510(k) · Cleared
ClearedStealthStation S8 Spine Software
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 Oct 17, 2025 as substantially equivalent to K201189 (Medtronic Navigation, Inc., 2020) after a 176-day review. Its family tree reaches back 5 generations to 2005. 2 of the 9 devices in its family, counting itself, have a Class I recall. 2 later devices descend from it.
- Decided
- Oct 17, 2025
- Review
- 176 days
- Class
- Class II
- Product code
- OLO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K050438 (2005). 6 ancestors in all, the oldest K992927 (1999). 2 later devices descend from it, 2 citing it directly. 2 of the 9 devices in this family, counting this one, have a Class I recall.
- Root · 5 generations backK050438 Stealthstation System UpdateMedtronic Surgical Navigation Technologies · 2005 · Recalled
- 4 generations backK150216 Synergy CranialMedtronic Navigation, Inc. · 2015 · Recalled (Class I)
- 3 generations backK153660 StealthStation System with Cranial SoftwareMedtronic Navigation, Inc. · 2016 · Recalled (Class I)
- 2 generations backK170011 StealthStation S8 Spine Software v1.0.0Medtronic Navigation · 2017
- 1 generation backK201189 Stealthstation S8 Spine Software v1.3.0Medtronic Navigation, Inc. · 2020 · Recalled
- This deviceK251282 StealthStation S8 Spine SoftwareMedtronic Navigation, Inc. · 2025
- Descendant · cites it directly · 0 of its ownK254157 CROSSNAV Navigation Enabled Instruments for Disc Preparation and…Medos International SARL · 2026
- Descendant · cites it directly · 0 of its ownK253381 Stealth AXiS™ Surgical System with Stealth AXiS™ Spine clinical…Medtronic Navigation, Inc. · 2026
Class I recalls in this family
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K050438 | Stealthstation System Update | Medtronic Surgical Navigation Technologies | 2005 | 11 |
| −4 | K150216 | Synergy Cranial | Medtronic Navigation, Inc. | 2015 | Class I |
| −3 | K153660 | StealthStation System with Cranial Software | Medtronic Navigation, Inc. | 2016 | Class I |
| −2 | K170011 | StealthStation S8 Spine Software v1.0.0 | Medtronic Navigation | 2017 | — |
| −1 | K201189 | Stealthstation S8 Spine Software v1.3.0 | Medtronic Navigation, Inc. | 2020 | 1 |
| 0 (this device) | K251282 | StealthStation S8 Spine Software | Medtronic Navigation, Inc. | 2025 | — |
| +1 | K254157 | CROSSNAV Navigation Enabled Instruments for Disc Preparation and Interbody | Medos International SARL | 2026 | — |
| +1 | 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 |
|---|---|---|
| 1999 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 2 | 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.
2 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.
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (2 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.
What does this lineage say?
- The line of descent spans 20 years and passes through 3 companies; a new generation was cleared every 3.1 years on median.
- 5 of the 6 ancestors have a recall of any class; 2 have a Class I recall.
- Of its descendants, K254157 (Medos International SARL, 2026) has gone furthest, with 0 descendants of its own.
- 7 other devices also cite its predicate K201189.
How does its category compare?
All OLO devicesOLO Orthopedic Stereotaxic Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, 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 in adult and skeletally mature pediatric (adolescent) patients. 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…
Read the full statement (118 words)
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 in adult and skeletally mature pediatric (adolescent) patients. 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 in adult patients, such as:
• Pedicle Screw Placement
• Iliosacral Screw Placement
• Interbody Device Placement
This can include the following spinal implant procedures in skeletally mature pediatric (adolescent) patients:
• Pedicle Screw Placement
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K251282 · printed Nov 5, 2026
Cite this page
510(k) Report. “K251282: StealthStation S8 Spine Software.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K251282
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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