510(k) · Cleared
ClearedNavigated Instrument System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Orthofix, Inc. · OLO Orthopedic Stereotaxic Instrument
Cleared on Mar 8, 2018 as substantially equivalent to K153442 (Medtronic Sofamor Danek USA, Inc., 2016) and 3 other predicates after a 238-day review. Its family tree reaches back 16 generations to 2004. 1 of the 391 devices in its family, counting itself, has a Class I recall. 4 later devices descend from it.
- Decided
- Mar 8, 2018
- Review
- 238 days
- Class
- Class II
- Product code
- OLO
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 16 generations to K040583 (2004). 386 ancestors in all, the oldest K781443 (1978). 4 later devices descend from it, 2 citing it directly. 1 of the 391 devices in this family, counting this one, has a Class I recall.
- Root · 16 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 12 generations between
- 3 generations backK130932 Firebird Spinal Fixation SystemOrthofix, Inc. · 2013 · Recalled
- 2 generations backK151488 Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation SystemOrthofix, Inc. · 2015 · Recalled
- 1 generation backK153428 Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation SystemOrthofix, Inc. · 2016 · Recalled
- This deviceK172115 Navigated Instrument SystemOrthofix, Inc. · 2018
- Descendant · cites it directly · 2 of its ownK191722 Vital Navigation SystemZimmer Biomet Spine, Inc. · 2019
- Descendant · 2 generations on · 0 of its ownK233443 Vital™ Navigation SystemZimvie Spine (Zimmer Biomet Spine, Inc.) · 2023
- Descendant · cites it directly · 0 of its ownK213491 Universal Pilot Guidance Instrument SystemCtl Medical Corporation · 2022
- Descendant · 2 generations on · 0 of its ownK213720 Vital Navigation SystemZimvie (Zimmer Biomet Spine, Inc.) · 2022
Show all 16 generations
- Root · 16 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 15 generations backK041118 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 14 generations backK042025 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2004 · Recalled
- 13 generations backK043151 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
- 12 generations backK050809 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2005
- 11 generations backK052187 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
- 10 generations backK053101 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2006
- 9 generations backK091442 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2009
- 8 generations backK091974 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2009 · Recalled
- 7 generations backK102555 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2010
- 6 generations backK112473 CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2011
- 5 generations backK113174 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2011 · Recalled
- 4 generations backK121630 Range Spinal SystemK2m, Inc. · 2012
- 3 generations backK130932 Firebird Spinal Fixation SystemOrthofix, Inc. · 2013 · Recalled
- 2 generations backK151488 Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation SystemOrthofix, Inc. · 2015 · Recalled
- 1 generation backK153428 Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation SystemOrthofix, Inc. · 2016 · Recalled
- This deviceK172115 Navigated Instrument SystemOrthofix, Inc. · 2018
Class I recalls in this family
- K070106 VV Fluoro 3Ddirect predicate · 2007
Most influential descendants
Showing 4 of 4 · See all- K191722Vital Navigation SystemZimmer Biomet Spine, Inc. · 2019 · cites it directly2descendants
- K233443Vital™ Navigation SystemZimvie Spine (Zimmer Biomet Spine, Inc.) · 2023 · 2 generations on0descendants
- K213491Universal Pilot Guidance Instrument SystemCtl Medical Corporation · 2022 · cites it directly0descendants
- K213720Vital Navigation SystemZimvie (Zimmer Biomet Spine, Inc.) · 2022 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −16 | K040583 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −15 | K041118 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −14 | K042025 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek, Inc. | 2004 | 4 |
| −13 | K043151 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2005 | — |
| −12 | K050809 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2005 | — |
| −11 | K052187 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2005 | — |
| −10 | K053101 | CD Horizon Spinal System | Medtronic Sofamor Danek | 2006 | — |
| −9 | K091442 | CD Horizon Spinal System | Medtronic Sofamor Danek | 2009 | — |
| −8 | K091974 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2009 | 1 |
| −7 | K102555 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2010 | — |
| −6 | K112473 | CD Horizon Spinal System | Medtronic Sofamor Danek, Inc. | 2011 | — |
| −5 | K113174 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2011 | 1 |
| −4 | K121630 | Range Spinal System | K2m, Inc. | 2012 | — |
