510(k) · Cleared
ClearedVirage Navigation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zimmer Biomet Spine, Inc. · OLO Orthopedic Stereotaxic Instrument
Cleared on Aug 27, 2021 as substantially equivalent to K173338 (Medtronic Sofamor Danek USA, Inc., 2018) and 1 other predicate after a 59-day review. Its family tree reaches back 12 generations to 1986. 2 of the 71 devices in its family, counting itself, have a Class I recall. 1 later device descends from it.
- Decided
- Aug 27, 2021
- Review
- 59 days
- Class
- Class II
- Product code
- OLO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 12 generations to K862807 (1986). 69 ancestors in all, the oldest K842956 (1984). 1 later device descends from it, 1 citing it directly. 2 of the 71 devices in this family, counting this one, have a Class I recall.
- Root · 12 generations backK862807 Treace Drill SystemTreace Medical, Inc. · 1986
- 8 generations between
- 3 generations backK140454 Navigated CD Horizon Solera Screwdriver/TapsMedtronic Sofamor Danek USA, Inc. · 2014 · Recalled
- 2 generations backK143628 Navigated Vertex Select InstrumentsMedtronic Sofamor Danek USA, Inc. · 2015
- 1 generation backK173338 Navigated INFINITY™ InstrumentsMedtronic Sofamor Danek USA, Inc. · 2018
- This deviceK212023 Virage Navigation SystemZimmer Biomet Spine, Inc. · 2021
- Descendant · cites it directly · 0 of its ownK240647 Virage® Navigation SystemZimvie Spine (Zimmer Biomet Spine, Inc.) · 2024
Show all 12 generations
- Root · 12 generations backK862807 Treace Drill SystemTreace Medical, Inc. · 1986
- 11 generations backK964548 Apex Universal Drive SystemLinvatec Corp. · 1997
- 10 generations backK971059 Universal Drive SystemLinvatec Corp. · 1997
- 9 generations backK981637 Integrated Drive/Pump System for OtolaryngologyLinvatec Corp. · 1998
- 8 generations backK990524 E9000 SystemLinvatec Corp. · 1999
- 7 generations backK012456 Sodem High Speed System (Electric) (Ear, Nose, and Throat)Sodemsystems · 2001
- 6 generations backK081277 XPS 4000 System, Midas Rex Legend Ehs System, Integrated Power…Medtronic Xomed, Inc. · 2008 · Recalled
- 5 generations backK111520 Ipc Powerease SystemMedtronic Xomed, Inc. · 2011 · Recalled
- 4 generations backK123270 Powerease SystemMedtronic Sofamor Danek USA, Inc. · 2013
- 3 generations backK140454 Navigated CD Horizon Solera Screwdriver/TapsMedtronic Sofamor Danek USA, Inc. · 2014 · Recalled
- 2 generations backK143628 Navigated Vertex Select InstrumentsMedtronic Sofamor Danek USA, Inc. · 2015
- 1 generation backK173338 Navigated INFINITY™ InstrumentsMedtronic Sofamor Danek USA, Inc. · 2018
- This deviceK212023 Virage Navigation SystemZimmer Biomet Spine, Inc. · 2021
Class I recalls in this family
Most influential descendants
Showing 1 of 1 · See all- K240647Virage® Navigation SystemZimvie Spine (Zimmer Biomet Spine, Inc.) · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K862807 | Treace Drill System | Treace Medical, Inc. | 1986 | — |
| −11 | K964548 | Apex Universal Drive System | Linvatec Corp. | 1997 | — |
| −10 | K971059 | Universal Drive System | Linvatec Corp. | 1997 | — |
| −9 | K981637 | Integrated Drive/Pump System for Otolaryngology | Linvatec Corp. | 1998 | — |
| −8 | K990524 | E9000 System | Linvatec Corp. | 1999 | — |
| −7 | K012456 | Sodem High Speed System (Electric) (Ear, Nose, and Throat) | Sodemsystems | 2001 | — |
| −6 | K081277 | XPS 4000 System, Midas Rex Legend Ehs System, Integrated Power CONS0LE (Ipc) | Medtronic Xomed, Inc. | 2008 | 1 |
| −5 | K111520 | Ipc Powerease System | Medtronic Xomed, Inc. | 2011 | 2 |
| −4 | K123270 | Powerease System | Medtronic Sofamor Danek USA, Inc. | 2013 | — |
| −3 | K140454 | Navigated CD Horizon Solera Screwdriver/Taps | Medtronic Sofamor Danek USA, Inc. | 2014 | 1 |
| −2 | K143628 | Navigated Vertex Select Instruments | Medtronic Sofamor Danek USA, Inc. | 2015 | — |
| −1 | K173338 | Navigated INFINITY™ Instruments | Medtronic Sofamor Danek USA, Inc. | 2018 | — |
| 0 (this device) | K212023 | Virage Navigation System | Zimmer Biomet Spine, Inc. | 2021 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 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? (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 |
|---|---|---|---|
| * | K173338 | Navigated INFINITY™ InstrumentsSummary page 4…edic Stereotaxic Instrument (21 CFR 882.4560) Device Panel Orthopedic Predicate Devices Primary Predicate: Navigated INFINITYTM Instruments (K173338) Additional Predicate: StealthStation® System (K170011) Reference Devi… | 2018 |
| * | K170011 | StealthStation S8 Spine Software v1.0.0Summary page 4…ic Predicate Devices Primary Predicate: Navigated INFINITYTM Instruments (K173338) Additional Predicate: StealthStation® System (K170011) Reference Devices: Virage OCT Spinal Fixation System (K153631)… | 2017 |
| † | K153631 | Zimmer Virage OCT Spinal Fixation System | 2016 |
| † | K190576 | WalterLorenz Surgical Assist Arm Scope Holder | 2019 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K240647 | Virage® Navigation System | 2024 | 0 |
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 35 years and passes through 6 companies; a new generation was cleared every 2.2 years on median.
- 13 of the 69 ancestors have a recall of any class; 2 have a Class I recall.
- Of its descendants, K240647 (Zimvie Spine (Zimmer Biomet Spine, Inc.), 2024) has gone furthest, with 0 descendants of its own.
- 6 other devices also cite its predicate K173338.
How does its category compare?
All OLO devicesOLO Orthopedic Stereotaxic Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, 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. The Virage® Navigation System Instruments are 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…
Read the full statement (117 words)
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. The Virage® Navigation System Instruments are 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 vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks for the anatomy.
The Virage® Navigation Instruments are also compatible with the Zimmer Biomet Universal Power System and the WalterLorenz® Surgical Assist Arm.
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/K212023 · printed Nov 6, 2026
Cite this page
510(k) Report. “K212023: 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/K212023
Report an extraction error
Are you the manufacturer?
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