510(k) · Cleared
ClearedNuVasive Navigation.S Instruments
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nu Vasive, Incorporated · OLO Orthopedic Stereotaxic Instrument
Cleared on Dec 2, 2020 as substantially equivalent to K192336 (Medtronic Sofamor Danek USA, Inc., 2019) and 1 other predicate after a 258-day review. Its family tree reaches back 19 generations to 2001. 4 later devices descend from it.
- Decided
- Dec 2, 2020
- Review
- 258 days
- Class
- Class II
- Product code
- OLO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 19 generations to K003155 (2001). 295 ancestors in all, the oldest K792352 (1979). 4 later devices descend from it, 2 citing it directly.
- Root · 19 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
- 15 generations between
- 3 generations backK163581 Navigated ELEVATE Inserter, Navigated Disc Prep InstrumentsMedtronic Sofamor Danek USA, Inc. · 2017
- 2 generations backK191039 Navigated T2 STRATOSPHERE Inserters and Navigated TemplatesMedtronic Sofamor Danek USA, Inc. · 2019
- 1 generation backK192336 Navigated Anterolateral Disc Prep InstrumentsMedtronic Sofamor Danek USA, Inc. · 2019
- This deviceK200719 NuVasive Navigation.S InstrumentsNu Vasive, Incorporated · 2020
- Descendant · cites it directly · 2 of its ownK210574 NuVasive Pulse SystemNu Vasive, Incorporated · 2021 · Recalled
- Descendant · 2 generations on · 0 of its ownK243814 NuVasive Pulse SystemGlobus Medical, Inc. · 2025
- Descendant · 2 generations on · 0 of its ownK230989 Rod Registration FrameNu Vasive, Incorporated · 2023
- Descendant · cites it directly · 0 of its ownK223765 ATEC Lateral Navigation InstrumentsAlphatec Spine, Inc. · 2023 · Recalled
Show all 19 generations
- Root · 19 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
- 18 generations backK012254 VBROsteotech, Inc. · 2001
- 17 generations backK021791 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
- 16 generations backK023570 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
- 15 generations backK030601 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2003
- 14 generations backK040536 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
- 13 generations backK041556 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
- 12 generations backK043561 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
- 11 generations backK060719 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2006
- 10 generations backK062133 Modification to Verte-Stack Spinal SystemMedtronic Spinal and Biologics Div · 2006
- 9 generations backK070173 Verte-Stack Spinal SystemMedtronic Sofamor Danek, Inc. · 2007
- 8 generations backK073285 Peek Prevail Cervical Interbody DeviceMedtronic Sofamor Danek USA, Inc. · 2008
- 7 generations backK100214 Cornerstone PSR Cervical Interbody Fusion DeviceMedtronic Sofamor Danek · 2010
- 6 generations backK111264 Cornerstone (R) PSR Cervical Fusion SystemMedtronic Sofamor Danek USA · 2011
- 5 generations backK122037 Anatomic Peek Cervical Fusion System Cornerstone PSR Cervical Fusion…Medtronic Sofamor Danek, Inc. · 2013
- 4 generations backK142559 ELEVATE Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2015
- 3 generations backK163581 Navigated ELEVATE Inserter, Navigated Disc Prep InstrumentsMedtronic Sofamor Danek USA, Inc. · 2017
- 2 generations backK191039 Navigated T2 STRATOSPHERE Inserters and Navigated TemplatesMedtronic Sofamor Danek USA, Inc. · 2019
- 1 generation backK192336 Navigated Anterolateral Disc Prep InstrumentsMedtronic Sofamor Danek USA, Inc. · 2019
- This deviceK200719 NuVasive Navigation.S InstrumentsNu Vasive, Incorporated · 2020
Most influential descendants
Showing 4 of 4 · See all- K210574NuVasive Pulse SystemNu Vasive, Incorporated · 2021 · cites it directly2descendants
- K243814NuVasive Pulse SystemGlobus Medical, Inc. · 2025 · 2 generations on0descendants
- K230989Rod Registration FrameNu Vasive, Incorporated · 2023 · 2 generations on0descendants
- K223765ATEC Lateral Navigation InstrumentsAlphatec Spine, Inc. · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −19 | K003155 | Vertebral Body Replacement | Osteotech, Inc. | 2001 | — |
| −18 | K012254 | VBR | Osteotech, Inc. | 2001 | — |
| −17 | K021791 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2002 | — |
| −16 | K023570 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2002 | — |
| −15 | K030601 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2003 | — |
| −14 | K040536 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −13 | K041556 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −12 | K043561 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −11 | K060719 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2006 | — |
| −10 | K062133 | Modification to Verte-Stack Spinal System | Medtronic Spinal and Biologics Div | 2006 | — |
| −9 | K070173 | Verte-Stack Spinal System | Medtronic Sofamor Danek, Inc. | 2007 | — |
