510(k) Report

510(k) · Cleared

Cleared

SPINEART Navigation Instrument System

K183630510(k) TraditionalCleared Jun 10, 2019166-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

Spineart SA · OLO Orthopedic Stereotaxic Instrument

Cleared on Jun 10, 2019 as substantially equivalent to K143628 (Medtronic Sofamor Danek USA, Inc., 2015) and 4 other predicates after a 166-day review. Its family tree reaches back 17 generations to 2004. 6 later devices descend from it.

Decided
Jun 10, 2019
Review
166 days
Class
Class II
Product code
OLO
Recalls
None
Predicates
5

Its longest line of descent runs back 17 generations to K040583 (2004). 155 ancestors in all, the oldest K841189 (1984). 6 later devices descend from it, 4 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2018: 1 other ancestor2015: 1 other ancestor2014: 2 other ancestors2016: 1 other ancestor2013: 3 other ancestors2012: 1 other ancestor2011: 2 other ancestors2010: 2 other ancestors2009: 1 other ancestor2008: 5 other ancestors2006: 8 other ancestors2005: 14 other ancestors2004: 19 other ancestors2003: 8 other ancestors2007: 3 other ancestors2002: 8 other ancestors2001: 9 other ancestors2000: 11 other ancestors1999: 3 other ancestors1997: 5 other ancestors1996: 2 other ancestors1994: 4 other ancestors1998: 6 other ancestors1995: 7 other ancestors1988: 2 other ancestors1987: 1 other ancestor1984: 2 other ancestors1992: 2 other ancestors1989: 1 other ancestor1986: 2 other ancestors1985: 1 other ancestor1990: 1 other ancestor2026: 2 descendants cleared2021: 1 descendant cleared2025: 2 descendants cleared2024: 1 descendant clearedReference device: K140948 · Romeo Posterior Osteosynthesis System · Spineart · 2014Reference device: K153386 · Perla Posterior Cervico-Thoracic Fixation system · Spineart · 2016×7: 7 generations cleared close together, K040583 (2004), K041118 (2004), K042025 (2004), K043151 (2005), K050809 (2005), K052187 (2005), K053101 (2006) ×2: 2 generations cleared close together, K091442 (2009), K091974 (2009) K102555 · CD Horizon Spinal System · Medtronic Sofamor Danek USA, Inc. · 2010×2: 2 generations cleared close together, K112473 (2011), K113174 (2011) ×2: 2 generations cleared close together, K121680 (2012), K122862 (2012) K141605 · CD Horizon Spinal System · Medtronic Sofamor Danek USA, Inc. · 2014K143375 · CD HORIZON Spinal System, Medtronic Navigated Reusable Instruments · Medtronic Sofamor Danek USA, Inc. · 2015K153203 · Navigation Instruments · Globus Medical, Inc. · 201619801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 3 other ancestors2 generations back: 7 other ancestors3 generations back: 21 other ancestors4 generations back: 38 other ancestors5 generations back: 34 other ancestors6 generations back: 13 other ancestors7 generations back: 8 other ancestors8 generations back: 14 other ancestors 1 generation forward: 4 descendants2 generations forward: 2 descendants K153203 · Navigation Instruments · Globus Medical, Inc. · 2016K143375 · CD HORIZON Spinal System, Medtronic Navigated Reusable Instruments · Medtronic Sofamor Danek USA, Inc. · 2015K141605 · CD Horizon Spinal System · Medtronic Sofamor Danek USA, Inc. · 2014K122862 · CD Horizon Spinal System · Medtronic Sofamor Danek USA, Inc. · 2012K121680 · CD Horizon Spinal System · Medtronic Sofamor Danek USA, Inc. · 2012K113174 · CD Horizon Spinal System · Medtronic Sofamor Danek USA, Inc. · 2011 · recalledK112473 · CD Horizon Spinal System · Medtronic Sofamor Danek, Inc. · 2011K102555 · CD Horizon Spinal System · Medtronic Sofamor Danek USA, Inc. · 2010K091974 · Modification to CD Horizon Spinal System · Medtronic Sofamor Danek USA, Inc. · 2009 · recalledK091442 · CD Horizon Spinal System · Medtronic Sofamor Danek · 2009K053101 · CD Horizon Spinal System · Medtronic Sofamor Danek · 2006K052187 · Modification to: CD Horizon Spinal System · Medtronic Sofamor Danek · 2005K050809 · CD Horizon Spinal System · Medtronic Sofamor Danek USA, Inc. · 2005K043151 · Modification to: CD Horizon Spinal System · Medtronic Sofamor Danek · 2005K042025 · Modification to CD Horizon Spinal System · Medtronic Sofamor Danek, Inc. · 2004 · recalledK041118 · Modification to CD Horizon Spinal System · Medtronic Sofamor Danek · 2004K040583 · Modification to: CD Horizon Spinal System · Medtronic Sofamor Danek · 2004−15−10−50
  1. Root · 17 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
  2. 13 generations between
  3. 3 generations backK141605 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2014
  4. 2 generations backK143375 CD HORIZON Spinal System, Medtronic Navigated Reusable InstrumentsMedtronic Sofamor Danek USA, Inc. · 2015
  5. 1 generation backK153203 Navigation InstrumentsGlobus Medical, Inc. · 2016
  6. This deviceK183630 SPINEART Navigation Instrument SystemSpineart SA · 2019
  7. Descendant · cites it directly · 5 of its ownK210472 SPINEART Navigation Instrument SystemSpineart · 2021
  8. Descendant · 2 generations on · 3 of its ownK242890 SPINEART Navigation Instrument SystemSpineart SA · 2025
  9. Descendant · cites it directly · 3 of its ownK241644 SPINEART Navigation Instrument SystemSpineart SA · 2024
  10. Descendant · cites it directly · 2 of its ownK242933 SPINEART Navigation Instrument SystemSpineart SA · 2025
  11. Descendant · cites it directly · 1 of its ownK254158 SPINEART Navigation Instrument SystemSpineart SA · 2026
Show all 17 generations
  1. Root · 17 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
  2. 16 generations backK041118 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
  3. 15 generations backK042025 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2004 · Recalled
  4. 14 generations backK043151 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
  5. 13 generations backK050809 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2005
  6. 12 generations backK052187 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
  7. 11 generations backK053101 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2006
  8. 10 generations backK091442 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2009
  9. 9 generations backK091974 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2009 · Recalled
  10. 8 generations backK102555 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2010
  11. 7 generations backK112473 CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2011
  12. 6 generations backK113174 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2011 · Recalled
  13. 5 generations backK121680 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2012
  14. 4 generations backK122862 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2012
  15. 3 generations backK141605 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2014
  16. 2 generations backK143375 CD HORIZON Spinal System, Medtronic Navigated Reusable InstrumentsMedtronic Sofamor Danek USA, Inc. · 2015
  17. 1 generation backK153203 Navigation InstrumentsGlobus Medical, Inc. · 2016
  18. This deviceK183630 SPINEART Navigation Instrument SystemSpineart SA · 2019

