510(k) · Cleared
ClearedCORUS Navigation Access System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Providence Medical Technology, Inc. · OLO Orthopedic Stereotaxic Instrument
Cleared on May 3, 2024 as substantially equivalent to K211441 (Medtronic Sofamor Danek USA, Inc., 2021) and 2 other predicates after a 58-day review. Its family tree reaches back 20 generations to 2001. 4 of the 335 devices in its family, counting itself, have a Class I recall. 4 later devices descend from it.
- Decided
- May 3, 2024
- Review
- 58 days
- Class
- Class II
- Product code
- OLO
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 20 generations to K003155 (2001). 330 ancestors in all, the oldest K792352 (1979). 4 later devices descend from it, 3 citing it directly. 4 of the 335 devices in this family, counting this one, have a Class I recall.
- Root · 20 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
- 16 generations between
- 3 generations backK191039 Navigated T2 STRATOSPHERE Inserters and Navigated TemplatesMedtronic Sofamor Danek USA, Inc. · 2019
- 2 generations backK192336 Navigated Anterolateral Disc Prep InstrumentsMedtronic Sofamor Danek USA, Inc. · 2019
- 1 generation backK211441 Navigated Anterolateral Disc Prep InstrumentsMedtronic Sofamor Danek USA, Inc. · 2021
- This deviceK240625 CORUS Navigation Access SystemProvidence Medical Technology, Inc. · 2024
- Descendant · cites it directly · 1 of its ownK260329 Ion-C Navigation InstrumentsSurGenTec, LLC · 2026
- Descendant · 2 generations on · 0 of its ownK262121 Ion-L Navigated InstrumentsSurGenTec, LLC · 2026
- Descendant · cites it directly · 0 of its ownK251060 CORUS™ Navigation System-GXProvidence Medical Technology, Inc. · 2025
- Descendant · cites it directly · 0 of its ownK243659 FLASH™ Facet Fusion Instruments, IsoTis® Facet Fusion InstrumentsSeaSpine Orthopedics Corporation · 2025
Show all 20 generations
- Root · 20 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
- 19 generations backK012254 VBROsteotech, Inc. · 2001
- 18 generations backK021791 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
- 17 generations backK023570 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
- 16 generations backK030601 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2003
- 15 generations backK040536 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
- 14 generations backK041556 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
- 13 generations backK043561 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
- 12 generations backK060719 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2006
- 11 generations backK062133 Modification to Verte-Stack Spinal SystemMedtronic Spinal and Biologics Div · 2006
- 10 generations backK070173 Verte-Stack Spinal SystemMedtronic Sofamor Danek, Inc. · 2007
- 9 generations backK073285 Peek Prevail Cervical Interbody DeviceMedtronic Sofamor Danek USA, Inc. · 2008
- 8 generations backK100214 Cornerstone PSR Cervical Interbody Fusion DeviceMedtronic Sofamor Danek · 2010
- 7 generations backK111264 Cornerstone (R) PSR Cervical Fusion SystemMedtronic Sofamor Danek USA · 2011
- 6 generations backK122037 Anatomic Peek Cervical Fusion System Cornerstone PSR Cervical Fusion…Medtronic Sofamor Danek, Inc. · 2013
- 5 generations backK142559 ELEVATE Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2015
- 4 generations backK163581 Navigated ELEVATE Inserter, Navigated Disc Prep InstrumentsMedtronic Sofamor Danek USA, Inc. · 2017
- 3 generations backK191039 Navigated T2 STRATOSPHERE Inserters and Navigated TemplatesMedtronic Sofamor Danek USA, Inc. · 2019
- 2 generations backK192336 Navigated Anterolateral Disc Prep InstrumentsMedtronic Sofamor Danek USA, Inc. · 2019
- 1 generation backK211441 Navigated Anterolateral Disc Prep InstrumentsMedtronic Sofamor Danek USA, Inc. · 2021
