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 Dec 1, 2011 as substantially equivalent to K110911 (Mazor Robotics, Ltd., 2011) and 2 other predicates after a 30-day review. Its family tree reaches back 10 generations to 1994. 1 of the 58 devices in its family, counting itself, has a Class I recall. 23 later devices descend from it.
- Decided
- Dec 1, 2011
- Review
- 30 days
- Class
- Class II
- Product code
- HAW
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 10 generations to K911783 (1994). 34 ancestors in all, the oldest K811452 (1981). 23 later devices descend from it, 2 citing it directly. 1 of the 58 devices in this family, counting this one, has a Class I recall.
- Root · 10 generations backK911783 Allegro Viewing WandI.S.G. Technologies, Inc. · 1994
- 6 generations between
- 3 generations backK073467 Spineassist SystemMazor Surgical Technologies, Ltd. · 2008
- 2 generations backK102130 Tenzing SystemMazor Surgical Technologies, Ltd. · 2010
- 1 generation backK110911 Renaissance SystemMazor Robotics, Ltd. · 2011
- This deviceK113228 Renaissance SystemMazor Robotics, Ltd. · 2011
- Descendant · cites it directly · 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
- Descendant · 4 generations on · 17 of its ownK180307 Mazor XMazor Robotics, Ltd. · 2018
Show all 10 generations
- Root · 10 generations backK911783 Allegro Viewing WandI.S.G. Technologies, Inc. · 1994
- 9 generations backK960714 Isg Viewing WandI.S.G. Technologies, Inc. · 1996
- 8 generations backK964229 Regulus NavigatorCompass Intl., Inc. · 1997
- 7 generations backK981315 NavitrackOrthosoft, Inc. · 1998
- 6 generations backK033413 Spineassist DeviceMazor Surgical Technologies, Ltd. · 2004
- 5 generations backK051676 Spineassist Device with Additional AccessoriesMazor Surgical Technologies, Ltd. · 2005
- 4 generations backK063607 Spineassist SystemMazor Surgical Technologies, Ltd. · 2007
- 3 generations backK073467 Spineassist SystemMazor Surgical Technologies, Ltd. · 2008
- 2 generations backK102130 Tenzing SystemMazor Surgical Technologies, Ltd. · 2010
- 1 generation backK110911 Renaissance SystemMazor Robotics, Ltd. · 2011
- This deviceK113228 Renaissance SystemMazor Robotics, Ltd. · 2011
Showing 5 of 23 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K003837 Flexiview 8800 Digital Mobile Imaging System5 generations back · 2001
Most influential descendants
Showing 5 of 23 · See all- K140167Renaissance X SystemMazor Robotics, Ltd. · 2014 · cites it directly21descendants
- K120812RenaissanceMazor Robotics, Ltd. · 2012 · cites it directly21descendants
- K152041Renaissance X SystemMazor Robotics, Ltd. · 2015 · 2 generations on20descendants
- K163221Mazor XMazor Robotics, Ltd. · 2017 · 3 generations on19descendants
- K180307Mazor XMazor Robotics, Ltd. · 2018 · 4 generations on17descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K911783 | Allegro Viewing Wand | I.S.G. Technologies, Inc. | 1994 | — |
| −9 | K960714 | Isg Viewing Wand | I.S.G. Technologies, Inc. | 1996 | — |
| −8 | K964229 | Regulus Navigator | Compass Intl., Inc. | 1997 | — |
| −7 | K981315 | Navitrack | Orthosoft, Inc. | 1998 | — |
| −6 | K033413 | Spineassist Device | Mazor Surgical Technologies, Ltd. | 2004 | — |
| −5 | K051676 | Spineassist Device with Additional Accessories | Mazor Surgical Technologies, Ltd. | 2005 | — |
| −4 | K063607 | Spineassist System | Mazor Surgical Technologies, Ltd. | 2007 | — |
| −3 | K073467 | Spineassist System | Mazor Surgical Technologies, Ltd. | 2008 | — |
| −2 | K102130 | Tenzing System | Mazor Surgical Technologies, Ltd. | 2010 | — |
| −1 | K110911 | Renaissance System | Mazor Robotics, Ltd. | 2011 | — |
| 0 (this device) | K113228 | Renaissance System | Mazor Robotics, Ltd. | 2011 | — |
| +1 | 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 | — |
| +4 | K180307 | Mazor X | Mazor Robotics, Ltd. | 2018 | — |
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 | 2 | 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 |
|---|---|---|
| 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? (3)
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 |
|---|---|---|---|
| * | K110911 | Renaissance SystemSummary page 1…Manufacturer Device 510(k) Date Cleared Mazor Robotics Renaissance System KI110911 April 28, 2011 Medtronic Navigation StealthStation System K050438 June 2, 2005… | 2011 |
| * | K050438 | Stealthstation System UpdateSummary page 1…ed Mazor Robotics Renaissance System KI110911 April 28, 2011 Medtronic Navigation StealthStation System K050438 June 2, 2005 ________________ ______________ K022414 August 14, 2002… | 2005 |
| * | K022414 | Stealthstation System Three Dimensional C-Arm InterfaceSummary page 1…2011 Medtronic Navigation StealthStation System K050438 June 2, 2005 ________________ ______________ K022414 August 14, 2002 677 5. Device Description The Ren… | 2002 |
What descends from it? (23)
See all 232 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 · 5 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 34 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K140167 (Mazor Robotics, Ltd., 2014) has gone furthest, with 21 descendants of its own.
- 1 other device also cites its predicate K110911.
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.
Renaissance 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 as stated in the FDA summary.
https://510kreport.com/device/K113228 · printed Nov 6, 2026
Cite this page
510(k) Report. “K113228: 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/K113228
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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