510(k) · Cleared
Cleared7D Surgical System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
7D Surgical, Inc. · HAW Neurological Stereotaxic Instrument
Cleared on Aug 7, 2019 as substantially equivalent to K180352 (7D Surgical, Inc., 2018) after a 257-day review. Its family tree reaches back 4 generations to 2005.
- Decided
- Aug 7, 2019
- Review
- 257 days
- Class
- Class II
- Product code
- HAW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K050438 (2005). No later device cites it as a predicate yet.
- Root · 4 generations backK050438 Stealthstation System UpdateMedtronic Surgical Navigation Technologies · 2005 · Recalled
- 3 generations backK133444 Stealthstation S7 / I7 / Fusion Navigation Systems, Axiem Navigation…Medtronic Navigation, Inc. · 2014 · Recalled
- 2 generations backK162375 Envision 3D: Image Guidance System7D Surgical, Inc. · 2016
- 1 generation backK180352 7D Surgical System7D Surgical, Inc. · 2018
- This deviceK183276 7D Surgical System7D Surgical, Inc. · 2019
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 | K133444 | Stealthstation S7 / I7 / Fusion Navigation Systems, Axiem Navigation System | Medtronic Navigation, Inc. | 2014 | 1 |
| −2 | K162375 | Envision 3D: Image Guidance System | 7D Surgical, Inc. | 2016 | — |
| −1 | K180352 | 7D Surgical System | 7D Surgical, Inc. | 2018 | — |
| 0 (this device) | K183276 | 7D Surgical System | 7D Surgical, Inc. | 2019 | — |
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 HAW? 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 HAW device
- #1 K253856 Geniant Cranial (Navigated Neurosurgical…score 15.0 · 11 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 |
|---|---|---|---|
| * | K180352 | 7D Surgical SystemSummary page 4…bstantially equivalent to the following currently marketed devices: Product 510(k) 7D Surgical System K180352 The indications for use of the subject device 7D Surgical System are equivalent to the predicate device K180352. Furthermore, th… | 2018 |
| † | K133444 | Stealthstation S7 / I7 / Fusion Navigation Systems, Axiem Navigation System | 2014 |
| † | K153442 | CD HORIZON Spinal System, Medtronic Navigated Manual Reusable Instruments for Use with… | 2016 |
What descends from it?
No later submission names this one as a predicate yet.
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 14 years and passes through 3 companies; a new generation was cleared every 2.4 years on median.
- 2 of the 4 ancestors have a recall of any class.
- 4 other devices also cite its predicate K180352.
How does its category compare?
All HAW devicesHAW Neurological Stereotaxic Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · HAW
9in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HAW
163in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HAW
2in 2025
Class I (9 since 2007) Class II/III not classified
Adverse event reports per year · HAW
3,425in 2025
MAUDE reports naming product code HAW, 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 | 15 | 107 | 2 | 49 |
| 2008 | 12 | 112 | 10 | 53 |
| 2009 | 8 | 221 | 6 | 96 |
| 2010 | 6 | 138 | 28 | 299 |
| 2011 | 4 | 66 | 5 | 1,725 |
| 2012 | 8 | 178 | 4 | 986 |
| 2013 | 3 | 172 | 6 (1) | 1,290 |
| 2014 | 5 | 238 | 5 | 1,606 |
| 2015 | 10 | 232 | 3 | 1,767 |
| 2016 | 9 | 175 | 5 | 1,828 |
| 2017 | 7 | 226 | 2 | 3,505 |
| 2018 | 6 | 112 | 2 (2) | 4,439 |
| 2019 | 10 | 147 | 4 (1) | 6,062 |
| 2020 | 5 | 88 | 1 | 3,480 |
| 2021 | 9 | 168 | 4 (2) | 2,827 |
| 2022 | 7 | 128 | 1 | 1,929 |
| 2023 | 14 | 142 | 4 (1) | 2,510 |
| 2024 | 7 | 107 | 2 (2) | 3,755 |
| 2025 | 9 | 163 | 2 | 3,425 |
| 2026 | 5 | 162 | 6 | — |
What is it indicated for?
The 7D Surgical 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 as stated in the FDA summary.
https://510kreport.com/device/K183276 · printed Nov 6, 2026
Cite this page
510(k) Report. “K183276: 7D Surgical System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K183276
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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