510(k) · Cleared
Recalled · Class II · 2024Stealthstation S8 Spine Software v1.3.0
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 May 29, 2020 as substantially equivalent to K170011 (Medtronic Navigation, 2017) after a 28-day review. Its family tree reaches back 4 generations to 2005. 2 of the 21 devices in its family, counting itself, have a Class I recall. 15 later devices descend from it. It has been recalled once.
- Decided
- May 29, 2020
- Review
- 28 days
- Class
- Class II
- Product code
- OLO
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 4 generations to K050438 (2005). 5 ancestors in all, the oldest K992927 (1999). 15 later devices descend from it, 8 citing it directly. 2 of the 21 devices in this family, counting this one, have a Class I recall.
- Root · 4 generations backK050438 Stealthstation System UpdateMedtronic Surgical Navigation Technologies · 2005 · Recalled
- 3 generations backK150216 Synergy CranialMedtronic Navigation, Inc. · 2015 · Recalled (Class I)
- 2 generations backK153660 StealthStation System with Cranial SoftwareMedtronic Navigation, Inc. · 2016 · Recalled (Class I)
- 1 generation backK170011 StealthStation S8 Spine Software v1.0.0Medtronic Navigation · 2017
- This deviceK201189 Stealthstation S8 Spine Software v1.3.0Medtronic Navigation, Inc. · 2020
- Descendant · cites it directly · 4 of its ownK220241 “POINT” Kinguide Robotic-Assisted Surgical SystemPoint Robotics MedTech, Inc. · 2022
- Descendant · cites it directly · 3 of its ownK230087 “POINT” Kinguide Agile Hybrid Navigation SystemPoint Robotics MedTech, Inc. · 2023
- Descendant · cites it directly · 2 of its ownK251282 StealthStation S8 Spine SoftwareMedtronic Navigation, Inc. · 2025
- Descendant · cites it directly · 2 of its ownK241130 “POINT” Kinguide Agile Hybrid Navigation System (PSHF01-000)Point Robotics MedTech, Inc. · 2024
- Descendant · cites it directly · 2 of its ownK213034 SpineAR SNAPSurgical Theater, Inc. · 2022
Showing 5 of 15 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 15 · See all- K220241“POINT” Kinguide Robotic-Assisted Surgical SystemPoint Robotics MedTech, Inc. · 2022 · cites it directly4descendants
- K230087“POINT” Kinguide Agile Hybrid Navigation SystemPoint Robotics MedTech, Inc. · 2023 · cites it directly3descendants
- K251282StealthStation S8 Spine SoftwareMedtronic Navigation, Inc. · 2025 · cites it directly2descendants
- K241130“POINT” Kinguide Agile Hybrid Navigation System (PSHF01-000)Point Robotics MedTech, Inc. · 2024 · cites it directly2descendants
- K213034SpineAR SNAPSurgical Theater, Inc. · 2022 · cites it directly2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K050438 | Stealthstation System Update | Medtronic Surgical Navigation Technologies | 2005 | 11 |
| −3 | K150216 | Synergy Cranial | Medtronic Navigation, Inc. | 2015 | Class I |
| −2 | K153660 | StealthStation System with Cranial Software | Medtronic Navigation, Inc. | 2016 | Class I |
| −1 | K170011 | StealthStation S8 Spine Software v1.0.0 | Medtronic Navigation | 2017 | — |
| 0 (this device) | K201189 | Stealthstation S8 Spine Software v1.3.0 | Medtronic Navigation, Inc. | 2020 | — |
| +1 | K220241 | “POINT” Kinguide Robotic-Assisted Surgical System | Point Robotics MedTech, Inc. | 2022 | — |
| +1 | K230087 | “POINT” Kinguide Agile Hybrid Navigation System | Point Robotics MedTech, Inc. | 2023 | — |
| +1 | K251282 | StealthStation S8 Spine Software | Medtronic Navigation, Inc. | 2025 | — |
| +1 | K241130 | “POINT” Kinguide Agile Hybrid Navigation System (PSHF01-000) | Point Robotics MedTech, Inc. | 2024 | — |
| +1 | K213034 | SpineAR SNAP | Surgical Theater, Inc. | 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 |
|---|---|---|
| 2022 | 2 | 0 |
| 2023 | 1 | 0 |
| 2024 | 2 | 0 |
| 2025 | 3 | 0 |
| 2026 | 7 | 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K170011 | StealthStation S8 Spine Software v1.0.0Summary page 5…e Devices (StealthStation v1.3.0 (Subject Devices) S8 Spine Software v1.0.0) K170011 Intended Use The StealthStation™ System, with The StealthStation® System, with StealthStation Spi… | 2017 |
What descends from it? (15)
See all 158 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K220241 | “POINT” Kinguide Robotic-Assisted Surgical System | 2022 | 4 |
| K230087 | “POINT” Kinguide Agile Hybrid Navigation System | 2023 | 3 |
| K251282 | StealthStation S8 Spine Software | 2025 | 2 |
| K241130 | “POINT” Kinguide Agile Hybrid Navigation System (PSHF01-000) | 2024 | 2 |
| K213034 | SpineAR SNAP | 2022 | 2 |
| K254158 | SPINEART Navigation Instrument System | 2026 | 1 |
| K252088 | Firebird SI Navigation System | 2025 | 1 |
| K252989 | “POINT” Kinguide Agile Hybrid Navigation System; DRF Accessories Set | 2026 | 0 |
Has anything in its family been recalled? (2 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 22, 2024 | Class II | Z-0050-2025 | Software design | Due to two software anomalies that can occur within a spine procedure. Two issues are: 1. Navigation Orientation - when lateral orientation radiographic images are taken, information may appear flipped when utilizing the system (180… |
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 15 years and passes through 3 companies; a new generation was cleared every 3.1 years on median.
- 4 of the 5 ancestors have a recall of any class; 2 have a Class I recall.
- Of its descendants, K220241 (Point Robotics MedTech, Inc., 2022) has gone furthest, with 4 descendants of its own.
- 10 other devices also cite its predicate K170011.
How does its category compare?
All OLO devicesOLO Orthopedic Stereotaxic Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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/K201189 · printed Nov 6, 2026
Cite this page
510(k) Report. “K201189: Stealthstation S8 Spine Software v1.3.0.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K201189
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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