| −3 | K130932 | Firebird Spinal Fixation System | Orthofix, Inc. | 2013 | 1 |
| −2 | K151488 | Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation System | Orthofix, Inc. | 2015 | 1 |
| −1 | K153428 | Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation System | Orthofix, Inc. | 2016 | 1 |
| 0 (this device) | K172115 | Navigated Instrument System | Orthofix, Inc. | 2018 | — |
| +1 | K191722 | Vital Navigation System | Zimmer Biomet Spine, Inc. | 2019 | — |
| +2 | K233443 | Vital™ Navigation System | Zimvie Spine (Zimmer Biomet Spine, Inc.) | 2023 | — |
| +1 | K213491 | Universal Pilot Guidance Instrument System | Ctl Medical Corporation | 2022 | — |
| +2 | K213720 | Vital Navigation System | Zimvie (Zimmer Biomet Spine, Inc.) | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1984 | 2 | 0 |
| 1985 | 2 | 0 |
| 1986 | 2 | 0 |
| 1987 | 1 | 0 |
| 1988 | 2 | 0 |
| 1989 | 1 | 0 |
| 1990 | 3 | 0 |
| 1992 | 7 | 0 |
| 1993 | 3 | 0 |
| 1994 | 7 | 0 |
| 1995 | 15 | 0 |
| 1996 | 12 | 0 |
| 1997 | 12 | 0 |
| 1998 | 21 | 0 |
| 1999 | 16 | 0 |
| 2000 | 26 | 0 |
| 2001 | 32 | 0 |
| 2002 | 26 | 0 |
| 2003 | 25 | 0 |
| 2004 | 33 | 0 |
| 2005 | 26 | 0 |
| 2006 | 20 | 0 |
| 2007 | 12 | 1 |
| 2008 | 21 | 0 |
| 2009 | 6 | 0 |
| 2010 | 10 | 0 |
| 2011 | 10 | 0 |
| 2012 | 5 | 0 |
| 2013 | 3 | 0 |
| 2014 | 4 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 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.
1 device in this family has 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? (4)
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 |
|---|---|---|---|
| * | K153442 | CD HORIZON Spinal System, Medtronic Navigated Manual Reusable Instruments for Use with…Summary page 4…Product Code: OLO Regulatory Classification: Class II - 21 CFR § 882.4560 Review Panel: Orthopedic Device Panel Predicate Devices: K153442 – Medtronic Navigated Instrument System – Navigated Reusable Instruments for Use with StealthStation… | 2016 |
| * | K070106 | VV Fluoro 3DSummary page 4…K153442 – Medtronic Navigated Instrument System – Navigated Reusable Instruments for Use with StealthStation K070106 – Brainlab Navigated Instruments for use with the VectorVision System (Individually/Manual Calibrated)… | 2007 |
| * | K162921 | Navigated Instrument SystemSummary page 4…K070106 – Brainlab Navigated Instruments for use with the VectorVision System (Individually/Manual Calibrated) K162921 – Navigated Instrument System – Orthofix K153428 – Firebird Spinal Fixation System / Phoenix MIS Spin… | 2017 |
| * | K153428 | Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation SystemSummary page 4…VectorVision System (Individually/Manual Calibrated) K162921 – Navigated Instrument System – Orthofix K153428 – Firebird Spinal Fixation System / Phoenix MIS Spinal Fixation System - Orthofix Reason for 510(k) S… | 2016 |
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? (1 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.
- K070106VV Fluoro 3DBrainlab AG · 2007 · Direct predicate · ◆ in the 2007 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 14 years and passes through 5 companies; a new generation was cleared every 7 months on median.
- 46 of the 386 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K191722 (Zimmer Biomet Spine, Inc., 2019) has gone furthest, with 2 descendants of its own.
- 12 other devices also cite its predicate K153442.
How does its category compare?
All OLO devicesOLO Orthopedic Stereotaxic Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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 Navigated Instrument System is indicated for use during the preparation and placement of Orthofix screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. The Navigated Instrument System reusable instruments are specifically designed for use with the BrainLab Vector Vision system and the Medtronic StealthStation System which are indicated for any medical condition…
Read the full statement (133 words)
The Navigated Instrument System is indicated for use during the preparation and placement of Orthofix screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. The Navigated Instrument System reusable instruments are specifically designed for use with the BrainLab Vector Vision system and the Medtronic StealthStation System which are 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 skull, a long bone, or vertebra can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks for the anatomy.
Use of the Navigated Instrument System is limited to use only with the Firebird Spinal Fixation System / Phoenix MIS Spinal Fixation Systems.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K172115 · printed Nov 6, 2026
Cite this page
510(k) Report. “K172115: Navigated Instrument System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K172115
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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