| −8 | K073285 | Peek Prevail Cervical Interbody Device | Medtronic Sofamor Danek USA, Inc. | 2008 | — |
| −7 | K100214 | Cornerstone PSR Cervical Interbody Fusion Device | Medtronic Sofamor Danek | 2010 | — |
| −6 | K111264 | Cornerstone (R) PSR Cervical Fusion System | Medtronic Sofamor Danek USA | 2011 | — |
| −5 | K122037 | Anatomic Peek Cervical Fusion System Cornerstone PSR Cervical Fusion System… | Medtronic Sofamor Danek, Inc. | 2013 | — |
| −4 | K142559 | ELEVATE Spinal System | Medtronic Sofamor Danek USA, Inc. | 2015 | — |
| −3 | K163581 | Navigated ELEVATE Inserter, Navigated Disc Prep Instruments | Medtronic Sofamor Danek USA, Inc. | 2017 | — |
| −2 | K191039 | Navigated T2 STRATOSPHERE Inserters and Navigated Templates | Medtronic Sofamor Danek USA, Inc. | 2019 | — |
| −1 | K192336 | Navigated Anterolateral Disc Prep Instruments | Medtronic Sofamor Danek USA, Inc. | 2019 | — |
| 0 (this device) | K200719 | NuVasive Navigation.S Instruments | Nu Vasive, Incorporated | 2020 | — |
| +1 | K210574 | NuVasive Pulse System | Nu Vasive, Incorporated | 2021 | 1 |
| +2 | K243814 | NuVasive Pulse System | Globus Medical, Inc. | 2025 | — |
| +2 | K230989 | Rod Registration Frame | Nu Vasive, Incorporated | 2023 | — |
| +1 | K223765 | ATEC Lateral Navigation Instruments | Alphatec Spine, Inc. | 2023 | 2 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1980 | 1 | 0 |
| 1984 | 2 | 0 |
| 1985 | 1 | 0 |
| 1986 | 2 | 0 |
| 1987 | 1 | 0 |
| 1988 | 2 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1992 | 2 | 0 |
| 1994 | 4 | 0 |
| 1995 | 7 | 0 |
| 1996 | 4 | 0 |
| 1997 | 5 | 0 |
| 1998 | 7 | 0 |
| 1999 | 7 | 0 |
| 2000 | 11 | 0 |
| 2001 | 14 | 0 |
| 2002 | 13 | 0 |
| 2003 | 20 | 0 |
| 2004 | 38 | 0 |
| 2005 | 23 | 0 |
| 2006 | 12 | 0 |
| 2007 | 14 | 0 |
| 2008 | 23 | 0 |
| 2009 | 14 | 0 |
| 2010 | 10 | 0 |
| 2011 | 13 | 0 |
| 2012 | 8 | 0 |
| 2013 | 5 | 0 |
| 2014 | 3 | 0 |
| 2015 | 3 | 0 |
| 2016 | 2 | 0 |
| 2017 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 2023 | 2 | 0 |
| 2025 | 1 | 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.
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 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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K192336 | Navigated Anterolateral Disc Prep InstrumentsSummary page 4…OLO C. Predicate Devices The subject device is substantially equivalent to the primary predicate device Navigated Anterolateral Disc Prep Instruments (K192336) and additional predicate device NuVasive Navigation Instruments (K172623). Stimulation/Dissection Instruments (K112709… | 2019 |
| * | K172623 | NuVasive Navigation InstrumentsSummary page 4…valent to the primary predicate device Navigated Anterolateral Disc Prep Instruments (K192336) and additional predicate device NuVasive Navigation Instruments (K172623). Stimulation/Dissection Instruments (K112709) is being used as a reference predicate for materials and sterilization m… | 2017 |
| † | K112709 | Stimulation/Dissection Instruments | 2012 |
What descends from it? (4)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 19 years and passes through 7 companies; a new generation was cleared every 1.0 years on median.
- 32 of the 295 ancestors have a recall of any class.
- Of its descendants, K210574 (Nu Vasive, Incorporated, 2021) has gone furthest, with 2 descendants of its own.
- 3 other devices also cite its predicate K192336.
How does its category compare?
All OLO devicesOLO Orthopedic Stereotaxic Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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?
NuVasive Navigation.S Instruments are intended to be used during the preparation and placement of NuVasive screws (Reline, Reline C, and VuePoint fixation systems) and disc preparation during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. The navigated disc preparation instruments are intended to be used to facilitate a discectomy or boney resection during spinal surgery.…
Read the full statement (146 words)
NuVasive Navigation.S Instruments are intended to be used during the preparation and placement of NuVasive screws (Reline, Reline C, and VuePoint fixation systems) and disc preparation during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures.
The navigated disc preparation instruments are intended to be used to facilitate a discectomy or boney resection during spinal surgery. The navigated trials are intended to be used to facilitate implant size selection of NuVasive intervertebral body fusion devices during spinal surgery.
NuVasive Navigation.S Instruments are 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 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/K200719 · printed Nov 6, 2026
Cite this page
510(k) Report. “K200719: NuVasive Navigation.S Instruments.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K200719
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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