510(k) · Cleared
ClearedRenaissance X System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mazor Robotics, Ltd. · OLO Orthopedic Stereotaxic Instrument
Cleared on Nov 17, 2015 as substantially equivalent to K140167 (Mazor Robotics, Ltd., 2014) and 1 other predicate after a 118-day review. Its family tree reaches back 12 generations to 1994. 1 of the 58 devices in its family, counting itself, has a Class I recall. 20 later devices descend from it.
- Decided
- Nov 17, 2015
- Review
- 118 days
- Class
- Class II
- Product code
- OLO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 12 generations to K911783 (1994). 37 ancestors in all, the oldest K811452 (1981). 20 later devices descend from it, 1 citing it directly. 1 of the 58 devices in this family, counting this one, has a Class I recall.
- Root · 12 generations backK911783 Allegro Viewing WandI.S.G. Technologies, Inc. · 1994
- 8 generations between
- 3 generations backK110911 Renaissance SystemMazor Robotics, Ltd. · 2011
- 2 generations backK113228 Renaissance SystemMazor Robotics, Ltd. · 2011
- 1 generation backK120812 RenaissanceMazor Robotics, Ltd. · 2012 · Recalled
- This deviceK152041 Renaissance X SystemMazor Robotics, Ltd. · 2015
- Descendant · cites it directly · 19 of its ownK163221 Mazor XMazor Robotics, Ltd. · 2017
- Descendant · 2 generations on · 17 of its ownK180307 Mazor XMazor Robotics, Ltd. · 2018
- Descendant · 3 generations on · 16 of its ownK182077 Mazor X System (Mazor X Stealth Edition)Mazor Robotics, Ltd. · 2018 · Recalled
- Descendant · 4 generations on · 15 of its ownK200935 Mazor XMazor Robotics, Ltd. · 2020
- Descendant · 5 generations on · 14 of its ownK203005 Mazor XMazor Robotics, Ltd. · 2020 · Recalled
Show all 12 generations
- Root · 12 generations backK911783 Allegro Viewing WandI.S.G. Technologies, Inc. · 1994
- 11 generations backK960714 Isg Viewing WandI.S.G. Technologies, Inc. · 1996
- 10 generations backK964229 Regulus NavigatorCompass Intl., Inc. · 1997
- 9 generations backK981315 NavitrackOrthosoft, Inc. · 1998
- 8 generations backK033413 Spineassist DeviceMazor Surgical Technologies, Ltd. · 2004
- 7 generations backK051676 Spineassist Device with Additional AccessoriesMazor Surgical Technologies, Ltd. · 2005
- 6 generations backK063607 Spineassist SystemMazor Surgical Technologies, Ltd. · 2007
- 5 generations backK073467 Spineassist SystemMazor Surgical Technologies, Ltd. · 2008
- 4 generations backK102130 Tenzing SystemMazor Surgical Technologies, Ltd. · 2010
- 3 generations backK110911 Renaissance SystemMazor Robotics, Ltd. · 2011
- 2 generations backK113228 Renaissance SystemMazor Robotics, Ltd. · 2011
- 1 generation backK120812 RenaissanceMazor Robotics, Ltd. · 2012 · Recalled
- This deviceK152041 Renaissance X SystemMazor Robotics, Ltd. · 2015
Showing 5 of 20 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K003837 Flexiview 8800 Digital Mobile Imaging System6 generations back · 2001
Most influential descendants
Showing 5 of 20 · See all- K163221Mazor XMazor Robotics, Ltd. · 2017 · cites it directly19descendants
- K180307Mazor XMazor Robotics, Ltd. · 2018 · 2 generations on17descendants
- K182077Mazor X System (Mazor X Stealth Edition)Mazor Robotics, Ltd. · 2018 · 3 generations on16descendants
- K200935Mazor XMazor Robotics, Ltd. · 2020 · 4 generations on15descendants
- K203005Mazor XMazor Robotics, Ltd. · 2020 · 5 generations on14descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K911783 | Allegro Viewing Wand | I.S.G. Technologies, Inc. | 1994 | — |
| −11 | K960714 | Isg Viewing Wand | I.S.G. Technologies, Inc. | 1996 | — |
| −10 | K964229 | Regulus Navigator | Compass Intl., Inc. | 1997 | — |
| −9 | K981315 | Navitrack | Orthosoft, Inc. | 1998 | — |
| −8 | K033413 | Spineassist Device | Mazor Surgical Technologies, Ltd. | 2004 | — |