- This deviceK240625 CORUS Navigation Access SystemProvidence Medical Technology, Inc. · 2024
Class I recalls in this family
Most influential descendants
Showing 4 of 4 · See all- K260329Ion-C Navigation InstrumentsSurGenTec, LLC · 2026 · cites it directly1descendant
- K262121Ion-L Navigated InstrumentsSurGenTec, LLC · 2026 · 2 generations on0descendants
- K251060CORUS™ Navigation System-GXProvidence Medical Technology, Inc. · 2025 · cites it directly0descendants
- K243659FLASH™ Facet Fusion Instruments, IsoTis® Facet Fusion InstrumentsSeaSpine Orthopedics Corporation · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −20 | K003155 | Vertebral Body Replacement | Osteotech, Inc. | 2001 | — |
| −19 | K012254 | VBR | Osteotech, Inc. | 2001 | — |
| −18 | K021791 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2002 | — |
| −17 | K023570 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2002 | — |
| −16 | K030601 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2003 | — |
| −15 | K040536 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −14 | K041556 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −13 | K043561 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −12 | K060719 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2006 | — |
| −11 | K062133 | Modification to Verte-Stack Spinal System | Medtronic Spinal and Biologics Div | 2006 | — |
| −10 | K070173 | Verte-Stack Spinal System | Medtronic Sofamor Danek, Inc. | 2007 | — |
| −9 | K073285 | Peek Prevail Cervical Interbody Device | Medtronic Sofamor Danek USA, Inc. | 2008 | — |
| −8 | K100214 | Cornerstone PSR Cervical Interbody Fusion Device | Medtronic Sofamor Danek | 2010 | — |
| −7 | K111264 | Cornerstone (R) PSR Cervical Fusion System | Medtronic Sofamor Danek USA | 2011 | — |
| −6 | K122037 | Anatomic Peek Cervical Fusion System Cornerstone PSR Cervical Fusion System… | Medtronic Sofamor Danek, Inc. | 2013 | — |
| −5 | K142559 | ELEVATE Spinal System | Medtronic Sofamor Danek USA, Inc. | 2015 | — |
| −4 | K163581 | Navigated ELEVATE Inserter, Navigated Disc Prep Instruments | Medtronic Sofamor Danek USA, Inc. | 2017 | — |
| −3 | K191039 | Navigated T2 STRATOSPHERE Inserters and Navigated Templates | Medtronic Sofamor Danek USA, Inc. | 2019 | — |
| −2 | K192336 | Navigated Anterolateral Disc Prep Instruments | Medtronic Sofamor Danek USA, Inc. | 2019 | — |
| −1 | K211441 | Navigated Anterolateral Disc Prep Instruments | Medtronic Sofamor Danek USA, Inc. | 2021 | — |
| 0 (this device) | K240625 | CORUS Navigation Access System | Providence Medical Technology, Inc. | 2024 | — |
| +1 | K260329 | Ion-C Navigation Instruments | SurGenTec, LLC | 2026 | — |
| +2 | K262121 | Ion-L Navigated Instruments | SurGenTec, LLC | 2026 | — |
| +1 | K251060 | CORUS™ Navigation System-GX | Providence Medical Technology, Inc. | 2025 | — |
| +1 | K243659 | FLASH™ Facet Fusion Instruments, IsoTis® Facet Fusion Instruments | SeaSpine Orthopedics Corporation | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1980 | 1 | 0 |
| 1981 | 1 | 0 |
| 1984 | 3 | 0 |
| 1985 | 1 | 0 |
| 1986 | 2 | 0 |
| 1987 | 2 | 0 |
| 1988 | 2 | 0 |
| 1989 | 1 | 0 |
| 1990 | 3 | 0 |
| 1991 | 4 | 0 |
| 1992 | 3 | 0 |
| 1993 | 1 | 0 |
| 1994 | 7 | 0 |
| 1995 | 15 | 0 |
| 1996 | 6 | 0 |
| 1997 | 9 | 0 |
| 1998 | 9 | 0 |
| 1999 | 13 | 0 |
| 2000 | 13 | 0 |
| 2001 | 22 | 1 |
| 2002 | 19 | 0 |
| 2003 | 21 | 0 |
| 2004 | 27 | 0 |
| 2005 | 15 | 0 |
| 2006 | 10 | 0 |
| 2007 | 14 | 0 |
| 2008 | 24 | 0 |
| 2009 | 11 | 0 |
| 2010 | 9 | 0 |
| 2011 | 13 | 0 |
| 2012 | 6 | 0 |
| 2013 | 4 | 0 |
| 2014 | 3 | 0 |
| 2015 | 3 | 1 |
| 2016 | 1 | 1 |
| 2017 | 4 | 1 |
| 2018 | 3 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 2 | 0 |
| 2026 | 2 | 0 |
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.
