510(k) · Cleared
ClearedStealth AXiS™ Surgical System with Stealth AXiS™ Spine clinical application
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic Navigation, Inc. · OLO Orthopedic Stereotaxic Instrument
Cleared on Feb 12, 2026 as substantially equivalent to K251316 (Mazor Robotics, Ltd., 2025) and 2 other predicates after a 135-day review. Its family tree reaches back 20 generations to 1994. 4 of the 75 devices in its family, counting itself, have a Class I recall.
- Decided
- Feb 12, 2026
- Review
- 135 days
- Class
- Class II
- Product code
- OLO
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 20 generations to K911783 (1994). 74 ancestors in all, the oldest K811452 (1981). No later device cites it as a predicate yet. 4 of the 75 devices in this family, counting this one, have a Class I recall.
- Root · 20 generations backK911783 Allegro Viewing WandI.S.G. Technologies, Inc. · 1994
- 16 generations between
- 3 generations backK203005 Mazor XMazor Robotics, Ltd. · 2020 · Recalled
- 2 generations backK230064 Mazor X System (Mazor X Stealth Edition)Mazor Robotics, Ltd. · 2023 · Recalled
- 1 generation backK251316 Mazor X System / Mazor X Stealth EditionMazor Robotics, Ltd. · 2025
- This deviceK253381 Stealth AXiS™ Surgical System with Stealth AXiS™ Spine clinical…Medtronic Navigation, Inc. · 2026
Show all 20 generations
- Root · 20 generations backK911783 Allegro Viewing WandI.S.G. Technologies, Inc. · 1994
- 19 generations backK960714 Isg Viewing WandI.S.G. Technologies, Inc. · 1996
- 18 generations backK964229 Regulus NavigatorCompass Intl., Inc. · 1997
- 17 generations backK981315 NavitrackOrthosoft, Inc. · 1998
- 16 generations backK033413 Spineassist DeviceMazor Surgical Technologies, Ltd. · 2004
- 15 generations backK051676 Spineassist Device with Additional AccessoriesMazor Surgical Technologies, Ltd. · 2005
- 14 generations backK063607 Spineassist SystemMazor Surgical Technologies, Ltd. · 2007
- 13 generations backK073467 Spineassist SystemMazor Surgical Technologies, Ltd. · 2008
- 12 generations backK102130 Tenzing SystemMazor Surgical Technologies, Ltd. · 2010
- 11 generations backK110911 Renaissance SystemMazor Robotics, Ltd. · 2011
- 10 generations backK113228 Renaissance SystemMazor Robotics, Ltd. · 2011
- 9 generations backK120812 RenaissanceMazor Robotics, Ltd. · 2012 · Recalled
- 8 generations backK152041 Renaissance X SystemMazor Robotics, Ltd. · 2015
- 7 generations backK163221 Mazor XMazor Robotics, Ltd. · 2017
- 6 generations backK180307 Mazor XMazor Robotics, Ltd. · 2018
- 5 generations backK182077 Mazor X System (Mazor X Stealth Edition)Mazor Robotics, Ltd. · 2018 · Recalled
- 4 generations backK200935 Mazor XMazor Robotics, Ltd. · 2020
- 3 generations backK203005 Mazor XMazor Robotics, Ltd. · 2020 · Recalled
- 2 generations backK230064 Mazor X System (Mazor X Stealth Edition)Mazor Robotics, Ltd. · 2023 · Recalled
- 1 generation backK251316 Mazor X System / Mazor X Stealth EditionMazor Robotics, Ltd. · 2025
- This deviceK253381 Stealth AXiS™ Surgical System with Stealth AXiS™ Spine clinical…Medtronic Navigation, Inc. · 2026
Class I recalls in this family
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −20 | K911783 | Allegro Viewing Wand | I.S.G. Technologies, Inc. | 1994 | — |
| −19 | K960714 | Isg Viewing Wand | I.S.G. Technologies, Inc. | 1996 | — |
| −18 | K964229 | Regulus Navigator | Compass Intl., Inc. | 1997 | — |
| −17 | K981315 | Navitrack | Orthosoft, Inc. | 1998 | — |
| −16 | K033413 | Spineassist Device | Mazor Surgical Technologies, Ltd. | 2004 | — |
| −15 | K051676 | Spineassist Device with Additional Accessories | Mazor Surgical Technologies, Ltd. | 2005 | — |
| −14 | K063607 | Spineassist System | Mazor Surgical Technologies, Ltd. | 2007 | — |
| −13 | K073467 | Spineassist System | Mazor Surgical Technologies, Ltd. | 2008 | — |
| −12 | K102130 | Tenzing System | Mazor Surgical Technologies, Ltd. | 2010 | — |
| −11 | K110911 | Renaissance System | Mazor Robotics, Ltd. | 2011 | — |
| −10 | K113228 | Renaissance System | Mazor Robotics, Ltd. | 2011 | — |
| −9 | K120812 | Renaissance | Mazor Robotics, Ltd. | 2012 | 1 |
| −8 | K152041 | Renaissance X System | Mazor Robotics, Ltd. | 2015 | — |