Showing 5 of 6 descendants. See all descendants

Descendants cleared per year

2021: 12024: 12025: 22026: 2
2021high 2 (2025) · low 0 (2022)2026

Most influential descendants

Showing 5 of 6 · See all
  • K210472SPINEART Navigation Instrument SystemSpineart · 2021 · cites it directly5descendants
  • K242890SPINEART Navigation Instrument SystemSpineart SA · 2025 · 2 generations on3descendants
  • K241644SPINEART Navigation Instrument SystemSpineart SA · 2024 · cites it directly3descendants
  • K242933SPINEART Navigation Instrument SystemSpineart SA · 2025 · cites it directly2descendants
  • K254158SPINEART Navigation Instrument SystemSpineart SA · 2026 · cites it directly1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−17K040583Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek2004—
−16K041118Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek2004—
−15K042025Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.20044
−14K043151Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek2005—
−13K050809CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2005—
−12K052187Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek2005—
−11K053101CD Horizon Spinal SystemMedtronic Sofamor Danek2006—
−10K091442CD Horizon Spinal SystemMedtronic Sofamor Danek2009—
−9K091974Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.20091
−8K102555CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2010—
−7K112473CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.2011—
−6K113174CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.20111
−5K121680CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2012—
−4K122862CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2012—
−3K141605CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2014—
−2K143375CD HORIZON Spinal System, Medtronic Navigated Reusable InstrumentsMedtronic Sofamor Danek USA, Inc.2015—
−1K153203Navigation InstrumentsGlobus Medical, Inc.2016—
0 (this device)K183630SPINEART Navigation Instrument SystemSpineart SA2019—
+1K210472SPINEART Navigation Instrument SystemSpineart2021—
+2K242890SPINEART Navigation Instrument SystemSpineart SA2025—
+1K241644SPINEART Navigation Instrument SystemSpineart SA2024—
+1K242933SPINEART Navigation Instrument SystemSpineart SA2025—
+1K254158SPINEART Navigation Instrument SystemSpineart SA2026—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198420
198510
198620
198710
198820
198910
199010
199220
199440
199570
199620
199750
199860
199930
2000110
200190
200280
200380
2004190
2005140
200680
200730
200850
200910
201020
201120
201210
201330
201420
201510
201610
201810