4 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 K240662 Spine Guidance Software (version 5.0); Xia 3/…score 23.7 · 15 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K211441 | Navigated Anterolateral Disc Prep InstrumentsSummary page 4…Manufacturer Product Predicate Code Type K211441 Navigated Anterolateral Disc Prep Instruments Medtronic Sofamor Danek USA, Inc. OLO Primary K212636 CORUS™ Spina… | 2021 |
| * | K212636 | CORUS Spinal System-XSummary page 4…Code Type K211441 Navigated Anterolateral Disc Prep Instruments Medtronic Sofamor Danek USA, Inc. OLO Primary K212636 CORUS™ Spinal System-X Providence Medical Technology HRX Additional K150231 Navigated… | 2021 |
| * | K150231 | Navigated Disc Prep Instruments and CAPSTONE TrialsSummary page 4…onic Sofamor Danek USA, Inc. OLO Primary K212636 CORUS™ Spinal System-X Providence Medical Technology HRX Additional K150231 Navigated Disc Preparation Instruments Medtronic Sofamor Danek, USA Inc. OLO Additional… | 2015 |
What descends from it? (4)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (4 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.
- K162309StealthStation S8 System Platforms and StealthStation Cranial SoftwareMedtronic Navigation, Inc. · 2017 · 5 generations back · ◆ in the 2017 ancestors bar of FIG. 12 Class I recalls
- K153660StealthStation System with Cranial SoftwareMedtronic Navigation, Inc. · 2016 · 6 generations back · ◆ in the 2016 ancestors bar of FIG. 13 Class I recalls
- K150216Synergy CranialMedtronic Navigation, Inc. · 2015 · 7 generations back · ◆ in the 2015 ancestors bar of FIG. 13 Class I recalls
- K003837Flexiview 8800 Digital Mobile Imaging SystemGe Oec Medical Systems · 2001 · 13 generations back · ◆ in the 2001 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 23 years and passes through 7 companies; a new generation was cleared every 1.2 years on median.
- 46 of the 330 ancestors have a recall of any class; 4 have a Class I recall.
- Of its descendants, K260329 (SurGenTec, LLC, 2026) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K211441.
How does its category compare?
All OLO devicesOLO Orthopedic Stereotaxic Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
FDA decisions per year · OLO
40in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OLO
119in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OLO
1in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · OLO
3,306in 2025
MAUDE reports naming product code OLO, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 1 |
| 2009 | 11 | 126 | 0 | 4 |
| 2010 | 9 | 113 | 1 | 4 |
| 2011 | 11 | 138 | 1 | 10 |
| 2012 | 7 | 129 | 1 | 60 |
| 2013 | 7 | 137 | 0 | 36 |
| 2014 | 10 | 119 | 3 | 245 |
| 2015 | 10 | 176 | 2 | 466 |
| 2016 | 14 | 120 | 3 | 750 |
| 2017 | 33 | 91 | 2 | 1,076 |
| 2018 | 24 | 97 | 1 | 1,230 |
| 2019 | 35 | 95 | 1 | 1,585 |
| 2020 | 34 | 89 | 6 | 2,746 |
| 2021 | 28 | 91 | 0 | 1,696 |
| 2022 | 40 | 89 | 5 | 1,568 |
| 2023 | 45 | 90 | 7 (1) | 1,493 |
| 2024 | 44 | 90 | 4 | 2,353 |
| 2025 | 40 | 119 | 1 | 3,306 |
| 2026 | 42 | 109 | 6 | — |
What is it indicated for?
The CORUS™ Navigation Access System for use with the CORUS™ Spinal System is intended to be used during spinal surgery to assist the surgeon in locating and preparing facet joints in either open, or minimally invasive procedures. The CORUS™ Navigation Access System is 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 long bone, or vertebra can be identified relative to a CT or MR-based model, fluoroscopy images, or digitized landmarks of the anatomy.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K240625 · printed Nov 6, 2026
Cite this page
510(k) Report. “K240625: CORUS Navigation Access System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K240625
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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