510(k) · Cleared
ClearedStealthStation S8 Spine Software v1.0.0
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic Navigation · OLO Orthopedic Stereotaxic Instrument
Cleared on May 1, 2017 as substantially equivalent to K050438 (Medtronic Surgical Navigation Technologies, 2005) and 1 other predicate after a 118-day review. Its family tree reaches back 3 generations to 2005. 3 of the 131 devices in its family, counting itself, have a Class I recall. 126 later devices descend from it.
- Decided
- May 1, 2017
- Review
- 118 days
- Class
- Class II
- Product code
- OLO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K050438 (2005). 4 ancestors in all, the oldest K992927 (1999). 126 later devices descend from it, 11 citing it directly. 3 of the 131 devices in this family, counting this one, have a Class I recall.
- Root · 3 generations backK050438 Stealthstation System UpdateMedtronic Surgical Navigation Technologies · 2005 · Recalled
- 2 generations backK150216 Synergy CranialMedtronic Navigation, Inc. · 2015 · Recalled (Class I)
- 1 generation backK153660 StealthStation System with Cranial SoftwareMedtronic Navigation, Inc. · 2016 · Recalled (Class I)
- This deviceK170011 StealthStation S8 Spine Software v1.0.0Medtronic Navigation · 2017
- Descendant · cites it directly · 42 of its ownK191100 ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc. · 2019
- Descendant · cites it directly · 31 of its ownK190929 xvision Spine system (XVS)Augmedics, Ltd. · 2019
- Descendant · 2 generations on · 23 of its ownK222270 HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable…Globus Medical, Inc. · 2022
- Descendant · cites it directly · 16 of its ownK182077 Mazor X System (Mazor X Stealth Edition)Mazor Robotics, Ltd. · 2018 · Recalled
- Descendant · cites it directly · 15 of its ownK212245 Spine and Trauma Navigation System, Spine & Trauma 3D Navigation…Brainlab AG · 2022
Showing 5 of 126 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 126 · See all- K191100ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc. · 2019 · cites it directly42descendants
- K190929xvision Spine system (XVS)Augmedics, Ltd. · 2019 · cites it directly31descendants
- K222270HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS…Globus Medical, Inc. · 2022 · 2 generations on23descendants
- K182077Mazor X System (Mazor X Stealth Edition)Mazor Robotics, Ltd. · 2018 · cites it directly16descendants
- K212245Spine and Trauma Navigation System, Spine & Trauma 3D Navigation, Instrument Selection…Brainlab AG · 2022 · cites it directly15descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K050438 | Stealthstation System Update | Medtronic Surgical Navigation Technologies | 2005 | 11 |
| −2 | K150216 | Synergy Cranial | Medtronic Navigation, Inc. | 2015 | Class I |
| −1 | K153660 | StealthStation System with Cranial Software | Medtronic Navigation, Inc. | 2016 | Class I |
| 0 (this device) | K170011 | StealthStation S8 Spine Software v1.0.0 | Medtronic Navigation | 2017 | — |
| +1 | K191100 | ExcelsiusGPS Spine 1.1 Interbody Module | Globus Medical, Inc. | 2019 | — |
| +1 | K190929 | xvision Spine system (XVS) | Augmedics, Ltd. | 2019 | — |
| +2 | K222270 | HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer… | Globus Medical, Inc. | 2022 | — |
| +1 | K182077 | Mazor X System (Mazor X Stealth Edition) | Mazor Robotics, Ltd. | 2018 | 2 |
| +1 | K212245 | Spine and Trauma Navigation System, Spine & Trauma 3D Navigation, Instrument… | Brainlab AG | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 2 | 0 |
| 2019 | 2 | 0 |
| 2020 | 7 | 0 |
| 2021 | 9 | 1 |
| 2022 | 11 | 0 |
| 2023 | 17 | 0 |
| 2024 | 24 | 0 |
| 2025 | 26 | 0 |
| 2026 | 28 | 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.
3 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? (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 |
|---|---|---|---|
| * | K050438 | Stealthstation System UpdateSummary page 5…l Screw Placement • Interbody Device Placement IX. Identification of Legally Marketed Devices (Predicate Devices) • StealthStation System Update (K050438, Main Predicate) • Synergy Cranial 3.0 Software (K153660, System Accuracy Predicate) X. Comparison of the Technolo… | 2005 |
| * | K153660 | StealthStation System with Cranial SoftwareSummary page 5…ification of Legally Marketed Devices (Predicate Devices) • StealthStation System Update (K050438, Main Predicate) • Synergy Cranial 3.0 Software (K153660, System Accuracy Predicate) X. Comparison of the Technological Characteristics: Subject Device (Stealt… | 2016 |
What descends from it? (126)
See all 12611 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K191100 | ExcelsiusGPS Spine 1.1 Interbody Module | 2019 | 42 |
| K190929 | xvision Spine system (XVS) | 2019 | 31 |
| K182077 | Mazor X System (Mazor X Stealth Edition) | 2018 | 16 |
| K212245 | Spine and Trauma Navigation System, Spine & Trauma 3D Navigation, Instrument Selection… | 2022 | 15 |
| K201189 | Stealthstation S8 Spine Software v1.3.0 | 2020 | 15 |
| K210859 | NextAR™ Spine Platform | 2021 | 4 |
| K180038 | NuVasive Pulse System | 2018 | 3 |
| K210574 | NuVasive Pulse System | 2021 | 2 |
| K211254 | ARAI Surgical Navigation System | 2022 | 1 |
| K212023 | Virage Navigation System | 2021 | 1 |
Has anything in its family been recalled? (3 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.
- K153660StealthStation System with Cranial SoftwareMedtronic Navigation, Inc. · 2016 · Direct predicate · ◆ on the line of descent in FIG. 13 Class I recalls
- K150216Synergy CranialMedtronic Navigation, Inc. · 2015 · 2 generations back · ◆ on the line of descent in FIG. 13 Class I recalls
- K211616ExcelsiusHubGlobus Medical, Inc. · 2021 · 2 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 12 years and passes through 3 companies; a new generation was cleared every 1.3 years on median.
- 4 of the 4 ancestors have a recall of any class; 2 have a Class I recall.
- Of its descendants, K191100 (Globus Medical, Inc., 2019) has gone furthest, with 42 descendants of its own.
- 22 other devices also cite its predicate K050438.
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 StealthStation® System, with StealthStation Spine Software, is intended as an aid for precisely locating anatomical structures in either open or percutaneous neurosurgical and orthopedic procedures. Their use is indicated for any medical condition 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 the following spinal implant procedures, such as:
o Pedicle Screw Placement
o Iliosacral Screw Placement
o Interbody Device Placement
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K170011 · printed Nov 6, 2026
Cite this page
510(k) Report. “K170011: StealthStation S8 Spine Software v1.0.0.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K170011
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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