| −7 | K051676 | Spineassist Device with Additional Accessories | Mazor Surgical Technologies, Ltd. | 2005 | — |
| −6 | K063607 | Spineassist System | Mazor Surgical Technologies, Ltd. | 2007 | — |
| −5 | K073467 | Spineassist System | Mazor Surgical Technologies, Ltd. | 2008 | — |
| −4 | K102130 | Tenzing System | Mazor Surgical Technologies, Ltd. | 2010 | — |
| −3 | K110911 | Renaissance System | Mazor Robotics, Ltd. | 2011 | — |
| −2 | K113228 | Renaissance System | Mazor Robotics, Ltd. | 2011 | — |
| −1 | K120812 | Renaissance | Mazor Robotics, Ltd. | 2012 | 1 |
| 0 (this device) | K152041 | Renaissance X System | Mazor Robotics, Ltd. | 2015 | — |
| +1 | K163221 | Mazor X | Mazor Robotics, Ltd. | 2017 | — |
| +2 | K180307 | Mazor X | Mazor Robotics, Ltd. | 2018 | — |
| +3 | K182077 | Mazor X System (Mazor X Stealth Edition) | Mazor Robotics, Ltd. | 2018 | 2 |
| +4 | K200935 | Mazor X | Mazor Robotics, Ltd. | 2020 | — |
| +5 | K203005 | Mazor X | Mazor Robotics, Ltd. | 2020 | 1 |
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 |
| 2014 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 OLO device
- #1 K240662 Spine Guidance Software (version 5.0); Xia 3/…score 23.7 · 15 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 |
|---|---|---|---|
| * | K140167 | Renaissance X SystemSummary page 4…ent to the following devices: Manufacturer Device 510(k) Date Cleared Mazor Robotics Ltd. Renaissance X System K140167 September 10, 2014 Mazor Robotics Ltd. Renaissance System with K120812 July 12, 2012 B… | 2014 |
| * | K120812 | RenaissanceSummary page 4…510(k) Date Cleared Mazor Robotics Ltd. Renaissance X System K140167 September 10, 2014 Mazor Robotics Ltd. Renaissance System with K120812 July 12, 2012 Brain Application 20… | 2012 |
What descends from it? (20)
See all 201 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K163221 | Mazor X | 2017 | 19 |
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 · 6 generations back · ◆ in the 2001 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 21 years and passes through 5 companies; a new generation was cleared every 1.7 years on median.
- 8 of the 37 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K163221 (Mazor Robotics, Ltd., 2017) has gone furthest, with 19 descendants of its own.
How does its category compare?
All OLO devicesOLO Orthopedic Stereotaxic Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · OLO
40in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OLO
119in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OLO
1in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · OLO
3,306in 2025
MAUDE reports naming product code OLO, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 1 |
| 2009 | 11 | 126 | 0 | 4 |
| 2010 | 9 | 113 | 1 | 4 |
| 2011 | 11 | 138 | 1 | 10 |
| 2012 | 7 | 129 | 1 | 60 |
| 2013 | 7 | 137 | 0 | 36 |
| 2014 | 10 | 119 | 3 | 245 |
| 2015 | 10 | 176 | 2 | 466 |
| 2016 | 14 | 120 | 3 | 750 |
| 2017 | 33 | 91 | 2 | 1,076 |
| 2018 | 24 | 97 | 1 | 1,230 |
| 2019 | 35 | 95 | 1 | 1,585 |
| 2020 | 34 | 89 | 6 | 2,746 |
| 2021 | 28 | 91 | 0 | 1,696 |
| 2022 | 40 | 89 | 5 | 1,568 |
| 2023 | 45 | 90 | 7 (1) | 1,493 |
| 2024 | 44 | 90 | 4 | 2,353 |
| 2025 | 40 | 119 | 1 | 3,306 |
| 2026 | 42 | 109 | 6 | — |
What is it indicated for?
The modified Renaissance X System is indicated for precise positioning of surgical instruments or spinal implants during general spinal and brain surgery. It may be used in either open or minimally invasive or percutaneous procedures.
Renaissance X 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/K152041 · printed Nov 6, 2026
Cite this page
510(k) Report. “K152041: Renaissance X System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K152041
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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