510(k) · Cleared
Recalled · Class II · 2025Mazor 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 Apr 7, 2023 as substantially equivalent to K203005 (Mazor Robotics, Ltd., 2020) after an 88-day review. Its family tree reaches back 18 generations to 1994. 4 of the 74 devices in its family, counting itself, have a Class I recall. 3 later devices descend from it. It has been recalled 2 times.
- Decided
- Apr 7, 2023
- Review
- 88 days
- Class
- Class II
- Product code
- OLO
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 18 generations to K911783 (1994). 70 ancestors in all, the oldest K811452 (1981). 3 later devices descend from it, 2 citing it directly. 4 of the 74 devices in this family, counting this one, have a Class I recall.
- Root · 18 generations backK911783 Allegro Viewing WandI.S.G. Technologies, Inc. · 1994
- 14 generations between
- 3 generations backK182077 Mazor X System (Mazor X Stealth Edition)Mazor Robotics, Ltd. · 2018 · Recalled
- 2 generations backK200935 Mazor XMazor Robotics, Ltd. · 2020
- 1 generation backK203005 Mazor XMazor Robotics, Ltd. · 2020 · Recalled
- This deviceK230064 Mazor X System (Mazor X Stealth Edition)Mazor Robotics, Ltd. · 2023
- Descendant · cites it directly · 1 of its ownK251316 Mazor X System / Mazor X Stealth EditionMazor Robotics, Ltd. · 2025
- Descendant · 2 generations on · 0 of its ownK253381 Stealth AXiS™ Surgical System with Stealth AXiS™ Spine clinical…Medtronic Navigation, Inc. · 2026
- Descendant · cites it directly · 0 of its ownK230716 Robotic Graft Delivery InstrumentsMedtronic Sofamor Danek, Inc. · 2023
Show all 18 generations
- Root · 18 generations backK911783 Allegro Viewing WandI.S.G. Technologies, Inc. · 1994
- 17 generations backK960714 Isg Viewing WandI.S.G. Technologies, Inc. · 1996
- 16 generations backK964229 Regulus NavigatorCompass Intl., Inc. · 1997
- 15 generations backK981315 NavitrackOrthosoft, Inc. · 1998
- 14 generations backK033413 Spineassist DeviceMazor Surgical Technologies, Ltd. · 2004
- 13 generations backK051676 Spineassist Device with Additional AccessoriesMazor Surgical Technologies, Ltd. · 2005
- 12 generations backK063607 Spineassist SystemMazor Surgical Technologies, Ltd. · 2007
- 11 generations backK073467 Spineassist SystemMazor Surgical Technologies, Ltd. · 2008
- 10 generations backK102130 Tenzing SystemMazor Surgical Technologies, Ltd. · 2010
- 9 generations backK110911 Renaissance SystemMazor Robotics, Ltd. · 2011
- 8 generations backK113228 Renaissance SystemMazor Robotics, Ltd. · 2011
- 7 generations backK120812 RenaissanceMazor Robotics, Ltd. · 2012 · Recalled
- 6 generations backK152041 Renaissance X SystemMazor Robotics, Ltd. · 2015
- 5 generations backK163221 Mazor XMazor Robotics, Ltd. · 2017
- 4 generations backK180307 Mazor XMazor Robotics, Ltd. · 2018
- 3 generations backK182077 Mazor X System (Mazor X Stealth Edition)Mazor Robotics, Ltd. · 2018 · Recalled
- 2 generations backK200935 Mazor XMazor Robotics, Ltd. · 2020
- 1 generation backK203005 Mazor XMazor Robotics, Ltd. · 2020 · Recalled
- This deviceK230064 Mazor X System (Mazor X Stealth Edition)Mazor Robotics, Ltd. · 2023
Class I recalls in this family
Most influential descendants
Showing 3 of 3 · See all- K251316Mazor X System / Mazor X Stealth EditionMazor Robotics, Ltd. · 2025 · cites it directly1descendant
- K253381Stealth AXiS™ Surgical System with Stealth AXiS™ Spine clinical applicationMedtronic Navigation, Inc. · 2026 · 2 generations on0descendants
- K230716Robotic Graft Delivery InstrumentsMedtronic Sofamor Danek, Inc. · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −18 | K911783 | Allegro Viewing Wand | I.S.G. Technologies, Inc. | 1994 | — |
| −17 | K960714 | Isg Viewing Wand | I.S.G. Technologies, Inc. | 1996 | — |
| −16 | K964229 | Regulus Navigator | Compass Intl., Inc. | 1997 | — |
| −15 | K981315 | Navitrack | Orthosoft, Inc. | 1998 | — |
| −14 | K033413 | Spineassist Device | Mazor Surgical Technologies, Ltd. | 2004 | — |
