510(k) · Cleared
ClearedMazor X
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 4, 2017 as substantially equivalent to K152041 (Mazor Robotics, Ltd., 2015) and 1 other predicate after a 139-day review. Its family tree reaches back 13 generations to 1994. 1 of the 79 devices in its family, counting itself, has a Class I recall. 19 later devices descend from it.
- Decided
- Apr 4, 2017
- Review
- 139 days
- Class
- Class II
- Product code
- OLO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 13 generations to K911783 (1994). 59 ancestors in all, the oldest K811452 (1981). 19 later devices descend from it, 2 citing it directly. 1 of the 79 devices in this family, counting this one, has a Class I recall.
- Root · 13 generations backK911783 Allegro Viewing WandI.S.G. Technologies, Inc. · 1994
- 9 generations between
- 3 generations backK113228 Renaissance SystemMazor Robotics, Ltd. · 2011
- 2 generations backK120812 RenaissanceMazor Robotics, Ltd. · 2012 · Recalled
- 1 generation backK152041 Renaissance X SystemMazor Robotics, Ltd. · 2015
- This deviceK163221 Mazor XMazor Robotics, Ltd. · 2017
- Descendant · cites it directly · 17 of its ownK180307 Mazor XMazor Robotics, Ltd. · 2018
- Descendant · 2 generations on · 16 of its ownK182077 Mazor X System (Mazor X Stealth Edition)Mazor Robotics, Ltd. · 2018 · Recalled
- Descendant · 3 generations on · 15 of its ownK200935 Mazor XMazor Robotics, Ltd. · 2020
- Descendant · 4 generations on · 14 of its ownK203005 Mazor XMazor Robotics, Ltd. · 2020 · Recalled
- Descendant · 5 generations on · 9 of its ownK211441 Navigated Anterolateral Disc Prep InstrumentsMedtronic Sofamor Danek USA, Inc. · 2021
Show all 13 generations
- Root · 13 generations backK911783 Allegro Viewing WandI.S.G. Technologies, Inc. · 1994
- 12 generations backK960714 Isg Viewing WandI.S.G. Technologies, Inc. · 1996
- 11 generations backK964229 Regulus NavigatorCompass Intl., Inc. · 1997
- 10 generations backK981315 NavitrackOrthosoft, Inc. · 1998
- 9 generations backK033413 Spineassist DeviceMazor Surgical Technologies, Ltd. · 2004
- 8 generations backK051676 Spineassist Device with Additional AccessoriesMazor Surgical Technologies, Ltd. · 2005
- 7 generations backK063607 Spineassist SystemMazor Surgical Technologies, Ltd. · 2007
- 6 generations backK073467 Spineassist SystemMazor Surgical Technologies, Ltd. · 2008
- 5 generations backK102130 Tenzing SystemMazor Surgical Technologies, Ltd. · 2010
- 4 generations backK110911 Renaissance SystemMazor Robotics, Ltd. · 2011
- 3 generations backK113228 Renaissance SystemMazor Robotics, Ltd. · 2011
- 2 generations backK120812 RenaissanceMazor Robotics, Ltd. · 2012 · Recalled
- 1 generation backK152041 Renaissance X SystemMazor Robotics, Ltd. · 2015
- This deviceK163221 Mazor XMazor Robotics, Ltd. · 2017
Showing 5 of 19 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K003837 Flexiview 8800 Digital Mobile Imaging System7 generations back · 2001
Most influential descendants
Showing 5 of 19 · See all- K180307Mazor XMazor Robotics, Ltd. · 2018 · cites it directly17descendants
- K182077Mazor X System (Mazor X Stealth Edition)Mazor Robotics, Ltd. · 2018 · 2 generations on16descendants
- K200935Mazor XMazor Robotics, Ltd. · 2020 · 3 generations on15descendants
- K203005Mazor XMazor Robotics, Ltd. · 2020 · 4 generations on14descendants
- K211441Navigated Anterolateral Disc Prep InstrumentsMedtronic Sofamor Danek USA, Inc. · 2021 · 5 generations on9descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K911783 | Allegro Viewing Wand | I.S.G. Technologies, Inc. | 1994 | — |
| −12 | K960714 | Isg Viewing Wand | I.S.G. Technologies, Inc. | 1996 | — |
| −11 | K964229 | Regulus Navigator | Compass Intl., Inc. | 1997 | — |
| −10 | K981315 | Navitrack | Orthosoft, Inc. | 1998 | — |
| −9 | K033413 | Spineassist Device | Mazor Surgical Technologies, Ltd. | 2004 | — |
| −8 | K051676 | Spineassist Device with Additional Accessories | Mazor Surgical Technologies, Ltd. | 2005 | — |
| −7 | K063607 | Spineassist System | Mazor Surgical Technologies, Ltd. | 2007 | — |
| −6 | K073467 | Spineassist System | Mazor Surgical Technologies, Ltd. | 2008 | — |
| −5 | K102130 | Tenzing System | Mazor Surgical Technologies, Ltd. | 2010 | — |
| −4 | K110911 | Renaissance System | Mazor Robotics, Ltd. | 2011 | — |
| −3 | K113228 | Renaissance System | Mazor Robotics, Ltd. | 2011 | — |
| −2 | K120812 | Renaissance | Mazor Robotics, Ltd. | 2012 | 1 |
| −1 | K152041 | Renaissance X System | Mazor Robotics, Ltd. | 2015 | — |
| 0 (this device) | K163221 | Mazor X | Mazor Robotics, Ltd. | 2017 | — |
| +1 | K180307 | Mazor X | Mazor Robotics, Ltd. | 2018 | — |
| +2 | K182077 | Mazor X System (Mazor X Stealth Edition) | Mazor Robotics, Ltd. | 2018 | 2 |
| +3 | K200935 | Mazor X | Mazor Robotics, Ltd. | 2020 | — |
| +4 | K203005 | Mazor X | Mazor Robotics, Ltd. | 2020 | 1 |
| +5 | K211441 | Navigated Anterolateral Disc Prep Instruments | Medtronic Sofamor Danek USA, Inc. | 2021 | — |
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 | 1 | 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 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 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 |
|---|---|---|---|
| * | K152041 | Renaissance X SystemSummary page 4…t to the following devices: Manufacturer Device 510(k) Date Cleared Mazor Robotics Ltd. Renaissance X System K152041 November 17, 2015 Nemaris Inc. Surgimap K111019 September 30, 2011… | 2015 |
| * | K111019 | Surgimap (TM) SpineSummary page 4…10(k) Date Cleared Mazor Robotics Ltd. Renaissance X System K152041 November 17, 2015 Nemaris Inc. Surgimap K111019 September 30, 2011 17… | 2011 |
What descends from it? (19)
See all 192 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 · 7 generations back · ◆ in the 2001 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 23 years and passes through 5 companies; a new generation was cleared every 1.4 years on median.
- 13 of the 59 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K180307 (Mazor Robotics, Ltd., 2018) has gone furthest, with 17 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. 2017, 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 either 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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K163221 · printed Nov 4, 2026
Cite this page
510(k) Report. “K163221: Mazor X.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K163221
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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