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 13, 2017 as substantially equivalent to K153442 (Medtronic Sofamor Danek USA, Inc., 2016) and 1 other predicate after a 146-day review. Its family tree reaches back 15 generations to 1985. 1 of the 265 devices in its family, counting itself, has a Class I recall. 5 later devices descend from it.
- Decided
- Mar 13, 2017
- Review
- 146 days
- Class
- Class II
- Product code
- OLO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 15 generations to K853033 (1985). 259 ancestors in all, the oldest K841189 (1984). 5 later devices descend from it, 1 citing it directly. 1 of the 265 devices in this family, counting this one, has a Class I recall.
- Root · 15 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
- 11 generations between
- 3 generations backK111571 Viper SystemsJohnson & Johnson · 2011
- 2 generations backK121020 Viper SystemDepuy Spine, Inc. · 2012
- 1 generation backK153442 CD HORIZON Spinal System, Medtronic Navigated Manual Reusable…Medtronic Sofamor Danek USA, Inc. · 2016
- This deviceK162921 Navigated Instrument SystemOrthofix, Inc. · 2017
- Descendant · cites it directly · 4 of its ownK172115 Navigated Instrument SystemOrthofix, Inc. · 2018
- Descendant · 2 generations on · 2 of its ownK191722 Vital Navigation SystemZimmer Biomet Spine, Inc. · 2019
- Descendant · 3 generations on · 0 of its ownK233443 Vital™ Navigation SystemZimvie Spine (Zimmer Biomet Spine, Inc.) · 2023
- Descendant · 2 generations on · 0 of its ownK213491 Universal Pilot Guidance Instrument SystemCtl Medical Corporation · 2022
- Descendant · 3 generations on · 0 of its ownK213720 Vital Navigation SystemZimvie (Zimmer Biomet Spine, Inc.) · 2022
Show all 15 generations
- Root · 15 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
- 14 generations backK965221 Ransford Cervical Fixation SystemSurgicraft, Ltd. · 1997
- 13 generations backK982322 Synthes Spine Occipital-Cervical Plate/Rod and Hook SystemSynthes (Usa) · 1998
- 12 generations backK002733 Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2000
- 11 generations backK013222 Summit Occipito-Cervico- Thoracic (Oct) Spinal SystemDepuyacromed · 2001
- 10 generations backK022190 Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2002
- 9 generations backK030103 Summit Oct Spinal System Minipolyaxial ScrewsDepuyacromed · 2003
- 8 generations backK041203 Summit Oct Spinal SystemDepuy Spine, Inc. · 2004
- 7 generations backK062174 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2006
- 6 generations backK063156 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2006
- 5 generations backK063741 Expedium Spine SystemDepuy Spine, Inc. · 2007
- 4 generations backK080313 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2008
- 3 generations backK111571 Viper SystemsJohnson & Johnson · 2011
- 2 generations backK121020 Viper SystemDepuy Spine, Inc. · 2012
- 1 generation backK153442 CD HORIZON Spinal System, Medtronic Navigated Manual Reusable…Medtronic Sofamor Danek USA, Inc. · 2016
- This deviceK162921 Navigated Instrument SystemOrthofix, Inc. · 2017
Class I recalls in this family
- K070106 VV Fluoro 3Ddirect predicate · 2007
Most influential descendants
Showing 5 of 5 · See all- K172115Navigated Instrument SystemOrthofix, Inc. · 2018 · cites it directly4descendants
- K191722Vital Navigation SystemZimmer Biomet Spine, Inc. · 2019 · 2 generations on2descendants
- K233443Vital™ Navigation SystemZimvie Spine (Zimmer Biomet Spine, Inc.) · 2023 · 3 generations on0descendants
- K213491Universal Pilot Guidance Instrument SystemCtl Medical Corporation · 2022 · 2 generations on0descendants