| −13 | K051676 | Spineassist Device with Additional Accessories | Mazor Surgical Technologies, Ltd. | 2005 | — |
| −12 | K063607 | Spineassist System | Mazor Surgical Technologies, Ltd. | 2007 | — |
| −11 | K073467 | Spineassist System | Mazor Surgical Technologies, Ltd. | 2008 | — |
| −10 | K102130 | Tenzing System | Mazor Surgical Technologies, Ltd. | 2010 | — |
| −9 | K110911 | Renaissance System | Mazor Robotics, Ltd. | 2011 | — |
| −8 | K113228 | Renaissance System | Mazor Robotics, Ltd. | 2011 | — |
| −7 | K120812 | Renaissance | Mazor Robotics, Ltd. | 2012 | 1 |
| −6 | K152041 | Renaissance X System | Mazor Robotics, Ltd. | 2015 | — |
| −5 | K163221 | Mazor X | Mazor Robotics, Ltd. | 2017 | — |
| −4 | K180307 | Mazor X | Mazor Robotics, Ltd. | 2018 | — |
| −3 | K182077 | Mazor X System (Mazor X Stealth Edition) | Mazor Robotics, Ltd. | 2018 | 2 |
| −2 | K200935 | Mazor X | Mazor Robotics, Ltd. | 2020 | — |
| −1 | K203005 | Mazor X | Mazor Robotics, Ltd. | 2020 | 1 |
| 0 (this device) | K230064 | Mazor X System (Mazor X Stealth Edition) | Mazor Robotics, Ltd. | 2023 | — |
| +1 | K251316 | Mazor X System / Mazor X Stealth Edition | Mazor Robotics, Ltd. | 2025 | — |
| +2 | K253381 | Stealth AXiS™ Surgical System with Stealth AXiS™ Spine clinical application | Medtronic Navigation, Inc. | 2026 | — |
| +1 | K230716 | Robotic Graft Delivery Instruments | Medtronic Sofamor Danek, Inc. | 2023 | — |
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 |
|---|---|---|
| 2023 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 1 | 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? (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 |
|---|---|---|---|
| * | K203005 | Mazor XSummary page 4…trument Classification Code: OLO and LLZ Device class: II Regulation number: 882.4560 Panel: Orthopedic Predicate Devices: Mazor X System (Mazor X Stealth Edition) (K203005) Intended Use / Indications for Use The Mazor X is indicated for precise positioning of surgical instruments or spinal implants… | 2020 |
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (4 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 10, 2025 | Class II | Z-1122-2026 | Under Investigation by firm | Software errors that can result in incorrect surgical instrument positioning during spinal surgery. |
| Jul 17, 2024 | Class II | Z-3156-2024 | Device Design | Software anomalies which can result in two separate issues: A lagging screen display during a navigated procedure; or the potential for a mismatch between the navigated screw and the screw information presented on the screen. |
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 · 4 generations back · ◆ in the 2017 ancestors bar of FIG. 12 Class I recalls
- K153660StealthStation System with Cranial SoftwareMedtronic Navigation, Inc. · 2016 · 5 generations back · ◆ in the 2016 ancestors bar of FIG. 13 Class I recalls
- K150216Synergy CranialMedtronic Navigation, Inc. · 2015 · 6 generations back · ◆ in the 2015 ancestors bar of FIG. 13 Class I recalls
- K003837Flexiview 8800 Digital Mobile Imaging SystemGe Oec Medical Systems · 2001 · 12 generations back · ◆ in the 2001 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 29 years and passes through 5 companies; a new generation was cleared every 1.4 years on median.
- 20 of the 70 ancestors have a recall of any class; 4 have a Class I recall.
- Of its descendants, K251316 (Mazor Robotics, Ltd., 2025) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K203005.
How does its category compare?
All OLO devicesOLO Orthopedic Stereotaxic Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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 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 a 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/K230064 · printed Nov 5, 2026
Cite this page
510(k) Report. “K230064: Mazor X System (Mazor X Stealth Edition).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K230064
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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