510(k) · Cleared
ClearedRenaissance System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mazor Robotics, Ltd. · HAW Neurological Stereotaxic Instrument
Cleared on Apr 28, 2011 as substantially equivalent to K102130 (Mazor Surgical Technologies, Ltd., 2010) after a 28-day review. Its family tree reaches back 9 generations to 1994. 1 of the 57 devices in its family, counting itself, has a Class I recall. 24 later devices descend from it.
- Decided
- Apr 28, 2011
- Review
- 28 days
- Class
- Class II
- Product code
- HAW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K911783 (1994). 32 ancestors in all, the oldest K811452 (1981). 24 later devices descend from it, 2 citing it directly. 1 of the 57 devices in this family, counting this one, has a Class I recall.
- Root · 9 generations backK911783 Allegro Viewing WandI.S.G. Technologies, Inc. · 1994
- 5 generations between
- 3 generations backK063607 Spineassist SystemMazor Surgical Technologies, Ltd. · 2007
- 2 generations backK073467 Spineassist SystemMazor Surgical Technologies, Ltd. · 2008
- 1 generation backK102130 Tenzing SystemMazor Surgical Technologies, Ltd. · 2010
- This deviceK110911 Renaissance SystemMazor Robotics, Ltd. · 2011
- Descendant · cites it directly · 23 of its ownK113228 Renaissance SystemMazor Robotics, Ltd. · 2011
- Descendant · 2 generations on · 21 of its ownK140167 Renaissance X SystemMazor Robotics, Ltd. · 2014
- Descendant · cites it directly · 21 of its ownK120812 RenaissanceMazor Robotics, Ltd. · 2012 · Recalled
- Descendant · 2 generations on · 20 of its ownK152041 Renaissance X SystemMazor Robotics, Ltd. · 2015
- Descendant · 3 generations on · 19 of its ownK163221 Mazor XMazor Robotics, Ltd. · 2017
Show all 9 generations
- Root · 9 generations backK911783 Allegro Viewing WandI.S.G. Technologies, Inc. · 1994
- 8 generations backK960714 Isg Viewing WandI.S.G. Technologies, Inc. · 1996
- 7 generations backK964229 Regulus NavigatorCompass Intl., Inc. · 1997
- 6 generations backK981315 NavitrackOrthosoft, Inc. · 1998
- 5 generations backK033413 Spineassist DeviceMazor Surgical Technologies, Ltd. · 2004
- 4 generations backK051676 Spineassist Device with Additional AccessoriesMazor Surgical Technologies, Ltd. · 2005
- 3 generations backK063607 Spineassist SystemMazor Surgical Technologies, Ltd. · 2007
- 2 generations backK073467 Spineassist SystemMazor Surgical Technologies, Ltd. · 2008
- 1 generation backK102130 Tenzing SystemMazor Surgical Technologies, Ltd. · 2010
- This deviceK110911 Renaissance SystemMazor Robotics, Ltd. · 2011
Showing 5 of 24 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K003837 Flexiview 8800 Digital Mobile Imaging System4 generations back · 2001
Most influential descendants
Showing 5 of 24 · See all- K113228Renaissance SystemMazor Robotics, Ltd. · 2011 · cites it directly23descendants
- K140167Renaissance X SystemMazor Robotics, Ltd. · 2014 · 2 generations on21descendants
- K120812RenaissanceMazor Robotics, Ltd. · 2012 · cites it directly21descendants
- K152041Renaissance X SystemMazor Robotics, Ltd. · 2015 · 2 generations on20descendants
- K163221Mazor XMazor Robotics, Ltd. · 2017 · 3 generations on19descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K911783 | Allegro Viewing Wand | I.S.G. Technologies, Inc. | 1994 | — |
| −8 | K960714 | Isg Viewing Wand | I.S.G. Technologies, Inc. | 1996 | — |
| −7 | K964229 | Regulus Navigator | Compass Intl., Inc. | 1997 | — |
| −6 | K981315 | Navitrack | Orthosoft, Inc. | 1998 | — |
| −5 | K033413 | Spineassist Device | Mazor Surgical Technologies, Ltd. | 2004 | — |
| −4 | K051676 | Spineassist Device with Additional Accessories | Mazor Surgical Technologies, Ltd. | 2005 | — |
| −3 | K063607 | Spineassist System | Mazor Surgical Technologies, Ltd. | 2007 | — |
| −2 | K073467 | Spineassist System | Mazor Surgical Technologies, Ltd. | 2008 | — |
| −1 | K102130 | Tenzing System | Mazor Surgical Technologies, Ltd. | 2010 | — |
| 0 (this device) | K110911 | Renaissance System | Mazor Robotics, Ltd. | 2011 | — |
| +1 | K113228 | Renaissance System | Mazor Robotics, Ltd. | 2011 | — |
| +2 | K140167 | Renaissance X System | Mazor Robotics, Ltd. | 2014 | — |
| +1 | K120812 | Renaissance | Mazor Robotics, Ltd. | 2012 | 1 |
| +2 | K152041 | Renaissance X System | Mazor Robotics, Ltd. | 2015 | — |
| +3 | K163221 | Mazor X | Mazor Robotics, Ltd. | 2017 | — |
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 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 2 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2023 | 3 | 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? (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 |
|---|---|---|---|
| * | K102130 | Tenzing SystemSummary page 1…Predicate Devices The Renaissance System is substantially equivalent to the following device: i\'lanfifacfufer o | Deviee . 510(k)° | DateCleared Mazor Robotics TenZing K102130 08/26/2010 613 3, Device Description The Renaissance system is a device modification of the TenZing system (K102… | 2010 |
| † | K033413 | Spineassist Device | 2004 |
| † | K051676 | Spineassist Device with Additional Accessories | 2005 |
| † | K063607 | Spineassist System | 2007 |
| † | K073467 | Spineassist System | 2008 |
| † | K081672 | C-Insight | 2008 |
What descends from it? (24)
See all 242 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 · 4 generations back · ◆ in the 2001 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 17 years and passes through 5 companies; a new generation was cleared every 1.7 years on median.
- 7 of the 32 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K113228 (Mazor Robotics, Ltd., 2011) has gone furthest, with 23 descendants of its own.
- 1 other device also cites its predicate K102130.
How does its category compare?
All HAW devicesHAW Neurological Stereotaxic Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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 Renaissance System is indicated for precise positioning of 'surgical instruments or implants during general spinal surgery. It may be used in either open or percutaneous procedures
Renalssance 3D imaging capabilities provide 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.
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/K110911 · printed Nov 6, 2026
Cite this page
510(k) Report. “K110911: Renaissance System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K110911
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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