510(k) · Cleared
ClearedSeaSpine 7D Navigation Instruments
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
SeaSpine Orthopedics Corporation · OLO Orthopedic Stereotaxic Instrument
Cleared on Dec 9, 2022 as substantially equivalent to K192140 (7D Surgical, Inc., 2019) and 1 other predicate after an 88-day review. Its family tree reaches back 5 generations to 2005. 1 later device descends from it.
- Decided
- Dec 9, 2022
- Review
- 88 days
- Class
- Class II
- Product code
- OLO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K050438 (2005). 1 later device descends from it, 1 citing it directly.
- Root · 5 generations backK050438 Stealthstation System UpdateMedtronic Surgical Navigation Technologies · 2005 · Recalled
- 4 generations backK133444 Stealthstation S7 / I7 / Fusion Navigation Systems, Axiem Navigation…Medtronic Navigation, Inc. · 2014 · Recalled
- 3 generations backK162375 Envision 3D: Image Guidance System7D Surgical, Inc. · 2016
- 2 generations backK180352 7D Surgical System7D Surgical, Inc. · 2018
- 1 generation backK192140 7D Surgical System7D Surgical, Inc. · 2019
- This deviceK222753 SeaSpine 7D Navigation InstrumentsSeaSpine Orthopedics Corporation · 2022
- Descendant · cites it directly · 0 of its ownK243659 FLASH™ Facet Fusion Instruments, IsoTis® Facet Fusion InstrumentsSeaSpine Orthopedics Corporation · 2025
Most influential descendants
Showing 1 of 1 · See all- K243659FLASH™ Facet Fusion Instruments, IsoTis® Facet Fusion InstrumentsSeaSpine Orthopedics Corporation · 2025 · cites it directly0descendants
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 | K133444 | Stealthstation S7 / I7 / Fusion Navigation Systems, Axiem Navigation System | Medtronic Navigation, Inc. | 2014 | 1 |
| −3 | K162375 | Envision 3D: Image Guidance System | 7D Surgical, Inc. | 2016 | — |
| −2 | K180352 | 7D Surgical System | 7D Surgical, Inc. | 2018 | — |
| −1 | K192140 | 7D Surgical System | 7D Surgical, Inc. | 2019 | — |
| 0 (this device) | K222753 | SeaSpine 7D Navigation Instruments | SeaSpine Orthopedics Corporation | 2022 | — |
| +1 | K243659 | FLASH™ Facet Fusion Instruments, IsoTis® Facet Fusion Instruments | SeaSpine Orthopedics Corporation | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 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? (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 |
|---|---|---|---|
| * | K192140 | 7D Surgical SystemSummary page 4…ently marketed devices: Product 510(k) 7D Surgical System- Universal Tracking Clamp K192140 (Primary) Envision 3D™: Image Guidance System (7D Surgical K162375 System was initially named “Envi… | 2019 |
| * | K162375 | Envision 3D: Image Guidance SystemSummary page 4…510(k) 7D Surgical System- Universal Tracking Clamp K192140 (Primary) Envision 3D™: Image Guidance System (7D Surgical K162375 System was initially named “Envision 3D “)… | 2016 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K243659 | FLASH™ Facet Fusion Instruments, IsoTis® Facet Fusion Instruments | 2025 | 0 |
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 17 years and passes through 4 companies; a new generation was cleared every 2.4 years on median.
- 2 of the 5 ancestors have a recall of any class.
- Of its descendants, K243659 (SeaSpine Orthopedics Corporation, 2025) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K192140.
How does its category compare?
All OLO devicesOLO Orthopedic Stereotaxic Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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 SeaSpine 7D Navigation Instruments are intended to be used during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. The SeaSpine 7D Navigation Instruments are specifically designed for use with the 7D Surgical System, which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure can be identified.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K222753 · printed Nov 5, 2026
Cite this page
510(k) Report. “K222753: SeaSpine 7D Navigation Instruments.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K222753
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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