510(k) · Cleared
Recalled · Class II · 2014Renaissance
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 Jul 12, 2012 as substantially equivalent to K113228 (Mazor Robotics, Ltd., 2011) and 2 other predicates after a 118-day review. Its family tree reaches back 11 generations to 1994. 1 of the 57 devices in its family, counting itself, has a Class I recall. 21 later devices descend from it. It has been recalled once.
- Decided
- Jul 12, 2012
- Review
- 118 days
- Class
- Class II
- Product code
- HAW
- Recalls
- 1
- Predicates
- 3
Its longest line of descent runs back 11 generations to K911783 (1994). 35 ancestors in all, the oldest K811452 (1981). 21 later devices descend from it, 1 citing it directly. 1 of the 57 devices in this family, counting this one, has a Class I recall.
- Root · 11 generations backK911783 Allegro Viewing WandI.S.G. Technologies, Inc. · 1994
- 7 generations between
- 3 generations backK102130 Tenzing SystemMazor Surgical Technologies, Ltd. · 2010
- 2 generations backK110911 Renaissance SystemMazor Robotics, Ltd. · 2011
- 1 generation backK113228 Renaissance SystemMazor Robotics, Ltd. · 2011
- This deviceK120812 RenaissanceMazor Robotics, Ltd. · 2012
- Descendant · cites it directly · 20 of its ownK152041 Renaissance X SystemMazor Robotics, Ltd. · 2015
- Descendant · 2 generations on · 19 of its ownK163221 Mazor XMazor Robotics, Ltd. · 2017
- Descendant · 3 generations on · 17 of its ownK180307 Mazor XMazor Robotics, Ltd. · 2018
- Descendant · 4 generations on · 16 of its ownK182077 Mazor X System (Mazor X Stealth Edition)Mazor Robotics, Ltd. · 2018 · Recalled
- Descendant · 5 generations on · 15 of its ownK200935 Mazor XMazor Robotics, Ltd. · 2020
Show all 11 generations
- Root · 11 generations backK911783 Allegro Viewing WandI.S.G. Technologies, Inc. · 1994
- 10 generations backK960714 Isg Viewing WandI.S.G. Technologies, Inc. · 1996
- 9 generations backK964229 Regulus NavigatorCompass Intl., Inc. · 1997
- 8 generations backK981315 NavitrackOrthosoft, Inc. · 1998
- 7 generations backK033413 Spineassist DeviceMazor Surgical Technologies, Ltd. · 2004
- 6 generations backK051676 Spineassist Device with Additional AccessoriesMazor Surgical Technologies, Ltd. · 2005
- 5 generations backK063607 Spineassist SystemMazor Surgical Technologies, Ltd. · 2007
- 4 generations backK073467 Spineassist SystemMazor Surgical Technologies, Ltd. · 2008
- 3 generations backK102130 Tenzing SystemMazor Surgical Technologies, Ltd. · 2010
- 2 generations backK110911 Renaissance SystemMazor Robotics, Ltd. · 2011
- 1 generation backK113228 Renaissance SystemMazor Robotics, Ltd. · 2011
- This deviceK120812 RenaissanceMazor Robotics, Ltd. · 2012
Showing 5 of 21 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 21 · See all- K152041Renaissance X SystemMazor Robotics, Ltd. · 2015 · cites it directly20descendants
- K163221Mazor XMazor Robotics, Ltd. · 2017 · 2 generations on19descendants
- K180307Mazor XMazor Robotics, Ltd. · 2018 · 3 generations on17descendants
- K182077Mazor X System (Mazor X Stealth Edition)Mazor Robotics, Ltd. · 2018 · 4 generations on16descendants
- K200935Mazor XMazor Robotics, Ltd. · 2020 · 5 generations on15descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K911783 | Allegro Viewing Wand | I.S.G. Technologies, Inc. | 1994 | — |
| −10 | K960714 | Isg Viewing Wand | I.S.G. Technologies, Inc. | 1996 | — |
| −9 | K964229 | Regulus Navigator | Compass Intl., Inc. | 1997 | — |
| −8 | K981315 | Navitrack | Orthosoft, Inc. | 1998 | — |
| −7 | K033413 | Spineassist Device | Mazor Surgical Technologies, Ltd. | 2004 | — |
| −6 | K051676 | Spineassist Device with Additional Accessories | Mazor Surgical Technologies, Ltd. | 2005 | — |
| −5 | K063607 | Spineassist System | Mazor Surgical Technologies, Ltd. | 2007 | — |
| −4 | K073467 | Spineassist System | Mazor Surgical Technologies, Ltd. | 2008 | — |
| −3 | K102130 | Tenzing System | Mazor Surgical Technologies, Ltd. | 2010 | — |
| −2 | K110911 | Renaissance System | Mazor Robotics, Ltd. | 2011 | — |
| −1 | K113228 | Renaissance System | Mazor Robotics, Ltd. | 2011 | — |
| 0 (this device) | K120812 | Renaissance | Mazor Robotics, Ltd. | 2012 | — |
| +1 | K152041 | Renaissance X System | Mazor Robotics, Ltd. | 2015 | — |
| +2 | K163221 | Mazor X | Mazor Robotics, Ltd. | 2017 | — |
| +3 | K180307 | Mazor X | Mazor Robotics, Ltd. | 2018 | — |
| +4 | K182077 | Mazor X System (Mazor X Stealth Edition) | Mazor Robotics, Ltd. | 2018 | 2 |
| +5 | K200935 | Mazor X | Mazor Robotics, Ltd. | 2020 | — |
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 |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K113228 | Renaissance SystemSummary page 2…h Brain Application is substantially equivalent to the original Renaissance system (manufactured by, Mazor Robotics Ltd., and .the subject of 5 10(k) Idocument no. K113228 and K110911) and to the ,StealthStation System (manufactured by Medtronic and the subject of 510(k) document no K050438). A… | 2011 |
| * | K110911 | Renaissance SystemSummary page 2…ication is substantially equivalent to the original Renaissance system (manufactured by, Mazor Robotics Ltd., and .the subject of 5 10(k) Idocument no. K113228 and K110911) and to the ,StealthStation System (manufactured by Medtronic and the subject of 510(k) document no K050438). A comparison t… | 2011 |
| * | K050438 | Stealthstation System UpdateSummary page 2…and .the subject of 5 10(k) Idocument no. K113228 and K110911) and to the ,StealthStation System (manufactured by Medtronic and the subject of 510(k) document no K050438). A comparison table and detailed discussion are presented in Section 12 of this application. * Device Description: The R… | 2005 |
What descends from it? (21)
See all 211 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K152041 | Renaissance X System | 2015 | 20 |
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 26, 2014 | Class II | Z-0609-2019 | Device Design | In some situations the carousel position pin (locker) may cause the carousel upper plate to pop out and the carousel may then inadvertently move. |
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 18 years and passes through 5 companies; a new generation was cleared every 1.2 years on median.
- 7 of the 35 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K152041 (Mazor Robotics, Ltd., 2015) has gone furthest, with 20 descendants of its own.
- 1 other device also cites its predicate K113228.
How does its category compare?
All HAW devicesHAW Neurological Stereotaxic Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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
spinal implants during general spinal and brain surgery. It may be used in open or
minimally invasive 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/K120812 · printed Nov 6, 2026
Cite this page
510(k) Report. “K120812: Renaissance.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K120812
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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