510(k) · Cleared
Recalled · Class II · 2019Mazor X System (Mazor X Stealth Edition)
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 2, 2018 as substantially equivalent to K180307 (Mazor Robotics, Ltd., 2018) and 2 other predicates after a 93-day review. Its family tree reaches back 15 generations to 1994. 4 of the 84 devices in its family, counting itself, have a Class I recall. 16 later devices descend from it. It has been recalled 2 times.
- Decided
- Nov 2, 2018
- Review
- 93 days
- Class
- Class II
- Product code
- OLO
- Recalls
- 2
- Predicates
- 3
Its longest line of descent runs back 15 generations to K911783 (1994). 67 ancestors in all, the oldest K811452 (1981). 16 later devices descend from it, 1 citing it directly. 4 of the 84 devices in this family, counting this one, have a Class I recall.
- Root · 15 generations backK911783 Allegro Viewing WandI.S.G. Technologies, Inc. · 1994
- 11 generations between
- 3 generations backK152041 Renaissance X SystemMazor Robotics, Ltd. · 2015
- 2 generations backK163221 Mazor XMazor Robotics, Ltd. · 2017
- 1 generation backK180307 Mazor XMazor Robotics, Ltd. · 2018
- This deviceK182077 Mazor X System (Mazor X Stealth Edition)Mazor Robotics, Ltd. · 2018
- Descendant · cites it directly · 15 of its ownK200935 Mazor XMazor Robotics, Ltd. · 2020
- Descendant · 2 generations on · 14 of its ownK203005 Mazor XMazor Robotics, Ltd. · 2020 · Recalled
- Descendant · 3 generations on · 9 of its ownK211441 Navigated Anterolateral Disc Prep InstrumentsMedtronic Sofamor Danek USA, Inc. · 2021
- Descendant · 4 generations on · 4 of its ownK240625 CORUS Navigation Access SystemProvidence Medical Technology, Inc. · 2024
- Descendant · 3 generations on · 3 of its ownK230064 Mazor X System (Mazor X Stealth Edition)Mazor Robotics, Ltd. · 2023 · Recalled
Show all 15 generations
- Root · 15 generations backK911783 Allegro Viewing WandI.S.G. Technologies, Inc. · 1994
- 14 generations backK960714 Isg Viewing WandI.S.G. Technologies, Inc. · 1996
- 13 generations backK964229 Regulus NavigatorCompass Intl., Inc. · 1997
- 12 generations backK981315 NavitrackOrthosoft, Inc. · 1998
- 11 generations backK033413 Spineassist DeviceMazor Surgical Technologies, Ltd. · 2004
- 10 generations backK051676 Spineassist Device with Additional AccessoriesMazor Surgical Technologies, Ltd. · 2005
- 9 generations backK063607 Spineassist SystemMazor Surgical Technologies, Ltd. · 2007
- 8 generations backK073467 Spineassist SystemMazor Surgical Technologies, Ltd. · 2008
- 7 generations backK102130 Tenzing SystemMazor Surgical Technologies, Ltd. · 2010
- 6 generations backK110911 Renaissance SystemMazor Robotics, Ltd. · 2011
- 5 generations backK113228 Renaissance SystemMazor Robotics, Ltd. · 2011
- 4 generations backK120812 RenaissanceMazor Robotics, Ltd. · 2012 · Recalled
- 3 generations backK152041 Renaissance X SystemMazor Robotics, Ltd. · 2015
- 2 generations backK163221 Mazor XMazor Robotics, Ltd. · 2017
- 1 generation backK180307 Mazor XMazor Robotics, Ltd. · 2018
- This deviceK182077 Mazor X System (Mazor X Stealth Edition)Mazor Robotics, Ltd. · 2018
Showing 5 of 16 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 16 · See all- K200935Mazor XMazor Robotics, Ltd. · 2020 · cites it directly15descendants
- K203005Mazor XMazor Robotics, Ltd. · 2020 · 2 generations on14descendants
- K211441Navigated Anterolateral Disc Prep InstrumentsMedtronic Sofamor Danek USA, Inc. · 2021 · 3 generations on9descendants
- K240625CORUS Navigation Access SystemProvidence Medical Technology, Inc. · 2024 · 4 generations on4descendants
- K230064Mazor X System (Mazor X Stealth Edition)Mazor Robotics, Ltd. · 2023 · 3 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −15 | K911783 | Allegro Viewing Wand | I.S.G. Technologies, Inc. | 1994 | — |
| −14 | K960714 | Isg Viewing Wand | I.S.G. Technologies, Inc. | 1996 | — |
| −13 | K964229 | Regulus Navigator | Compass Intl., Inc. | 1997 | — |
| −12 | K981315 | Navitrack | Orthosoft, Inc. | 1998 | — |
| −11 | K033413 | Spineassist Device | Mazor Surgical Technologies, Ltd. | 2004 | — |
| −10 | K051676 | Spineassist Device with Additional Accessories | Mazor Surgical Technologies, Ltd. | 2005 | — |
| −9 | K063607 | Spineassist System | Mazor Surgical Technologies, Ltd. | 2007 | — |
| −8 | K073467 | Spineassist System | Mazor Surgical Technologies, Ltd. | 2008 | — |
| −7 | K102130 | Tenzing System | Mazor Surgical Technologies, Ltd. | 2010 | — |
| −6 | K110911 | Renaissance System | Mazor Robotics, Ltd. | 2011 | — |
| −5 | K113228 | Renaissance System | Mazor Robotics, Ltd. | 2011 | — |
| −4 | K120812 | Renaissance | Mazor Robotics, Ltd. | 2012 | 1 |
