510(k) · Cleared
ClearedEnvision 3D: Image Guidance System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
7D Surgical, Inc. · OLO Orthopedic Stereotaxic Instrument
Cleared on Dec 29, 2016 as substantially equivalent to K133444 (Medtronic Navigation, Inc., 2014) after a 127-day review. Its family tree reaches back 2 generations to 2005. 21 later devices descend from it.
- Decided
- Dec 29, 2016
- Review
- 127 days
- Class
- Class II
- Product code
- OLO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K050438 (2005). 21 later devices descend from it, 5 citing it directly.
- Root · 2 generations backK050438 Stealthstation System UpdateMedtronic Surgical Navigation Technologies · 2005 · Recalled
- 1 generation backK133444 Stealthstation S7 / I7 / Fusion Navigation Systems, Axiem Navigation…Medtronic Navigation, Inc. · 2014 · Recalled
- This deviceK162375 Envision 3D: Image Guidance System7D Surgical, Inc. · 2016
- Descendant · cites it directly · 8 of its ownK180352 7D Surgical System7D Surgical, Inc. · 2018
- Descendant · cites it directly · 6 of its ownK181041 7D Surgical System Cranial Application7D Surgical, Inc. · 2018
- Descendant · 2 generations on · 5 of its ownK192945 7D Surgical System Cranial Biopsy and Ventricular Catheter Placement…7D Surgical, Inc. · 2019
- Descendant · 3 generations on · 3 of its ownK230661 Zeta Cranial Navigation SystemZeta Surgical · 2023
- Descendant · cites it directly · 3 of its ownK222291 Paradigm SystemProprio, Inc. · 2023
Showing 5 of 21 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 21 · See all- K1803527D Surgical System7D Surgical, Inc. · 2018 · cites it directly8descendants
- K1810417D Surgical System Cranial Application7D Surgical, Inc. · 2018 · cites it directly6descendants
- K1929457D Surgical System Cranial Biopsy and Ventricular Catheter Placement Application7D Surgical, Inc. · 2019 · 2 generations on5descendants
- K230661Zeta Cranial Navigation SystemZeta Surgical · 2023 · 3 generations on3descendants
- K222291Paradigm SystemProprio, Inc. · 2023 · cites it directly3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K050438 | Stealthstation System Update | Medtronic Surgical Navigation Technologies | 2005 | 11 |
| −1 | K133444 | Stealthstation S7 / I7 / Fusion Navigation Systems, Axiem Navigation System | Medtronic Navigation, Inc. | 2014 | 1 |
| 0 (this device) | K162375 | Envision 3D: Image Guidance System | 7D Surgical, Inc. | 2016 | — |
| +1 | K180352 | 7D Surgical System | 7D Surgical, Inc. | 2018 | — |
| +1 | K181041 | 7D Surgical System Cranial Application | 7D Surgical, Inc. | 2018 | — |
| +2 | K192945 | 7D Surgical System Cranial Biopsy and Ventricular Catheter Placement Application | 7D Surgical, Inc. | 2019 | — |
| +3 | K230661 | Zeta Cranial Navigation System | Zeta Surgical | 2023 | — |
| +1 | K222291 | Paradigm System | Proprio, Inc. | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 2 | 0 |
| 2019 | 4 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 3 | 0 |
| 2024 | 4 | 0 |
| 2025 | 4 | 0 |
| 2026 | 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.
Planning a device in OLO? 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 |
|---|---|---|---|
| * | K133444 | Stealthstation S7 / I7 / Fusion Navigation Systems, Axiem Navigation SystemSummary page 4…valent to the following currently marketed devices: Product 510(k) Medtronic StealthStation System K133444 The indications for use of the subject device Envision 3D™: Image Guidance System are equivalent to the predicat… | 2014 |
| † | K033621 | Ndi Passive Spheres | 2004 |
What descends from it? (21)
See all 215 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 11 years and passes through 3 companies; a new generation was cleared every 9.1 years on median.
- 2 of the 2 ancestors have a recall of any class.
- Of its descendants, K180352 (7D Surgical, Inc., 2018) has gone furthest, with 8 descendants of its own.
- 8 other devices also cite its predicate K133444.
How does its category compare?
All OLO devicesOLO Orthopedic Stereotaxic Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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 Envision 3D™: Image Guidance System is a stereotaxic image guidance system intended for the spatial positioning and orientation of neurosurgical instruments used by surgeons. The system is also intended to be used as the primary surgical luminaire during image guided surgery. The device is indicated for posterior approach spine surgery where reference to a rigid anatomical structure can be identified.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K162375 · printed Nov 6, 2026
Cite this page
510(k) Report. “K162375: Envision 3D: Image Guidance System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K162375
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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