510(k) Report

510(k) · Cleared

Cleared

7D Surgical System

K180352510(k) SpecialCleared May 2, 201883-day reviewClass II21 CFR 882.4560

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

7D Surgical, Inc. · OLO Orthopedic Stereotaxic Instrument

Cleared on May 2, 2018 as substantially equivalent to K133444 (Medtronic Navigation, Inc., 2014) and 1 other predicate after an 83-day review. Its family tree reaches back 3 generations to 2005. 8 later devices descend from it.

Decided
May 2, 2018
Review
83 days
Class
Class II
Product code
OLO
Recalls
None
Predicates
2

Its longest line of descent runs back 3 generations to K050438 (2005). 8 later devices descend from it, 5 citing it directly.

Descendants, by year cleared 2019: 3 descendants cleared2021: 1 descendant cleared2020: 1 descendant cleared2024: 1 descendant cleared2022: 1 descendant cleared2025: 1 descendant clearedReference device: K033621 · Ndi Passive Spheres · Northern Digital, Inc. · 2004 · recalledK050438 · Stealthstation System Update · Medtronic Surgical Navigation Technologies · 2005 · recalledK133444 · Stealthstation S7 / I7 / Fusion Navigation Systems, Axiem Navigation System · Medtronic Navigation, Inc. · 2014 · recalledK162375 · Envision 3D: Image Guidance System · 7D Surgical, Inc. · 201620052010201520202025
Descendants, by generation 1 generation forward: 5 descendants2 generations forward: 2 descendants3 generations forward: 1 descendant K162375 · Envision 3D: Image Guidance System · 7D Surgical, Inc. · 2016K133444 · Stealthstation S7 / I7 / Fusion Navigation Systems, Axiem Navigation System · Medtronic Navigation, Inc. · 2014 · recalledK050438 · Stealthstation System Update · Medtronic Surgical Navigation Technologies · 2005 · recalled0
  1. Root · 3 generations backK050438 Stealthstation System UpdateMedtronic Surgical Navigation Technologies · 2005 · Recalled
  2. 2 generations backK133444 Stealthstation S7 / I7 / Fusion Navigation Systems, Axiem Navigation…Medtronic Navigation, Inc. · 2014 · Recalled
  3. 1 generation backK162375 Envision 3D: Image Guidance System7D Surgical, Inc. · 2016
  4. This deviceK180352 7D Surgical System7D Surgical, Inc. · 2018
  5. Descendant · cites it directly · 3 of its ownK192140 7D Surgical System7D Surgical, Inc. · 2019
  6. Descendant · 2 generations on · 1 of its ownK222753 SeaSpine 7D Navigation InstrumentsSeaSpine Orthopedics Corporation · 2022
  7. Descendant · cites it directly · 1 of its ownK191012 Navigated Pedicle Access KitIzi Medical Products, LLC · 2019
  8. Descendant · 3 generations on · 0 of its ownK243659 FLASH™ Facet Fusion Instruments, IsoTis® Facet Fusion InstrumentsSeaSpine Orthopedics Corporation · 2025
  9. Descendant · 2 generations on · 0 of its ownK232800 Navigation Tracking InstrumentsSI-BONE, Inc. · 2024

Showing 5 of 8 descendants. See all descendants

Descendants cleared per year

2019: 32020: 12021: 12022: 12024: 12025: 1
2019high 3 (2019) · low 0 (2023)2026

Most influential descendants

Showing 5 of 8 · See all
  • K1921407D Surgical System7D Surgical, Inc. · 2019 · cites it directly3descendants
  • K222753SeaSpine 7D Navigation InstrumentsSeaSpine Orthopedics Corporation · 2022 · 2 generations on1descendant
  • K191012Navigated Pedicle Access KitIzi Medical Products, LLC · 2019 · cites it directly1descendant
  • K243659FLASH™ Facet Fusion Instruments, IsoTis® Facet Fusion InstrumentsSeaSpine Orthopedics Corporation · 2025 · 3 generations on0descendants
  • K232800Navigation Tracking InstrumentsSI-BONE, Inc. · 2024 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K050438Stealthstation System UpdateMedtronic Surgical Navigation Technologies200511
−2K133444Stealthstation S7 / I7 / Fusion Navigation Systems, Axiem Navigation SystemMedtronic Navigation, Inc.20141
−1K162375Envision 3D: Image Guidance System7D Surgical, Inc.2016—
0 (this device)K1803527D Surgical System7D Surgical, Inc.2018—
+1K1921407D Surgical System7D Surgical, Inc.2019—
+2K222753SeaSpine 7D Navigation InstrumentsSeaSpine Orthopedics Corporation2022—
+1K191012Navigated Pedicle Access KitIzi Medical Products, LLC2019—
+3K243659FLASH™ Facet Fusion Instruments, IsoTis® Facet Fusion InstrumentsSeaSpine Orthopedics Corporation2025—
+2K232800Navigation Tracking InstrumentsSI-BONE, Inc.2024—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201930
202010
202110
202210
202410
202510
FIG. 1 — Lineage of K180352, 2005–2025Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K240662 Spine Guidance Software (version 5.0); Xia 3/…score 23.7 · 15 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K133444Stealthstation S7 / I7 / Fusion Navigation Systems, Axiem Navigation System
Summary page 4
…lent to the following currently marketed devices: Product 510(k) Medtronic StealthStation System K133444 Envision 3D: Image Guidance System K162375 The indications for use of the subject device 7D Surgical Syst…
Medtronic Navigation, Inc.20141
*K162375Envision 3D: Image Guidance System
Summary page 4
…oduct 510(k) Medtronic StealthStation System K133444 Envision 3D: Image Guidance System K162375 The indications for use of the subject device 7D Surgical System are equivalent to the predicate device K133444 and K162…
7D Surgical, Inc.2016—
†K033621Ndi Passive SpheresNorthern Digital, Inc.200428