| −3 | K152041 | Renaissance X System | Mazor Robotics, Ltd. | 2015 | — |
| −2 | K163221 | Mazor X | Mazor Robotics, Ltd. | 2017 | — |
| −1 | K180307 | Mazor X | Mazor Robotics, Ltd. | 2018 | — |
| 0 (this device) | K182077 | Mazor X System (Mazor X Stealth Edition) | Mazor Robotics, Ltd. | 2018 | — |
| +1 | K200935 | Mazor X | Mazor Robotics, Ltd. | 2020 | — |
| +2 | K203005 | Mazor X | Mazor Robotics, Ltd. | 2020 | 1 |
| +3 | K211441 | Navigated Anterolateral Disc Prep Instruments | Medtronic Sofamor Danek USA, Inc. | 2021 | — |
| +4 | K240625 | CORUS Navigation Access System | Providence Medical Technology, Inc. | 2024 | — |
| +3 | K230064 | Mazor X System (Mazor X Stealth Edition) | Mazor Robotics, Ltd. | 2023 | 2 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1987 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 2 | 0 |
| 1994 | 1 | 0 |
| 1995 | 3 | 0 |
| 1996 | 2 | 0 |
| 1997 | 2 | 0 |
| 1998 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 3 | 0 |
| 2001 | 7 | 1 |
| 2002 | 5 | 0 |
| 2003 | 4 | 0 |
| 2004 | 2 | 0 |
| 2005 | 3 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
| 2011 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 1 | 1 |
| 2016 | 1 | 1 |
| 2017 | 2 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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.
4 devices in this family have 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? (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 |
|---|---|---|---|
| * | K180307 | Mazor XSummary page 4…nt to the following device: Manufacturer Device 510(k) Date Cleared Mazor Robotics Ltd. Mazor X System K180307 April 30, 2018 Medtronic StealthStation System with K170011 May 1, 2017… | 2018 |
| * | K170011 | StealthStation S8 Spine Software v1.0.0Summary page 4…510(k) Date Cleared Mazor Robotics Ltd. Mazor X System K180307 April 30, 2018 Medtronic StealthStation System with K170011 May 1, 2017 and Navigation Inc. the S8 Spine Software… | 2017 |
| * | K162309 | StealthStation S8 System Platforms and StealthStation Cranial SoftwareSummary page 4…and Navigation Inc. the S8 Spine Software March 31, 2017 K162309 Page 1 of 4. 5. Device Descr… | 2017 |
What descends from it? (16)
See all 161 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K200935 | Mazor X | 2020 | 15 |
Has anything in its family been recalled? (4 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 5, 2019 | Class II | Z-2330-2020 | Device Design | There is a potential for the surgical system to detach from the operational room table unexpectedly. This could result in the surgical system falling onto the patient resulting in blunt injury [hemorrhage, hematoma, bleeding, or… |
| Jul 2, 2019 | Class II | Z-0721-2020 | Other | The firm has become aware that the Snapshot Trackers were not manufactured in accordance with specifications and could potentially lead to navigational inaccuracies, which may result in patient injury, e.g. nerve damage or neurological… |
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.
- K162309StealthStation S8 System Platforms and StealthStation Cranial SoftwareMedtronic Navigation, Inc. · 2017 · Direct predicate · ◆ in the 2017 ancestors bar of FIG. 12 Class I recalls
- K153660StealthStation System with Cranial SoftwareMedtronic Navigation, Inc. · 2016 · 2 generations back · ◆ in the 2016 ancestors bar of FIG. 13 Class I recalls
- K150216Synergy CranialMedtronic Navigation, Inc. · 2015 · 3 generations back · ◆ in the 2015 ancestors bar of FIG. 13 Class I recalls
- K003837Flexiview 8800 Digital Mobile Imaging SystemGe Oec Medical Systems · 2001 · 9 generations back · ◆ in the 2001 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 24 years and passes through 5 companies; a new generation was cleared every 1.2 years on median.
- 18 of the 67 ancestors have a recall of any class; 4 have a Class I recall.
- Of its descendants, K200935 (Mazor Robotics, Ltd., 2020) has gone furthest, with 15 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. 2018, 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 Mazor X 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.
Mazor 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.
The Mazor X navigation tracks the position of instruments, during spinal surgery, in relation to the surgical anatomy and identifies this position on diagnostic or intraoperative images of a patient.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K182077 · printed Nov 6, 2026
Cite this page
510(k) Report. “K182077: Mazor X System (Mazor X Stealth Edition).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K182077
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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