510(k) Report

510(k) · Cleared

Cleared

SPINEART Navigation Instrument System

K254158510(k) SpecialCleared Apr 9, 2026108-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 Apr 9, 2026 as substantially equivalent to K212245 (Brainlab AG, 2022) and 5 other predicates after a 108-day review. Its family tree reaches back 21 generations to 2004. 3 of the 217 devices in its family, counting itself, have a Class I recall. 1 later device descends from it.

Decided
Apr 9, 2026
Review
108 days
Class
Class II
Product code
OLO
Recalls
None
Predicates
6

Its longest line of descent runs back 21 generations to K040583 (2004). 215 ancestors in all, the oldest K811452 (1981). 1 later device descends from it, 1 citing it directly. 3 of the 217 devices in this family, counting this one, have a Class I recall.

Other ancestors, by year clearedDescendants, by year cleared 2022: 4 other ancestors2020: 1 other ancestor2025: 1 other ancestor2019: 2 other ancestors2018: 1 other ancestor2017: 1 other ancestor2015: 2 other ancestors, 1 with a Class I recall12014: 4 other ancestors2023: 1 other ancestor2016: 3 other ancestors, 1 with a Class I recall12013: 4 other ancestors2012: 1 other ancestor2011: 2 other ancestors2009: 3 other ancestors2005: 17 other ancestors2021: 1 other ancestor2010: 3 other ancestors2008: 5 other ancestors2007: 4 other ancestors, 1 with a Class I recall12006: 11 other ancestors2004: 24 other ancestors2003: 11 other ancestors1999: 6 other ancestors2002: 11 other ancestors2001: 13 other ancestors2000: 17 other ancestors1997: 7 other ancestors1996: 2 other ancestors1994: 4 other ancestors1998: 7 other ancestors1995: 7 other ancestors1988: 2 other ancestors1987: 2 other ancestors1984: 2 other ancestors1992: 2 other ancestors1989: 1 other ancestor1986: 2 other ancestors1985: 1 other ancestor1990: 1 other ancestor1981: 1 other ancestor2026: 1 descendant cleared×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. · 2016K183630 · SPINEART Navigation Instrument System · Spineart SA · 2019K210472 · SPINEART Navigation Instrument System · Spineart · 2021K241644 · SPINEART Navigation Instrument System · Spineart SA · 2024K242933 · SPINEART Navigation Instrument System · Spineart SA · 202519801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors2 generations back: 6 other ancestors3 generations back: 11 other ancestors, 1 with a Class I recall14 generations back: 27 other ancestors, 2 with a Class I recall25 generations back: 43 other ancestors6 generations back: 45 other ancestors7 generations back: 18 other ancestors8 generations back: 16 other ancestors9 generations back: 16 other ancestors10 generations back: 6 other ancestors11 generations back: 2 other ancestors12 generations back: 2 other ancestors 1 generation forward: 1 descendant K242933 · SPINEART Navigation Instrument System · Spineart SA · 2025K241644 · SPINEART Navigation Instrument System · Spineart SA · 2024K210472 · SPINEART Navigation Instrument System · Spineart · 2021K183630 · SPINEART Navigation Instrument System · Spineart SA · 2019K153203 · 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 · 2004−20−15−10−50
  1. Root · 21 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
  2. 17 generations between
  3. 3 generations backK210472 SPINEART Navigation Instrument SystemSpineart · 2021
  4. 2 generations backK241644 SPINEART Navigation Instrument SystemSpineart SA · 2024
  5. 1 generation backK242933 SPINEART Navigation Instrument SystemSpineart SA · 2025
  6. This deviceK254158 SPINEART Navigation Instrument SystemSpineart SA · 2026
  7. Descendant · cites it directly · 0 of its ownK261205 SPINEART Navigation Instrument SystemSpineart SA · 2026
Show all 21 generations
  1. Root · 21 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
  2. 20 generations backK041118 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
  3. 19 generations backK042025 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2004 · Recalled
  4. 18 generations backK043151 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
  5. 17 generations backK050809 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2005
  6. 16 generations backK052187 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
  7. 15 generations backK053101 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2006
  8. 14 generations backK091442 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2009
  9. 13 generations backK091974 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2009 · Recalled
  10. 12 generations backK102555 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2010
  11. 11 generations backK112473 CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2011
  12. 10 generations backK113174 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2011 · Recalled
  13. 9 generations backK121680 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2012
  14. 8 generations backK122862 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2012
  15. 7 generations backK141605 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2014
  16. 6 generations backK143375 CD HORIZON Spinal System, Medtronic Navigated Reusable InstrumentsMedtronic Sofamor Danek USA, Inc. · 2015
  17. 5 generations backK153203 Navigation InstrumentsGlobus Medical, Inc. · 2016
  18. 4 generations backK183630 SPINEART Navigation Instrument SystemSpineart SA · 2019
  19. 3 generations backK210472 SPINEART Navigation Instrument SystemSpineart · 2021
  20. 2 generations backK241644 SPINEART Navigation Instrument SystemSpineart SA · 2024
  21. 1 generation backK242933 SPINEART Navigation Instrument SystemSpineart SA · 2025
  22. This deviceK254158 SPINEART Navigation Instrument SystemSpineart SA · 2026