Also cleared against K133444: 8 other devices →

What descends from it? (8)

5 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K1921407D Surgical System7D Surgical, Inc.20193
K191012Navigated Pedicle Access KitIzi Medical Products, LLC20191
K2105557D Surgical System - Drill Guide7D Surgical, Inc.20210
K2019667D Surgical FlashLock 1, 7D Surgical Flex Rod Connector - 5.5 mm - 150 mm, 7D Surgical…7D Surgical, Inc.20200
K1832767D Surgical System7D Surgical, Inc.20190

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 13 years and passes through 3 companies; a new generation was cleared every 2.4 years on median.
  • 2 of the 3 ancestors have a recall of any class.
  • Of its descendants, K192140 (7D Surgical, Inc., 2019) has gone furthest, with 3 descendants of its own.
  • 8 other devices also cite its predicate K133444.

How does its category compare?

All OLO devices

OLO Orthopedic Stereotaxic Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.

FDA decisions per year · OLO

40in 2025

2009: 112010: 92011: 112012: 72013: 72014: 102015: 102016: 142017: 332018: 242019: 352020: 342021: 282022: 402023: 452024: 442025: 402026 (partial year): 42
2007high 45 (2023) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · OLO

119in 2025

2009: 126 days median2010: 113 days median2011: 138 days median2012: 129 days median2013: 137 days median2014: 119 days median2015: 176 days median2016: 120 days median2017: 91 days median2018: 97 days median2019: 95 days median2020: 89 days median2021: 91 days median2022: 89 days median2023: 90 days median2024: 90 days median2025: 119 days median2026 (partial year): 109 days median
2007high 176 (2015) · low 89 (2020)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · OLO

1in 2025

2010: 12011: 12012: 12014: 32015: 22016: 32017: 22018: 12019: 12020: 62022: 52023: 7, 1 Class I2024: 42025: 12026 (partial year): 6
2007high 7 (2023) · low 0 (2007)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · OLO

3,306in 2025

2008: 12009: 42010: 42011: 102012: 602013: 362014: 2452015: 4662016: 7502017: 1,0762018: 1,2302019: 1,5852020: 2,7462021: 1,6962022: 1,5682023: 1,4932024: 2,3532025: 3,306
2007high 3,306 (2025) · low 0 (2007)2025

MAUDE reports naming product code OLO, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—01
20091112604
2010911314
201111138110
20127129160
20137137036
2014101193245
2015101762466
2016141203750
2017339121,076
2018249711,230
2019359511,585
2020348962,746
2021289101,696
2022408951,568
202345907 (1)1,493
2024449042,353
20254011913,306
2026421096—

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.

Also cleared against K133444

8 other devices cite the same predicate.

  • K213720Vital Navigation SystemZimvie (Zimmer Biomet Spine, Inc.) · 2022
  • K190556Zimmer Biomet Universal Navigation SystemZimmer Biomet Spine, Inc. · 2019
  • K180523INTAI Surgery Navigation SystemIntai Technology Corporation · 2019
  • K1810417D Surgical System Cranial Application7D Surgical, Inc. · 2018
  • K171651Excelsius GPSGlobus Medical, Inc. · 20171 recall
  • K162309StealthStation S8 System Platforms and StealthStation Cranial SoftwareMedtronic Navigation, Inc. · 20172 Class I recalls

More from 7D Surgical, Inc.

9 FDA decisions under this applicant name. See the company

  • K2104577D Registration Frame, 7D Flex Iliac Pin Connector, 7D Pin Guide Block, 7D 3.2 mm Steinmann Pin, 7D Iliac…7D Surgical, Inc. · 2021
  • K2105557D Surgical System - Drill Guide7D Surgical, Inc. · 2021
  • K2019667D Surgical FlashLock 1, 7D Surgical Flex Rod Connector - 5.5 mm - 150 mm, 7D Surgical Flex Array7D Surgical, Inc. · 2020
  • K1929457D Surgical System Cranial Biopsy and Ventricular Catheter Placement Application7D Surgical, Inc. · 2019
  • K1921407D Surgical System7D Surgical, Inc. · 2019

Recent decisions in OLO

The OLO category page

  • K2604037D Surgical System (10-0001)7D Surgical ULC · 2026
  • K263234TMINI Miniature Robotic SystemTHINK Surgical, Inc. · 2026
  • K263154CarboClear® Cervical Navigated InstrumentsCarboFix Orhtopedics, Ltd. · 2026
  • K262257Spine Planning (3.0); Spine & Trauma Navigation; Alignment System SpineBrainlab SE · 2026
  • K262506Remex Spine Surgery Navigation - Universal InstrumentsRemex Medical Corp. · 2026

https://510kreport.com/device/K180352 · printed Nov 3, 2026

Cite this page

510(k) Report. “K180352: 7D Surgical System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K180352

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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