510(k) · Cleared
ClearedVirage® Navigation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zimvie Spine (Zimmer Biomet Spine, Inc.) · OLO Orthopedic Stereotaxic Instrument
Cleared on Apr 5, 2024 as substantially equivalent to K212023 (Zimmer Biomet Spine, Inc., 2021) after a 29-day review. Its family tree reaches back 13 generations to 1986. 2 of the 71 devices in its family, counting itself, have a Class I recall.
- Decided
- Apr 5, 2024
- Review
- 29 days
- Class
- Class II
- Product code
- OLO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 13 generations to K862807 (1986). 70 ancestors in all, the oldest K842956 (1984). No later device cites it as a predicate yet. 2 of the 71 devices in this family, counting this one, have a Class I recall.
- Root · 13 generations backK862807 Treace Drill SystemTreace Medical, Inc. · 1986
- 9 generations between
- 3 generations backK143628 Navigated Vertex Select InstrumentsMedtronic Sofamor Danek USA, Inc. · 2015
- 2 generations backK173338 Navigated INFINITY™ InstrumentsMedtronic Sofamor Danek USA, Inc. · 2018
- 1 generation backK212023 Virage Navigation SystemZimmer Biomet Spine, Inc. · 2021
- This deviceK240647 Virage® Navigation SystemZimvie Spine (Zimmer Biomet Spine, Inc.) · 2024
Show all 13 generations
- Root · 13 generations backK862807 Treace Drill SystemTreace Medical, Inc. · 1986
- 12 generations backK964548 Apex Universal Drive SystemLinvatec Corp. · 1997
- 11 generations backK971059 Universal Drive SystemLinvatec Corp. · 1997
- 10 generations backK981637 Integrated Drive/Pump System for OtolaryngologyLinvatec Corp. · 1998
- 9 generations backK990524 E9000 SystemLinvatec Corp. · 1999
- 8 generations backK012456 Sodem High Speed System (Electric) (Ear, Nose, and Throat)Sodemsystems · 2001
- 7 generations backK081277 XPS 4000 System, Midas Rex Legend Ehs System, Integrated Power…Medtronic Xomed, Inc. · 2008 · Recalled
- 6 generations backK111520 Ipc Powerease SystemMedtronic Xomed, Inc. · 2011 · Recalled
- 5 generations backK123270 Powerease SystemMedtronic Sofamor Danek USA, Inc. · 2013
- 4 generations backK140454 Navigated CD Horizon Solera Screwdriver/TapsMedtronic Sofamor Danek USA, Inc. · 2014 · Recalled
- 3 generations backK143628 Navigated Vertex Select InstrumentsMedtronic Sofamor Danek USA, Inc. · 2015
- 2 generations backK173338 Navigated INFINITY™ InstrumentsMedtronic Sofamor Danek USA, Inc. · 2018
- 1 generation backK212023 Virage Navigation SystemZimmer Biomet Spine, Inc. · 2021
- This deviceK240647 Virage® Navigation SystemZimvie Spine (Zimmer Biomet Spine, Inc.) · 2024
Class I recalls in this family
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K862807 | Treace Drill System | Treace Medical, Inc. | 1986 | — |
| −12 | K964548 | Apex Universal Drive System | Linvatec Corp. | 1997 | — |
| −11 | K971059 | Universal Drive System | Linvatec Corp. | 1997 | — |
| −10 | K981637 | Integrated Drive/Pump System for Otolaryngology | Linvatec Corp. | 1998 | — |
| −9 | K990524 | E9000 System | Linvatec Corp. | 1999 | — |
| −8 | K012456 | Sodem High Speed System (Electric) (Ear, Nose, and Throat) | Sodemsystems | 2001 | — |
| −7 | K081277 | XPS 4000 System, Midas Rex Legend Ehs System, Integrated Power CONS0LE (Ipc) | Medtronic Xomed, Inc. | 2008 | 1 |
| −6 | K111520 | Ipc Powerease System | Medtronic Xomed, Inc. | 2011 | 2 |
| −5 | K123270 | Powerease System | Medtronic Sofamor Danek USA, Inc. | 2013 | — |
| −4 | K140454 | Navigated CD Horizon Solera Screwdriver/Taps | Medtronic Sofamor Danek USA, Inc. | 2014 | 1 |
| −3 | K143628 | Navigated Vertex Select Instruments | Medtronic Sofamor Danek USA, Inc. | 2015 | — |
| −2 | K173338 | Navigated INFINITY™ Instruments | Medtronic Sofamor Danek USA, Inc. | 2018 | — |
| −1 | K212023 | Virage Navigation System | Zimmer Biomet Spine, Inc. | 2021 | — |
| 0 (this device) | K240647 | Virage® Navigation System | Zimvie Spine (Zimmer Biomet Spine, Inc.) | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1985 | 1 | 0 |
| 1986 | 1 | 0 |
| 1987 | 1 | 0 |
| 1988 | 2 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1992 | 2 | 0 |
| 1994 | 4 | 0 |
| 1995 | 7 | 0 |
| 1996 | 1 | 0 |
| 1997 | 3 | 0 |
| 1998 | 3 | 0 |
| 1999 | 2 | 0 |
| 2000 | 5 | 0 |
| 2001 | 2 | 0 |
| 2002 | 3 | 0 |
| 2003 | 2 | 0 |
| 2004 | 2 | 0 |
| 2005 | 4 | 0 |
| 2006 | 3 | 0 |
| 2008 | 2 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 1 |
| 2016 | 1 | 1 |
| 2017 | 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.
2 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? (1)
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 |
|---|---|---|---|
| * | K212023 | Virage Navigation SystemSummary page 4…Predicate Devices Primary Predicate: Virage® Navigation System (K212023) Reference Devices Reference Device Medtronic StealthStation S7… | 2021 |
| † | K133444 | Stealthstation S7 / I7 / Fusion Navigation Systems, Axiem Navigation System | 2014 |
| † | K212245 | Spine and Trauma Navigation System, Spine & Trauma 3D Navigation, Instrument Selection… | 2022 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (2 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.
What does this lineage say?
- The line of descent spans 38 years and passes through 7 companies; a new generation was cleared every 2.2 years on median.
- 13 of the 70 ancestors have a recall of any class; 2 have a Class I recall.
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 Virage Navigation System instruments are to be used during the preparation and placement of Virage® OCT polyaxial screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in open procedures. When used with the Medtronic NavLock arrays, the Virage Navigation instruments can be used with the Medtronic StealthStation ® S7. When used with the ZimVie reference arrays, the Virage Navigation instruments can be used with the Brainlab Navigation System.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K240647 · printed Nov 6, 2026
Cite this page
510(k) Report. “K240647: Virage® Navigation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K240647
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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