Class I recalls in this family

  • K153660 StealthStation System with Cranial Software3 generations back · 2016
  • K150216 Synergy Cranial4 generations back · 2015
  • K070106 VV Fluoro 3D4 generations back · 2007

Most influential descendants

Showing 1 of 1 · See all
  • K261205SPINEART Navigation Instrument SystemSpineart SA · 2026 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−21K040583Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek2004—
−20K041118Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek2004—
−19K042025Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.20044
−18K043151Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek2005—
−17K050809CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2005—
−16K052187Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek2005—
−15K053101CD Horizon Spinal SystemMedtronic Sofamor Danek2006—
−14K091442CD Horizon Spinal SystemMedtronic Sofamor Danek2009—
−13K091974Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.20091
−12K102555CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2010—
−11K112473CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.2011—
−10K113174CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.20111
−9K121680CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2012—
−8K122862CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2012—
−7K141605CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2014—
−6K143375CD HORIZON Spinal System, Medtronic Navigated Reusable InstrumentsMedtronic Sofamor Danek USA, Inc.2015—
−5K153203Navigation InstrumentsGlobus Medical, Inc.2016—
−4K183630SPINEART Navigation Instrument SystemSpineart SA2019—
−3K210472SPINEART Navigation Instrument SystemSpineart2021—
−2K241644SPINEART Navigation Instrument SystemSpineart SA2024—
−1K242933SPINEART Navigation Instrument SystemSpineart SA2025—
0 (this device)K254158SPINEART Navigation Instrument SystemSpineart SA2026—
+1K261205SPINEART Navigation Instrument SystemSpineart SA2026—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198110
198420
198510
198620
198720
198820
198910
199010
199220
199440
199570
199620
199770
199870
199960
2000170
2001130
2002110
2003110
2004240
2005170
2006110
200741
200850
200930
201030
201120
201210
201340
201440
201521
201631
201710
201810
201920
202010
202110
202240
202310
202510

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202610
FIG. 1 — Lineage of K254158, 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.

3 devices in this family have a Class I recall. 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? (6)