- K213720Vital Navigation SystemZimvie (Zimmer Biomet Spine, Inc.) · 2022 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −15 | K853033 | Hartshill Rect & Wires, Spinal Fixation System | A.W. Showell (Surgicraft), Ltd. | 1985 | — |
| −14 | K965221 | Ransford Cervical Fixation System | Surgicraft, Ltd. | 1997 | — |
| −13 | K982322 | Synthes Spine Occipital-Cervical Plate/Rod and Hook System | Synthes (Usa) | 1998 | — |
| −12 | K002733 | Summit Occipito-Cervico-Thoracic (Oct) Spinal System | Depuyacromed | 2000 | — |
| −11 | K013222 | Summit Occipito-Cervico- Thoracic (Oct) Spinal System | Depuyacromed | 2001 | — |
| −10 | K022190 | Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal System | Depuyacromed | 2002 | — |
| −9 | K030103 | Summit Oct Spinal System Minipolyaxial Screws | Depuyacromed | 2003 | — |
| −8 | K041203 | Summit Oct Spinal System | Depuy Spine, Inc. | 2004 | — |
| −7 | K062174 | Modification to Expedium Spine System | Depuy Spine, Inc. | 2006 | — |
| −6 | K063156 | Modification to Expedium Spine System | Depuy Spine, Inc. | 2006 | — |
| −5 | K063741 | Expedium Spine System | Depuy Spine, Inc. | 2007 | — |
| −4 | K080313 | Modification to Expedium Spine System | Depuy Spine, Inc. | 2008 | — |
| −3 | K111571 | Viper Systems | Johnson & Johnson | 2011 | — |
| −2 | K121020 | Viper System | Depuy Spine, Inc. | 2012 | — |
| −1 | K153442 | CD HORIZON Spinal System, Medtronic Navigated Manual Reusable Instruments for… | Medtronic Sofamor Danek USA, Inc. | 2016 | — |
| 0 (this device) | K162921 | Navigated Instrument System | Orthofix, Inc. | 2017 | — |
| +1 | K172115 | Navigated Instrument System | Orthofix, Inc. | 2018 | — |
| +2 | K191722 | Vital Navigation System | Zimmer Biomet Spine, Inc. | 2019 | — |
| +3 | K233443 | Vital™ Navigation System | Zimvie Spine (Zimmer Biomet Spine, Inc.) | 2023 | — |
| +2 | K213491 | Universal Pilot Guidance Instrument System | Ctl Medical Corporation | 2022 | — |
| +3 | K213720 | Vital Navigation System | Zimvie (Zimmer Biomet Spine, Inc.) | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 2 | 0 |
| 1985 | 1 | 0 |
| 1986 | 2 | 0 |
| 1987 | 1 | 0 |
| 1988 | 2 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1992 | 2 | 0 |
| 1993 | 1 | 0 |
| 1994 | 5 | 0 |
| 1995 | 10 | 0 |
| 1996 | 7 | 0 |
| 1997 | 6 | 0 |
| 1998 | 12 | 0 |
| 1999 | 13 | 0 |
| 2000 | 14 | 0 |
| 2001 | 23 | 0 |
| 2002 | 14 | 0 |
| 2003 | 16 | 0 |
| 2004 | 29 | 0 |
| 2005 | 23 | 0 |
| 2006 | 14 | 0 |
| 2007 | 9 | 1 |
| 2008 | 11 | 0 |
| 2009 | 5 | 0 |
| 2010 | 5 | 0 |
| 2011 | 6 | 0 |
| 2013 | 3 | 0 |
| 2014 | 4 | 0 |
| 2015 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K153442 | CD HORIZON Spinal System, Medtronic Navigated Manual Reusable Instruments for Use with…Summary page 4…uct 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 Calibrate… | 2007 |
| † | K140927 | Universal Navigation Instruments | 2014 |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K172115 | Navigated Instrument System | 2018 | 4 |
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 32 years and passes through 8 companies; a new generation was cleared every 1.3 years on median.
- 30 of the 259 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K172115 (Orthofix, Inc., 2018) has gone furthest, with 4 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. 2017, 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 (110 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K162921 · printed Nov 6, 2026
Cite this page
510(k) Report. “K162921: 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/K162921
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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