510(k) · Cleared
ClearedSpine Navigation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medivis, Inc. · OLO Orthopedic Stereotaxic Instrument
Cleared on Jul 26, 2024 as substantially equivalent to K190929 (Augmedics, Ltd., 2019) after a 248-day review. Its family tree reaches back 5 generations to 2005. 2 of the 7 devices in its family, counting itself, have a Class I recall.
- Decided
- Jul 26, 2024
- Review
- 248 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). No later device cites it as a predicate yet. 2 of the 7 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 backK190929 xvision Spine system (XVS)Augmedics, Ltd. · 2019
- This deviceK233725 Spine Navigation SystemMedivis, Inc. · 2024
Class I recalls in this family
View 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 | K190929 | xvision Spine system (XVS) | Augmedics, Ltd. | 2019 | — |
| 0 (this device) | K233725 | Spine Navigation System | Medivis, Inc. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 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.
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 |
|---|---|---|---|
| * | K190929 | xvision Spine system (XVS)Summary page 4…reotaxic Instrument Classification Name: Orthopedic Stereotaxic Instrument Regulation Number: 882.4560 Product Code: OLO Legally Marketed Predicate Devices Predicate #: K190929 Predicate Trade Name: xvision spine system (XVS) Product Code: OLO Device Description Summary The Medivis Spine Navigation Syste… | 2019 |
What descends from it?
No later submission names this one as a predicate yet.
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 19 years and passes through 5 companies; a new generation was cleared every 2.6 years on median.
- 4 of the 6 ancestors have a recall of any class; 2 have a Class I recall.
- 4 other devices also cite its predicate K190929.
How does its category compare?
All OLO devicesOLO Orthopedic Stereotaxic Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, 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 Spine Navigation system is intended as an aid for precisely locating anatomical structures in either open or percutaneous spine 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, can be identified relative to CT imagery of the anatomy. This can include the spinal implant procedures, such as Posterior Pedicle…
Read the full statement (160 words)
The Spine Navigation system is intended as an aid for precisely locating anatomical structures in either open or percutaneous spine 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, can be identified relative to CT imagery of the anatomy.
This can include the spinal implant procedures, such as Posterior Pedicle Screw Placement in the sacro-lumbar region.
The headset of the Spine Navigation system displays 2D stereotaxic screens and a virtual anatomy screen. The stereotaxic screen is indicated for correlating the tracked instrument location to the registered patient imagery. The virtual screen is indicated for displaying the virtual instrument location in relation to the virtual anatomy to assist in percutaneous visualization and trajectory planning.
The virtual display should not be relied upon solely for absolute positional information and should always be used in conjunction with the displayed stereotaxic information.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K233725 · printed Nov 6, 2026
Cite this page
510(k) Report. “K233725: Spine Navigation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K233725
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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