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
*K212245Spine and Trauma Navigation System, Spine & Trauma 3D Navigation, Instrument Selection…
Summary page 5
…882.4560 Product Code(s) OLO | Legally Marketed Predicate Devices 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K212245 Spine and Trauma Navigation System OLO K201189 Stealthstation S8 Spine Software v1.3.0 OLO K183630 SPINEART Navigation Instrument…
Brainlab AG2022—
*K201189Stealthstation S8 Spine Software v1.3.0
Summary page 5
…ed Predicate Devices 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K212245 Spine and Trauma Navigation System OLO K201189 Stealthstation S8 Spine Software v1.3.0 OLO K183630 SPINEART Navigation Instrument System OLO K210472 SPINEART Navigation Instrum…
Medtronic Navigation, Inc.20201
*K183630SPINEART Navigation Instrument System
Summary page 5
…Predicate Trade Name (Primary Predicate is listed first) Product Code K212245 Spine and Trauma Navigation System OLO K201189 Stealthstation S8 Spine Software v1.3.0 OLO K183630 SPINEART Navigation Instrument System OLO K210472 SPINEART Navigation Instrument System OLO K241644 SPINEART Navigation Instrumen…
Spineart SA2019—
*K210472SPINEART Navigation Instrument System
Summary page 5
…first) Product Code K212245 Spine and Trauma Navigation System OLO K201189 Stealthstation S8 Spine Software v1.3.0 OLO K183630 SPINEART Navigation Instrument System OLO K210472 SPINEART Navigation Instrument System OLO K241644 SPINEART Navigation Instrument System OLO K242933 SPINEART Navigation Instrumen…
Spineart2021—
*K241644SPINEART Navigation Instrument System
Summary page 5
…gation System OLO K201189 Stealthstation S8 Spine Software v1.3.0 OLO K183630 SPINEART Navigation Instrument System OLO K210472 SPINEART Navigation Instrument System OLO K241644 SPINEART Navigation Instrument System OLO K242933 SPINEART Navigation Instrument System OLO Device Description Summary 21 CFR 807…
Spineart SA2024—
*K242933SPINEART Navigation Instrument System
Summary page 5
…Software v1.3.0 OLO K183630 SPINEART Navigation Instrument System OLO K210472 SPINEART Navigation Instrument System OLO K241644 SPINEART Navigation Instrument System OLO K242933 SPINEART Navigation Instrument System OLO Device Description Summary 21 CFR 807.92(a)(4) The SPINEART® Navigation Instrument Sys…
Spineart SA2025—

Also cleared against K212245: 4 other devices →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K261205SPINEART Navigation Instrument SystemSpineart SA20260

Has anything in its family been recalled? (3 Class I)

No FDA recall names this device.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

  • K153660StealthStation System with Cranial SoftwareMedtronic Navigation, Inc. · 2016 · 3 generations back · ◆ in the 2016 ancestors bar of FIG. 13 Class I recalls
  • K150216Synergy CranialMedtronic Navigation, Inc. · 2015 · 4 generations back · ◆ in the 2015 ancestors bar of FIG. 13 Class I recalls
  • K070106VV Fluoro 3DBrainlab AG · 2007 · 4 generations back · ◆ in the 2007 ancestors bar of FIG. 11 Class I recall

What does this lineage say?

  • The line of descent spans 22 years and passes through 6 companies; a new generation was cleared every 7 months on median.
  • 42 of the 215 ancestors have a recall of any class; 3 have a Class I recall.
  • Of its descendants, K261205 (Spineart SA, 2026) has gone furthest, with 0 descendants of its own.
  • 4 other devices also cite its predicate K212245.

How does its category compare?

All OLO devices

OLO Orthopedic Stereotaxic Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, 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 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 reusable instruments are specifically designed for use with the Medtronic® StealthStation® System and the Brainlab® Spine & Trauma Navigation System, which are…

Read the full statement (112 words)

The SPINEART Navigation 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 reusable instruments are specifically designed for use with the Medtronic® StealthStation® System and the Brainlab® Spine & Trauma Navigation System, which are 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 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K212245

4 other devices cite the same predicate.

  • K242933SPINEART Navigation Instrument SystemSpineart SA · 2025
  • K223553Spine Planning (2.0), Elements Spine Planning, Elements Planning SpineBrainlab AG · 2023
  • K221618Spine & Trauma Navigation, Spine Navigation, Navigation Software Spine & Trauma, Alignment System Spine…Brainlab AG · 2022
  • K212756Discectomy Navigation Ready Instruments and Universal Navigation Adaptor SetMedos International SARL · 2022

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
  • K242933SPINEART Navigation Instrument SystemSpineart SA · 2025

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/K254158 · printed Nov 6, 2026

Cite this page

510(k) Report. “K254158: 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/K254158

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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