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202110
202410
202520
202620
FIG. 1 — Lineage of K183630, 2004–2026Source: 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? (5)

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
*K143628Navigated Vertex Select Instruments
Summary page 5
…mber Trade or Proprietary or Manufacturer Predicate Model Name Type K143628/K140454/ Medtronic Navigated Medtronic Sofamor Primary K143375 Instruments…
Medtronic Sofamor Danek USA, Inc.2015—
*K140454Navigated CD Horizon Solera Screwdriver/Taps
Summary page 5
…Trade or Proprietary or Manufacturer Predicate Model Name Type K143628/K140454/ Medtronic Navigated Medtronic Sofamor Primary K143375 Instruments…
Medtronic Sofamor Danek USA, Inc.20141
*K143375CD HORIZON Spinal System, Medtronic Navigated Reusable Instruments
Summary page 5
…Model Name Type K143628/K140454/ Medtronic Navigated Medtronic Sofamor Primary K143375 Instruments Danek USA, Inc. K172517 SeaSpine Navigation SeaSpi…
Medtronic Sofamor Danek USA, Inc.2015—
*K172517SeaSpine Navigation System
Summary page 5
…Type K143628/K140454/ Medtronic Navigated Medtronic Sofamor Primary K143375 Instruments Danek USA, Inc. K172517 SeaSpine Navigation SeaSpine Orthopedics Additional System…
SeaSpine Orthopedics Corporation20181
*K153203Navigation Instruments
Summary page 5
…, Inc. K172517 SeaSpine Navigation SeaSpine Orthopedics Additional System Corporation K153203 Navigation Instruments Globus Medical, Inc. Additional K140948 ROMEO® Posterior…
Globus Medical, Inc.2016—
†K140948Romeo Posterior Osteosynthesis SystemSpineart2014—
†K153386Perla Posterior Cervico-Thoracic Fixation systemSpineart2016—

Also cleared against K143628: 19 other devices →

What descends from it? (6)

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

NumberDeviceApplicantDecidedDescendants
K210472SPINEART Navigation Instrument SystemSpineart20215
K241644SPINEART Navigation Instrument SystemSpineart SA20243
K242933SPINEART Navigation Instrument SystemSpineart SA20252
K254158SPINEART Navigation Instrument SystemSpineart SA20261

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 15 years and passes through 5 companies; a new generation was cleared every 5 months on median.
  • 22 of the 155 ancestors have a recall of any class.
  • Of its descendants, K210472 (Spineart, 2021) has gone furthest, with 5 descendants of its own.
  • 19 other devices also cite its predicate K143628.

How does its category compare?

All OLO devices

OLO Orthopedic 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 · 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 SPINEART® Navigation Instrument System reusable instruments are intended to be used during the preparation and placement of Spineart screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. The SPINEART® Navigation Instrument System reusable instruments are specifically designed for use with the Medtronic StealthStation System, which is indicated for any medical…

Read the full statement (109 words)

The SPINEART® Navigation Instrument System reusable instruments are intended to be used during the preparation and placement of Spineart screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. The SPINEART® Navigation Instrument System reusable instruments are specifically designed for use with the Medtronic StealthStation 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, such as a skull, a long bone, or vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks for the anatomy.

Indications for use as stated in the FDA summary.

Also cleared against K143628

19 other devices cite the same predicate.

  • K253444EUROPA™ Posterior Cervical Fusion Navigated InstrumentsMiRus, LLC · 2026
  • K252087Navigation Module of the Cortium® SystemUlrich Medical USA, Inc. · 2026
  • K230369EUROPA™ Navigated InstrumentsMiRus, LLC · 2023
  • K223200Curiteva Navigation SystemCuriteva, Inc. · 2023
  • K220024ChoiceSpine Navigation SystemChoice Spine, LLC · 2022
  • K212007VERTICALE Navigation InstrumentsSilony Medical GmbH · 2021

More from Spineart SA

14 FDA decisions under this applicant name. See the company

  • K261049Scala® TLSpineart SA · 2026
  • K262639BAGUERA® C Cervical Disc Surgical InstrumentsSpineart SA · 2026
  • K261205SPINEART Navigation Instrument SystemSpineart SA · 2026
  • K253966PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA · 2026
  • K254158SPINEART Navigation Instrument SystemSpineart SA · 2026

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/K183630 · printed Nov 6, 2026

Cite this page

510(k) Report. “K183630: SPINEART Navigation Instrument System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K183630

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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