| −7 | K163221 | Mazor X | Mazor Robotics, Ltd. | 2017 | — |
| −6 | K180307 | Mazor X | Mazor Robotics, Ltd. | 2018 | — |
| −5 | K182077 | Mazor X System (Mazor X Stealth Edition) | Mazor Robotics, Ltd. | 2018 | 2 |
| −4 | K200935 | Mazor X | Mazor Robotics, Ltd. | 2020 | — |
| −3 | K203005 | Mazor X | Mazor Robotics, Ltd. | 2020 | 1 |
| −2 | K230064 | Mazor X System (Mazor X Stealth Edition) | Mazor Robotics, Ltd. | 2023 | 2 |
| −1 | K251316 | Mazor X System / Mazor X Stealth Edition | Mazor Robotics, Ltd. | 2025 | — |
| 0 (this device) | K253381 | Stealth AXiS™ Surgical System with Stealth AXiS™ Spine clinical application | Medtronic Navigation, Inc. | 2026 | — |
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 |
| 2020 | 1 | 0 |
| 2025 | 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? (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 |
|---|---|---|---|
| * | K251316 | Mazor X System / Mazor X Stealth EditionSummary page 5…Stealth AXiS Surgical Mazor X System with Software StealthStation S8 Platform System v5.2 K251316 K162309 S.E. September 11, 2025 S.E. March 31, 2017… | 2025 |
| * | K162309 | StealthStation S8 System Platforms and StealthStation Cranial SoftwareSummary page 5…System with Software StealthStation S8 Platform System v5.2 K251316 K162309 S.E. September 11, 2025 S.E. March 31, 2017 Stealth AXiS Spine… | 2017 |
| * | K251282 | StealthStation S8 Spine Software Cleared while this submission was under review Summary page 5…n S8 Spine Clinical Application Software v2.1 K251282 S.E. October 17, 2025… | 2025 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (4 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.
- 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 · 14 generations back · ◆ in the 2001 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 32 years and passes through 6 companies; a new generation was cleared every 1.4 years on median.
- 22 of the 74 ancestors have a recall of any class; 4 have a Class I recall.
How does its category compare?
All OLO devicesOLO Orthopedic Stereotaxic Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, 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 Stealth AXiS™ Surgical System is intended for precise positioning of surgical instruments and as an aid for precisely locating anatomical structures in open, minimally invasive, and percutaneous procedures. The Stealth AXiS™ Surgical System is indicated for medical conditions in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the vertebra, can be identified relative to a CT or MR…
Read the full statement (224 words)
The Stealth AXiS™ Surgical System is intended for precise positioning of surgical instruments and as an aid for precisely locating anatomical structures in open, minimally invasive, and percutaneous procedures. The Stealth AXiS™ Surgical System is indicated for medical conditions in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.
The Stealth AXiS™ Surgical System is indicated for precise robotic positioning of surgical instruments or implants during orthopedic or neurosurgery. It may be used in open, minimally invasive, and percutaneous procedures.
The Stealth AXiS™ Surgical System, with the Stealth AXiS™ Spine clinical application, is intended for precise positioning of surgical instruments and as an aid for precisely locating anatomical structures in open, minimally invasive, and percutaneous procedures. Their use is indicated for medical conditions in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the spine or pelvis, can be identified relative to images of the anatomy.
This can include procedures in adult patients, such as:
•Interbody device placement
• Pedicle screw placement
•Iliosacral screw placement
This can include the following spinal implant procedure in skeletally mature pediatric (adolescent) patients:
• Pedicle screw placement
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K253381 · printed Nov 5, 2026
Cite this page
510(k) Report. “K253381: Stealth AXiS™ Surgical System with Stealth AXiS™ Spine clinical application.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K253381
Report an extraction error
Are you the manufacturer?
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