineAssist Workstation:
The SpineAssistTM System is indicated for precise positioning of surgical instruments or implants during general spinal surgery. The SpineAssistTM System may be used in either open or percutaneous procedures.
The C-InSight software provides a processing and conversion of 2D fluoroscopic projections from standard C-Arms into volumetric 3D image.
It is intended to be used whenever the clinician and/or patient benefits from generated 3D imaging of high contrast objects, particularly for orthopedic applications.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K102130 · printed Nov 6, 2026
Cite this page
510(k) Report. “K102130: Tenzing System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K102130
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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