510(k) Report

510(k) · Cleared

Cleared

Op.n (TM) Navigation

K242914510(k) TraditionalCleared Mar 7, 2025164-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

Ecential Robotics · OLO Orthopedic Stereotaxic Instrument

Cleared on Mar 7, 2025 after a 164-day review. The FDA summary names no predicate by number. 2 later devices descend from it.

Decided
Mar 7, 2025
Review
164 days
Class
Class II
Product code
OLO
Recalls
None
Predicates
0

2 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2026: 2 descendants cleared2026
  1. This deviceK242914 Op.n (TM) NavigationEcential Robotics · 2025
  2. Descendant · cites it directly · 1 of its ownK261113 Op.n™ Spine Navigation and Robotic GuidanceEcential Robotics · 2026
  3. Descendant · 2 generations on · 0 of its ownK261205 SPINEART Navigation Instrument SystemSpineart SA · 2026

Most influential descendants

Showing 2 of 2 · See all
  • K261113Op.n™ Spine Navigation and Robotic GuidanceEcential Robotics · 2026 · cites it directly1descendant
  • K261205SPINEART Navigation Instrument SystemSpineart SA · 2026 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K242914Op.n (TM) NavigationEcential Robotics2025—
+1K261113Op.n™ Spine Navigation and Robotic GuidanceEcential Robotics2026—
+2K261205SPINEART Navigation Instrument SystemSpineart SA2026—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202620
FIG. 1 — Lineage of K242914, 2025–2026Source: 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?

The FDA summary names no predicate by number.

What descends from it? (2)

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

NumberDeviceApplicantDecidedDescendants
K261113Op.n™ Spine Navigation and Robotic GuidanceEcential Robotics20261

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?

  • Of its descendants, K261113 (Ecential Robotics, 2026) has gone furthest, with 1 descendant of its own.

How does its category compare?

All OLO devices

OLO Orthopedic Stereotaxic Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, 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?

Op.n™ Navigation is indicated for the positioning of compatible surgical instruments to be used by surgeons during general spinal surgery.

The guidance is based on an intra-operative surgical plan developed with Op.n™ Navigation Software and based on intra-operative 3D images provided by a compatible imaging system.

The device is indicated for the placement of pedicle screws, in instrument navigation mode, in vertebrae with a posterior approach in the thoracolumbar region.

Op.n™ Navigation Software is indicated for the navigation of compatible surgical instruments to be used by surgeons.

Indications for use as stated in the FDA summary.

More from Ecential Robotics

7 FDA decisions under this applicant name. See the company

  • K261113Op.n™ Spine Navigation and Robotic GuidanceEcential Robotics · 2026
  • K233228Spine Navigation and Robotic-Assistance DeviceEcential Robotics · 20241 recall
  • K231886SURGIVISIO DeviceEcential Robotics · 2023
  • K221028SURGIVISIO DeviceEcential Robotics · 2022
  • K220946SURGIVISIO DeviceEcential Robotics · 2022

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/K242914 · printed Nov 6, 2026

Cite this page

510(k) Report. “K242914: Op.n (TM) Navigation.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K242914

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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